Lessons from Novartis case

Published : Apr 17, 2013 00:00 IST

THE Supreme Court’s April 1 judgment in the Novartis case clearly defends the public interest against the corporate greed of multinational pharmaceuticals (see separate story). But the process of the court’s decision to hear the matter tells its own story of balancing competing interests.

The fact that important and sensitive matters are heard by just two-judge or three-judge Benches leaves the decisions rendered by them somewhat uncertain. This is not to suggest that the Novartis judgment has not finally resolved the question of whether the patent regime in pharmaceuticals can be subjected to legislative restrictions to defend the public interest. But the gaps in the judgment suggest that future litigation on the issue cannot be ruled out.

The judges, for instance, did not want to give a final answer on the exact scope of “therapeutic efficacy”, leaving it to be determined by future courts even while acknowledging disagreement among the experts it heard. The two-judge Bench pointed out that Novartis had not filed any data on the therapeutic efficacy of Glivec. Critics may infer that this offers companies such as Novartis a window to identify possible loopholes to exploit in future legal battles.

The point is not just that a bigger Bench of, say, five judges could have achieved better clarity on some complex issues before the Court. It is that had the matter been heard by another two-judge Bench not so committed to the public interest there was the risk of the decision going in favour of Novartis.

Novartis was represented by two high-profile lawyers, Gopal Subramanium and Andhyarujina, who left no stone unturned to bring relief to their client. At one stage, they sought to distinguish between the scope of coverage and the scope of disclosure in a patent. Where it is a pioneering invention (as in the case of the Zimmermann invention, which preceded that of imatinib mesylate), Novartis’ counsel argued, the patent may be entitled to larger coverage than what is specifically disclosed in it. Therefore, they argued, it would be wrong to say that Novartis’ claims for the beta crystalline form of imatinib mesylate is a case of double or repeat patenting, that is, the same invention sought to be patented twice. Thus, Gopal Subramanium maintained that the boundary of the Zimmermann patent was extended up to imatinib mesylate, but the enablement or disclosure made therein ended at imatinib.

The Bench rejected the argument that the coverage in a patent might go much beyond the disclosure as it negates the fundamental rule underlying the grant of patents: a monopoly is granted to a private individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it.

The Bench pointed out that in India, the law of patent, after the introduction of product patents, is in its infancy. “We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.”

Even as the two-judge Bench comprising Justices Aftab Alam and Ranjana Prakash Desai deserves appreciation for its nuanced interpretation of the legal dispute before it, observers cannot fail to notice that the case came to be heard by it in almost fortuitous circumstances. The case was first listed before Justices Markandey Katju and Asok Kumar Ganguly in 2009. Justice Katju recused himself from the case on August 31, 2009, when it became known that he had written an article against the liberal grant of pharma patents. The case was then heard by the Bench of Justices Dalveer Bhandari and Deepak Verma. This Bench heard the case for five days, until September 6, 2011, when Justice Bhandari recused himself from hearing the case because a newspaper had reported about his participation in two international conferences for judges organised by a U.S.-based association of intellectual property professionals, which included Novartis.

Justices Alam and Ranjana Desai said in their judgment that they too were reluctant to admit the Novartis case for regular hearing for a different reason: Novartis had appealed directly in the Supreme Court against the Intellectual Property Appellate Board’s verdict (delivered on June 26, 2009) rejecting its patent claim over Glivec without exhausting the intermediate appeal in a High Court. Had the matter first been heard in a High Court, it would have still reached the Supreme Court, but much later.

Justices Alam and Ranjana Desai, therefore, made an exception in this case and agreed to hear the matter so that a verdict could be delivered well before the expiry, in 2018, of Novartis’ 1998 application for a patent. The parties who objected to the grant of a patent to Novartis also agreed to the hearing of their appeal directly in the Supreme Court. The court, however, made it clear that such an exception would not become a precedent for similar appeals in future. The Bench, thus, delivered the verdict after hearing the parties to the dispute in 27 days, between September 26, 2011, and December 4, 2012.

V. Venkatesan

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