Unless Roche is able to demonstrate empirically that CIPLA’s lower prices for Erlotinib (the lung cancer drug in issue) does not really translate to increased access to poor patients, it is difficult to see how Justice Bhat’s order will be overturned in appeal.
“The rhetoric of ‘patent busting’
Posted online: Saturday, April 12, 2008 at 0028 hrs IST
The verdict on one of the most keenly watched patent litigations was finally out last month. In a carefully nuanced and remarkably well-researched judgment, Justice S. Ravindra Bhat of the Delhi High Court refused to injunct Cipla from selling generic versions of a patented anti-cancer drug belonging to Roche. The judgment has received mixed reviews, while innovative pharmaceutical companies see this as “patent busting” of the worst order, public health activists are ecstatic at this clear preference for patients over patents.
To me at least, the judgment appears to strike the right balance between private patent rights and public health imperatives. A careful reading of the 58-page order suggests that the key factors that influenced the judge to decide way he did were: First, Cipla’s drug, Erlocib was being sold at one-third the price of Roche’s patented anti-cancer drug, Tarceva.
Second, Roche was not manufacturing the drug in India, but importing it — causing the judge to worry about the prospects of long term supplies from a multinational corporation operating within India.
Third, Cipla raised very serious doubts about the validity of the patent.
Fourth, Roche’s attorneys were ill prepared and committed a number of lapses. Illustratively, they requested an ex-parte interim injunction from the court without so much as producing a copy of the patent claims. Besides this, as the judge himself points out in his judgment — they failed to raise the issue of “irreparable hardship”, a critical component of the three step injunction test in India.
Apart from the above, an ill reasoned order from the patent office in response to a pre-grant opposition filed by Natco against Roche’s patent application influenced the court. In particular, the court found that the patent office, while granting the patent, wrongly relied on a recently overturned US test that considerably lowered the threshold for patentability. Little wonder then that Roche’s argument that the patent office decision in its favour renders the patent immune from attacks on validity did not sway the court much.
What is most unique about Justice Bhat’s judgment is that it stresses that “public interest” has to be factored in before a court decides to grant a temporary injunction or restraining order against an alleged infringer.
The crux of his judgment appears to be this: At this “interim” stage, one cannot conclusively determine whether or not Roche’s patent is valid. In the light of this uncertainty, the critical factor for consideration is “public interest” — whether or not the grant of an injunction will cause “irreparable hardship” to critically ill lung cancer patients, who may not be able to afford Roche’s monopoly prices. And if the court finally finds in favour of Roche that the patent is a valid one, then Cipla can be made to compensate Roche for all the losses up to that stage. To this extent, the court asked Cipla to maintain a clear account of moneys made from the sales of its drugs.
Given that the validity of the Roche patent is in serious challenge, does the denial of a temporary injunction to the patentee amount to patent busting? Should patent injunctions be granted as a matter of right at this stage? Has India got its policy wrong? We need look no further than the most patent friendly nation on the face of this planet — the US, where the Supreme Court held that the grant of an injunction in patent cases is not a matter of right but a discretionary remedy. And this discretion has to be exercised carefully, taking into account several factors, one of which is “public interest”.
Even as we speak, Roche is asking a US court to do exactly what Cipla had requested Justice Bhat to do — not to grant an injunction on grounds of “public interest”. Effectively Roche’s claim is that, although its anaemia drug, Mircera infringes Amgen’s patented Epogen, there ought to be no injunction on grounds of “public interest” because Mircera is cheaper, requiring less frequent “dosing” and is therefore beneficial to patients. Surely what’s sauce for the goose is sauce for the gander as well!
What remains to be seen is whether future Indian judges will apply the tenets laid down in Justice Bhat’s judgment in an unbiased manner to home grown patentees such as Ranbaxy and Dr Reddy’s. In other words, if the concern is that patients are prejudiced by potentially “invalid” patents and high prices, then the concern ought to equally apply when the patent in question is held by Ranbaxy and not by an MNC.
To conclude, one is not certain at this stage if the Roche patent over Tarceva is a valid one or not. Prior to a final decision on this count, deploying adjectives such as “patent busting” or “patent breaking” to describe the Delhi High Court order smacks of ignorance. If at all anything has been “busted”, it is the notion that patents are sacrosanct monopolies that cannot be derogated from. Most patent scholars today readily agree that patents are nothing more than a statutorily granted right by the state in exchange for the useful disclosure of scientific information. As with other statutory rights, they can be derogated from, when “public interest” so demands. Sophisticated patent policy requires a careful balancing of innovation imperatives through patents against other competing and perhaps more important interests, such as the right to health. And it is this delicate balance that Justice Bhat strives for and achieves in his judgment — a judgment that will no doubt go down in the annals of history as representing a milestone in Indian patent jurisprudence.