By Vikas Dandekar, ET Bureau Jul 14, 2019, 12.10 PM IST
MUMBAI: The acrimonious patent-related tussles between Indian and multinational drug makers are down but not yet out. In the latest development, a division bench of the Delhi High Court dismissed an injunction petition filed by German drug maker BayerNSE 1.13 % to protect its drug Regorafenib sold under brands Stivarga, Nublexa and Resihance against Hyderabad-based drug maker Natco Pharma
Bayer raised the objection against Natco’s brand launched under the name Regonat alleging infringement of its patent rights. The court has sent back the case to the single judge for hearing the matter afresh. The case is likely to come up for hearings later this month.
Regorafenib is used to treat colorectal cancer, known to be the sixth most prevalent cancer in India. Bayer alleged its drug was granted patents in 2004 and is therefore eligible for intellectual property protection right ..
According to the July 11 order, Bayer’s products, marketed since 2013 in India, were priced at INR36000 to INR40000 per bottle of 28 tablets while Natco’s product was made available at INR9000 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 INR25 crore, according to the document.
Industry insiders said a patient is prescribed three tablets a day.
Patent experts said Natco contended that regorafenib is already disclosed in an earlier patent filing and hence the new patent claims is not valid for protection. It had also filed a lawsuit in a Hyderabad court for such clarification. Bayer, on the other hand, filed its claims of patent infringement at Delhi High Court asserting its patents.
In response to ET on the case, Bayer said, “The division bench of the Delhi High Court has considered the appeal filed by Natco, challenging the order dated 5 July 2019 passed by the single judge in a patent infringement lawsuit filed by Bayer against Natco for regorafenib. We will review the order passed by the Division Bench and decide future course of action.”
Questions sent to Natco remained unanswered till press time.
Notably, this is the second time the two drug makers are engaged in a battle over patents. The first was a closely watched one over kidney cancer drug sorafenib branded Nexavar by Bayer. In that protracted case that lasted several years, Natco had challenged Bayer’s patent, following which it was granted a compulsory license in 2012 to sell generic copies. That remains the only compulsory license granted in India for a pharmaceutical product.
That decision however sparked an international controversy leading to pressure from US lobbies and government agencies that alleged India had disregarded patent rights of global corporations and played a discriminatory policy favoring the local companies. India, however, maintained it had followed the WTO provisions and exercised flexibilities allowed in determining patent rules.