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10

JUN

2019

Issues:

In the case of Novartis AG & ANR v Natco Pharma Ltd, Swiss Pharma major Novartis has been granted patent for novel and inventive compound “Certinib” for treatment of non-small cell lung cancer. The suit patent was filed claiming priority since 2007, and was granted on 28th September, 2015.

Novartis came across NOXALK (Natco Pharma’s product) at a pharmaceutical conference at Kolkata and noticed the launch of “Certinib Capsules”.

Natco Pharma claimed that the Certinib molecule is neither novel nor inventive as it is covered under the broad “Markush” formula which is disclosed in the patent granted to AstraZeneca ortwo other patents granted to Rigel. Based on such contentions Natco Pharma opposed Novartis’s patent by post-grant opposition.

Novartis filed a case in High court against Natco Pharma seeking permanent injunction, damages, rendition of accounts and delivery up in respect of its granted patent and restraining Natco Pharma from manufacturing and selling “Certinib” capsules.

Judgement:

Justice Pratibha M Singh passed an order on May 2, 2019 directing Natco to file a response to the injunction moved by Novartis within 2 weeks.

Referring to the decision of the Supreme Court in Aloys Wobben, the judge held that though the patent rights may be crystallized once the opposition is actually decided, during the pendency of the post-grant opposition, the rights of a patentee subsist. Thus, confirming that Section 48 of the Patents Act grants rights in favour of a patentee, are not affected during the pendency of a post-grant opposition.

The court remarked that Natco Pharma ought to have waited for the decision of the court on the post-grant opposition instead of launching the product.

In an interim the court allowed selling of the stock that is already manufactured by Natcounder the mark NOXALK (Certinib) considering the interest of the patient community holding that stopping the sale of defendant’s product would only harm the patient community.

The Delhi court restrained Natco Pharma from manufacturing any fresh stock of drugs comprising “Certinib” compound.

The court also directed the Controller General of Patents, Designs and Trade Marks with a request to pass the order on the post grant opposition before the next date of hearing so that the Court can have the benefit of the decision of the Patent Office.

Author: Ms. Mita Sheikh – Associate Director and Co- Author- Siddhi Mundada , Intern at Khurana & Khurana, Advocates and IP Attorneys. In case of any queries please contact/write back to us at mita@iiprd.com .

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