This is an informal case summary prepared for the purposes of facilitating exchange during the 2022 WIPO IP Judges Forum.
Session 1: Role of the Judiciary in Promoting Balanced and Effective IP, Innovation and Creative Ecosystems
Intellectual Property Appellate Board, Chennai, India [2013]: Bayer Corporation v Natco Pharma Ltd. & Ors., OA/35/2012/PT/MUM
Date of judgment: March 4, 2013
Issuing authority: Intellectual Property Appellate Board, Chennai
Level of the issuing authority: N/A
Subject matter: Patents (inventions)
Plaintiff: Bayer Corporation (appellant)
Defendant: Union of India, the Controller of Patents, Natco Pharma Limited (respondents)
Type of Procedure: Administrative
Keywords: Compulsory license
Basic facts: The Appellant, Bayer Corporation (Bayer), was granted a patent for Sorafenib Tosylate, a palliative drug for renal cell carcinoma and hepato-cellular carcinoma at stage IV, marketed under the name Nexavar. The third Respondent, Natco Pharma Limited (Natco) approached the Appellant in December 2010 requesting a grant for a license. In May 2011, the Appellant filed a civil suit against the third Respondent before the Delhi High Court for infringement of its patent. The third Respondent applied for compulsory license in July 2011, stating that the high price of the cancer treatment was denying access to most patients in India and that they would be able to lower its price for the Indian public. The compulsory license was granted by the Controller of Patents, with 6% of royalties on net sales to be paid to Bayer. This case was an appeal to that order.
Held: The Intellectual Property Appellate Board (Board) dismissed the appeal and confirmed the grant of the compulsory license to Natco. Only the royalty rate owed to the patentee was modified.
Relevant holdings in relation to compulsory license: The Board reviewed and elaborated on the conditions for the grant of a compulsory license set out in section 84(1) of the Patent Act were satisfied, namely: that the reasonable requirements of the public with respect to the patented invention have not been satisfied; or, that the patented invention is not available to the public at a reasonably affordable price; or, that the patented invention is not worked in the territory of India. This was the first compulsory license granted in India under the Patents Act.
Relevant legislation:
S.84 of the Patent Act of India
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)