{"id":211318,"date":"2007-08-06T00:00:00","date_gmt":"2007-08-05T18:30:00","guid":{"rendered":"https:\/\/www.legalindia.com\/judgments\/novartis-ag-vs-union-of-india-on-6-august-2007"},"modified":"2014-12-20T09:09:25","modified_gmt":"2014-12-20T03:39:25","slug":"novartis-ag-vs-union-of-india-on-6-august-2007","status":"publish","type":"post","link":"https:\/\/www.legalindia.com\/judgments\/novartis-ag-vs-union-of-india-on-6-august-2007","title":{"rendered":"Novartis Ag vs Union Of India on 6 August, 2007"},"content":{"rendered":"
Madras High Court<\/div>\n
Novartis Ag vs Union Of India on 6 August, 2007<\/div>\n
       \n\n  \n\n  \n\n \n \n           IN THE HIGH COURT OF JUDICATURE AT MADRAS\n                              \n                     DATED:   06.08.2007\n                              \n                            CORAM\n                              \n          THE HON'BLE MR.JUSTICE R.BALASUBRAMANIAN\n                             and\n           THE HON'BLE MRS.JUSTICE PRABHA SRIDEVAN\n                              \n             W.P. Nos.24759 and 24760 of 2006\n\n\n                              \nNovartis AG\nSchwarzwaldalle 215\n4058 Basel and Lichstrasse 35\n4002 Basel, \nSwitzerland \nrepresented by \nit's Power of Attorney\nRanjna Mehta Dutt                       \t\t\t..Petitioner in\n\t\t\t\t\t\t\t\t\t  W.P.24759\/06\n\nNovartis India Ltd.\nSandoz House\nDr.Annie Besant Road\nWorli, \nMumbai 400 018\nrepresented by \nit's Power of Attorney \nSaibal Mukherjee                    \t\t\t..Petitioner in\n\t\t\t\t\t\t\t\t\t  W.P.24760\/06\n\n\n\t   Vs.\n      \n                        \n1. Union of India\n   through the Secretary\n   Department of Industry\n   Ministry of Industry and Commerce\n   Udyog Bhavan\n   New Delhi.\n\n2. The Controller General of \n           Patents & Designs\n   through the Patent Office\n   Intellectual Property Rights \n                       Building\n   G.S.T.Road, Guindy\n   Chennai 600 032.\n\n3. Natco Pharma Ltd.\n   \"Natco House\"\n   Road No.2\n   Banjara Hills\n   Hyderabad 500 033.\n\n4. M\/s.Cipla Ltd., India\n   289, Bellasis Road\n   Opp.Hotel Sahil\n   Mumbai Central (E)\n   Mumbai 400 008.\n\n5. M\/s.Hetro Drugs Ltd., India\n   H No.8-3-168\/7\/1\n   Erragada\n   Hyderabad 500 018.\n\n6. M\/s.Cancer Patient Aid \n       Association, India\n   No.5, Malhotra House, \n   Opp.G.P.O.\n   Mumbai 400 001.\n\n7. M\/s.Ranbaxy Laboratories \n                Ltd., India\n   12th Floor, \n   Deviks Tower\n   No.6, Nehru Place, \n   New Delhi 110 019.\n\n8. Indian Pharmaceutical Alliance\n   represented by it's Secretary General\n   C\/o.Vision Consulting Group\n   No.201, Darvesh Chambers\n   Khar, \n   Mumbai 400 052.\n\n9. M\/s.Sun Pharmaceutical \n       Industries Limited\n   Acme Plaza, Opp.Sangam Cinema\n   Andheri - Kurla Road\n   Andheri (E), \n   Mumbai 400 059.\n\n   ( R8   and   R9  impleaded \n     as   per   order   dated\n     29.01.2007   passed   in \n     M.P. Nos.3 and 5 of 2006 \n     in W.P. No.24759 of 2006 )                       ..Respondents in<\/pre>\n
\t\t\t\t\t\t\t     \t\t  W.P.24759\/06<\/p>\n
1. Union of India
\n   through the Secretary
\n   Department of Industry
\n   Ministry of Industry and Commerce
\n   Udyog Bhavan
\n   New Delhi.\n<\/p>\n
2. The Controller General of
\n           Patents & Designs
\n   through the Patent Office
\n   Intellectual Property Rights
\n                       Building
\n   G.S.T.Road, Guindy,
\n   Chennai 600 032.\n<\/p>\n
3. Natco Pharma Ltd.\n<\/p>\n
   “Natco House”\n<\/p>\n
   Road No.2, Banjara Hills
\n   Hyderabad 500 033.\n<\/p>\n
4. M\/s.Cipla Ltd., India
\n   289, Bellasis Road
\n   Opp.Hotel Sahil,
\n   Mumbai Central (E)
\n   Mumbai 400 008.\n<\/p>\n
5. M\/s.Hetro Drugs Ltd., India
\n   H No.8-3-168\/7\/1
\n   Erragada
\n   Hyderabad 500 018.\n<\/p>\n
6. M\/s.Cancer Patient Aid
\n         Association, India
\n   No.5, Malhotra House,
\n   Opp.G.P.O.\n<\/p>\n
   Mumbai 400 001.\n<\/p>\n
7. M\/s.Ranbaxy Laboratories Ltd., India
\n   12th Floor, Deviks Tower
\n   No.6,  Nehru Place,
\n   New Delhi 110 019  \t\t\t  \t\t      ..Respondents in
\n\t                                                  W.P.24760\/06<\/p>\n
       Prayer  in  W.P.No.24759\/2006:  Writ  petition  under
\nArticle 226 of the Constitution of India praying to issue  a
\nwrit  of  declaration  declaring that section  3(d)  of  the
\nPatents  Act, 1970 as substituted by the Patents (Amendment)
\nAct,  2005  (Act  15\/2005) is non-complaint with  the  TRIPS
\nAgreement   and  \/  or  is  unconstitutional  being   vague,
\narbitrary and violative of Article 14 of the Constitution of
\nIndia and consequentially to direct the second respondent to
\nallow the Patent Application bearing No.1602\/MAS\/98 filed by
\nthe petitioner.\n<\/p>\n
       Prayer  in  W.P.No.24760\/2006:  Writ  petition  under
\nArticle 226 of the Constitution of India praying to issue  a
\nwrit  of  declaration  declaring that section  3(d)  of  the
\nPatents  Act, 1970 as substituted by the Patents (Amendment)
\nAct,  2005  (Act  15\/2005) is non-complaint with  the  TRIPS
\nAgreement   and  \/  or  is  unconstitutional  being   vague,
\narbitrary and violative of Article 14 of the Constitution of
\nIndia.\n<\/p>\n<\/p>\n
– – – – – – – – – – – – – – – – – – – – – – – – – – – – – – –\n<\/p>\n
For Petitioner in both W.Ps : Mr.Habuibulla Badsha, SC,
\n                            : Mr.Soli Sorabjee, SC and
\n                            : Mr.Shanthi Bhushan, SC for
\n                            : Mr.C.Daniel\n<\/p>\n
– – – – – – – – – – – – – – – – – – – – – – – – – – – – – – –\n<\/p>\n
For R1 and R2               : Mr.V.T.Gopalan, SC for\n                            : Mr.P.Wilson, Asst.Sol.General\n- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -\nFor Respondent  No.3        : Mr.P.S.Raman, AAG  for\n                            : Mr.A.A.Mohan\n- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -\nFor R4, R8 and R9           : Mr.P.Aravind Datar, SC\n                            : Mr.R.Thiagarajan, SC &\n                            : Mr.K.M.Vijayan, SC for\n                            : Mr.A.Ramesh Kumar\n- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -\nFor Respondent No.5  & 7    : Mr.Lakshmi Kumaran\n- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -\nFor Respondent No.6         : Mr.Anand Grover  for\n                            : Ms.R.Vaigai\n- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -\n\n\n                        COMMON ORDER\n                              \n            (Order of the court was delivered by\n                 Justice R.Balasubramanian)\n\n\n<\/pre>\n
      The writ petitioner in both the writ petitions is  one<\/p>\n
and  the  same.  In the first writ petition,  Novartis  –  a<\/p>\n
foreign company represented by it’s Indian Power of Attorney<\/p>\n
holder,  is  the  writ  petitioner.   In  the  second   writ<\/p>\n
petition, Novartis India represented by it’s power agent  is<\/p>\n
the  writ  petitioner.   The respondents in  both  the  writ<\/p>\n
petitions are one and the same.  The prayer in both the writ<\/p>\n
petitions is one and the same namely, for a declaration that<\/p>\n
section  3(d) of the Patents Act, 1970, amended by   Patents<\/p>\n
(Amendment)  Act 15\/2005, is unconstitutional.  However,  in<\/p>\n
the  first  writ petition there was an additional prayer  in<\/p>\n
addition to the relief asked for.  The additional prayer was<\/p>\n
to  direct  the  second  respondent in  that  writ  petition<\/p>\n
namely,  the  Controller General of Patents and Designs,  to<\/p>\n
allow  the  patent application bearing No.1602\/NAS\/98  filed<\/p>\n
by the petitioner seeking patent.  However at a later stage,<\/p>\n
during  the  pendency  of the writ petitions,  M.P.No.1\/2007<\/p>\n
came  to  be filed in that  writ petition seeking to  delete<\/p>\n
the prayer for a direction to the Patent Controller to allow<\/p>\n
the  application and it was accordingly ordered.   Therefore<\/p>\n
as  on  date  in the two  writ petitions, the Constitutional<\/p>\n
validity of section 3(d) alone is in challenge, both on  the<\/p>\n
ground  that  it  violates  not  only  Article  14  of   the<\/p>\n
Constitution of India but also on the ground that it is  not<\/p>\n
in  compliance  to “TRIPS”.  Both the writ  petitions  along<\/p>\n
with the connected miscellaneous petitions were admitted  by<\/p>\n
a  learned  Judge  of this court and before  the  very  same<\/p>\n
learned  Judge,  at  a  later stage, all  the  miscellaneous<\/p>\n
petitions  came  up  for disposal.   We  are  informed  that<\/p>\n
elaborate  arguments  were advanced by  the  learned  senior<\/p>\n
counsels  on  either side at that stage  and  on  26.09.2006<\/p>\n
learned  Judge,  who  heard these writ  petitions  with  the<\/p>\n
connected  miscellaneous petitions, came to  the  conclusion<\/p>\n
that  the writ petitions require the attention of a Division<\/p>\n
Bench  of  this  court, as according to the  learned  single<\/p>\n
Judge,  the writ petitions involve substantial questions  of<\/p>\n
law.   Therefore   learned  single  Judge  passed  an  order<\/p>\n
directing  the Registry to place the entire material  papers<\/p>\n
before  the Hon’ble Chief Justice for disposal by a Division<\/p>\n
Bench.   Subsequently,  by  orders  of  the  Hon’ble   Chief<\/p>\n
Justice,  these writ petitions are listed before us.   Heard<\/p>\n
Mr.Soli Sorabji, Mr.Shanthi Bhushan and Mr.Habibulla Badsha,<\/p>\n
learned  senior  counsels appearing   for  the  petitioners;<\/p>\n
Mr.V.T.Gopalan, learned Additional Solicitor General for the<\/p>\n
Government  of  India  and  the Controller  of  Patents  and<\/p>\n
Designs;  Mr.Anand  Grover, learned   counsel;  Mr.P.S.Raman<\/p>\n
learned  senior  counsel; Mr.Aravind P Datar learned  senior<\/p>\n
counsel;   Mr.K.M.Vijayan   learned   senior   counsel   and<\/p>\n
Mr.Lakshmi  Kumaran,  learned  counsel  appearing  for   the<\/p>\n
various respondents.\n<\/p>\n<\/p>\n
      2.  In  this judgment, for convenience sake,  we  will<\/p>\n
hereinafter  refer the Patents Act as the  “Principal  Act”;<\/p>\n
Ordinance 7\/2004 introducing an amendment to section 3(d) of<\/p>\n
the  Act  as the “Ordinance”;  Amending Act of 2005 amending<\/p>\n
section 3(d) of the Act as the “Amending Act”; section  3(d)<\/p>\n
as  the  amended section and the Act after the amendment  as<\/p>\n
the “Amended Act”.  The challenge to the amended section  is<\/p>\n
mainly on two grounds namely,<\/p>\n
           (a) it is not compatible to the agreement on<\/p>\n
     Trade  Related  aspects  of Intellectual  Property<\/p>\n
     Rights,  hereinafter referred to  as  “TRIPS”  for<\/p>\n
     convenience sake; and<\/p>\n
           (b)  it  is arbitrary, illogical, vague  and<\/p>\n
     offends Article 14 of the Constitution of India.<\/p>\n
For  a  better  understanding of the attack to  the  amended<\/p>\n
section,  we feel that it is desirable to extract  hereunder<\/p>\n
section  3(d) of the Principal  Act; the nature of amendment<\/p>\n
to that section sought to be brought in by the Ordinance and<\/p>\n
the amended section itself:\n<\/p>\n<\/p>\n
          “Unamended section 3(d):  The mere discovery<\/p>\n
     of  any  new  property or  new  use  of  a  known<\/p>\n
     substance or of the mere use of a known  process,<\/p>\n
     machine  or  apparatus unless such known  process<\/p>\n
     results  in a new product or employs atleast  one<\/p>\n
     new reactant.<\/p>\n
<\/blockquote>\n
           Amendment  to section 3(d) under  Ordinance<\/p>\n
     7\/2004: The mere discovery of any new property or<\/p>\n
     mere  new use of a known substance or of the mere<\/p>\n
     use  of  a  known  process; machine  or  aparatus<\/p>\n
     unless  such  known  process  results  in  a  new<\/p>\n
     product or employs atleast one new reactant.<\/p><\/blockquote>\n
\n<\/blockquote>\n
           Section  3(d)  as amended  by  the  Patents<\/p>\n
     (Amendment)   Act,   2005   with   effect    from<\/p>\n
     01.01.2005:  The mere discovery of a new form  of<\/p>\n
     a  known substance which does not result  in  the<\/p>\n
     enhancement  of  the  known  efficacy   of   that<\/p>\n
     substance  or  the  mere  discovery  of  any  new<\/p>\n
     property or new use for a known substance  or  of<\/p>\n
     the  mere  use  of  a known process,  machine  or<\/p>\n
     apparatus unless such known process results in  a<\/p>\n
     new product or employs atleast one new reactant.<\/p>\n<\/blockquote>\n
            Explanation:  For  the  purposes  of  this<\/p>\n
     clause,   salts,   esters,  ethers,   polymorphs,<\/p>\n
     metabolites,  pureform,  particle  size  isomers,<\/p>\n
     mixtures of isomers, complexes, combinations  and<\/p>\n
     other  derivatives  of known substance  shall  be<\/p>\n
     considered to be the same substance, unless  they<\/p>\n
     differ significantly in properties with regard to<\/p>\n
     efficacy.”<\/p><\/blockquote>\n
       3.   Learned  senior  counsels  appearing   for   the<\/p>\n
petitioners took us through the various covenants\/clauses in<\/p>\n
“TRIPS”  to  argue that the amended section,  as  it  stands<\/p>\n
today,   runs   contra   to  the  various   articles   found<\/p>\n
incorporated in “TRIPS”.  The main thrust is with  reference<\/p>\n
to article 27 of “TRIPS”.  It is contended that article 1(1)<\/p>\n
of  the “TRIPS” mandates every member country to give effect<\/p>\n
to  the  provisions of the “TRIPS” and India being a  member<\/p>\n
country,  in implementing the various provisions of  “TRIPS”<\/p>\n
brought  in the amended section violating their  obligations<\/p>\n
under   “TRIPS”.   It is argued by  learned senior  counsels<\/p>\n
that  the  proposed amendment brought in under the Ordinance<\/p>\n
is  compatible to “TRIPS”.  However, without  any  rhyme  or<\/p>\n
reason,  the  proposed amendment sought to be introduced  by<\/p>\n
the  Ordinance had been completely given up and instead, the<\/p>\n
offending  amended  section  was  brought.   The   sum   and<\/p>\n
substance  of  the  argument  advanced  by   learned  senior<\/p>\n
counsels for the petitioner company is, by bringing  in  the<\/p>\n
amended  section and  the Explanation attached  to  it,  the<\/p>\n
Union  of India had infact not carried out it’s  obligations<\/p>\n
arising  out of “TRIPS” and instead, by the amended  section<\/p>\n
making  that   the  discovery of  a  new  form  of  a  known<\/p>\n
substance, which does not result in the enhancement  of  the<\/p>\n
known  efficacy  of  that substance as not  patentable,  the<\/p>\n
right  to  have  an  invention  patented   guaranteed  under<\/p>\n
section  27  of the “TRIPS” is taken away.   As far  as  the<\/p>\n
attack  to  the  section on the ground of arbitrariness  and<\/p>\n
vagueness  thereby offending Article 14 of the  Constitution<\/p>\n
of  India,  it is argued by Mr.Soli Sorabji, learned  senior<\/p>\n
counsel,  that  the amended section as it  stands  today  is<\/p>\n
unworkable.  Section 3 of the Act  enumerates what  are  not<\/p>\n
inventions.   Under Article 27 of “TRIPS”,  all  inventions,<\/p>\n
subject  to  paragraphs  2  and  3  of  that  Article,   are<\/p>\n
patentable.   Reading Article 27 as a whole,  it  is  argued<\/p>\n
that  the  drug invented in the case on hand is  patentable.<\/p>\n
Under the amended section, the  patent applicant is required<\/p>\n
to  show  that  the invention has enhanced efficacy  of  the<\/p>\n
known  substance.  Though the efficacy of a known  substance<\/p>\n
may be well known, yet, unless there are some guidelines  in<\/p>\n
the  amended  section  itself to understand  the  expression<\/p>\n
“enhancement of the known efficacy” namely,  what  would  be<\/p>\n
treated  as  “enhanced efficacy”, an uncontrolled discretion<\/p>\n
is   given  to  the  Patent  Controller  to  apply  his  own<\/p>\n
standards,  which  may not be uniform, in  deciding  whether<\/p>\n
there   is  enhancement  of  the  known  efficacy  of   that<\/p>\n
substance.   Such  wide discretion vested with  a  Statutory<\/p>\n
Authority without any guidelines to follow, would result  in<\/p>\n
arbitrary  exercise of power.  In other  words,  the  Patent<\/p>\n
Controller may be in a position to decide any case, based on<\/p>\n
his  whims  and fancies namely, whether there is enhancement<\/p>\n
in  the  known efficacy or not.  On this short  ground,  the<\/p>\n
section  must be held to be violative of Article 14  of  the<\/p>\n
Constitution   of  India.   Likewise,  in  the   Explanation<\/p>\n
attached  to  the amended section also, there is  vagueness.<\/p>\n
The  Explanation declares that all derivatives  of  a  known<\/p>\n
substance  shall  be  considered to be  the  same  substance<\/p>\n
unless  they “differ significantly in properties with regard<\/p>\n
to efficacy”.  Derivatives need not be the same substance in<\/p>\n
all cases.  Unless the Explanation contains guidelines as to<\/p>\n
when  a  derivative can be held to differ  significantly  in<\/p>\n
properties  with  regard to efficacy, the Patent  Controller<\/p>\n
will  have an unguided power to decide the issue, which once<\/p>\n
again  would  result in arbitrariness.    It  is  argued  by<\/p>\n
