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India Update – Patent Infringement

An action for patent infringement in India is not maintainable during the pendency of an appeal against an order revoking the patent.

In Novartis AG & Anr. V. Natco Pharma Limited CS (COMM) 229/2019 and I.As. 11304/2019, 11305/2019, the Delhi High Court (the ‘Court’) has clarified that an action for infringement is not maintainable in respect of a revoked patent, even whilst an appeal against the revocation order is pending and until disposal of the appeal. The facts of the case and the decision are summarized below:

Novartis (the ‘plaintiff’) filed a suit seeking a permanent injunction, damages, rendition of accounts and delivery-up in respect of its granted patent (Indian Patent No. 276026 entitled ‘Novel Pyrimidine Compounds and Compositions as Protein Kinase Inhibitors’). The patent related to a novel and inventive compound Ceritinib, which is a drug meant for the treatment of non-small cell lung cancer. According to the Plaintiff, the molecule, which forms part of the broader group of 2, 4- diaminopyrimidines, is novel and inventive. The patent application was filed as a Patent Convention Treaty (‘PCT’) application claiming priority since 2007, and was granted on 28 September 2015. Natco Pharma (the ‘defendant’) filed a post-grant opposition under Section 25(2) of the Patents Act, 1970 (as amended) (the ‘Act’). The opposition was initially referred to the Opposition Board, which issued a report in favour of the Plaintiff. However, the defendant thereafter filed additional material. A hearing was held and orders were reserved on 10th April 2019. The suit was first listed on 2 May 2019; while granting an interim order on 2 May 2019, the Court had directed that the post-grant opposition (wherein orders were reserved) be decided by the Patent Office prior to the next hearing date. However, on the next date, the Court was informed that no orders had been passed in the post-grant opposition proceedings. Thereafter, the order in the post-grant opposition proceeding was issued on 16 August 2019 and the patent was revoked on the grounds that the patent lacked novelty. The Plaintiff submitted that the order passed in the post-grant opposition proceedings had been appealed against and that the same was listed before the Intellectual Property Appellate Board (‘IPAB’) on 19 August 2019, and that until an order was passed by the IPAB the injunction ought to stand.

The Court held as follows:

1. Rights in a patent are only for the life of a patent that remains granted and which has not been revoked. The manner in which patent rights operate is that they are merely statutory rights and there are no common law rights in patents. Patent infringement actions are maintainable only in respect of granted and live patents. The fact that no infringement action is maintainable in respect of an unregistered or revoked patent is clear from Section 62(2) and Section 11A(7) of the Act. If a patent is not renewed, no infringement action would lie. Similarly, once the patent is published, no infringement action can be filed until the patent is granted, though damages can be sought with effect from the date of publication. Thus, the continuation of an injunction, even for a day, would not be permissible once the patent is revoked.

2. In light of the factual matrix (specifically, the passing of the order dated 16 August 2019, revoking the patent), the interim order restraining the defendant from carrying out any fresh manufacturing of pharmaceutical preparations comprising the Active Pharmaceutical Ingredient (‘API’) Ceritinib, stands suspended.

3. Be that as it may, the Court stated that the Plaintiffs are at liberty to seek appropriate orders, if any order is passed in favour of the Plaintiffs by the IPAB.

By: Ian Mirandah

A version of this article was first published in the membership journal of the Chartered Institute of Patent Attorneys – see more at http://www.cipa.org.uk/.