Swiss pharma company Novartis Tuesday told the Supreme Court that there cannot be conflicting provisions in a patents statute where one provision recognises innovation in drug development and another knocks it down.
Novartis told an apex court bench of Justice Aftab Alam and Justice Ranjana Prakash Desai that once the Intellectual Property Appellate Board (IPAB) had accepted that beta crystalline form of compound imatinib mesylate was an innovation under 2(j) and 2(j)a) of the Patents Act, then it could not be asked to re-establish its patentability under Section 3(d) of the law.
“Can there be a situation that a product is an innovation under sections 2(j) and 2(j)a) and sought to be denuded of invention under section 3(d) in terms of pharmaceutical efficacy,” senior counsel Gopal Subramanium, appearing for Novartis, told the court.
“Section 3(d) is not intended for invention but discovery of a new form. It deals with a known substance with known efficacy,” Subramanium told the court.
The apex court was told this during the hearing on a petition by the pharmaceutical giant challenging the IPAB verdict declining patent to Novartis anti-cancer drug Glivec (imatinib mesylate) used for the treatment of chronic myeloid leukemia (CML) and malignant gastrointestinal stromal tumors (MGST).
The IPAB asked the pharmaceutical company to prove the enhanced therapeutic efficacy of its pharmaceutical product Glivec under 3(d) of the Patents Act, 1970.
The Section 3(d) of the Patents Act seeks to thwart the “evergreening” of the pharmaceutical products with minor changes in the content and form without any innovation. Section 2(j) and 2(j)(a) deals with the grant of innovation to the product claimed to be an original and a novelty.
As Subramanium sought to point to the fine distinction between Sections 3(d) and 2(j) and 2(j)(a), Justice Alam asked him if these were not the two sides of the same coin.
Responding to the query from the court, Subramanium said: “Section 3(d) is an exception to 2(j) and 2(j)(a) and has a restricted meaning and can’t be used to destroy each other.”
“It is impossible to conceive that that something is an innovation under Sections 2(j) and 2(j)(a) and not so under Section 3(d),” the court was told.
Responding to the plea of Additional SolicitorGeneral Paras Kuhad that larger public interest had made inroads even in international law, Subramanium said that “there should not be an imbalance between the right that should come to me and the doctrine of larger public interest”.