learned  senior  counsels that though efficacy  of  a  known<\/p>\n
substance could be clinically found, any discovery of a  new<\/p>\n
form  of  the said substance or it’s derivatives, though  by<\/p>\n
themselves are inventions as defined in the Act,  are denied<\/p>\n
patent  based  on the amended section containing   specified<\/p>\n
offending clauses namely, it should show enhancement of  the<\/p>\n
known  efficacy  and  that  the  derivatives  should  differ<\/p>\n
significantly in properties with regard to efficacy.<\/p>\n
      4.  Learned senior counsels on the opposite side would<\/p>\n
vehemently   contend that the amended section is  definitely<\/p>\n
compatible to “TRIPS”.  Even assuming that it is not so, the<\/p>\n
remedy   to  have  the “TRIPS” agreement  complied  with  in<\/p>\n
letter and spirit  available  to  the member countries  does<\/p>\n
not lie before the Indian courts but only before the Dispute<\/p>\n
Settlement  Board, hereinafter referred to as “DSB”  created<\/p>\n
under  “TRIPS” itself.  According to them, even assuming  if<\/p>\n
“TRIPS”  confers rights on any citizen\/legal  entity   of  a<\/p>\n
member country, then such person should also approach  “DSB”<\/p>\n
only.    “DSB” had been constituted to address all  disputes<\/p>\n
that   may   arise  between   member  countries  and   their<\/p>\n
citizens\/legal  entity in implementing or  not  implementing<\/p>\n
“TRIPS” and that is the exclusive authority to go into those<\/p>\n
controversies.  Therefore the challenge to the  validity  of<\/p>\n
the  amended section on the ground that it is not compatible<\/p>\n
to  “TRIPS”,  cannot  be  legally  sustained  before  Indian<\/p>\n
courts.  It is contended by  learned senior counsels and the<\/p>\n
other  counsels  on  the opposite side that  in  discharging<\/p>\n
their  obligations under “TRIPS”, Government  of  India  had<\/p>\n
brought  in  several amendments to the Parent  Act  and  the<\/p>\n
amended section is one such provision.  Every member country<\/p>\n
is  given  enough  elbow room to bring in  a  local  law  in<\/p>\n
discharging their obligation under “TRIPS” having regard  to<\/p>\n
the  various  needs of their citizens.  India is  a  welfare<\/p>\n
country and it’s first obligation under the Constitution  is<\/p>\n
to  provide good health care to it’s citizens.  When that is<\/p>\n
it’s  priority commitment under the Constitution  of  India,<\/p>\n
the Union of India has every right to bring in any local law<\/p>\n
in  discharging their obligations under “TRIPS” to  suit  to<\/p>\n
the  needs  and welfare of it’s citizens.  On the attack  to<\/p>\n
the   amended  section  that  it  is  vague,  arbitrary  and<\/p>\n
therefore unconstitutional, it is argued by  learned  senior<\/p>\n
counsels  and the other counsels in the opposite camp   that<\/p>\n
the  amended section as it stands is workable.   The  Patent<\/p>\n
Controllers  are all experts having undergone   considerable<\/p>\n
training  abroad  in this field.  The petitioner  is  not  a<\/p>\n
novice  to the field but on the other hand it is one of  the<\/p>\n
pharmaceutical giants in the world.  The efficacy of a known<\/p>\n
substance  is  well-known  and it  is  definitely  known  to<\/p>\n
everyone in the pharmaceutical field.   When the efficacy of<\/p>\n
that   substance  would  stand  enhanced  could    also   be<\/p>\n
clinically  found by those in the field.  The petitioner  is<\/p>\n
not  a common man but it is having the expertise behind  it.<\/p>\n
When   does   the   properties  in   a   derivative   differ<\/p>\n
significantly  with  regard  to  efficacy   could   also  be<\/p>\n
scientifically  established by  the  people  in  the  field.<\/p>\n
Therefore   when   everyone  in  the  pharmaceutical   field<\/p>\n
understands  what  is  meant by  enhancement  in  the  known<\/p>\n
efficacy  of  a  substance or when it can be said  that  the<\/p>\n
derivatives  differ significantly in properties with  regard<\/p>\n
to  efficacy and the Patent Controller also understands  it,<\/p>\n
the  amended section cannot be struck down on the ground  of<\/p>\n
arbitrariness  and  vagueness.   If the  Patent  Controller,<\/p>\n
exercising  his Statutory power, wrongly rejects the  patent<\/p>\n
application  on  the ground that the drug is excluded  under<\/p>\n
the  amended section, then such a decision could  always  be<\/p>\n
corrected by the Appellate Authority and then by the  higher<\/p>\n
forums.     In other words, a wrong decision arrived  at  by<\/p>\n
the  Patent  Controller based on wrong  application  of  the<\/p>\n
amended  section cannot be a ground to strike down the  said<\/p>\n
amended section which is otherwise in order.    Case law was<\/p>\n
cited  at  the  Bar  by  learned  counsel  Mr.Lakshmikumaran<\/p>\n
appearing for the opposite party that Indian courts have  no<\/p>\n
jurisdiction to test the validity of a municipal law on  the<\/p>\n
ground  that it is in violation of an International  Treaty,<\/p>\n
assuming  it  is  so.   It  is argued by  Mr.Lakshmikumaran,<\/p>\n
learned counsel, by citing an English Court decision, that a<\/p>\n
member has a right to make a Law of it’s own by breaking  an<\/p>\n
International Treaty, if making such a Law is warranted,  to<\/p>\n
meet  the  welfare  of it’s citizens.    Responding  to  the<\/p>\n
arguments  advanced by the learned senior counsels  and  the<\/p>\n
other  counsels  for the opposite party that  Indian  courts<\/p>\n
cannot  test  the  validity of the amended  section  on  the<\/p>\n
ground  that it is in violation of an  International Treaty,<\/p>\n
learned senior counsels appearing for the petitioner in each<\/p>\n
case  contended, by showing a precedent, that Indian  courts<\/p>\n
do  have  the power.   It is also argued by them  that  even<\/p>\n
assuming  for a moment without conceding that an Indian  Law<\/p>\n
cannot  be struck down on the ground that it is in violation<\/p>\n
of  an  International Treaty, yet, there is no  bar,  either<\/p>\n
express  or  implied, disabling  Indian  courts  to  give  a<\/p>\n
declaration that the amended section is in violation of  the<\/p>\n
International   Treaty.     After  broadly   stating   their<\/p>\n
respective contentions, R3, R4, R5 & R7, R6, R8 and R9 filed<\/p>\n
their respective written submissions.\n<\/p>\n<\/p>\n
      5.  On  the  submissions made by  the  learned  senior<\/p>\n
counsels  on  either side, we are of the considered  opinion<\/p>\n
that  the following issues arise for consideration in  these<\/p>\n
two writ petitions:\n<\/p>\n<\/p>\n
           (a) Assuming that the amended section is  in<\/p>\n
     clear  breach of Article 27 of “TRIPS” and thereby<\/p>\n
     suffers    the    wise   of   irrationality    and<\/p>\n
     arbitrariness  violating  Article   14   of    the<\/p>\n
     Constitution of India, could the courts  in  India<\/p>\n
     have  jurisdiction  to test the  validity  of  the<\/p>\n
     amended  section in the back drop of such  alleged<\/p>\n
     violation of “TRIPS”?      OR<\/p>\n
           Even if the amended section cannot be struck<\/p>\n
     down  by this court for the reasons stated  above,<\/p>\n
     cannot this court grant a declaratory relief  that<\/p>\n
     the  amended  section  is  not  in  compliance  of<\/p>\n
     Article 27 of “TRIPS”?.\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
           (b)  If it is held that courts in India have<\/p>\n
     jurisdiction  to  go into the  above  referred  to<\/p>\n
     issue, then, is the amended section compatible  or<\/p>\n
     non-compatible to Article 27 of “TRIPS”?<\/p>\n<\/blockquote>\n
           (c  ) Dehors issues (a) and (b) referred  to<\/p>\n
     above,   could the amended section be held  to  be<\/p>\n
     violative  of  Article 14 of the  Constitution  of<\/p>\n
     India  on  the  ground of vagueness, arbitrariness<\/p>\n
     and   conferring  un-canalised   powers   on   the<\/p>\n
     Statutory Authority?\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
     6. Let us take the first issue.<\/p><\/blockquote>\n
       (a)  Assuming that the amended section  is  in  clear<\/p>\n
breach of Article 27 of “TRIPS” and thereby suffers the vice<\/p>\n
of  irrationality and arbitrariness violating Article 14  of<\/p>\n
the  Constitution of India, could the courts in  India  have<\/p>\n
jurisdiction to test the validity of the amended section  in<\/p>\n
the  back  drop of such alleged violation of “TRIPS”    (OR)<\/p>\n
Even  if  the amended section cannot be struck down by  this<\/p>\n
court  for the reasons stated above, cannot this court grant<\/p>\n
a  declaratory  relief that the amended section  is  not  in<\/p>\n
compliance  of  Article 27 of “TRIPS”?:  In support  of  the<\/p>\n
arguments that Indian courts have jurisdiction to decide the<\/p>\n
issue under consideration, learned senior counsels appearing<\/p>\n
for the petitioners relied upon the decision of the House of<\/p>\n
Lords in the case reported in Equal Opportunities Commission<\/p>\n
&  Another Vs. Secretary of State for Employment [ (1994)  1<\/p>\n
AII  ER Pg.910].  Employment Protection (Consolidation) Act,<\/p>\n
1978 was under consideration in that judgment in the context<\/p>\n
of  discrimination against women alleged.   Under that  Act,<\/p>\n
full-time  workers, who worked for 16 or more hours  a  week<\/p>\n
had  to be in continuous employment for two years to qualify<\/p>\n
for  Statutory  rights  under  the  Act  whereas,  part-time<\/p>\n
workers, who worked between 8 and 16 hours in a week had  to<\/p>\n
be  in  continuous employment for five years to qualify  for<\/p>\n
the  Statutory  rights under that Act.  That judgment  noted<\/p>\n
that  a  great majority of full-time employers in the United<\/p>\n
Kingdom  were  men  while the great  majority  of  part-time<\/p>\n
workers were women.  Equal Opportunities Commission took the<\/p>\n
view   that   such   discrimination  conflicted   with   the<\/p>\n
obligations  of  the United Kingdom under  EEC  Law  namely,<\/p>\n
Article 119 of EEC Treaty and Council Directives 75\/117 (the<\/p>\n
Equal   Pay  Directive)  and  76\/207  (the  Equal  Treatment<\/p>\n
Directive).    The Secretary of the State declined to accept<\/p>\n
that  the  United Kingdom was in breach of it’s  obligations<\/p>\n
under   Community   Law  while  providing  less   favourable<\/p>\n
treatment  in  the  conditions of  employment  of  full-time<\/p>\n
workers   and  part-time  workers.   Therefore,  the   Equal<\/p>\n
Opportunities Commission applied for judicial review of  the<\/p>\n
Secretary of State’s decision and sought a declaration  that<\/p>\n
the Secretary of State and United Kingdom were in breach  of<\/p>\n
Community Law obligations and an order of mandamus requiring<\/p>\n
the  Secretary of State to introduce Legislation to  provide<\/p>\n
the  right for men and women to receive equal pay for  equal<\/p>\n
work.   Further reliefs were also asked for.  The  Secretary<\/p>\n
of  State  raised  two objections namely, the  claim  of  an<\/p>\n
individual applicant is a private law claim, which ought not<\/p>\n
to  have been brought against the Secretary of State by  way<\/p>\n
of  judicial  review and that the Commission  had  no  locus<\/p>\n
standi  to  bring  the proceedings as it  ‘s  case  did  not<\/p>\n
involve  any  decision on justiciable issue  susceptible  of<\/p>\n
judicial  review.     It  was  further  contended   by   the<\/p>\n
Secretary  of  State that the court had no  jurisdiction  to<\/p>\n
declare that United Kingdom or the Secretary of State was in<\/p>\n
breach  of any obligations under the Community Law and  that<\/p>\n
the  Divisional  Court  was  not the  appropriate  forum  to<\/p>\n
determine the substantive issue raised by the applicant. The<\/p>\n
Divisional  Court, among other things, held that  the  court<\/p>\n
only  had  jurisdiction  to declare rights  and  obligations<\/p>\n
enforceable under the existing state of the Law and  had  no<\/p>\n
jurisdiction  to order  mandamus requiring the Secretary  of<\/p>\n
State  to introduce Legislation to amend the 1978 Act or  to<\/p>\n
declare  that he was under a duty to do so.   The Commission<\/p>\n
as well as the individual applicant appealed to the Court of<\/p>\n
Appeal, which dismissed the individual applicant’s appeal on<\/p>\n
the  ground that her application was essentially  a  private<\/p>\n
law  claim,  which  should  have been  brought  against  her<\/p>\n
employer  in  an  Industrial  Tribunal  and  dismissed   the<\/p>\n
Commission’s  appeal  on the ground that  the  Secretary  of<\/p>\n
State had not made any “decision”.  The Court of Appeal also<\/p>\n
held  that  there  was  no justiciable  issue  suitable  for<\/p>\n
consideration by way of judicial review.  The Commission and<\/p>\n
the individual appealed to the House of Lords.  The House of<\/p>\n
Lords raised various questions to be addressed by it in that<\/p>\n
appeal  and in our respectful opinion, the decision  of  the<\/p>\n
House  of Lords on one of the questions raised by it  to  be<\/p>\n
addressed, would be relevant for the purpose of the case  on<\/p>\n
hand.  We extract that question hereunder:<\/p>\n
           “The question is, whether judicial review is<\/p>\n
     available   for   the  purpose   of   securing   a<\/p>\n
     declaration  that certain United  Kingdom  primary<\/p>\n
     Legislation is incompatible with Community Law?”<\/p>\n<\/blockquote>\n
In  deciding  that  issue, the House of  Lords  referred  to<\/p>\n
Article  119  of  the  EEC Treaty, which  provides  for  the<\/p>\n
following:\n<\/p>\n<\/p>\n
          “Equal  pay for equal work to men and  women;<\/p>\n
    Council  Directive  (EEC)  75\/117  (the  equal  pay<\/p>\n
    directive);  and Article 2(1) of Council  Directive<\/p>\n
    (EEC) 76\/207 (the equal treatment directive)”.<\/p>\n<\/blockquote>\n
Section  2  of the European Communities Act, 1972  was  also<\/p>\n
brought  to the attention of the House of Lords.   It  being<\/p>\n
the  telling provision in deciding the issue before  us,  we<\/p>\n
extract it hereunder:\n<\/p>\n<\/p>\n
          “(1)  All  such rights, powers, liabilities,<\/p>\n
    obligations  and restrictions from  time  to  time<\/p>\n
    created  or arising by or under the Treaties   and<\/p>\n
    all  such  remedies and procedures  from  time  to<\/p>\n
    time provided for by or under the Treaties, as  in<\/p>\n
    accordance  with the Treaties are without  further<\/p>\n
    enactment to be given legal effect or used in  the<\/p>\n
    United  Kingdom shall be recognised and  available<\/p>\n
    in  law,  and  be enforced, allowed  and  followed<\/p>\n
    accordingly;   and  the  expression   “enforceable<\/p>\n
    Community right” and similar expressions shall  be<\/p>\n
    read  as  referring  to one  to  which  this  sub-<\/p>\n
    section applies.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
The  House  of Lords dismissed the appeal of the  individual<\/p>\n
claimant  agreeing with the decision of the  earlier  courts<\/p>\n
that  it  was  only her private law claim.  But however,  in<\/p>\n
deciding  the appeal of Equal Opportunities Commission,  the<\/p>\n
House of Lords gave a declaration that Employment Protection<\/p>\n
(Consolidation) Act, 1978 is incompatible with  Article  119<\/p>\n
of  the  EEC  Treaty and Council Directive (EEC) 75\/117  and<\/p>\n
Council  Directive (EEC) 76\/207.  Therefore  learned  senior<\/p>\n
counsels  Mr.Soli  Sorabji and Mr.Shanthi  Bhushan,  relying<\/p>\n
upon  this judgment, argued, as they have done earlier, that<\/p>\n
there  is  no legal bar for this court to give a simplicitor<\/p>\n
declaratory  relief that the amended section is incompatible<\/p>\n
with  Article  27  of  “TRIPS”.  It is also  argued  by  the<\/p>\n
learned  senior  counsels that this court can  go  into  the<\/p>\n
validity  of the amended section, as being not in compliance<\/p>\n
with  Article  27  of  “TRIPS”, under  Article  226  of  the<\/p>\n
Constitution  of  India, since there is neither  express  nr<\/p>\n
implied bar in the Article itself.\n<\/p>\n<\/p>\n
     7. Learned counsels, in particular, Mr.Anand Grover and<\/p>\n
Mr.Lakshmikumaran, argued with tremendous ease   –  as  they<\/p>\n
are shown to possess – stating that the judgment referred to<\/p>\n
above  and relied upon by the learned senior counsels  could<\/p>\n
not  be applied to the case on hand on facts.  By taking  us<\/p>\n
through  the very same judgment, it is argued by  them  that<\/p>\n
under  section 2(1) of the European Communities  Act,  1972,<\/p>\n
Article   119  of  the  EEC  Treaty  with  the  two  Council<\/p>\n
Directives referred to earlier have been domesticated  as  a<\/p>\n
domestic Law in England.  When the relevant provision of the<\/p>\n
EEC Treaty and the Councils Directives stand domesticated by<\/p>\n
an  Act  of  the  State, then it becomes Law of  that  State<\/p>\n
enforceable  in  letter and spirit by the citizens  of  that<\/p>\n
State.  It is their argument that “TRIPS” do not become  Law<\/p>\n
in  India  on  it’s  own  force  without  any  domestic  Law<\/p>\n
legislated  by  the Indian Government.  Only in  discharging<\/p>\n
their   obligations   under  “TRIPS”,  several   amendments,<\/p>\n
