The Battle for Erlotinib – High Court Decision Raises a Number of Procedural and Practice Issues

26 Mar 2008

The High Court of Delhi has now published its decision in the case between Roche/Pfizer v Cipla. The case has attracted a lot of attention (see SPICY IP here and here for some great coverage), in particular how India will handle requests for interim injunctions in patent infringement matters.

Some of the salient issues coming from the judgement are:

•    On the application for an interim injunction, Justice Ravindra Bhat followed the line of cases saying that an interim injunction is not to be granted for infringement where the patent has been recently granted and a counterclaim is filed against its validity. According to Indian case law a patent is considered ‘untested’ or ‘new’ (or not presumed valid) until it reaches the six year period. Although Justice  Bhat expresses bafflement at this six year rule (see para 63), given that there is no provision for it in law, he stresses that it stems from a cautious approach developed by the Indian courts to granting interim injunctions all too readily, in particular where the question of validity of the patent is substantial.

It is notable, as Spicy IP has already picked up on here, that the UK (and many other jurisdictions) does not refuse an interim order everytime there is a counterclaim questioning the validity of a patent. To do so would make interim injunctions virtually redundant. It remains to be seen how the Indian courts will develop this area of law in light of the modern patent system it is now having to deal with. That said, the practice of presuming the validity of a patent is also problematic, as is the case in U.S law.

•    The refusal to grant an interim injunction seems to ultimately fall on the issue of the public interest and Roche’s inability to persuade the court that patients would not suffer irreparable hardship if Cipla’s drug is blocked from the market. The court also makes reference to Article 21 of the Indian Constitution (the right to life) in this context. However, it seems, other than the issues of price, this decision was reached without Roche or Cipla having provided specific (or even estimated) figures of the number of patients that are using their drugs. Without such evidence, it begs the question how the court can assess the balance of convenience in such a case.

•    The decision sheds further light on the application of s3d and how it may take shape going forward. One of the most notable assessments in this respect is made at para 58. Justice Bhat, in response to Roche’s attempt to define s3d within the test of obviousness, rejects such an interpretation. He makes clear the point that applicants must show that there was inventive step and that any new form listed in the explanation to s3d shows a significant enhancement of the efficacy over known forms. In other words, “the test of patentability has become more precise and specific” (para 57).

•    Notably the court has picked up on the KSR International v Teleflex case and rejects the teaching, suggestion, motivation test. The judge also points out that the patent office erred in its decision in the pre-grant opposition because it conflated anticipation with obviousness. The patent office also seems to have missed some key prior art raised by Cipla in its counterclaim.

•    The judgement also suggests that there is some merit in Cipla’s argument that Roche failed to provide any comparative data regarding the efficacy of Roche’s drug against existing forms of the drug at the time of examination. This raises the frequent question as to how applications for drugs that have no efficacy data at the time of application will be judged.

•    It is worth noting that the evidence presented by Roche as to the efficacy of  Erlotinib in the hearing againt Natco seems rather weak. In particular, some of the publications relied upon by Roche compare the effect of Erlotinib against placebos. Section 3d clearly requires efficacy to be measured against known forms/compounds, not inactive substances.

A number of other issues come out of the case. For example, was Natco’s opposition technically a pre-grant or post-grant given the confusion over the date of grant of the patent? Roche’s attempt at arguing that offering generics causes a serious hazard to patients and was a reason for an injunction didnt impress the judge.

It will be intriguing to see whether the hints of interpretation of s3d and the procedural issues given in this decision materialise in to practice.

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