Fourth factor in Pharma patent infringement cases

This post analyses the weightage of fourth factor that is ‘public interest’ in granting interim injunction in the pharmaceutical cases in light of an ex parte interim injunction granted in Novartis Ag & Anr vs Sun Pharmaceutical Industries [CS(COMM) 85/2020].


Novartis Ag (hereinafter ‘Novartis’) on the basis of a patent (IN 237430) for their compound ‘NILOTINIB’ filed an infringement suit against Sun Pharmaceutical Industries (hereinafter ‘Sun’). Novartis argued that its patent is valid until 4th July, 2023. They have come to know about Sun’s intention to launch the product through an official announcement made by them at an annual conference and also on the basis of a report that confirms Sun has already obtained a manufacturing license for NILOTINIB and intends to commercialize, manufacture and supply the drug on receipt of orders.

The court while granting the injunction looked into the following:

  1. Cipla Ltd. had filed a pre-grant opposition to Novartis patent application for NILOTINIB claiming anticipation, obviousness and that no inventive step was involved. The pre-grant opposition of Cipla Ltd. was rejected by the Patent Office;
  2. The Court noted Novartis contention that the patent has successfully worked in India at a reasonable price and number of other companies who proposed to launch the product infringing the plaintiff’s suit patent IN 237430 agreed not to do so until the validity of the suit patent.

The court concluded that the validity of the patent has already been tested in the pre-grant opposition filed by Cipla. Thus, prima facie case is made out in favour of Novartis and restrained Sun from launching the product that would infringe Novartis patent. The order has been criticized for court not having elaborated on three elements for grant of interim injunction i.e. prima facie case, balance of convenience and irreparable harm and more on the account of not having discussed the fourth element in pharma cases i.e. public interest.

The public interest defence has often been pushed as a “one size fits all” approach in every pharma patent infringement matter. While, it is a strong argument that an injunction in pharma patent matter not only affects the interest of the infringer but also the consumer. However, in this case while granting the interim injunction, the court did note specific pleading of the Novartis that the patent is successfully worked at a reasonable price. The question then comes should public interest be determined after trial in all pharma patent infringement suits. The trial is obviously a time consuming exercise and life of a Patent is limited. In other words denying interim injunction in all pharma patent cases, on account of public interest being determined post trial does not address the likely prejudice caused to the patentee. The question is debatable and there is of course no easy answer as the public interest finding would vary based on facts of each case.

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