including the amended section, were brought into the Statute<\/p>\n
book  namely,  Patents  Act, by the Government.    Therefore<\/p>\n
they  argued  that when Equal Opportunities Commission  case<\/p>\n
can be distinguished on facts, it would be inappropriate  to<\/p>\n
rely upon the same to hold that a declaratory relief can  be<\/p>\n
granted by this court.  As the learned counsels were  making<\/p>\n
their  submissions  on the above point, Mr.Shanthi  Bhushan,<\/p>\n
learned senior counsel appearing for the petitioner  in  one<\/p>\n
of  the writ petitions, very fairly conceded and stated that<\/p>\n
Equal  Opportunities Commission’s case can be  distinguished<\/p>\n
on  facts.   We  do find, on going through the  judgment  in<\/p>\n
Equal  Opportunities Commission’s case,  that the provisions<\/p>\n
of  EEC Treaty and the Councils Directives by an Act of  the<\/p>\n
State  was domesticated and therefore all the rights flowing<\/p>\n
out of the said Treaty and the Directives were available  as<\/p>\n
Law  in the United Kingdom, which can be enforceable.   Only<\/p>\n
in  that  context, we state with respect that the  House  of<\/p>\n
Lords  has  given  a  declaration as  prayed  for.   Learned<\/p>\n
counsels  appearing for the contesting parties did not  rest<\/p>\n
with  the laurel of making us accept and Mr.Shanthi  Bhushan<\/p>\n
to  concede  that  Equal Opportunities  Commission  case  is<\/p>\n
distinguishable on facts but spared no efforts in  advancing<\/p>\n
arguments  in  their own way, supported by case  laws,  that<\/p>\n
Indian  Courts  have  no jurisdiction  either  to  test  the<\/p>\n
validity  of  a  State  Act  as  being  incompatible  to  an<\/p>\n
International Treaty namely, Article 27 or even  to  give  a<\/p>\n
declaration  simplicitor  that  such  State   Act   is   not<\/p>\n
compatible  to an International Treaty.  We will be  failing<\/p>\n
in  our  duty  if  we  do  not mention that  Mr.V.T.Gopalan,<\/p>\n
learned  Additional Solicitor General was leading  from  the<\/p>\n
forefront the entire band of lawyers in the opposite camp by<\/p>\n
contending that this court has no jurisdiction at all to  go<\/p>\n
into  the issue referred to above; in any event the  amended<\/p>\n
section is in compliance with Article 27 of “TRIPS” and that<\/p>\n
there  is no violation of Article 14 of the Constitution  of<\/p>\n
India.     Mr.Lakshmikumaran, learned counsel appearing  for<\/p>\n
R5  and  R7  relied upon a judgment reported  in  1966-3-All<\/p>\n
England  Law  Reports  Pg.871 (Salomn  Vs.  Commissioner  of<\/p>\n
Customs) to contend that if any domestic court is approached<\/p>\n
challenging  a municipal law on the ground that it  violates<\/p>\n
International Law, then, the remedy for that lies in a forum<\/p>\n
other  than the domestic court.  In that judgment, the Court<\/p>\n
of Appeal through LORD DIPLOCK held as hereunder:<\/p>\n
           “If  the terms of the legislation are clear<\/p>\n
     and  unambiguous, they must be  given  effect  to<\/p>\n
     whether ornot they carry our Her Majesty’s treaty<\/p>\n
     obligations, for the sovereign power of the Queen<\/p>\n
     in  Parliament extends to breaking treaties [(see<\/p>\n
     Ellerman  Lines, Ltd. Vs. Murray (4) ],  and  any<\/p>\n
     remedy  for  such  a breach of  an  international<\/p>\n
     obligation  lies  in  a  forum  other  than   Her<\/p>\n
     Majesty’s own courts.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
The  above  extracted passage refers to an  earlier  English<\/p>\n
decision.  The learned English Judge, in the latter  portion<\/p>\n
of   his  judgment,  had  reiterated  that  Ellerman   Lines<\/p>\n
Limited’s  case  is the authority for the  proposition  that<\/p>\n
when  a domestic law is challenged on the ground of it being<\/p>\n
in  violation  of  an International Treaty, domestic  courts<\/p>\n
would  have  no  jurisdiction.   In our considered  opinion,<\/p>\n
this  is  the direct judgment on the point.  We have already<\/p>\n
noted  that  the judgment in Equal Opportunities  Commission<\/p>\n
case is distinguishable on facts.\n<\/p>\n<\/p>\n
      8.  Even otherwise, we are of the considered view that<\/p>\n
in  whichever  manner one may name it namely,  International<\/p>\n
Covenant, International Treaty, International Agreement  and<\/p>\n
so  on and so forth, yet, such documents are essentially  in<\/p>\n
the  nature of a contract.  In Head Money cases namely,  the<\/p>\n
judgment  of the Supreme Court of the United States reported<\/p>\n
in 112 U.S. 580, it is held as follows:\n<\/p>\n<\/p>\n
           “A  treaty  is primarily a compact  between<\/p>\n
     independent   Nations,  and   depends   for   the<\/p>\n
     enforcement  of its provisions on the  honor  and<\/p>\n
     the interest of the governments which are parties<\/p>\n
     to it.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
Therefore there cannot be any difficulty at all in examining<\/p>\n
such treaties on principles applied in examining  contracts.<\/p>\n
Under  these circumstances, when a dispute is brought before<\/p>\n
a   court  arising  out of an International  Treaty,  courts<\/p>\n
would  not  be  committing any error in deciding   the  said<\/p>\n
dispute  on principles applicable to  contracts.   In  other<\/p>\n
words,  the  court  has  to  analyse   the  terms  of   such<\/p>\n
International  Treaty; the enforceability of  the  same;  by<\/p>\n
whom and against whom; and if there is violation, is there a<\/p>\n
mechanism for solving that dispute under the treaty  itself?<\/p>\n
Based  on  such  construction of  the  International  Treaty<\/p>\n
namely,  “TRIPS”,  it  is  argued very  strenuously  by  the<\/p>\n
learned  counsels appearing for the contesting parties  that<\/p>\n
there is a settlement mechanism under the Treaty itself  and<\/p>\n
therefore   even   assuming  without  conceding   that   the<\/p>\n
petitioner  has the right to enforce the terms of  the  said<\/p>\n
Treaty,  yet, he must go only before the Dispute  Settlement<\/p>\n
Body  provided  under the “TRIPS” itself.    Article  64  of<\/p>\n
“TRIPS” is pressed into service to sustain this point.    It<\/p>\n
is  contended  by Mr.Anand Grover learned counsel  that  the<\/p>\n
settlement mechanism provided under Article 64 of “TRIPS” is<\/p>\n
governed  by the procedure as understood by the World  Trade<\/p>\n
Organisation.   Mr.Anand  Grover  learned  counsel  took  us<\/p>\n
through the said Dispute Settlement Understanding.   Article<\/p>\n
1  of  the  Dispute Settlement Understanding,  defines   the<\/p>\n
areas covered under that Rule.  Article 1 declares that  the<\/p>\n
agreements  listed in Appendix 1 to the said Rule  would  be<\/p>\n
covered  by the procedure.  “TRIPS” is mentioned as  one  of<\/p>\n
the  agreements in Appendix 1 (B) – Annexure 1C.    We  have<\/p>\n
been   taken  through  the  above  referred  to  Rules   and<\/p>\n
Procedures governing the settlement of disputes and we  find<\/p>\n
that it contains comprehensive provisions for resolving  the<\/p>\n
disputes  arising  out  of  any  agreements  enumerated   in<\/p>\n
Appendix  1  to  that Rules.  Under the  Rules  there  is  a<\/p>\n
Dispute Settlement Body.  The manner of it’s constitution is<\/p>\n
also  provided  therein.  Various  steps  to  sort  out  the<\/p>\n
problem  arising  out of an agreement are provided  therein.<\/p>\n
Article  17  of  the  Rules referred to  above  provides  an<\/p>\n
appellate  review  against the order passed  by  the  panel.<\/p>\n
Therefore  we have no difficulty at all that Article  64  of<\/p>\n
“TRIPS”  read  with World Trade Organisation’s understanding<\/p>\n
on Rules and Procedures governing the settlement of disputes<\/p>\n
provides a comprehensive settlement mechanism of any dispute<\/p>\n
arising  under  the  agreement.   Article  3  of  the  Rules<\/p>\n
declares  that the dispute settlement system  of  the  World<\/p>\n
Trade Organisation is to provide security and predictability<\/p>\n
to   the   multilateral  trading  system.    When   such   a<\/p>\n
comprehensive  dispute settlement mechanism is  provided  as<\/p>\n
indicated  above and when it cannot be disputed that  it  is<\/p>\n
binding on the member States, we see no reason at all as  to<\/p>\n
why  the  petitioner, which itself is a part of that  member<\/p>\n
State,  should not be directed to have the dispute  resolved<\/p>\n
under  the  dispute settlement mechanism referred to  above.<\/p>\n
Several nations in the world are parties to “TRIPS” as  well<\/p>\n
as  the  “WTO”  agreement.   The agreements  are  discussed,<\/p>\n
finalised  and  entered  into at the  higher  level  of  the<\/p>\n
nations  participating  in such meeting.   Therefore  it  is<\/p>\n
binding  on  them.  When such participating nations,  having<\/p>\n
regard  to  the  terms  of  the agreement  and  the  complex<\/p>\n
problems that may arise out of the agreement between  nation<\/p>\n
to nation, decide that every participating nation shall have<\/p>\n
a  Common Dispute Settlement Mechanism, we see no reason  at<\/p>\n
all as to why we must disregard it.  As we began saying that<\/p>\n
any International Agreement possesses the basic nature of an<\/p>\n
ordinary  contract  and when courts respect  the  choice  of<\/p>\n
jurisdiction fixed under such ordinary contract, we  see  no<\/p>\n
compelling  reasons to deviate from such  judicial  approach<\/p>\n
when  we  consider  the  choice  of  forum  arrived  at   in<\/p>\n
International Treaties.  Since we have held that this  court<\/p>\n
has  no  jurisdiction to decide the validity of the  amended<\/p>\n
section, being in violation of Article 27 of “TRIPS”, we are<\/p>\n
not  going  into  the  question whether  any  individual  is<\/p>\n
conferred  with an enforceable right under “TRIPS”  or  not.<\/p>\n
For  the  same reason, we also hold that we are not deciding<\/p>\n
issue  No.(b)  namely,   whether  the   amended  section  is<\/p>\n
compatible  to Article 27 of “TRIPS” or not.<\/p>\n
      9. We also carefully applied our mind as to whether we<\/p>\n
can give a declaratory relief in exercise of the power under<\/p>\n
Article  226 of the Constitution of India?  We have  already<\/p>\n
found  that  the judgment in Equal Opportunities  Commission<\/p>\n
case  is not a precedent for giving such a declaration.   In<\/p>\n
the  judgment reported in AIR 1951 SC Pg.41  (Charanjit  Lal<\/p>\n
Vs. Union of India) and the judgment reported in AIR 1959 SC<\/p>\n
Pg.725 (K.K.Kochunni Vs. State of Madras) the Supreme  Court<\/p>\n
was considering the power of the court under Article 32   of<\/p>\n
the  Constitution  of  India to give a  declaratory  relief.<\/p>\n
Both the judgments were rendered by two Constitution Benches<\/p>\n
of  the  Supreme Court.  The Chief Justice of India presided<\/p>\n
the  Constitution Bench in the latter judgment and the  said<\/p>\n
Hon’ble  Judge  also constituted the coram  in  the  earlier<\/p>\n
judgment.   We  extract  the relevant portion  in  paragraph<\/p>\n
No.45 of the earlier judgment of the Supreme Court:<\/p>\n
           “As regards the other point, it would appear<\/p>\n
     from   the   language  of  Article   as   of   the<\/p>\n
     Constitution that the sole object of  the  article<\/p>\n
     is   the   enforcement   of   fundamental   rights<\/p>\n
     guaranteed  by  the  Constitution.   A  proceeding<\/p>\n
     under this Article cannot really have any affinity<\/p>\n
     to what is known as a declaratory suit.”<\/p>\n<\/blockquote>\n
           “Any  way,  Article 32 of the  Constitution<\/p>\n
     gives  us  very wide discretion in the matter  of<\/p>\n
     framing  our  writs  to suit  the  exigencies  of<\/p>\n
     particular  cases,  and the application,  of  the<\/p>\n
     petitioner  cannot be thrown out  simply  on  the<\/p>\n
     ground that the proper writ or direction has  not<\/p>\n
     been prayed for.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
In  the  latter  case,  the power  of  the  court  to  grant<\/p>\n
declaratory   relief   came  up  for   consideration.    The<\/p>\n
Constitutionality  of  Madras Act 32\/55  was  challenged  as<\/p>\n
infringing  fundamental rights under  Article  19(1)(f)  and<\/p>\n
Article  31(1).  The point that appears to have been  argued<\/p>\n
in  favour  of  granting  a declaratory  decree,   as  noted<\/p>\n
therein, is extracted hereunder:\n<\/p>\n<\/p>\n
            “The  next  argument  in  support  of   the<\/p>\n
     objection  as  to  the  maintainability  of  these<\/p>\n
     petitions is thus formulated: The impugned Act  is<\/p>\n
     merely  a  piece of a declaratory legislation  and<\/p>\n
     does  not contemplate or require any action to  be<\/p>\n
     taken  by  the  State  or any  other  person  and,<\/p>\n
     therefore,  none  of  the well  known  prerogative<\/p>\n
     writs can afford an adequate or appropriate remedy<\/p>\n
     to  a  person  whose fundamental  right  has  been<\/p>\n
     infringed by the mere passing of the Act.  If such<\/p>\n
     a  person  challenges  the  validity  of  such  an<\/p>\n
     enactment, he must file a regular suit in a  court<\/p>\n
     of   competent   jurisdiction   for   getting    a<\/p>\n
     declaration  that the law is void and,  therefore,<\/p>\n
     cannot  and does not affect his right.  In such  a<\/p>\n
     suit he can also seek consequential reliefs by way<\/p>\n
     of  injunction  or the like, but he  cannot  avail<\/p>\n
     himself of the remedy under Article 32.  In short,<\/p>\n
     the  argument is that the proceeding under Article<\/p>\n
     32  cannot  be  converted into or equated  with  a<\/p>\n
     declaratory suit under section 42 of the  Specific<\/p>\n
     Relief Act.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
The  Hon’ble  Judges  of  the Supreme  Court  in  that  case<\/p>\n
referred  to  the  earlier judgment  of  the  Supreme  Court<\/p>\n
referred to above as well as the judgments reported  in  AIR<\/p>\n
1950 SC 163 (Rashid Ahmed Vs. Municipal Board, Kairana); AIR<\/p>\n
1954  SC  440  (Basappa Vs. T. Nagappa);  AIR  1954  SC  229<\/p>\n
(Ebrahim  Vadir  Mavat  Vs. State of  Bombay)  and  held  as<\/p>\n
hereunder:\n<\/p>\n<\/p>\n
         “But on a consideration of the authorities it<\/p>\n
    appears  to be well established that this  Court’s<\/p>\n
    powers  under Article 32 are wide enough  to  make<\/p>\n
    even  a declaratory order where that is the proper<\/p>\n
    relief  to  be given to the aggrieved party.   The<\/p>\n
    present  case  appears to us precisely  to  be  an<\/p>\n
    appropriate  case, if the impugned Act  has  taken<\/p>\n
    away  or  abridged  the petitioners’  right  under<\/p>\n
    Article  19(1)(f)  by its own  terms  and  without<\/p>\n
    anything  more  being  done  and  such  infraction<\/p>\n
    cannot   be   justified.    If,   therefore,   the<\/p>\n
    contentions of the petitioners be well founded, as<\/p>\n
    to  which we say nothing at present, a declaration<\/p>\n
    as  to the invalidity of the impugned Act together<\/p>\n
    with the consequential relief by way of injunction<\/p>\n
    restraining  the  respondents  and  in  particular<\/p>\n
    respondents  2  to  17 from asserting  any  rights<\/p>\n
    under  the enactment so declared void will be  the<\/p>\n
    only  appropriate  reliefs which  the  petitioners<\/p>\n
    will  be  entitled to get.  Under  Article  32  we<\/p>\n
    must,   in   appropriate   cases,   exercise   our<\/p>\n
    discretion and frame our writ or order to suit the<\/p>\n
    exigencies  of  this  case brought  about  by  the<\/p>\n
    alleged   nature   of   the   enactment   we   are<\/p>\n
    considering.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
Therefore  it is clear that when an enactment infringes  the<\/p>\n
fundamental rights and a challenge is made to that  on  that<\/p>\n
ground, the Hon’ble Supreme Court of India had said that  it<\/p>\n
should  not  hesitate  to grant a declaratory  relief  under<\/p>\n
Article  32  of the Constitution of India.  In AIR  1975  SC<\/p>\n
1810  (S.G.Films Exchange Vs. Brijnath Singhji) and AIR 1976<\/p>\n
SC  888  (Vaish  Degree  College Vs.  Lakshmi  Narain),  the<\/p>\n
Supreme Court held that the relief of declaration under  the<\/p>\n
provisions   of   the   Specific  Relief   Act   is   purely<\/p>\n
discretionary.   In the latter judgment, the  Supreme  Court<\/p>\n
went  on  to  hold that while exercising it’s  discretionary<\/p>\n
powers,  the  court  must  keep in  mind  the  well  settled<\/p>\n
principles of justice and fair play and should exercise  the<\/p>\n
discretion  only  if  the ends of justice  require  it,  for<\/p>\n
justice  is  not  an  object which can  be  administered  in<\/p>\n
vacuum.     As  rightly  contended by  Mr.P.S.Raman  learned<\/p>\n
senior  counsel, we have to decide in this case whether  the<\/p>\n
amended  section  is  bad  in law for  lack  of  legislative<\/p>\n
competency   or it violates Part-III of the Constitution  of<\/p>\n
India or any other provisions in the Constitution.  We  also<\/p>\n
thought  whether  ends of justice require giving  a  helping<\/p>\n
legal hand to the petitioner.  The amended section does  not<\/p>\n
