Cancer Drug Patent Issues: Delhi HC junks Bayer plea to block Natco Pharma Regonat

New Delhi: The Delhi High Court recently junked the injunction petition filed by the German Drugmaker to restrain the Hyderabad-based Natco Pharma from making, using, selling, distributing, advertising, exporting, offering its cancer drug Regorafenib.

The sixth most common drug in India, Regorafenib is sold under different brand names including Nublexa, Resihance, Stivarga. The drug is indicative of treating is used for the treatment of metastatic colorectal cancer and advanced gastrointestinal stromal tumours.

Also Read: Setback: Delhi HC restricts Natco Pharma from manufacturing cancer drug Ceritinib

A division bench of Justice S Muralidhar and Talwant Singh while setting aside the injunction order against Natco Pharma held that the ordinary parameters for grant of interim injunctions should be followed in patent infringement suits as well. The bench observed;

"Although there are special features in litigation involving infringement of patents, that still would not obviate the Court dealing with the question of grant of interim injunction to record the three important elements as hav been stressed in a large number of decisions of the Supreme Court."

The decision comes after an injunction against Natco Pharma secured by Bayer on July 5 was challenged by Natco. Bayer claimed of patent infringement at Delhi High Court asserting its patents for the cancer drug Regorafenib launched by Natco under the name Regonat. Bayer claimed that Regorafenib was granted patents in 2004, thereby eligible for intellectual property protection rights for two decades.

Also Read: Bayer applies for Regorafenib authorization to treat liver cancer

However, Natco reportedly contended that regorafenib is already disclosed in an earlier patent filing and hence the new patent claim is not valid for protection. It had also filed a lawsuit in a Hyderabad court for such clarification.

Hyderabad-based pharma firm appealed to the division bench of Delhi High Court which has now held in favour of Natco Pharma.

As regards the order, the division bench observed :

"the learned Single Judge in the impugned order does not set out any prima facie view. On the contrary, it records in para 9 that „at this stage, it is not possible to form an opinion, even prima facie‟. As regards the other two elements viz., balance of convenience and irreparable hardship, there is no mention of these, even impliedly in the impugned order."

"'A reading of the impugned order does not reflect that the Court has formed such an opinion on the three elements", it added.

According to the July 11 order, Bayer's products, marketed since 2013 in India, were priced at INR 36000 to INR 40000 per bottle of 28 tablets while Natco's product was made available at INR 9000 per bottle. Natco had agreed to provide the medicine free to 2000 patients for life. The annual sales of Bayer's brands stood at around INR 25 crore, according to the document.

Prior to this, the two drugmakers were in a feud over kidney cancer drug sorafenib branded Nexavar by Bayer.