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Delhi High Court restrains Cipla from infringing Novartis’ respiratory drug

Nalini Sharma

Upholding Justice Manmohan Singh’s order of January 2015, the division bench of Badar Durrez Ahmed and Sanjeev Sachdeva, JJ. of the Delhi High Court today restrained Cipla from infringing Novartis’ patent on its drug Indacaterol – marketed under the name “Onbrez”.

Onbrez is a respiratory drug, which provides relief to persons suffering from Chronic Obstructive Pulmonary Disease (COPD). It is a drug manufactured by the Swiss company in Switzerland and imported into India by Lupin.

In October 2004, Cipla had launched its own drug “Unibrez”, which provided the relief for the same disorder. Novartis filed a trademark infringement suit against the Indian company in January 2015 which was disposed of after Cipla agreed to change the name of the drug to “Indalfo”.

Soon after, Novartis filed a suit for patent infringement. The matter came up for hearing before Justice Manmohan Singh, who granted an injunction to Novartis, restraining Cipla from using, manufacturing, importing or selling any product containing Indacaterol.

However, Justice Singh had stated in the order that the injunction was granted only till the determination of any plea (if filed) by Cipla for compulsory licensing.

While on one hand, Cipla appealed against the single judge’s injunction, Novartis filed a cross-objection against the limit imposed on the grant of the injunction.

Cipla was represented by Senior Advocates P. Chidambaram, Abhishek Manu Singhvi and Prathiba M. Singh before the division bench. On the other hand, Senior Advocates Gopal Subramanium and C. Vaidyanathan argued for Novartis.

Counsel for Cipla contended that Novartis did not have a working patent in India since the drug was not manufactured in India, and was only imported in small quantities. Based on this, they submitted that Novartis was not entitled to an injunction.

Cipla also argued that ten tablets of Novartis’ drug cost Rs. 677 whereas ten tablets of their drug cost Rs. 130. This attracted ‘public interest’ – the fourth consideration for grant of injunction, in addition to a prima facie case, balance of convenience and irreparable harm and injury.

The counsel for Cipla further relied on Article 7 of the TRIPS Agreement, the Doha Declaration and India’s submissions during the GATT negotiations to substantiate their arguments.

While the counsel for Novartis argued that not manufacturing a drug did not mean the patent was not working in the country as long as sufficient quantities of the drug were imported. They also stated that Cipla had not challenged the patent itself, “at least not seriously”.

Subramanium and Vaidyanathan also established the prima facie inventiveness and usefulness of the patent through its “extraordinary utility and quality”.

Lastly, the counsel submitted that public interest could not outweigh the rights of the patentee granted under the Act.

The bench today allowed the injunction to continue stating that it “ought not to be disturbed.”

The judges observed that there was no credible challenge to Novartis’ patent and therefore Novartis would be entitled to an injunction. The bench also sided with Novartis on the argument that for a patent to be worked in India, it need not be manufactured in India.

Regarding, public interest, the Division Bench held that Cipla hadn’t made a case that public interest will be dis-served by the grant of injunction, whereas, Novartis had established a prima facie case that the injunction is valid.

The bench, therefore, dismissed the appeal.

Read the full judgment here.

Cipla-Novartis.pdf
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