take  away in toto the right of the petitioner to  carry  on<\/p>\n
the  trade.  It is contended by Mr.P.S.Raman learned  senior<\/p>\n
counsel  that  the petitioner gets only a proprietary  right<\/p>\n
over  the patent lasting for a fixed tenure and beyond  that<\/p>\n
it  does  not get anything else.  We agree with him on  this<\/p>\n
point.   We also find that ends of justice, on the facts  of<\/p>\n
this  case, is not in favour of the petitioner, which  would<\/p>\n
disable  us  from exercising our discretionary jurisdiction.<\/p>\n
It  has  been  held  by the Supreme Court in  an  unreported<\/p>\n
judgment  in Katakis Vs. Union of India (W.P.No.54\/68  dated<\/p>\n
28.10.1968)  that  no declaration would be  given  where  it<\/p>\n
would serve no useful purpose to the petitioner.  We thought<\/p>\n
what  will happen if a declaratory relief is given as  asked<\/p>\n
for,  assuming  for a moment that we have the  jurisdiction.<\/p>\n
It  is a settled position in law that nobody can compel  the<\/p>\n
Parliament to enact  a Law.  If that is the position,  then,<\/p>\n
assuming  that we give a declaration as prayed  for  namely,<\/p>\n
the  amended  provision is not in the discharge  of  India’s<\/p>\n
obligation under Article 27 of “TRIPS”, even then,  we  fail<\/p>\n
to  see for what use the petitioner can put it.  Even  if  a<\/p>\n
consequential  relief is not asked for,  courts  have  held,<\/p>\n
depending  upon  the facts available in each  case,  that  a<\/p>\n
declaratory relief could be granted, provided, it  is  shown<\/p>\n
that such a declaratory relief would be a stepping stone  to<\/p>\n
claim  relief at some other stage.  Having that in our mind,<\/p>\n
when  we again thought aloud as to what use to which such  a<\/p>\n
declaratory relief, if granted to the petitioner,  could  be<\/p>\n
put  to and we find that there is no scope at all to put  in<\/p>\n
use the declaratory relief, if granted, at a later point  of<\/p>\n
time.   In  other  words, the declaratory  relief,  even  if<\/p>\n
granted, would be only on paper, on the basis of which,  the<\/p>\n
petitioner  cannot claim any further relief  in  the  Indian<\/p>\n
courts.   Only  in  this context, we extract  hereunder  the<\/p>\n
relevant  portion in the unreported judgment of the  Supreme<\/p>\n
Court  in Katakis case referred to above, which was rendered<\/p>\n
by a Constitution Bench consisting of  Hon’ble Judges Sikri,<\/p>\n
Bachawat,  Mitter, Hegde and Grover, JJ:\n<\/p>\n<\/p>\n
           “It  is  not even stated that the petitioner<\/p>\n
     did  not apply because of the canalisation scheme.<\/p>\n
     The  Supreme  Court  in appropriate  circumstances<\/p>\n
     can give a declaration that a particular order  or<\/p>\n
     scheme    violates   the   provisions    of    the<\/p>\n
     constitution but the Supreme Court will  not  give<\/p>\n
     such  a declaration unless it is certain that  the<\/p>\n
     declaration will serve some useful purpose to  the<\/p>\n
     petitioners.   Even  if the declaration  is  given<\/p>\n
     the  petitioners  may possibly  not  apply  for  a<\/p>\n
     licence;  if  they  do apply,  the  conditions  of<\/p>\n
     import  and export may change drastically  by  the<\/p>\n
     time  the  application is filed, or the policy  of<\/p>\n
     the   Government   may   change.    But   if   the<\/p>\n
     petitioners  had applied for the  licence  on  the<\/p>\n
     basis  that  the canalisation scheme was  invalid,<\/p>\n
     their  application  would have been  processed  by<\/p>\n
     the   authorities  apart  from  the   canalisation<\/p>\n
     scheme  but  in  accordance with law.   The  Court<\/p>\n
     declined  to go into the question of the  validity<\/p>\n
     of the canalisation scheme.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
Therefore,  for the reasons stated above, we find  that  the<\/p>\n
petitioner in each writ petition is not entitled to even the<\/p>\n
declaratory relief.\n<\/p>\n<\/p>\n
     10. Let us now take the last issue for consideration.<\/p>\n
           ” (c) Dehors issues (a) and (b) referred to<\/p>\n
     above,  could the amended section be held  to  be<\/p>\n
     violative  of  Article 14 of the Constitution  of<\/p>\n
     India  on  the ground of vagueness, arbitrariness<\/p>\n
     and   conferring  un-canalised  powers   on   the<\/p>\n
     Statutory Authority?”\n<\/p>\n
The  main  grounds of attack to the validity of the  amended<\/p>\n
section  are  that,  it  is  vague,  arbitrary  and  confers<\/p>\n
uncanalised   powers  on  the  Statutory   Authority.    The<\/p>\n
Statutory  Authority in this case is the Patent  controller.<\/p>\n
There  is  no  doubt that he is exercising a  quasi-judicial<\/p>\n
function  namely, considers the patent claim application  in<\/p>\n
the  context  of the objections received; hears  parties  on<\/p>\n
both  sides  and then passes an order, either  granting  the<\/p>\n
patent  or  rejecting  the  patent  application,  by  giving<\/p>\n
reasons.  Prior to the amended section was brought into  the<\/p>\n
Statute  book  by  the  Patent (Amendment)  Act,  2005  (Act<\/p>\n
15\/2005)  with effect from 01.01.2005,  it was  preceded  by<\/p>\n
Ordinance  7\/2004 containing the proposed  amendment  to  be<\/p>\n
made  to  section  3(d).   In the earlier  portion  of  this<\/p>\n
judgment,  we  have extracted section 3(d) as it  originally<\/p>\n
stood;  section 3(d) as sought to be brought in by Ordinance<\/p>\n
7\/2004  and the amended section itself.  India is a  founder<\/p>\n
member of the World Trade Organisation, in short, “WTO”  and<\/p>\n
as  such a signatory of “TRIPS”, which itself is an Annexure<\/p>\n
to  the  “WTO”  agreement.  There is no dispute  that  under<\/p>\n
“TRIPS” agreement, India has to permit product patent in all<\/p>\n
fields  of  technology, including medicines and drugs,  with<\/p>\n
effect  from 01.01.2005.  Pending bringing in  comprehensive<\/p>\n
provisions,  the  Union  Government  of  India   made   some<\/p>\n
temporary  provisions  in  the Act itself,  which  temporary<\/p>\n
provisions came to an end on and with effect from the coming<\/p>\n
into  force of Act 15\/2005.  Prior to Amending Act  15\/2005,<\/p>\n
there  were  Amending  Acts 17\/1999  and  38\/2002.   In  the<\/p>\n
affidavits  filed  in  support of both the  writ  petitions,<\/p>\n
Parliamentary Debates on Ordinance 7\/2004, in the context of<\/p>\n
the amendment to section 3(d) are extensively extracted.   A<\/p>\n
speech  from  the Member of the Parliament from Kottayam  in<\/p>\n
that regard and the reply in regard thereto from the Hon’ble<\/p>\n
Minister   of   Commerce  are  found  so  extracted.     The<\/p>\n
Parliamentarians appear to have been opposing the  amendment<\/p>\n
to  section  3(d)  on the ground that, if the  amendment  as<\/p>\n
indicated  in  the Ordinance is allowed to  be  brought  in,<\/p>\n
then, there is a fear of the common man being denied  access<\/p>\n
to   life   saving   medicines  and   it   would   encourage<\/p>\n
evergreening.  The reply by the Hon’ble Minister shows  that<\/p>\n
he was aware of the impending problem namely, “evergreening”<\/p>\n
and  the  action which the Hon’ble Minister intend to  take.<\/p>\n
Admittedly, the amended section is not the amendment  sought<\/p>\n
to  be  introduced by Ordinance 7\/2004.   It  is  argued  by<\/p>\n
learned  senior counsels appearing for the petitioners  that<\/p>\n
had  the  amendment  proposed under  Ordinance  7\/2004  been<\/p>\n
brought  into  the Act in the form in which  it  was  shown,<\/p>\n
then,  it  would have been in strict compliance to  “TRIPS”.<\/p>\n
But   instead, the amended section has been brought into the<\/p>\n
Statute  book.  It is clear that the amended section appears<\/p>\n
to  have  been  drafted in a great hurry without   realising<\/p>\n
that it is likely to be struck down on the ground that it is<\/p>\n
incompatible  with  “TRIPS” (we have already  held  that  we<\/p>\n
cannot  go  into that question) and  also being in violation<\/p>\n
of  Article 14 of the Constitution of India (the later point<\/p>\n
alone survives now).    Since the ground of attack based  on<\/p>\n
vagueness and arbitrariness and conferring uncanalised power<\/p>\n
to the Statutory Authority over-lap each other and therefore<\/p>\n
our  points  of discussion are also likely to over-lap  each<\/p>\n
other.   So  we  have  decided to  take  up  all  the  three<\/p>\n
individual  grounds  raised for decision in  a  consolidated<\/p>\n
manner.\n<\/p>\n<\/p>\n
      11.  According  to  the learned senior  counsels,  the<\/p>\n
amended section is bad for the following reasons:<\/p>\n
     Under Ordinance 7\/2004 mere discovery of a new property<\/p>\n
is not treated as an invention.  But however, in the amended<\/p>\n
section,  a further clause is added to the effect  that  the<\/p>\n
discovery of a  new form of a known substance should  result<\/p>\n
in  the  enhancement of the known efficacy of that substance<\/p>\n
and if it does not, then, it is not an invention.  Therefore<\/p>\n
the  argument  goes on the validity of the  amended  section<\/p>\n
that, in the absence of any guideline in the amended section<\/p>\n
or  the  Act  itself as to how to find out,  when  there  is<\/p>\n
enhancement  of  the  known efficacy of the  substance  from<\/p>\n
which the discoveries are made, then, an unguided discretion<\/p>\n
is  vested  with the Statutory Authority and  therefore  the<\/p>\n
amended  section is bad in law.  They would then argue  that<\/p>\n
to  make  the  matter  worse,  to the  amended  section,  an<\/p>\n
Explanation is added, by which, a deeming fiction is created<\/p>\n
to  the  effect  that all  salts, esters,  etc.,  etc.,   if<\/p>\n
derived from a known substance, then,  such derivatives  are<\/p>\n
also  considered  to  be  the  same  substance,  unless  the<\/p>\n
derivatives are shown to differ significantly in  properties<\/p>\n
with  regard to efficacy.  It is argued that all derivatives<\/p>\n
need not necessarily be the same substance and therefore the<\/p>\n
deeming fiction created by  the Explanation is bereft of any<\/p>\n
guidelines and  is bad in Law.  It is argued that there must<\/p>\n
be some guidance or guideline in the Act itself as to when a<\/p>\n
derivative  shall  be held to be differing significantly  in<\/p>\n
properties  with  regard to efficacy.  In other  words,  the<\/p>\n
submission is that, both the amended section as well as  the<\/p>\n
Explanation to the amended section must prescribe  in  clear<\/p>\n
terms  for   the Authority constituted under  the  Act,  the<\/p>\n
guidelines  to decide in what circumstances it can  be  held<\/p>\n
that  the  discovery of a new form of a known substance  had<\/p>\n
resulted  in the enhancement of the known efficacy  of  that<\/p>\n
substance  and  when  the derivatives are  found  to  differ<\/p>\n
significantly in properties with regard to efficacy.  Though<\/p>\n
the  expression “efficacy” has a definite meaning,  yet,  no<\/p>\n
definite  meaning  could  be attributed  to  the  expression<\/p>\n
“enhancement   of   the   known   efficacy”   and    “differ<\/p>\n
significantly in properties with regard to efficacy”.  These<\/p>\n
expressions  are  ambiguous.   Therefore  it  is  argued  by<\/p>\n
learned  senior counsels that when  it is possible  for  the<\/p>\n
Legislature to  explain what is meant by “enhancement  of  a<\/p>\n
known  efficacy” and “differing significantly in  properties<\/p>\n
with regard to efficacy”,  the Legislature is duty bound  to<\/p>\n
clear  the  ambiguity.  According to them, if this ambiguity<\/p>\n
is  not  cleared,  then,   there is  every  chance  for  the<\/p>\n
Statutory Authority to exercise it’s power to it’s whims and<\/p>\n
fancies.   Therefore the amended section is also irrational.<\/p>\n
Opposing   these  arguments,  learned  Additional  Solicitor<\/p>\n
General  of India and the other learned senior counsels  and<\/p>\n
learned  counsels  for the contesting parties  would  submit<\/p>\n
that having regard to the field in which the amended section<\/p>\n
is  to  operate;  the technological and scientific  research<\/p>\n
oriented advances already made and likely to be made in  the<\/p>\n
coming future and which may be a continuing process for  all<\/p>\n
time  to  come, the Legislature thought it fit to  use  only<\/p>\n
general expressions in the Act, leaving it for the Statutory<\/p>\n
Authority to apply it’s mind to the various facts  that  are<\/p>\n
brought  to  it’s  notice  and then  find  out  whether  the<\/p>\n
invented drug is within the mischief of the amended  section<\/p>\n
or  outside  it.  Therefore it would be unwise  to  fix  any<\/p>\n
specific  formula  to  be applied, as  a  matter  of  static<\/p>\n
measure,  to  find  out whether the  new  form  of  a  known<\/p>\n
substance resulted in the enhancement of the known  efficacy<\/p>\n
or  the derivatives differ significantly in properties  with<\/p>\n
regard  to  efficacy.  Having regard to the inventions  that<\/p>\n
are  made and are likely to be made in the time to come,  it<\/p>\n
is humanly impossible to prescribe a fixed formula to decide<\/p>\n
the  issue  as indicated above and if it is so done  without<\/p>\n
even  knowing what would be the new discoveries,  then,  the<\/p>\n
hands of the Statutory Authority would be completely tied to<\/p>\n
a  fixed  and definite situation, from which it cannot  even<\/p>\n
wriggle out.  Discoveries that are likely to be made in  the<\/p>\n
future may not be alike and they may vary from each other in<\/p>\n
their therapeutic effect and properties.  Learned Additional<\/p>\n
Solicitor General of India and other learned senior counsels<\/p>\n
appearing for the pharmaceutical companies would argue  that<\/p>\n
in  the  given situation, the amended section as  it  stands<\/p>\n
today  is  a  classic Legislation by itself  thereby  giving<\/p>\n
enough  room  in the joints for the Statutory  Authority  to<\/p>\n
evaluate the materials placed before him in a case  to  case<\/p>\n
basis; analyse the comparative details that are likely to be<\/p>\n
placed  before  him  and then arrive at a  decision  to  say<\/p>\n
whether  the discovery \/ derivative is an invention or  not.<\/p>\n
Therefore  the  Statutory  Authority  has  been    given   a<\/p>\n
discretion,  which he has to  exercise based on the  details<\/p>\n
to   be   placed   before  him.    In  exercising   such   a<\/p>\n
discretionary  power vested in the  Statutory Authority,  if<\/p>\n
it  is  found that he has exercised that discretionary power<\/p>\n
wrongly  or  abused it, then, such an error  can  always  be<\/p>\n
corrected  by higher forums, which is provided for  in   the<\/p>\n
Act  itself and thereafter, by the courts of law.  In  other<\/p>\n
words,  a  provision  of law cannot be struck  down  on  the<\/p>\n
ground  that the Authority exercising the power  under  that<\/p>\n
provision  is likely to misuse it, unless it is  shown  that<\/p>\n
the  said provision itself ex-facie is violative of  Article<\/p>\n
14 of the Constitution of India, which is not the case here.<\/p>\n
When  there  would be enhancement of the known efficacy  and<\/p>\n
when   it  would  be  found  that  the  derivatives   differ<\/p>\n
significantly  in properties with regard to efficacy,  would<\/p>\n
vary  from discovery to discovery.   It is then argued  that<\/p>\n
the  Explanation to the amended section does not create  any<\/p>\n
additional criteria but it only explains the amended section<\/p>\n
itself.   Debates in Parliament could not be the  basis  for<\/p>\n
interpreting the Statute, is their last submission.<\/p>\n
      12.  In  the  light of the arguments advanced  by  the<\/p>\n
learned  senior  counsels all-round,  we  went  through  the<\/p>\n
entire  records.  We do find that section 3(d) as  shown  in<\/p>\n
Ordinance  7\/2004 had not been reproduced  in  the  form  in<\/p>\n
which  it  was  shown  in  the Act.  Therefore  the  amended<\/p>\n
section definitely differs from the form in which it was put<\/p>\n
in  the Ordinance.  The amended section is not confined only<\/p>\n
to  drugs as it deals with machines and apparatuses as well.<\/p>\n
But  however, we are clear in our mind that the portions  of<\/p>\n
the  amended  section  and the Explanation under  attack  is<\/p>\n
definitely  referable only to the pharmacology field namely,<\/p>\n
drugs.   Since  Parliamentary debates have been relied  upon<\/p>\n
by  the learned senior counsels for the petitioners to argue<\/p>\n
that  since  the amended section appears to be  a  hurriedly<\/p>\n
brought out Legislation, the   Parliamentary debates can  be<\/p>\n
looked into to find out whether the  amended section is  ex-<\/p>\n
facie  violative of Article 14 of the Constitution of India.<\/p>\n
We  went  through  the case laws brought to  our  notice  by<\/p>\n
Mr.V.T.Gopalan,  learned  Additional  Solicitor  General  of<\/p>\n
India;  Mr.P.S.Raman  learned senior  counsel  and  Mr.Anand<\/p>\n
Grover.   Mr.Shanthi Bhushan, learned senior counsel  relied<\/p>\n
upon  one  or  two judgments so brought to our  notice.   We<\/p>\n
also  tried  to  find out as to whether  the  “statement  of<\/p>\n
objects  and  reasons” of an Act would  help  the  court  to<\/p>\n
