The Supreme Court today admitted two Special Leave Petitions [SLP (C) No. 1677-78 of 2016] by Cipla against the Delhi High Court’s ruling holding that their drug ‘Erlocip’ infringes Roche’s patent IN ‘774. Roche’s claim of infringement was upheld after a long drawn out battle which even included an elaborate mini-trial over interim relief. One of the chief controversies in this case has been whether Roche’s patent IN ‘774 covers Cipla’s ‘Erlocip’, in that the latter infringes the former. The Single judge initially answered this question in Cipla’s favour, holding that infringement had not been proved by “positive evidence which include the medical and clinical evaluation of the product of the defendant.” The Division Bench rightly noted a fundamental flaw in this conclusion (one that was pointed out by Shamnad in his analysis here, here and here), namely, that the comparison for the purpose of infringement analysis was being done of the allegedly infringing product vis-a-vis the marketed product manufactured under the patent.
The Division Bench clarifies that the test for patent infringement is not a product to product comparison, but a product to claim comparison. Thus, they explained, that “the correct test of infringement in this case is to map Cipla product against the Roche‘s patent claims.” On this test, the court found that Cipla’s product, does, in fact, infringe Roche’s patent claims. However, since IN ‘774 is due to expire in March 2016, no injunction order was passed by the Court against Cipla. Instead, the Court directed Cipla liable to render accounts concerning manufacture and sale of Erlocip and decreed costs in favour of Roche and against Cipla in sum of Rs 5,00,000.
The reasoning in this judgement is well developed and, in my opinion, hard to dispute. However, apart from the arguments on patent law, this case has a ghost that could bolster Cipla’s appeal before the Supreme Court – the entire plagiarism scandal which resulted in the judges passing a corrective order expunging a large portion of their judgement. This raises the question of what the present version of the judgement is, since these portions, in providing a review of the decision of the Single Judge, would ordinarily be seen as integral to the sanctity of the judgement itself.
And so, as the litigation enters the next phase, it will be interesting to see what comes of the plagiarism controversy and what arguments Cipla tenders to defend its counter claim for revocation and its insistence that their drug ‘Erlocip’ does not, in fact, infringe Roche’s patent. A shout out to readers to give us updates if you happen to be in court and watching these proceedings!