‘Efficacy’ point in Glivec ruling impractical

The controversy over patent to Novartis’ magic bullet Glivec continues to deepen. After several months of wait, the Intellectual Property Appellate Board (IPAB) handed out a nearly 200-page judgement in June, triggering off a fresh debate over the efficiency of the patenting machinery in India and its ability to strike a balance between patents and patients.

Buried in those pages are enough contentious points that can lead to more bickering between patient rights groups and Indian firms on one side and multinationals on the other. However, for once, vowed antagonists of Glivec patents are wondering if the verdict will stand uncontested, given the many issues raised by the two-member IPAB panel. Indian firms like Natco have called it a landmark judgement but patent law experts say there is more contradiction in the final decision than clarity.

The panel has held the inventiveness of Glivec, stating that the drug meets all the international patent criteria but reserved its doubts about its “therapeutic efficacy”, bringing into light Section 3(d) of the Indian Patents Act. Section 3(d) is a highly debated clause which speaks of “significant” improvement or efficacy of an existing compound to become eligible for patents. The decision has also asked for therapeutic efficacy of the compound at the time of patent filing.

This is perhaps the most impractical condition put forth by the IPAB panel. How does one present the efficacy records of a drug? Globally, companies continuously undertake clinical trials to generate data and file patent applications for more indications for the same drug.

This has been the empirical understanding but the panel may be taking the case differently, almost assuming that frivolous patents should not be allowed to enter the market. We need to get into the fine print to establish what may have led the IPAB members to put this pre-requisite. The section has been faulted as it leaves many issues to an individual’s discretion than follow a laid out structure.

Patent experts in India have gone hammer and tongs over the judgment and said there are holes in the wordings of the verdict and sooner or later, Novartis will take this to international forums, as also an Indian court.

More surprising is the mention of Section 3(b) of the Indian Patent Act that is said to knock down patents that, experts say, are sought for commercial exploitation. The panel gets into the risky territory of linking patents to pricing and states that any patent grant to Glivec may go against public good. While the panel is fair in expressing concerns over the high price of the drug, the stand to dismiss its patentability may invite ire.

Agreed that every country has the right to frame its patent laws according to its needs. But Novartis may get a lot of ammunition to fight its case. In India, there are enough provisions to tackle high pricing of drugs. India can invoke compulsory license if a drug is not available in adequate quantities or is seen to be unaffordable due to pricing.

In its public statements, Novartis is already signalling its intent. It said, “We are concerned about the patent systems in India and are looking to have systems that support innovation in the pharmaceutical field.”

Glivec is known over the world more for its patent controversies than its capacity to treat cancer patients. The drug is truly a remarkable success, making headway in treating a deadly disease.

Patient rights groups have done a great job by challenging the creation of a monopolistic market for drugs but with the ruling of the IPAB, Novartis will, in all likelihood, go all out to defend its patents, this time with a stronger pitch calling for world attention.

Novartis’ global CEO Daniel Vasella is known to be passionate about his company’s Glivec discovery and being a litmus test for patenting rules, this case will take a long time to be resolved in India.