analyse  the provision which the writ petitioner alleges  is<\/p>\n
violating  Article  14 of the Constitution  of  India.   The<\/p>\n
earliest judgment of the Indian court brought to our  notice<\/p>\n
in  this context by Mr.P.S.Raman learned senior counsel,  is<\/p>\n
the  judgment of the Supreme Court reported in AIR  1952  SC<\/p>\n
Pg.369   (Aswini Kumar Vs. Arabinda Bose), in which the  law<\/p>\n
on the subject is laid down as hereunder:\n<\/p>\n<\/p>\n
           “The  speeches  made by the members  of  the<\/p>\n
     House  in  the  course  of  the  debate  are   not<\/p>\n
     admissible as extrinsic aids to the interpretation<\/p>\n
     of statutory provisions: AIR 1952 SC 366.”<\/p>\n<\/blockquote>\n
          “The Statement of Objects and Reasons, seeks<\/p>\n
    only to explain what reasons induced the mover  to<\/p>\n
    introduce  the bill in the House and what  objects<\/p>\n
    be  sought  to  achieve.  But  those  objects  and<\/p>\n
    reasons may or may not correspond to the objective<\/p>\n
    which  the  majority of members had in  view  when<\/p>\n
    they  passed  it  into law.   The  Bill  may  have<\/p>\n
    undergone  radical  changes  during  its   passage<\/p>\n
    through  the  House or Houses,  and  there  is  no<\/p>\n
    guarantee  that  the  reasons  which  led  to  the<\/p>\n
    introduction and the objects thereby sought to  be<\/p>\n
    achieved  have  remained the same throughout  till<\/p>\n
    the  Bill emerges from the House as an Act of  the<\/p>\n
    Legislature, for they do not form part of the Bill<\/p>\n
    and  are  not  voted  upon by  the  members.   The<\/p>\n
    Statement of Objects and Reasons<\/p>\n
    appended to the Bill should be ruled out as an aid<\/p>\n
    to the construction of a statute.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
Therefore  from the above pronouncement, it  is  clear  that<\/p>\n
when  the  Bill is debated, new things are likely to  emerge<\/p>\n
and  the emerging new things may be taken into account while<\/p>\n
a  final  shape is given to the Bill before it  was  brought<\/p>\n
into  an  Act.   The statement of objects and  reasons  also<\/p>\n
stands  excluded as extrinsic aid to the construction  of  a<\/p>\n
Statute.   The next in line is the judgment of  the  Supreme<\/p>\n
Court reported in  (1986) 2 SCC Pg.237 (Girdhari Lal &  Sons<\/p>\n
Vs.  Balbir  Nath  Mathur)   wherein,  on  the  subject   of<\/p>\n
interpretation of Statutes, the Supreme Court had laid  down<\/p>\n
the law as hereunder:\n<\/p>\n<\/p>\n
          “7.  Parliamentary intention may be gathered<\/p>\n
    from  several sources.  First, of course, it  must<\/p>\n
    be gathered from the statute itself, next from the<\/p>\n
    preamble  to the statute, next from the  Statement<\/p>\n
    of    Objects   and   Reasons,   thereafter   from<\/p>\n
    parliamentary  debates, reports of committees  and<\/p>\n
    commissions  which  preceded the  legislation  and<\/p>\n
    finally from all legitimate and admissible sources<\/p>\n
    from where there may be light.  Regard must be had<\/p>\n
    to legislative history too.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
            “8.   Once   parliamentary   intention   is<\/p>\n
     ascertained  and  the object and  purpose  of  the<\/p>\n
     legislation is known, it then becomes the duty  of<\/p>\n
     the  court to give the statute a purposeful  or  a<\/p>\n
     functional interpretation.  This is what is  meant<\/p>\n
     when,  for example, it is said that measures aimed<\/p>\n
     at  social amelioration should receive liberal  or<\/p>\n
     beneficent  construction.  Again, the words  of  a<\/p>\n
     statute  may  not be designed to meet the  several<\/p>\n
     uncontemplated forensic situations that may arise.<\/p>\n
     The  draftsman may have designed his words to meet<\/p>\n
     what  Lord  Simon of Glaisdale calls the  “primary<\/p>\n
     situation”.  It will then become necessary for the<\/p>\n
     court  to  impute  an intention to  Parliament  in<\/p>\n
     regard to “secondary situations”.  Such “secondary<\/p>\n
     intention”  may  be  imputed  in  relation  to   a<\/p>\n
     secondary situation so as to best serve  the  same<\/p>\n
     purpose as the primary statutory intention does in<\/p>\n
     relation to a primary situation.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
Mr.Anand  Grover, learned counsel appearing  for  the  sixth<\/p>\n
respondent   brought  to our notice  the   judgment  of  the<\/p>\n
Supreme  Court in the case reported in (1994) 5  SCC  Pg.593<\/p>\n
(K.S.Paripoornan Vs. State of Kerala), wherein, the  Supreme<\/p>\n
Court  had held on the Law of Interpretation of Statutes  as<\/p>\n
hereunder:\n<\/p>\n<\/p>\n
           “As  regards  the Statement of  Objects  and<\/p>\n
     Reasons  appended  to the Bill  the  law  is  well<\/p>\n
     settled  that the same cannot be used  except  for<\/p>\n
     the   limited   purpose   of   understanding   the<\/p>\n
     background and the state of affairs leading to the<\/p>\n
     legislation but it cannot be used as an aid to the<\/p>\n
     construction  of the statute.  (See  Aswini  Kumar<\/p>\n
     Ghosh Vs. Arabinda Bose; State of West Bengal  Vs.<\/p>\n
     Subodh Gopal Bose per Das, J; State of West Bengal<\/p>\n
     Vs.  Union  of India).  Similarly, with regard  to<\/p>\n
     speeches made by the members in the House  at  the<\/p>\n
     time of consideration of the Bill it has been held<\/p>\n
     that they are not admissible as extrinsic aids  to<\/p>\n
     the  interpretation  of the  statutory  provisions<\/p>\n
     though the speech of the mover of the Bill may  be<\/p>\n
     referred  to  for the purpose of finding  out  the<\/p>\n
     object  intended to be achieved by the Bill.  (See<\/p>\n
     State  of  Travancore, Cochin Vs. Bombay Co.  Ltd.<\/p>\n
     And Aswini Kumar Vs. Arabinda Bose).”<\/p>\n<\/blockquote>\n
Learned  senior counsels on either side also relied  upon  a<\/p>\n
judgment  of  the  Supreme Court reported in  (1998)  4  SCC<\/p>\n
Pg.626  (P.S.Narasimha Rao Vs. State (CBI\/SPE), wherein,  it<\/p>\n
has been held as follows:\n<\/p>\n<\/p>\n
          “It  would  thus  be seen that  as  per  the<\/p>\n
    decisions  of  this  court the  statement  of  the<\/p>\n
    Minister who had moved the Bill in Parliament  can<\/p>\n
    be  looked at to ascertain the mischief sought  to<\/p>\n
    be  remedied by the legislation and the object and<\/p>\n
    purpose  for  which  the legislation  is  enacted.<\/p>\n
    The  statement of the Minister who had  moved  the<\/p>\n
    Bill  in Parliament is not taken into account  for<\/p>\n
    the  purpose of interpreting the provisions of the<\/p>\n
    enactment.   The  decision  in  Pepper  Vs.   Hari<\/p>\n
    permits   reference  to  the  statement   of   the<\/p>\n
    Minister or other promoter of the Bill as  an  aid<\/p>\n
    to  construction of legislation which is ambiguous<\/p>\n
    or  abscure or the literal meaning of which  leads<\/p>\n
    to  an  absurdity  provided the  statement  relied<\/p>\n
    upon  clearly discloses the mischief aimed  at  or<\/p>\n
    the   legislative  intention  lying   behind   the<\/p>\n
    ambiguous  or  obscure  words  and  that  such   a<\/p>\n
    statement  of  the  Minister  must  be  clear  and<\/p>\n
    unambiguous.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
In Narasimha Rao’s case referred to supra, the Supreme Court<\/p>\n
had  held that the statement of the Minister, who makes  the<\/p>\n
Bill  in  Parliament  can be looked  at,  to  ascertain  the<\/p>\n
mischief sought to be remedied by the Legislation.   We  now<\/p>\n
go  back to Girdhari Lal’s case referred to supra , wherein,<\/p>\n
the Supreme Court had  held as follows:\n<\/p>\n<\/p>\n
           “Our own court has generally taken the view<\/p>\n
     that  ascertainment of legislative  intent  is  a<\/p>\n
     basic  rule of statutory construction and that  a<\/p>\n
     rule  of  construction should be preferred  which<\/p>\n
     advances  the purpose and object of a legislation<\/p>\n
     and  that  though  a construction,  according  to<\/p>\n
     plain  language,  should ordinarily  be  adopted,<\/p>\n
     such  a construction should not be adopted  where<\/p>\n
     it leads to anomalies, injustices or absurdities,<\/p>\n
     vide   K.P.Varghese  Vs.  ITO;  State   Bank   of<\/p>\n
     Travancore  Vs. Mohd. M.Khan; Som  Prakash  Rekhi<\/p>\n
     Vs.  Union  of India; Ravula Subba Rao  Vs.  CIT;<\/p>\n
     Govindlal   Vs.   Agricultural   Produce   Market<\/p>\n
     Committee  and Babaji Kondaji Vs. Nasik Merchants<\/p>\n
     Co-op. Bank Ltd.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
If we  read the Parliamentary debate on Ordinance 7\/2004, it<\/p>\n
appears  that there was a wide spread fear  in the  mind  of<\/p>\n
the  members of the House that if section 3(d) as  shown  in<\/p>\n
Ordinance 7\/2004 is brought into existence, then,  a  common<\/p>\n
man  would  be denied access to life saving drugs  and  that<\/p>\n
there is every possibility of “evergreening”.  The reply  by<\/p>\n
the  Hon’ble  Minister for Commerce shows that  the  Hon’ble<\/p>\n
Minister  was  sure  that  Ordinance  7\/2004  would  prevent<\/p>\n
“evergreening”.   The Parliamentary debates also  show  that<\/p>\n
the Hon’ble Minister was concerned with the other issues  as<\/p>\n
well.   Therefore it is clear to our mind that section  3(d)<\/p>\n
brought by Amending Act 15\/2005 is as a result of debates on<\/p>\n
Ordinance  7\/2004  in  the Parliament  and  due  to  debates<\/p>\n
change in the form is unavoidable and permissible, it is not<\/p>\n
possible  to  sustain the arguments advanced by the  learned<\/p>\n
senior  counsels  that  having  shown  section  3(d)  in   a<\/p>\n
particular  form in Ordinance 7\/2004 and bringing  it  in  a<\/p>\n
totally  different  form  in   Amending  Act  15\/2005,   the<\/p>\n
amending section ex-facie stands in violation of Article  14<\/p>\n
of the Constitution of India.\n<\/p>\n<\/p>\n
      13.  Let us now test the argument advanced before this<\/p>\n
court  by   learned Senior Counsels on the validity  of  the<\/p>\n
amended  section  on the touchstone of  Article  14  of  the<\/p>\n
Constitution of India. As we understand the amended section,<\/p>\n
it only declares that the very discovery of a new form of  a<\/p>\n
known substance which does not result in the enhancement  of<\/p>\n
the known efficacy of that substance, will not be treated as<\/p>\n
an  invention.  The position therefore is, if the  discovery<\/p>\n
of  a  new form of a known substance must be treated  as  an<\/p>\n
invention,  then the Patent applicant should show  that  the<\/p>\n
substance  so  discovered has a better  therapeutic  effect.<\/p>\n
Darland’s   Medical   Dictionary  defines   the   expression<\/p>\n
“efficacy” in the field of Pharmacology as “the ability of a<\/p>\n
drug   to  produce  the  desired  therapeutic  effect”   and<\/p>\n
“efficacy”   is  independent  of   potency  of   the   drug.<\/p>\n
Dictionary  meaning  of   “Therapeutic”,  is    healing   of<\/p>\n
disease – having a good effect on the body.”  Going  by  the<\/p>\n
meaning  for the word “efficacy” and “therapeutic” extracted<\/p>\n
above, what the patent applicant is expected to show is, how<\/p>\n
effective  the  new discovery made would  be  in  healing  a<\/p>\n
disease  \/  having  a good effect on the  body?    In  other<\/p>\n
words,  the patent applicant is definitely aware as to  what<\/p>\n
is  the  “therapeutic effect” of the drug for which  he  had<\/p>\n
already got a patent and what is the difference between  the<\/p>\n
therapeutic  effect of the patented drug  and  the  drug  in<\/p>\n
respect  of which patent is asked for.   Therefore it  is  a<\/p>\n
simple exercise of, though preceded by research,  – we state<\/p>\n
–  for  any Patent applicant to place on record what is  the<\/p>\n
therapeutic effect \/ efficacy of a known substance and  what<\/p>\n
is  the  enhancement  in that known efficacy.   The  amended<\/p>\n
section not only covers  the field of pharmacology but  also<\/p>\n
the   other  fields.   As  we could  see  from  the  amended<\/p>\n
section, it is made applicable to even machine, apparatus or<\/p>\n
known  process with a rider that mere use of a known process<\/p>\n
is not an invention unless such a known process results in a<\/p>\n
new  product or employs atleast one new reactant.  Therefore<\/p>\n
the  amended Section  is a comprehensive provision  covering<\/p>\n
all   fields   of  technology,  including   the   field   of<\/p>\n
pharmacology.  In our opinion, the explanation would come in<\/p>\n
aid  only  to  understand  what is meant by  the  expression<\/p>\n
“resulting  in the enhancement of a known efficacy”  in  the<\/p>\n
amended  section and therefore we have no doubt at all  that<\/p>\n
the Explanation would operate only when discovery is made in<\/p>\n
the  pharmacology  field.  In 1989 (4)  SCC  Pg.378  (Aphali<\/p>\n
Pharma.  Ltd. Vs. State of Maharashtra), in laying down  the<\/p>\n
law on “Explanation”, the Supreme Court held as hereunder:<\/p>\n
           “33.  An Explanation, as was found in Bihta<\/p>\n
     Marketing  Union  Vs. Bank  of  Bihar,  may  only<\/p>\n
     explain and may not expand or add to the scope of<\/p>\n
     the  original  section.  In State of  Bombay  Vs.<\/p>\n
     United  Motors, it was found that an  Explanation<\/p>\n
     could  introduce a fiction or settle a matter  of<\/p>\n
     controversy.   Explanation may  not  be  made  to<\/p>\n
     operate   as   “exception”  or  “proviso”.    The<\/p>\n
     construction of an Explanation, as  was  held  in<\/p>\n
     Collector  of  Customs Vs.  G.Dass  &  Co.,  must<\/p>\n
     depend  upon  its  terms and  no  theory  of  its<\/p>\n
     purpose  can be entertained unless it  is  to  be<\/p>\n
     inferred from the language used.  It was said  in<\/p>\n
     Burmah   Shell  Oil  Ltd.  Vs.  CTO,   that   the<\/p>\n
     Explanation was meant to explain the article  and<\/p>\n
     must  be  interpreted according to its own  tenor<\/p>\n
     and  it  was  an error to explain the Explanation<\/p>\n
     with  the  aid  of the article to  which  it  was<\/p>\n
     annexed.   We have to remember what was  held  in<\/p>\n
     Dattatraya   Govind   Mahajan   Vs.   State    of<\/p>\n
     Maharashtra, that mere description of  a  certain<\/p>\n
     provision, such as “Explanation” is not  decisive<\/p>\n
     of  its  true  meaning.   It  is  true  that  the<\/p>\n
     orthodox function of an Explanation is to explain<\/p>\n
     the  meaning and effect of the main provision  to<\/p>\n
     which  it is an explanation and to clear  up  any<\/p>\n
     doubt  or ambiguity in it, but ultimately  it  is<\/p>\n
     the  intention of legislature which is  paramount<\/p>\n
     and mere use of a label cannot control or deflect<\/p>\n
     such  intention.    State of  Bombay  Vs.  United<\/p>\n
     Motors  laid  down  that the interpretation  must<\/p>\n
     obviously depend upon the words used therein, but<\/p>\n
     this  must  be  borne  in  mind  that  when   the<\/p>\n
     provision is capable of two interpretations, that<\/p>\n
     should be adopted which fits the description.  An<\/p>\n
     Explanation is different in nature from a Proviso<\/p>\n
     for  a  Proviso  excepts, excludes  or  restricts<\/p>\n
     while an Explanation explains or clarifies.  Such<\/p>\n
     explanation or clarification may be in respect of<\/p>\n
     matters   whose  meaning  is  implicit  and   not<\/p>\n
     explicit in the main section itself.  In  Hiralal<\/p>\n
     Ratanlan Vs. State of U.P it was ruled that if on<\/p>\n
     a  true reading of an Explanation it appears that<\/p>\n
     it  has  widened the scope of the  main  section,<\/p>\n
     effect    be   given   to   legislative    intent<\/p>\n
     notwithstanding  the  fact that  the  legislature<\/p>\n
     named  that provision as an Explanation.  In  all<\/p>\n
     these  matters courts have to find out  the  true<\/p>\n
     intention of the legislature.  In D.G.Mahajan Vs.<\/p>\n
     State  of  Maharashtra,  this  court  said   that<\/p>\n
     legislature  has  different  ways  of  expressing<\/p>\n
     itself  and  in the last analysis the words  used<\/p>\n
     alone  are  repository of legislative intent  and<\/p>\n
     that   if   necessary  an  Explanation  must   be<\/p>\n
     construed according to its plain language and not<\/p>\n
     on any a priori consideration.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
In  2006 (8) SCC 613 ( (Hardev Motor Transport Vs. State  of<\/p>\n
M.P.), on the role of “Explanation”, the Supreme Court  held<\/p>\n
as hereunder:\n<\/p>\n<\/p>\n
          “31. The role of an Explanation of a statute<\/p>\n
     is  well  known.  By inserting an Explanation  in<\/p>\n
     the  Schedule of the Act, the main provisions  of<\/p>\n
     the  Act  cannot be defeated.  By  reason  of  an<\/p>\n
     Explanation, even otherwise, the scope and effect<\/p>\n
     of  a  provision cannot be enlarged.  It  was  so<\/p>\n
