The rhetoric of ‘patent busting’

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.

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.

... contd.