Delhi court rejects Bayer injunction against Natco Pharma generic

India’s Delhi High Court has dismissed a petition for an injunction by German pharma company Bayer against an Indian competitor.

In a judgment on Thursday July 11, the court said Bayer could not stop Natco Pharma from launching a generic used to treat colorectal cancer and advanced gastrointestinal tumours.

The dismissal comes after an earlier July 5 ruling in which Bayer secured an injunction against Natco, but Natco appealed the decision.

Bayer had filed the motion in a bid to protect its drug Regorafenib, which is sold under brands Stivarga Nublexa and Resihance, ahead of Natco’s launch of its generic Regonat (regorafenib).

Bayer argued that this infringed its patent (Indian number 240207), which it was granted in 2004 and is eligible for protection for 20 years.

It had asked the court for a permanent injunction restraining Natco from making, selling, distributing and advertising its generic in the country.

But, Natco said regorafenib was already disclosed as prior art in an earlier patent filing, and the ‘207 patent was not eligible for protection. It has also filed a petition with a Hyderabad-based court, asking for a declaration of invalidity.

Bayer said it became aware of Natco’s allegedly infringing activities after learning that Natco was planning to commercialise its regorafenib generic in the Indian market.

It said the tablet strength of Natco’s generic is “identical” to which Bayer markets, alleging that Natco had merely copied its patented product.

Bayer currently sells its products in India for 36,000-40,000 Indian rupees ($522-$580) per bottle of 28 tablets.

Natco’s product is priced at 9,000 Indian rupees per bottle. Natco had also pledged to make the medicine free for 2,000 patients for life.

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