     held in S.Sundaram Pillai Vs. V.R.Pattabiraman in<\/p>\n
     the following terms: (SCC p.613, para 53)<\/p>\n
           “53.   Thus,  from  a  conspectus  of   the<\/p>\n
    authorities  referred  to above,  it  is  manifest<\/p>\n
    that  the  object of an Explanation to a statutory<\/p>\n
    provision is-\n<\/p><\/blockquote>\n
               (a)  to  explain the  meaning  and<\/p>\n
         intendment of the Act itself,<\/p>\n<\/blockquote>\n
              (b) where there is any obscurity or<\/p>\n
         vagueness  in  the  main  enactment,  to<\/p>\n
         clarify  the  same  so  as  to  make  it<\/p>\n
         consistent  with  the  dominant   object<\/p>\n
         which it seems to subserve,<\/p>\n
               (c  )  to  provide  an  additional<\/p>\n
         support  to the dominant object  of  the<\/p>\n
         Act  in order to make it meaningful  and<\/p>\n
         purposeful.\n<\/p><\/blockquote>\n
               (d)  an Explanation cannot in  any<\/p>\n
         way   interfere  with  or   change   the<\/p>\n
         enactment or any part thereof but  where<\/p>\n
         some  gap is left which is relevant  for<\/p>\n
         the purpose of the Explanation, in order<\/p>\n
         to suppress the mischief and advance the<\/p>\n
         object  of the Act it can help or assist<\/p>\n
         the   court  in  interpreting  the  true<\/p>\n
         purport and intendment of the enactment,<\/p>\n
         ….”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
    (See  also  Swedish  Match  AB  Vs.  Securities  &<\/p>\n
    Exchange Board of India).”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
In this case  we find that the Explanation creates a deeming<\/p>\n
fiction of derivatives of a known substance are deemed to be<\/p>\n
the  same  substance  unless they  differ  significantly  in<\/p>\n
properties  with regard to efficacy. Therefore it  is  clear<\/p>\n
from  the amended section and the Explanation that    in the<\/p>\n
pharmacology  field, if a discovery is  made  from  a  known<\/p>\n
substance, a duty is cast upon the patent applicant to  show<\/p>\n
that  the  discovery had resulted in the  enhancement  of  a<\/p>\n
known efficacy of that substance and in deciding whether  to<\/p>\n
grant a Patent or not on such new discovery, the Explanation<\/p>\n
creates  a deeming fiction that all derivatives of  a  known<\/p>\n
substance would be deemed to be the same substance unless it<\/p>\n
differ  significantly in properties with regard to efficacy.<\/p>\n
In  our  opinion, the amended section and Explanation   give<\/p>\n
importance  to efficacy.  We have already referred  to   the<\/p>\n
meaning   of  “efficacy”  as  given  in  Dorland’s   Medical<\/p>\n
Dictionary.   Scientifically it is  possible  to  show  with<\/p>\n
certainty   what  are  the  properties  of  a   “substance”.<\/p>\n
Therefore  when the Explanation to the amended section  says<\/p>\n
that any derivatives must differ significantly in properties<\/p>\n
with  regard to efficacy, it only means that the derivatives<\/p>\n
should  contain  such  properties  which  are  significantly<\/p>\n
different  with  regard to efficacy to  the  substance  from<\/p>\n
which  the  derivative  is  made.   Therefore  in  sum   and<\/p>\n
substance  what  the  amended section with  the  Explanation<\/p>\n
prescribes  is the test to decide whether the  discovery  is<\/p>\n
an  invention  or  not  is that the Patent applicant  should<\/p>\n
show  the discovery has resulted in the enhancement  of  the<\/p>\n
known  efficacy  of that substance and if the  discovery  is<\/p>\n
nothing  other  than  the derivative of a  known  substance,<\/p>\n
then,   it  must  be  shown  that  the  properties  in   the<\/p>\n
derivatives  differ significantly with regard  to  efficacy.<\/p>\n
As we stated earlier, due to  the advanced technology in all<\/p>\n
fields  of  science,  it  is  possible  to  show  by  giving<\/p>\n
necessary comparative details based on such science that the<\/p>\n
discovery of a new form a of known substance had resulted in<\/p>\n
the  enhancement  of the  known efficacy  of   the  original<\/p>\n
substance and the derivative so derived will not be the same<\/p>\n
substance,  since  the properties of the derivatives  differ<\/p>\n
significantly with regard to efficacy. As rightly  contended<\/p>\n
by learned Additional Solicitor General India and the leaned<\/p>\n
Senior  Counsels and learned counsels for the Pharmaceutical<\/p>\n
Company opposing the Writ that the writ petitioner is not  a<\/p>\n
novice   to   the   pharmacology   field   but   it,   being<\/p>\n
pharmaceutical giant in the whole of the world, cannot plead<\/p>\n
that  they  do  not know what is meant by enhancement  of  a<\/p>\n
known  efficacy  and they cannot snow that  the  derivatives<\/p>\n
differ  significantly in properties with regard to efficacy.<\/p>\n
Mr.P.S.Raman   learned  senior  counsel  argued   that   the<\/p>\n
Legislature, while enacting a Law, is entitled to  create  a<\/p>\n
deeming fiction and for that purpose, brought to our  notice<\/p>\n
a  judgment of the Supreme Court reported in AIR 1988 SC 191<\/p>\n
(M\/s.J.K.Cotton Spinning and Weaving Mills Ltd. Vs. Union of<\/p>\n
India)  where, in paragraph 40, the Supreme Court  had  said<\/p>\n
that  “the Legislature is quite competent to enact a deeming<\/p>\n
provision  for  the purpose of assuming the existence  of  a<\/p>\n
fact which does not really exist.”  It is also stated in the<\/p>\n
very  same paragraph that “it is well settled that a deeming<\/p>\n
provision is an admission of the non-existence of  the  fact<\/p>\n
deemed.”\n<\/p>\n<\/p>\n
      14.  It  is argued by learned Senior Counsels for  the<\/p>\n
writ  petitioners that it is possible for the Parliament  to<\/p>\n
define in the Act itself what is meant by enhancement  of  a<\/p>\n
known  efficacy and what is meant by differing significantly<\/p>\n
in properties with regard to efficacy. The above expressions<\/p>\n
are  vague  and  ambiguous by themselves and  therefore  the<\/p>\n
meaning of such expressions ought to have been given in  the<\/p>\n
Act  or  the  amended section.  Therefore when  the  meaning<\/p>\n
is  not  so given, then the vagueness and ambiguity  in  the<\/p>\n
provision would result in arbitrary exercise of power by the<\/p>\n
statutory   authority.   Opposing  this  argument,   learned<\/p>\n
Additional  Solicitor General of India  would  contend  that<\/p>\n
Parliament  is not an expert;  it cannot foresee the  future<\/p>\n
contingencies  which  may arise, when  they  enact  an  Act;<\/p>\n
therefore the Parliament always thinks it wise to  use  only<\/p>\n
general  expressions in the Statute leaving it to the  Court<\/p>\n
to  interpret  it depending upon the context in which it  is<\/p>\n
used  and  the facts that are made available in  each  case.<\/p>\n
For  this  purpose,  learned  Additional  Solicitor  General<\/p>\n
brought  to  our  notice the judgment of the  Supreme  Court<\/p>\n
reported  in 1995 Supp. (1) SCC 235  (Benilal Vs.  State  of<\/p>\n
Maharashtra)  and  1980  (1) SCC 340  (Registrar  of  Co-op.<\/p>\n
Societies  Vs.  K.Kunjabmu).  Mr.P.S.Raman,  learned  senior<\/p>\n
counsel  in  supporting the argument of  learned  Additional<\/p>\n
Solicitor General that the Parliament cannot foresee  things<\/p>\n
that  may  arise  in the future, brought to our  notice  the<\/p>\n
judgment  of the English Court reported in (1949)   2    All<\/p>\n
England  Law Reports 155 (Seaford Court Estates Vs.  Asher),<\/p>\n
to   understand and realise whether it would be possible  at<\/p>\n
all  to  foresee things that may arise in the future when  a<\/p>\n
Statute  comes  up for consideration before the  Houses  and<\/p>\n
what   would   be  the  duty  of  the  Judge   before   whom<\/p>\n
interpretation  of  such a Statute arise for  consideration.<\/p>\n
The  Court of Appeal in that judgment had laid down  the Law<\/p>\n
in that context as hereunder:\n<\/p>\n<\/p>\n
            “Whenever   a   statute   comes   up    for<\/p>\n
    consideration,  it must be remembered  that  it  is<\/p>\n
    not  within  human powers to foresee  the  manifold<\/p>\n
    sets  of  facts which may arise, and,  even  if  it<\/p>\n
    were,  it  is not possible to provide for  them  in<\/p>\n
    terms   free  from  all  ambiguity.   The   English<\/p>\n
    language  is  not  an  instrument  of  mathematical<\/p>\n
    precision.   Our  literature  would  be  much   the<\/p>\n
    poorer if it were.  This is where the draftsmen  of<\/p>\n
    Acts   of   Parliament  have  often  been  unfairly<\/p>\n
    criticised.   A  Judge,  believing  himself  to  be<\/p>\n
    fettered by the supposed rule that he must look  to<\/p>\n
    the  language  and nothing else, laments  that  the<\/p>\n
    draftsmen  have not provided for this or  that,  or<\/p>\n
    have  been  guilty of some or other ambiguity.   It<\/p>\n
    would certainly save the judges trouble if Acts  of<\/p>\n
    Parliament were drafted with divine prescience  and<\/p>\n
    perfect  clarity.  In the absence  of  it,  when  a<\/p>\n
    defect  appears  a  judge cannot  simply  fold  his<\/p>\n
    hands  and  blame the draftsman.  He  must  set  to<\/p>\n
    work  on  the  constructive  task  of  finding  the<\/p>\n
    intention  of Parliament, and he must do  this  not<\/p>\n
    only  from  the language of the statute,  but  also<\/p>\n
    from  a  consideration  of  the  social  conditions<\/p>\n
    which gave rise to it and of the mischief which  it<\/p>\n
    was  passed  to remedy, and then he must supplement<\/p>\n
    the written word so as to give “force and life”  to<\/p>\n
    the   intention  of  the  legislature.   That   was<\/p>\n
    clearly   laid  down  (3  Co.  Rep.  7b)   by   the<\/p>\n
    resolution  of  the  judgdes  (SIR  ROGER  MANWOOD,<\/p>\n
    C.B.,       and  the other barons of the Exchequer)<\/p>\n
    in  Heydon’s  case (4), and it is the safest  guide<\/p>\n
    to-day.   Good practical advice on the subject  was<\/p>\n
    given  about the same time by FLOWDEN in  his  note<\/p>\n
    (2  Plowd. 465) to Eyston Vs. Studd (5).  Put  into<\/p>\n
    homely  metaphor  it is this: A  judge  should  ask<\/p>\n
    himself the question how, if the makers of the  Act<\/p>\n
    had   themselves  come  across  this  ruck  in  the<\/p>\n
    texture  of  it,  they would have  straightened  it<\/p>\n
    out?   He must then do as they would have done.   A<\/p>\n
    judge must not alter the material of which the  Act<\/p>\n
    is  woven,  but  he  can and should  iron  out  the<\/p>\n
    creases.”\n<\/p>\n
In  1980 (1) SCC 340 referred to supra the Supreme Court had<\/p>\n
held as hereunder:\n<\/p>\n<\/p>\n
          “(1)  Parliament and the State  Legislatures<\/p>\n
    function  best  when they concern themselves  with<\/p>\n
    general    principles,   broad   objectives    and<\/p>\n
    fundamental   issues,  instead  of  technical   or<\/p>\n
    situational intricacies which are better  left  to<\/p>\n
    better  equipped full time expert executive bodies<\/p>\n
    and  specialist  public servants.  Parliament  and<\/p>\n
    the  State Legislatures have neither the  time  or<\/p>\n
    expertise   to   be   involved   in   detail    or<\/p>\n
    circumstance,  nor can visualise and  provide  for<\/p>\n
    new    strange    unforeseen   or    unpredictable<\/p>\n
    situations.   That  is  the  raison   d’etre   for<\/p>\n
    delegated  legislation.  The  power  to  legislate<\/p>\n
    carries  with  it  the  power  to  delegate.   But<\/p>\n
    excessive  delegation  may amount  to  abdication.<\/p>\n
    Delegation   unlimited   may   invite    despotism<\/p>\n
    uninihibited.    So  the theory has  been  evolved<\/p>\n
    that the legislature cannot delegate its essential<\/p>\n
    legislative  function.   Legislate  it  must,   by<\/p>\n
    laying  down policy and principle and delegate  it<\/p>\n
    may  to fill in detail and carry out policy.   The<\/p>\n
    legislature  may  guide the delegate  by  speaking<\/p>\n
    through    the   express   provision    empowering<\/p>\n
    delegation or the other provisions of the  statute<\/p>\n
    such  as the preamble, the scheme or even the very<\/p>\n
    subject-matter of the statute.  If guidance  there<\/p>\n
    is,  wherever  it may be found, the delegation  is<\/p>\n
    valid.   A good deal of latitude has been held  to<\/p>\n
    be  permissible in the case of taxing statutes and<\/p>\n
    on  the same principle generous degree of latitude<\/p>\n
    must   be  permissible  in  the  case  of  welfare<\/p>\n
    legislation, particularly those statutes which are<\/p>\n
    designed  to  further the Directive Principles  of<\/p>\n
    State Policy.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
In  1995  Supp. (1) SCC 235 referred to supra,  the  Supreme<\/p>\n
Court had held as hereunder:\n<\/p>\n<\/p>\n
           “It  is  well  settled that the  legislative<\/p>\n
     scheme  may  employ words of generality  conveying<\/p>\n
     its  policy  and intention to achieve  the  object<\/p>\n
     set  out therein.  Every word need not be defined.<\/p>\n
     It  may  be  a matter of judicial construction  of<\/p>\n
     such   words  or  phrases.   Mere  fact   that   a<\/p>\n
     particular word or phrase has not been defined  is<\/p>\n
     not  a ground to declare the provisions of the Act<\/p>\n
     itself  or  the  order  as unconstitutional.   The<\/p>\n
     word  “habitual” cannot be put in  a  straitjacket<\/p>\n
     formula.   It is a matter of judicial construction<\/p>\n
     and  always  depends  upon  the  given  facts  and<\/p>\n
     circumstances  in  each  case.   As  to  when   an<\/p>\n
     inference  that a tenant is habitually in  arrears<\/p>\n
     disentitling  him to the protection of  the  Order<\/p>\n
     could  be  drawn  is a question of  fact  in  each<\/p>\n
     case.   But on that ground or circumstance itself,<\/p>\n
     the provision of the Act cannot be declared to  be<\/p>\n
     ultra vires.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
The commentary on canons – interpretation of broad terms  in<\/p>\n
Bennion  –  Statutory Interpretation contains the  following<\/p>\n
passage:\n<\/p>\n<\/p>\n
          “For  the  sake of brevity, or  because  the<\/p>\n
    enactment  has  to  deal with  a  multiplicity  of<\/p>\n
    circumstances, the draftsman often  uses  a  broad<\/p>\n
    term.    This   has  the  effect   of   delegating<\/p>\n
    legislative power to the courts and officials  who<\/p>\n
    are  called  upon  to  apply the  enactment.   The<\/p>\n
    governing  legal  maxim is  generalia  verba  sunt<\/p>\n
    generaliter intelligenda (general words are to  be<\/p>\n
    understood   generally).   {3   Co   Inst   76.See<\/p>\n
    Examples  78.5, 80.5 and 83.1}  It is  not  to  be<\/p>\n
    supposed  that  the draftsman could  have  had  in<\/p>\n
    mind  every  possible combination of circumstances<\/p>\n
    which  may  chance  to  fall  within  the  literal<\/p>\n
    meaning   of  general  words.   {For  a   detailed<\/p>\n
    discussion  of the concept of the broad  term  see<\/p>\n
    Bennion Statute Law (2nd edn, 1983) Chap. 13}<\/p>\n
          The  broad  term which is a substantive  has<\/p>\n
    been  called a nomen generale.  {Hunter Vs. Bowyer<\/p>\n
    (1850)  15 LTOS 281.}  Other judicial descriptions<\/p>\n
    of  the broad term include ‘open-ended expression’<\/p>\n
    {Express Newspapers Ltd Vs. McShane [1980]  2  WLR<\/p>\n
    89,  at  p  94.},  ‘word of  the  most  loose  and<\/p>\n
    flexible  description’ {Green v Marsden  (1853)  1<\/p>\n
    Drew   646.}   and  ‘somewhat  comprehensive   and<\/p>\n
    somewhat indeterminate term’.  {Campbell  v  Adair<\/p>\n
    [1945] JC 29.}<\/p>\n
          The broadest terms, such as ‘reasonable’  or<\/p>\n
    ‘just’,  virtually give the court or  official  an<\/p>\n
    unlimited  delegated  authority,  subject  to  the<\/p>\n
    remedies  available on judicial review or  appeal.<\/p>\n
    {As  to  these  see  s 24 of this  Code  (judicial<\/p>\n
    review) and s 23 (appeal).}”\n<\/p><\/blockquote>\n
In  Girdhari Lal’s case referred to supra, the Supreme Court<\/p>\n
held as hereunder:\n<\/p>\n<\/p>\n
           “Again,  the words of a statute may  not  be<\/p>\n
     designed   to   meet  the  several  uncontemplated<\/p>\n
     forensic situations that may arise.  The draftsman<\/p>\n
     may  have  designed his words to  meet  what  Lord<\/p>\n
     Simon  of Glaisdale calls the “primary situation”.<\/p>\n
     It  will  then become necessary for the  court  to<\/p>\n
     impute  an  intention to Parliament in  regard  to<\/p>\n
     “secondary     situations”.     Such    “secondary<\/p>\n
     intention”  may  be  imputed  in  relation  to   a<\/p>\n
     secondary situation so as to best serve  the  same<\/p>\n
     purpose as the primary statutory intention does in<\/p>\n
     relation to a primary situation.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
Therefore it is clear from the case laws referred  to  above<\/p>\n
that  Parliamentarians expresses its object and  purpose  in<\/p>\n
