MERCK files Patent Infringement Suit against TEVA

Merck Sharp & Dohme Corp. (Merck), the patentee of Indian patent No. 209816, filed a patent infringement suit in respect of the said patent against Teva API India Pvt. Ltd. (Teva), when it found out that Teva was manufacturing and exporting large quantities of Sitagliptin API, a product which was covered under Merck's patent. Merck was successful in obtaining an ex-parte ad-interim injunction against Teva in the said suit.

Teva thereafter not only filed an application seeking vacation of the ex-parte ad-interim injunction but also filed a review of the order granting the ex-parte ad-interim injunction, on the ground that Teva was manufacturing Sitagliptin API purely for R&D and pleading that the export of the Sitagliptin API was being done for generating information and data required for submission to the regulatory authorities around the world. That therefore the manufacture and export of Sitagliptin by Teva did not amount to infringement of the suit patent as it was a permissible activity under the bolar exemption provision of the Patents Act, 1970, i.e. Section 107A of the said Act.

While the two applications seeking vacation of the ex-parte ad-interim injunction and review of the order were pending, Teva preferred an appeal against the order granting the ex-parte ad-interim injunction before the division bench of the Delhi High Court.

A division bench comprising Hon'ble Justice Pradeep Nandrajog and Hon'ble Justice Mukta Gupta after admitting the appeal and hearing arguments of both the parties declined to interfere with the order passed by the Single Judge.

While deciding the appeal, Hon'ble Judges held that the present case required evaluation of facts in the context of Teva's contentions giving due consideration to the quantities of the infringing product exported by Teva. The Hon'ble Court also observed that the continuation of the injunction as granted by the Single Judge would not cause any injury to Teva because marketing authorizations would require at best 2-3 years and Merck's patent would only lapse in the year 2022.