Trying ‘mediation’

PURSUANT to a Delhi High Court order in April on a patent on Erlotinib, a lung cancer drug, the Swiss drug major Roche and the Indian generic drug-maker Cipla have, according to informed sources, entered into talks to find a solution on mutually agreeable terms to their protracted battle.

Roche had filed a suit in the Delhi High Court in 2008 for an alleged infringement of its patent on Erlotinib by Cipla, the first such suit against an Indian pharmaceutical company after India signed the Trade-Related Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation in 2005. The agreement sets out mandatory minimum standards of intellectual property rights protection and enforcement measures for WTO member-countries.

Roche filed around 10 lawsuits in the Delhi High Court in 2008 and 2009 against Natco Pharma, Dr Reddy’s, Glenmark, Oncare Life Sciences, Innova Life Sciences and Accura Care Pharmaceuticals over infringement of its Erlotinib patent. In 2012, a single-judge Bench of the Delhi High Court upheld the validity of Roche’s patent while acquitting Cipla of the charges of patent infringement. Roche appealed against this verdict, and the matter was being heard by a two-judge Bench, which, in April, passed an order requesting the parties to consider “mediation”.

The court-ordered “mediation” has raised legitimate concerns of the larger implications on public health. Roche was granted a patent for Erlotinib in 2007. Cipla introduced a polymorph, or new form, of Erlotinib in 2008 and made it available for Rs.1,600 a tablet, whereas Roche’s drug was priced at Rs.4,800 a tablet. Interestingly, Roche had also applied for a patent for the polymorph of Erlotinib, which was rejected.

Under Section 3(d) of the Indian Patents Act, the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance is not considered an innovation and therefore cannot be granted a patent. Accordingly, Roche was not granted a patent for the polymorph of Erlotinib.

The patent cases pending in the Delhi High Court raise issues similar to that in the Novartis case, in which the Supreme Court, in a landmark judgment in April last year, upheld the Indian Patent Office’s rejection of Novartis’ patent application filed in 1998 for its blockbuster cancer drug Glivec.

Among the pending cases are those that involve attempts by a pharmaceutical major to extend its monopoly over new forms of a known anti-cancer drug which prevents generic companies from manufacturing more affordable versions of the drug. Given that the Delhi High Court ruled in 2012 that there was no patent infringement, the subsequent “mediation” order has come as a surprise.

In an email interview to Frontline, the intellectual property rights expert Shamnad Basheer said this reflected a worrying trend.

He said: “After a full-fledged trial and several proceedings in the High Court, it is rather unusual for an appellate court to refer a matter of this kind of jurisprudential significance for mediation. Nonetheless, it is well within the court’s power to do so and it may have done it to save time, cost and resources. However, given that this was the first patent matter in which a full-fledged trial had concluded and interesting issues of patent validity and infringement had cropped up, one expected that the court would apply its mind and rule on this and provide guidance for future cases. In fact, many of us expected this to reach the Supreme Court, where the highest court could have provided guidance for the future and clarified key patent concepts.”

In the context of the spiralling prices of anti-cancer drugs and a large number of patent cases against generic manufacturers pending in courts, a “mediation” works against the public interest and the cause of affordable medicines.

Basheer said: “Given that a number of MNCs [multinational corporations] and domestic majors are now collaborating on a variety of fronts, it is expected that the number of pharma litigations and adversarial proceedings would anyway come down. This is worrying, as we all expect our generic majors to defend the public health turf and weed out undeserving pharma patents. If the generic majors are going to settle these privately, it presents a worrying trend. And the onus to challenge such undeserving patents falls on civil society and all of us.”

The senior advocate Anand Grover, who has argued a number of patent cases, including the Novartis case, was, however, doubtful that the proposed mediation would lead to a “settlement”. Speaking to Frontline, Grover said: “It is very unlikely that the mediation will result in a settlement on mutually agreeable terms because of the issues involved and the past history of patent judgments and the stakes involved in this case.”

Basheer pointed out: “Given the hostile nature of our adversarial proceedings and a desire to win at any cost, and the resulting waste of time, resources and money, alternative methods should be encouraged. However, given the sheer importance of pharmaceutical patents and their relation to public health objectives, I personally feel that the court should have applied its mind and given a ruling here. Perhaps after a few such cases, one might have seen the emergence of some foundational jurisprudence on patent law which could have guided future courts.”

Sagnik Dutta