general  terms when enacting a Statute and does not  foresee<\/p>\n
the  minute  details that are likely to arise in the  future<\/p>\n
and provide a solution for the same at the time when the Act<\/p>\n
itself  is enacted.  On the other hand, they would be acting<\/p>\n
wiser  if they make only general expressions, leaving it  to<\/p>\n
the  experts  \/  Statutory Authorities and then  courts,  to<\/p>\n
understand  the general expressions used in the  Statute  in<\/p>\n
the  context in which they are used in a case to case  basis<\/p>\n
depending  upon  the facts available in  each  case.   Using<\/p>\n
general  expressions  in a Statute,  leaving  the  court  to<\/p>\n
understand it’s meaning, would not be a ground to declare  a<\/p>\n
section or an Act ultra vires, is the law laid down  by  the<\/p>\n
Supreme   Court  in  Benilal’s  case  referred   to   supra.<\/p>\n
Interpretation  of a Statute must be to advance  the  object<\/p>\n
which the  Act wants to achieve.\n<\/p>\n<\/p>\n
      15. Now, we went through the statements of objects and<\/p>\n
reasons  of Amending Act 15\/2005.  As rightly emphasized  by<\/p>\n
Mr.Soli  Sorabji learned senior counsel for the petitioners,<\/p>\n
the  statement  of  objects  and reasons  for  Amending  Act<\/p>\n
15\/2005 emphasises in more than one place that the amendment<\/p>\n
is  in the discharge of India’s obligation to “TRIPS”, which<\/p>\n
forms  part  of the “WTO” agreement.  Therefore a  need  has<\/p>\n
arisen  for us to look into the relevant Articles of “TRIPS”<\/p>\n
for  the  limited  purpose of what obligations  are  created<\/p>\n
under  “TRIPS”, which, India was attempting to discharge  by<\/p>\n
bringing  in Amending Act 15\/2005.    Article 7  of  “TRIPS”<\/p>\n
provides  enough elbow room to a member country in complying<\/p>\n
with  “TRIPS”  obligations by bringing a  law  in  a  manner<\/p>\n
conducive to social and economic welfare and to a balance of<\/p>\n
rights  and  obligations.  Article 1 of  “TRIPS”  enables  a<\/p>\n
member  country free to determine the appropriate method  of<\/p>\n
implementing  the provisions of this agreement within  their<\/p>\n
own  legal system and practice.  But however, any protection<\/p>\n
which a member country provides, which is more extensive  in<\/p>\n
nature  than is required under “TRIPS”, shall not contravene<\/p>\n
“TRIPS”.  Article  27 speaks about patentability.    Lengthy<\/p>\n
arguments   have   been  advanced  by   learned   Additional<\/p>\n
Solicitor  General  appearing for the Government  of  India,<\/p>\n
learned  senior counsels and learned counsels appearing  for<\/p>\n
the pharmaceutical companies that India, being a welfare and<\/p>\n
a  developing country, which  is pre-dominantly occupied  by<\/p>\n
people  below poverty line, it has a constitutional duty  to<\/p>\n
provide  good  health care to it’s citizens by  giving  them<\/p>\n
easy access to life saving drugs.  In so doing, the Union of<\/p>\n
India would be right, it is argued, to take into account the<\/p>\n
various  factual aspects prevailing in this big country  and<\/p>\n
prevent  evergreening  by allowing generic  medicine  to  be<\/p>\n
available  in  the  market.   As rightly  contended  by  the<\/p>\n
learned   Additional  Solicitor  General   of   India,   the<\/p>\n
Parliamentary debates show that welfare of the people of the<\/p>\n
country  was  in  the  mind  of the   Parliamentarians  when<\/p>\n
Ordinance  7\/2004 was in the House.  They also had  in  mind<\/p>\n
the International obligations of India arising under “TRIPS”<\/p>\n
and  under “WTO” agreement.  Therefore the validity  of  the<\/p>\n
amended  section  on the touchstone of  Article  14  of  the<\/p>\n
Constitution of India must be decided having regard  to  the<\/p>\n
object which Amending Act 15\/2005 wanted to achieve.<\/p>\n
     16. It is argued by the learned senior counsels for the<\/p>\n
petitioners that since the amended section uses only general<\/p>\n
expressions,  leaving  it  to  the  Statutory  Authority  to<\/p>\n
understand what it means, the Statutory Authority is  likely<\/p>\n
to  act arbitrarily in exercising it’s discretion, since  it<\/p>\n
has  no  guidelines.  We have already held that the  amended<\/p>\n
section  cannot  be  said  to be  vague  or  ambiguous.   We<\/p>\n
reiterate  here at this stage that the amended section  with<\/p>\n
it’s  Explanation is capable of being understood and  worked<\/p>\n
out  in a normal manner not only by the Patent applicant but<\/p>\n
also  by the Patent controller.  In other words, the  patent<\/p>\n
controller would be guided by various relevant details which<\/p>\n
every  patent  applicant is expected to produce  before  him<\/p>\n
showing  that  the  new  discovery  had  resulted   in   the<\/p>\n
enhancement  of the known efficacy;  the derivatives  differ<\/p>\n
significantly  in  properties with regard  to  efficacy  and<\/p>\n
therefore  it cannot be said that the patent controller  had<\/p>\n
an  uncanalised power to exercise, leading to arbitrariness.<\/p>\n
The argument that the amended section must be held to be bad<\/p>\n
in  Law  since for want of guidelines it gives scope to  the<\/p>\n
Statutory Authority to exercise it’s power arbitrarily,  has<\/p>\n
to be necessarily rejected since, we find that there are in-<\/p>\n
built  materials in the amended section and the  Explanation<\/p>\n
itself,  which  would control \/ guide the discretion  to  be<\/p>\n
exercised by the Statutory Authority.   In other words,  the<\/p>\n
Statutory  Authority  would  be  definitely  guided  by  the<\/p>\n
materials  to  be  placed  before   it  for  arriving  at  a<\/p>\n
decision.   Mr.P.S.Raman learned senior counsel  brought  to<\/p>\n
our  notice  two judgments of the Supreme Court reported  in<\/p>\n
AIR  1957  SC 397 (M\/s.Pannalal Binjraj Vs. Union of  India)<\/p>\n
and  (1974)  1 SCC 549 (State of Punjab Vs. Khan  Chand)  to<\/p>\n
highlight   the   types   of  discretions,   if   exercised,<\/p>\n
affecting various rights and the outcome of such exercise of<\/p>\n
discretion.   We  extract  paragraph  34  of  the   judgment<\/p>\n
reported in AIR 1957 SC 397 hereunder:\n<\/p>\n<\/p>\n
           “34.  There is a broad distinction  between<\/p>\n
     discretion which has to be exercised with  regard<\/p>\n
     to   a   fundamental  right  guaranteed  by   the<\/p>\n
     Constitution  and some other right whichis  given<\/p>\n
     by  the  statute.  If the statute  deals  with  a<\/p>\n
     right  which is not fundamental in character  the<\/p>\n
     statute can take it away but a fundamental  right<\/p>\n
     the statute cannot take away.  Where for example,<\/p>\n
     a  discretion is given in the matter  of  issuing<\/p>\n
     licences  for  carrying on trade,  profession  or<\/p>\n
     business  or  where restrictions are  imposed  on<\/p>\n
     freedom  of  speech  etc., by the  imposition  of<\/p>\n
     censorship, the discretion must be controlled  by<\/p>\n
     clear rules so as to come within the category  of<\/p>\n
     reasonable  restrictions.   Discretion  of   that<\/p>\n
     nature must be differentiated from discretion  in<\/p>\n
     respect  of  matters  not  involving  fundamental<\/p>\n
     rights   such   as  transfers   of   cases.    As<\/p>\n
     inconvenience resulting from a change of place or<\/p>\n
     venue  occurs  when any case is transferred  from<\/p>\n
     one  place  to another but it is not  open  to  a<\/p>\n
     party  to  say that a fundamental right has  been<\/p>\n
     infringed by such transfer.  In other words,  the<\/p>\n
     discretion  vested has to be looked at  from  two<\/p>\n
     points  of view, viz., (1) does it admit  of  the<\/p>\n
     possibility   of   any   real   and   substantial<\/p>\n
     discrimination,  and (2) does  it  impinge  on  a<\/p>\n
     fundamental right guaranteed by the Constitution?<\/p>\n
     Article  14  can be invoked only when both  these<\/p>\n
     conditions are satisfied.  Applying this test, it<\/p>\n
     is  clear that the discretion which is vested  in<\/p>\n
     the  Commissioner of Income – Tax or the  Central<\/p>\n
     Board  of Revenue, as the case may be, under  s.5<\/p>\n
     (7-A) is not at all discriminatory.”<\/p>\n<\/blockquote>\n
From  the above extracted portion, it is clear that  Article<\/p>\n
14 can be invoked only when it is shown that in the exercise<\/p>\n
of  a  discretionary power there is a possibility of a  real<\/p>\n
and  substantial discrimination and such exercise interferes<\/p>\n
with  the  fundamental right guaranteed by the Constitution.<\/p>\n
This  judgment  is  by a Constitution Bench.     The  latter<\/p>\n
judgment   [(1974)  1 SCC 549]  is also  by  a  Constitution<\/p>\n
Bench,  which also quotes with approval the above  extracted<\/p>\n
passage,  in paragraph No.10 of that judgment.   It  is  not<\/p>\n
shown  by  the  learned senior counsels  appearing  for  the<\/p>\n
petitioners   before  us  that  in  the  exercise   of   the<\/p>\n
discretionary  power by the Patent controller,  any  of  the<\/p>\n
petitioner’s  fundamental rights  are  violated  namely,  to<\/p>\n
carry  on  the  trade  or  the petitioner  stand  singularly<\/p>\n
discriminated.  We find that the  amended section by  itself<\/p>\n
does  not discriminate nor does it prohibit the trade  being<\/p>\n
carried on.\n<\/p>\n<\/p>\n
     17. It is argued by the learned senior counsels for the<\/p>\n
petitioners that the Statutory Authority is likely to misuse<\/p>\n
the  discretion  vested in it  by throwing  out  the  patent<\/p>\n
application  as  “not  an invention”, by  relying  upon  the<\/p>\n
amended  section, when the amended section itself  does  not<\/p>\n
contain  any  guidelines.  We have already  found  that  the<\/p>\n
amended section has in-built protection enabling each of the<\/p>\n
patent  applicant to establish before the patent  controller<\/p>\n
that  his discovery had resulted in the enhancement  of  the<\/p>\n
known  efficacy  of that substance and the  derivatives  are<\/p>\n
significantly  differing  in  properties  with   regard   to<\/p>\n
efficacy.   Therefore  it boils down to  only  one  question<\/p>\n
namely, could an arbitrary exercise of a discretionary power<\/p>\n
invalidate  an Act?  We have a direct answer for this  point<\/p>\n
in  favour of the State from a judgment of the Supreme Court<\/p>\n
reported in 2006 (8) SCC 212 (M.Nagaraj Vs. Union of India),<\/p>\n
where,  in paragraph No.106, the Supreme Court had  held  as<\/p>\n
hereunder:\n<\/p>\n<\/p>\n
         “Every discretionary power is not necessarily<\/p>\n
    discriminatory.   According to the  Constitutional<\/p>\n
    Law  of  India, by H.M.Seervai, 4th  Edn.,  p.546,<\/p>\n
    equality  is  not violated by mere  conferment  of<\/p>\n
    discretionary power.  It is violated by  arbitrary<\/p>\n
    exercise  by those on whom it is conferred.   This<\/p>\n
    is  the theory of “guided power”.  This theory  is<\/p>\n
    based  on  the  assumption that in  the  event  of<\/p>\n
    arbitrary exercise by those on whom the  power  is<\/p>\n
    conferred, would be corrected by the courts.”<\/p>\n<\/blockquote>\n
In     the    judgment    reported    in    2007-1-LW.Pg.724<\/p>\n
(Selvi.J.Jayalalitha  & Others Vs.  The  Union  of  India  &<\/p>\n
Others), rendered by one of us (Justice Prabha Sridevan), in<\/p>\n
dealing  with  such  a contention namely,  an  Act  must  be<\/p>\n
invalidated because of possible misuse and abuse of the law,<\/p>\n
it was held as hereunder:\n<\/p>\n<\/p>\n
           “67. It was also contended that there could<\/p>\n
     be  flagrant  misuse and abuse of the  law.   The<\/p>\n
     possibility  of flagrant abuse or misuse  of  law<\/p>\n
     has  never  been a ground for holding a provision<\/p>\n
     ultra   vires.   We  cannot  presume   that   the<\/p>\n
     authorities will administer the law “with an evil<\/p>\n
     eye  and an unequal hand.”  This has been so held<\/p>\n
     in several cases where the constitutionality of a<\/p>\n
     legal  provision was attacked.  The  observations<\/p>\n
     of  the  Supreme  Court  in  Krishna  Lal’s  case<\/p>\n
     (supra),   where  the  Kerala  Abkari   Act   was<\/p>\n
     challenged,  are  squarely  applicable   to   the<\/p>\n
     present  case.  Merely because the  Act  requires<\/p>\n
     the   assessee   to   prove   that   there   were<\/p>\n
     circumstances  which prevented the assessee  from<\/p>\n
     filing  the  return,  it  would  not  amount   to<\/p>\n
     violation of Article 20(3) of the Constitution.”<\/p>\n<\/blockquote>\n
We  have  already  found  that  there  is  no  ambiguity  or<\/p>\n
vagueness   in  the  expressions  under  attack   as   found<\/p>\n
incorporated  in  the  amended section and  the  Explanation<\/p>\n
attached  to  it.  Ultimately,  in that case the conclusions<\/p>\n
were  summed up  by saying (See paragraph 75) that  “no  law<\/p>\n
can  be  declared illegal because there is a possibility  of<\/p>\n
its  misuse”  and  “the Legislature has a duty to  safeguard<\/p>\n
the economic interest of the country.”  When the validity of<\/p>\n
any  law  touching upon the economic interests of a  country<\/p>\n
comes  up  before court, what the court should do, had  been<\/p>\n
stated  by  the Supreme Court  in the judgment  reproted  in<\/p>\n
(2006)  6  SCC 213 (Reiz Electrocontrols (P) Ltd. Vs.  CCE).<\/p>\n
In  paragraph No.10 of that judgment, the Supreme Court  had<\/p>\n
extracted paragraph No.10 of it’s earlier judgment  reported<\/p>\n
in  (1996) 3 SCC 407 (Union of India Vs. Paliwal Electricals<\/p>\n
(P) Ltd.), wherein it was found stated as hereunder:<\/p>\n
           “It  is equally necessary to determine,  as<\/p>\n
     pointed  out  repeatedly by this court,  that  in<\/p>\n
     economic  and  taxation spheres,  large  latitude<\/p>\n
     should be allowed to the Legislature.”<\/p>\n<\/blockquote>\n
We  could  see  that the  Supreme Court, in  Paliwal’s  case<\/p>\n
namely,  (1996)  3  SCC  407 had  borne  in  it’s  mind  the<\/p>\n
observations  made by a Constitution Bench  of  the  Supreme<\/p>\n
Court  in R.K.Garg Vs. Union of India (1981) 4 SCC 675.   In<\/p>\n
R.K.Garg’s case,  the following paragraph is found:<\/p>\n
           “Another  rule of equal importance  is  that<\/p>\n
     laws  relating  to economic activities  should  be<\/p>\n
     viewed  with  greater latitude than laws  touching<\/p>\n
     civil  rights such as freedom of speech, religion,<\/p>\n
     etc.   It  has been said by no less a person  than<\/p>\n
     Holmes,  J. that the legislature should be allowed<\/p>\n
     some  play in the joints, because it has  to  deal<\/p>\n
     with  complex  problems  which  do  not  admit  of<\/p>\n
     solution  through any doctrinaire or  straitjacket<\/p>\n
     formula  and this is particularly true in case  of<\/p>\n
     legislation dealing with economic matters,  where,<\/p>\n
     having  regard  to  the  nature  of  the  problems<\/p>\n
     required  to  be dealt with, greater play  in  the<\/p>\n
     joints has to be allowed to the legislature.   The<\/p>\n
     Court  should feel more inclined to give  judicial<\/p>\n
     deference to legislative judgment in the field  of<\/p>\n
     economic  regulation  than in  other  areas  where<\/p>\n
     fundamental  human  rights are involved.   Nowhere<\/p>\n
     has   this   admonition  been  more   felicitously<\/p>\n
     expressed   than   in   Morey   Vs.   Doud   where<\/p>\n
     Frankfurter, J. said in his inimitable style:<\/p>\n<\/blockquote>\n
              “In the utilities, tax and economic<\/p>\n
         regulation cases, there are good reasons<\/p>\n
         for   judicial  self-restraint  if   not<\/p>\n
         judicial    deference   to   legislative<\/p>\n
         judgment.  The legislature after all has<\/p>\n
         the   affirmative  responsibility.   The<\/p>\n
         courts  have only the power to  destroy,<\/p>\n
         not  to  reconstruct.   When  these  are<\/p>\n
         added  to  the  complexity  of  economic<\/p>\n
         regulation,    the   uncertainty,    the<\/p>\n
         liability   to  error,  the  bewildering<\/p>\n
         conflict of the experts, and the  number<\/p>\n
         of  times the Judges have been overruled<\/p>\n
         by  events – self-limitation can be seen<\/p>\n
         to  be  the path of judicial wisdom  and<\/p>\n
         institutional prestige and stability.”<\/p>\n<\/blockquote>\n<\/blockquote>\n
     The  court  must always remember that “legislation<\/p>\n
     is   directed  to  practical  problems,  that  the<\/p>\n
     economic   mechanism  is  highly   sensitive   and<\/p>\n
     complex,  that  many  problems  are  singular  and<\/p>\n
     contingent,    that   laws   are   not    abstract<\/p>\n
     propositions  and do not relate to abstract  units<\/p>\n
     and  are  not to be measured by abstract symmetry”<\/p>\n
     that  exact wisdom and nice adaptation  of  remedy<\/p>\n
     are  not  always  possible and that  “judgment  is<\/p>\n
     largely   a   prophecy   based   on   meagre   and<\/p>\n
     uninterpreted   experience”.   Every   legislation<\/p>\n
     particularly  in economic matters  is  essentially<\/p>\n
