Keenly followed by almost everyone who has a stake in India’s pharma sector, the April 1 verdict on the patent of Novartis’ Glivec by the Supreme Court was the culmination of more than seven years of deliberations. The Swiss drug major touted the high profile litigation as ‘Novartis vs Union of India,’ a legal battle to salvage the commercial rights of innovations in the heartland of generics.

The rejection of Novartis’ claims for a new composition of imatinib (Glivec) by SC came as a “sigh of relief” and brought a great deal of jubilation among the home-grown companies. NGOs and health activists, who were looking forward to the Day of Judgment, felt “ecstatic,” as the verdict could facilitate access to cheaper medicines for the vast section of the poor and the needy, patient groups said. Even India’s commerce minister lauded it as historic.

On the other side of the fence, Novartis and others protested loudly. The Glivec-maker said India stood the risk of losing investments from innovators until the country ensured a fair and predictable patent ecosystem amid a flurry reports pointing to the verdict as a setback for innovation in a highly promising pharma market.

But does the Glivec verdict provide either for such an exalted revelry or sheer disillusionment?

Certainly, the ruling has tremendous value as the first major judgment made by India’s top judiciary on the country’s reformed patent law. Also, the judgment goes on to define contours of the patentability criteria for incremental innovations — one of the several clauses still seeking clarity in the revised patent law.

Not a Bolt from the Blue
Legal overtones aside, one can’t ignore a few facts about the scope and impact of the Glivec case verdict on Indian as well as global pharma. Firstly, the court’s rejection of Novartis’ plea for patent protection for beta crystalline form of imatinib mesylate is only an affirmation of three previous judgments. Earlier, the appeal got rejected by Indian Patent Office, a regional high court and Intellectual Property Appellate Board — India’s legal authority to settle patent-related disputes.

Neither did Novartis — nor other MNCs, for that matter —appear to have been anticipating a judgment that would be radically different from the previous judicial decisions. In fact, Novartis went on record saying a day before the verdict that it was planning to stop supplies of new medicines to India if the country’s top court refuses to grant a patent for Glivec.

Secondly, there is the script of the verdict itself. The 112-page judgment, without veering away into general propositions and macro issues such as affordability etc, goes straight to the contested clause: Section 3 (d) of the Indian Patent Law. The disputed section, which was inducted in the amended Patent Act in 2005, when India started honoring product patents for the first time to conform to WTO, lists the criteria for patenting incremental innovations. It states that a chemical analog can be patented only if it demonstrates significantly enhanced efficacy over and above a known substance.

Even after hundreds of hours of debating, the court observed, it was not convinced how the new salt is more beneficial to the patients in terms of efficacy than its predecessor: “No material has been offered to indicate that the beta crystalline form of the imatinib mesylate will provide an enhanced or superior efficacy (therapeutic) on a molecular basis than what could be achieved with imatinib free base.”

A Grave Mistake!
While ruling that Novartis’ new version of the drug was “not an invention as understood by the law of patents in India,” the court was quick to add that the judgment did not apply to all improvements in products. It would be a “grave mistake,” the court categorically said, to read the judgment to mean that it prohibited patents for all incremental inventions of chemical and pharmaceutical substances.

By narrowing down the scope of the judgment specific to Glivec, the court never raised the issue of affordability by Indians nor claims that the exigencies of poverty trump the rights of innovators.

Obviously, the verdict is not the end of the road for innovators, as many branded drugmakers fear. Nor is it an open license for generic-makers to unrestrictedly dole out copycat versions of all patented drugs, banking on the moral high-ground of affordability, as desi firms hope.

“So, the takeaways are clear now. The Indian pharma market, which is forecast to more than double or even triple in the new three to four years, is too important a marketplace to ignore for any serious player,” said an industry analyst with an investment firm.
Maybe, Novartis understands this best. The company said it would continue to file for patents in India and would continue to invest here, but with caution.