On July 11, 2019, a division bench of Judges of Delhi High Court passed an order which clearly dismisses an injunction petition filed by German drug maker, Bayer group, to protect its drug Regorafenib sold under brand name Stivarga against Natco Pharma.1
Background of the case
The Bayer Group (Plaintiff) of Companies filed an injunction petition against Natco Pharma in a bid to stop the company from making, distributing, advertising, exporting, offering for sale and in any other manner directly or indirectly dealing with any product that infringes the subject matter of the Plaintiff's Patent (Indian Patent No. 240207) or any claims thereof, including Regorafenib and any forms thereof. In the petition the plaintiff mentioned that the company was granted the patent for the drug Regorafenib on April 29, 2010. The drug Regorafenib covered in the patent is used in the treatment of metastatic colorectal cancer and advanced gastrointestinal stromal tumors. Earlier, on July 5, 2019, through a ruling, Bayer Group secured an injunction against Natco, followed which Natco Pharma appealed the judgement and the case was transferred to division bench of the Delhi High Court. The bench of judges reviewed the case and sent back the case to the Single Judge for hearing the matter afresh.
According to the order of the division bench:
"The learned Single Judge in the impugned order does not set out any prima fascia view. On the contrary. It records in para 912 that at this stage, it is not possible to form an opinion even prima fascia. As regards the other two elements, balance of convenience and irreparable hardship, there is no mention of these, even impliedly in the impugned order"2.
According to Natco Pharma, Regorafenib is already disclosed in an earlier patent filing and hence the new patent claims are not valid for protection.
Section 83 of the Patent Act, 1970, states that any "patent granted should not prevent public health and nutrition and should act as instrument to promote public interest specially in sectors of vital importance for socio-economic and technological development". In response to this consideration Natco Pharma's product is available at INR 9000 per bottle which is comparatively much lesser priced that Bayer's products available at INR 36000 to INR 40000 per bottle. Natco Pharma had also agreed to provide the medicine free to 2000 patients for life. 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 patent. However, the decision of Division Bench of Delhi High Court was strongly condemned and raised alert and controversies at an international level. There was an immense 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.
The division bench court has sent the case back to the Single Judge of the Delhi High Court to thoroughly review the case and to examine the order which is favorable for both. The judge should also make sure the order should not suspend any laws of the Patent Act.
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