     empiric  and  it  is  based on experimentation  or<\/p>\n
     what  one  may  call trial and  error  method  and<\/p>\n
     therefore  it  cannot  provide  for  all  possible<\/p>\n
     situations  or  anticipate  all  possible  abuses.<\/p>\n
     There   may   be   crudities  and  inequities   in<\/p>\n
     complicated experimental economic legislation  but<\/p>\n
     on  that account alone it cannot be struct down as<\/p>\n
     invalid.   The  courts cannot, as pointed  out  by<\/p>\n
     the  United  States Supreme Court in Secretary  of<\/p>\n
     Agriculture  Vs.  Central  Roig  Refining  Co.  be<\/p>\n
     converted  into  tribunals for  relief  from  such<\/p>\n
     crudities  and  inequities.   There  may  even  be<\/p>\n
     possibilities  of abuse, but that  too  cannot  of<\/p>\n
     itself   be   a   ground  for   invalidating   the<\/p>\n
     legislation,  because it is not possible  for  any<\/p>\n
     legislature  to  anticipate as if by  some  divine<\/p>\n
     prescience,   distortions  and   abuses   of   its<\/p>\n
     legislation which may be made by those subject  to<\/p>\n
     its   provisions  and  to  provide  against   such<\/p>\n
     distortions  and abuses.  Indeed, howsoever  great<\/p>\n
     may  be  the care bestowed on its framing,  it  is<\/p>\n
     difficult  to conceive of a legislation  which  is<\/p>\n
     not  capable  of  being abused by perverted  human<\/p>\n
     ingenuity.   The court must therefore adjudge  the<\/p>\n
     constitutionality  of  such  legislation  by   the<\/p>\n
     generality  of  its  provisions  and  not  by  its<\/p>\n
     crudities  or  inequities or by the  possibilities<\/p>\n
     of  abuse  come  to  light,  the  legislature  can<\/p>\n
     always  step  in  and  enact  suitable  amendatory<\/p>\n
     legislation.   That  is the essence  of  pragmatic<\/p>\n
     approach   which  must  guide  and   inspire   the<\/p>\n
     legislature  in  dealing  with  complex   economic<\/p>\n
     issues.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
In  fact,  we  find that the above position in law  is  also<\/p>\n
spoken  to  by  another  Constitution Bench of  the  Supreme<\/p>\n
Court in the judgment reported in 2001 (4) SCC 139 (Union of<\/p>\n
India Vs. Elphinstone Spinning & Weaving Co. Ltd.) (See para<\/p>\n
11).  It is a settled position in law  (See (2001) 4 SCC 139<\/p>\n
–  (at  page  158  )  that “it must  be  presumed  that  the<\/p>\n
Legislature understands and correctly appreciates  the  need<\/p>\n
of  its  own people, that its laws are directed to  problems<\/p>\n
made manifest by experience and that its discriminations are<\/p>\n
based    on    adequate     grounds.”      We    now    went <\/p>\n
through     the     Patents     Act,   1970     as   amended <\/p>\n
by    Act    15\/2005.    In    India    there   was  an  Act<\/p>\n
called  Indians  Patent & Designs Act enacted  in  the  year<\/p>\n
1911.   The statement of objects and reasons of the  Patents<\/p>\n
Act,   1970  (Act  39\/1970)  noticed  that  since  the  1911<\/p>\n
enactment,  there  had  been  substantial  changes  in   the<\/p>\n
political  and  economic  conditions  of  the  country   and<\/p>\n
therefore a need has arisen for a comprehensive law so as to<\/p>\n
ensure  more effectively that patent rights are  not  worked<\/p>\n
out to the detriment of the consumer or to the prejudice  of<\/p>\n
trade  or  the industrial development of the country,  which<\/p>\n
was  felt  as  early  as 1948 resulting  in  the  Government<\/p>\n
appointing  the  Patents  Enquiry Committee  to  review  the<\/p>\n
working  of the Patents Law in India.  Therefore right  from<\/p>\n
the  year  1948  or so, the Parliament was aware  about  the<\/p>\n
change in the economic conditions of the country, which made<\/p>\n
them  to  change the 1911 enactment to suit to the needs  of<\/p>\n
the  economic  conditions of the country.   Therefore  there<\/p>\n
cannot be any doubt at all that the Patents Act as it  stood<\/p>\n
then  and  as it stands today, is designed to safeguard  the<\/p>\n
economic  interests of this country and if that is  so,  the<\/p>\n
amended section must be viewed with greater latitude.<\/p>\n
      18. In 1996 (3) SCC 709 (State of A.P. Vs. Mc Dowell &<\/p>\n
Co.)  the Supreme Court reiterated the position that “a  law<\/p>\n
made by Parliament  or the Legislature can be struck down by<\/p>\n
courts on two grounds and two grounds alone namely, lack  of<\/p>\n
legislative  competence  and  violation  of   any   of   the<\/p>\n
fundamental   rights  guaranteed  in   Part   III   of   the<\/p>\n
Constitution   of  India  or  of  any  other  Constitutional<\/p>\n
provision.”   There is no third ground.  In the case  before<\/p>\n
us, learned senior counsels, except arguing that the amended<\/p>\n
section  must  be  struck down on the ground  of  ambiguity,<\/p>\n
arbitrariness, leading to exercise of uncanalised  powers  –<\/p>\n
with  which  we have not agreed at all – had not  shown  any<\/p>\n
other  legal  ground to invalidate the amended section.   In<\/p>\n
the same judgment, the Supreme Court had held as follows:<\/p>\n
          “No  enactment can be struck  down  by  just<\/p>\n
    saying  that  it  is  arbitrary  or  unreasonable.<\/p>\n
    Some  or other Constitutional infirmity has to  be<\/p>\n
    found  before  invalidating an Act.  An  enactment<\/p>\n
    cannot  be  struck down on the ground  that  court<\/p>\n
    thinks   it   unjustified.  Parliament   and   the<\/p>\n
    Legislatures,  composed  as  they   are   of   the<\/p>\n
    representatives  of the people,  are  supposed  to<\/p>\n
    know  and be aware of the needs of the people  and<\/p>\n
    what  is good and bad for them.  The court  cannot<\/p>\n
    sit in judgment over their wisdom.”<\/p>\n<\/blockquote>\n
In  (2006) 3 SCC 434 (Bombay Dyeing & Mfg. Co.Ltd.  (3)  Vs.<\/p>\n
Bombay  Environmental Action Group) (See paragraph  205)  it<\/p>\n
was  held  by the Supreme court that “arbitrariness  on  the<\/p>\n
part  of  the  legislature  so as to  make  the  legislation<\/p>\n
violative   of   Article  14  of  the  Constitution   should<\/p>\n
ordinarily   be  manifest  arbitrariness.  What   would   be<\/p>\n
arbitrary  exercise of legislative power would  depend  upon<\/p>\n
the  provisions  of the statute vis-a-vis  the  purpose  and<\/p>\n
object  thereof”.   In AIR 1961 SC 1602 (Jyoti  Pershad  Vs.<\/p>\n
Union  Territory  of  Delhi)  the  Supreme  Court  held   as<\/p>\n
hereunder:\n<\/p>\n<\/p>\n
         “So long as the Legislature indicates, in the<\/p>\n
    operative   provisions   of   the   statute   with<\/p>\n
    certainty,   the   policy  and  purpose   of   the<\/p>\n
    enactment,  the mere fact that the legislation  is<\/p>\n
    skeletal, or the fact that a discretion is left to<\/p>\n
    those   entrusted  with  administering  the   law,<\/p>\n
    affords  no  basis either for the contention  that<\/p>\n
    there   has   been  an  excessive  delegation   of<\/p>\n
    legislative power as to amount to an abdication of<\/p>\n
    its  functions, or that the discretion  vested  is<\/p>\n
    uncanalised and unguided as to amount to  a  carte<\/p>\n
    blanche   to  discriminate.   If  the   power   or<\/p>\n
    discretion has been conferred in a manner which is<\/p>\n
    legal and constitutional, the fact that Parliament<\/p>\n
    could possibly have made more detailed provisions,<\/p>\n
    could  obviously not be a ground for  invalidating<\/p>\n
    the law.”\n<\/p><\/blockquote>\n
\n<\/blockquote>\n
As  we  have already found, the amended section has in-built<\/p>\n
measures to guide the Statutory Authority in exercising it’s<\/p>\n
power  under  the Act.  We have also found that the  amended<\/p>\n
section   does  not  suffer  from  the  vice  of  vagueness,<\/p>\n
ambiguity and arbitrariness.   The Statutory Authority would<\/p>\n
be  definitely guided in deciding whether a discovery is  an<\/p>\n
invention or not by the materials to be placed before him by<\/p>\n
the Patent applicant.  If that is so, then, going by the law<\/p>\n
laid  down by the Supreme Court in M.Nagaraj’s case referred<\/p>\n
to  supra,  if  the Statutory Authority, in  exercising  his<\/p>\n
power,  mis-directs  himself;  abuses  his  power    in   an<\/p>\n
arbitrary  manner and passes an order, then, the same  could<\/p>\n
be  corrected by the hierarchy of forums provided in the Act<\/p>\n
itself  in addition to the further reliefs available  before<\/p>\n
the Courts of Law.  When that is the position, then, we have<\/p>\n
to  necessarily  state that the amended  section  cannot  be<\/p>\n
invalidated solely on the ground that there is a possibility<\/p>\n
of misusing the power.\n<\/p>\n<\/p>\n
     19. Now we refer to the decisions mainly relied upon by<\/p>\n
the  learned  senior counsel  for the petitioners.   Mr.Soli<\/p>\n
Sorabji  learned  senior counsel relied upon  the  following<\/p>\n
judgments:\n<\/p>\n<\/p>\n
         (a) AIR 1960 SC 554 (Hamdard Dawakhana & Anr.<\/p>\n
    Vs. The Union of India & Others);\n<\/p><\/blockquote>\n
<\/blockquote>\n
          (b)  1961 Crl.L.J. 442 (The State of  Madhya<\/p>\n
    Pradesh & Anr. Vs. Baldeo Prasad);\n<\/p><\/blockquote>\n
<\/blockquote>\n
         (c ) AIR 1970 SC 1453  (Harakchand Ratanchand<\/p>\n
    Banthia & Others Vs. Union of India);  and<\/p>\n<\/blockquote>\n
          (d)  AIR 1967 SC 829 (Lala Hari Chand  Sarda<\/p>\n
    Vs. Mizo District Council and Another).<\/p>\n<\/blockquote>\n
We  went through the judgments very carefully.  In the first<\/p>\n
case, the Legislation impugned was stated to be in violation<\/p>\n
of  Article 19 – restriction on freedom of speech –  of  the<\/p>\n
Constutiton of India.  In considering the provisions of  the<\/p>\n
Act  challenged, the Supreme Court found that sections  3(d)<\/p>\n
and  8 of the Act are unconstitutional and arbitrary as they<\/p>\n
provided uncontrolled power to the executives to do the act.<\/p>\n
In  the  second case, the validity of Central Provinces  and<\/p>\n
Berar  Goondas Act, 1946 was in challenge.  The  Apex  Court<\/p>\n
found  various infirmities in the operative sections of  the<\/p>\n
Act  and upheld the order of the High court invalidating the<\/p>\n
offending  provisions.  In the third case, the  validity  of<\/p>\n
certain provisions of the Gold Control Act was in challenge.<\/p>\n
In  the last case, there was a challenge to the validity  of<\/p>\n
section  3  of  the LUSHAI HILLS District (Trading  by  Non-<\/p>\n
Tribals)  Regulation  2,  1963 was in  challenge,  being  in<\/p>\n
violation of Article 19(1)(g) of the Act.  In our respectful<\/p>\n
opinion,  when the validity of an Act is challenged  on  the<\/p>\n
touchstone  of Article 14 of the Constitution of India,  the<\/p>\n
decision  has to depend upon the provisions of the concerned<\/p>\n
Statute itself, which are in challenge.  Of-course,  law  is<\/p>\n
well  settled that when there is vagueness in any  provision<\/p>\n
of  law leading to arbitrary exercise of power \/ uncanalised<\/p>\n
powers,  the  Act should be struck down.  Therefore  whether<\/p>\n
any   provision  of  law  is  hit  by  Article  14  of   the<\/p>\n
Constitution  of  India on the ground  stated  above,  would<\/p>\n
depend upon the construction of the provisions in challenge.<\/p>\n
When  a particular Act is found to be suffering the vice  of<\/p>\n
vagueness and arbitrariness, then, it must be held  that  it<\/p>\n
was  so  on the construction of that Statute.  It cannot  be<\/p>\n
said that whenever arbitrariness and vagueness are the vices<\/p>\n
projected as grounds of attack, the court should close  it’s<\/p>\n
eyes and simply strike down the law without even finding out<\/p>\n
whether  in  the  Act challenged there are such  vices.   In<\/p>\n
fact, that is what the Supreme Court itself had said in  the<\/p>\n
first  judgment  brought to our notice  by  Mr.Soli  Sorabji<\/p>\n
learned  senior counsel, which in turn quotes with  approval<\/p>\n
an  earlier judgment of the Supreme Court reported  in  1954<\/p>\n
SCR  674  wherein  it  is stated that “in  order  to  decide<\/p>\n
whether a particular legislative measure contravenes any  of<\/p>\n
the provisions of Part III of the Constitution of India,  it<\/p>\n
is  necessary to examine with some strictness the  substance<\/p>\n
of  the  legislation in order to decide what the Legislature<\/p>\n
has  really done.”  We again find in the first judgment that<\/p>\n
the Supeme Court had held  as follows:\n<\/p>\n<\/p>\n
           “Another principle which has to be borne  in<\/p>\n
     mind  in  examining  the  Constitutionality  of  a<\/p>\n
     Statute  is  that,  it must be  assumed  that  the<\/p>\n
     Legislature understands and appreciates  the  need<\/p>\n
     of  the people and the laws it enacts are directed<\/p>\n
     to  problems which are made manifest by experience<\/p>\n
     and that the elected representatives assembled  in<\/p>\n
     a Legislature enact laws which they consider to be<\/p>\n
     reasonable  for  the purpose for  which  they  are<\/p>\n
     enacted.   Presumption is therefore in  favour  of<\/p>\n
     the Constitutionality of an enactment.”<\/p>\n<\/blockquote>\n
If  we have the above referred to principles of law in  mind<\/p>\n
on  Statutory  Interpretation, we have to state  with  great<\/p>\n
respect  that the judgment of the Supreme Court  brought  to<\/p>\n
our  notice by Mr.Soli Sorabji learned senior counsel, would<\/p>\n
not  stand  attracted to the case on hand.  The validity  of<\/p>\n
the  provisions  of law considered in those  cases  and  the<\/p>\n
validity  of the provision of law in contest before  us  are<\/p>\n
not  in pari materia.   There is definitely a difference  in<\/p>\n
the  language  and wording of the provisions  challenged  in<\/p>\n
those cases and the one before us.  The context in which the<\/p>\n
offending  provisions are used in the Act  in  challenge  is<\/p>\n
also  totally  different  from  the  context  in  which  the<\/p>\n
offending  provisions in the cases decided  by  the  Supreme<\/p>\n
Court  are used.  Of course, in those judgments, the Supreme<\/p>\n
Court  had clearly laid down that vagueness \/ ambiguity  and<\/p>\n
arbitrariness resulting in uncanalised powers are grounds to<\/p>\n
invalidate  an Act.  In other words, with great respect,  we<\/p>\n
state that in all the cases brought to our notice by Mr.Soli<\/p>\n
Sorabji learned senior counsel, the Supreme Court, analysing<\/p>\n
the provisions of the Statute before them in the context  of<\/p>\n
the  arguments advanced, found that they are violative.   We<\/p>\n
state that in this case we have already found, analysing the<\/p>\n
alleged offending provision, that it is not in violation  of<\/p>\n
Article  14 of the Constitution of India.  We have borne  in<\/p>\n
mind  the  object which the Amending Act wanted  to  achieve<\/p>\n
namely,  to prevent evergreening; to provide easy access  to<\/p>\n
the  citizens  of this country to life saving drugs  and  to<\/p>\n
discharge their Constitutional obligation of providing  good<\/p>\n
health care to it’s citizens.  We have also referred to  the<\/p>\n
case  laws  brought  to  our notice by Mr.Habibullah  Badsha<\/p>\n
viz.,  (1974) 1 SCC Pg.549 (State of Punjab Vs. Khan Chand);<\/p>\n
(1985)  1  SCC  234  (State  of  Maharashtra  Vs.  Kamal  S.<\/p>\n
Durgule);  (1988)  2  SCC 415 (B.B.Rajwanshi  Vs.  State  of<\/p>\n
U.P.); (1989) 4 SCC 683 (A.N.Parasuraman Vs. State of  Tamil<\/p>\n
Nadu);  and (2005) 12 SCC 77 (State of Rajasthan Vs.  Basant<\/p>\n
Nahata).    On  a perusal of the same also,  we  are   in  a<\/p>\n
position  to  reiterate with respect  that  our  conclusions<\/p>\n
based  on  the  case laws brought to our notice  by  Mr.Soli<\/p>\n
Sorabji learned senior counsel would equally apply   to  the<\/p>\n
case  laws  brought  to  our notice by Mr.Habibullah  Badsha<\/p>\n
learned  senior counsel.  For all the reasons stated  above,<\/p>\n
on  issue  (c ) we hold that the amended section is  not  in<\/p>\n
violation  of  Article 14 of the Constitution of  India  and<\/p>\n
accordingly, both the writ petitions are dismissed  with  no<\/p>\n
order as to costs.\n<\/p>\n
vsl<\/p>\n","protected":false},"excerpt":{"rendered":"
Madras High Court Novartis Ag vs Union Of India on 6 August, 2007 IN THE HIGH COURT OF JUDICATURE AT MADRAS DATED: 06.08.2007 CORAM THE HON’BLE MR.JUSTICE R.BALASUBRAMANIAN and THE HON’BLE MRS.JUSTICE PRABHA SRIDEVAN W.P. Nos.24759 and 24760 of 2006 Novartis AG Schwarzwaldalle 215 4058 Basel and Lichstrasse 35 4002 Basel, Switzerland represented by it’s […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[8,13],"tags":[],"class_list":["post-211318","post","type-post","status-publish","format-standard","hentry","category-high-court","category-madras-high-court"],"yoast_head":"\nNovartis Ag vs Union Of India on 6 August, 2007 - Free Judgements of Supreme Court & High Court | Legal India<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.legalindia.com\/judgments\/novartis-ag-vs-union-of-india-on-6-august-2007\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novartis Ag vs Union Of India on 6 August, 2007 - 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