Bolar exemption clarified


Natco Pharma was represented by Anand Grover, on instructions from Rajeshwari H, managing partner of Rajewshwari & Associates, when Delhi High Court recently allowed Natco to export sorafenib tosylate, a drug patented by Bayer for which Natco had obtained a compulsory licence in 2012. Bayer Corporation was represented by senior advocate Sudhir Chandra, on instructions from advocate Arun Kumar Jana and Perfexio Legal managing partner Sanjay Kumar and partner Arpita Sawhney.

Bottle_pouring_pills_in_male_handNatco will export the drug to China for experimental purposes – a move that the court said does not amount to patent infringement, as it is allowed under an exemption provided in section 107A of the Patents Act, 1970.

Speaking to India Business Law Journal Rajeshwari H, who was assisted by Aparna Gaur, Tahir AJ and Gajendra, lawyers at the firm, said the ruling was significant as it “clarifies the situation for India’s generics industry”.

Meanwhile in an action initiated by Bayer Intellectual Property, a wholly owned subsidiary of Bayer Corporation, against Alembic Pharmaceuticals that was decided simultaneously, Alembic was cleared of infringing Bayer’s patent in rivaroxaban.

Bayer was represented by Anand and Anand managing partner Pravin Anand, partner Archana Shanker and senior associates Aditya Gupta and Utkarsh Srivastava.

Alembic was represented by senior advocate Prathiba Singh, Saya Chaudhary Kapur, a partner at Singh & Singh Lall & Sethi, Vivek Ranjan, a senior associate at the firm, Robin Koolwal and Sutapa Jana, associates at the firm, and advocate Devanshu Khanna.

Alembic had denied exporting rivaroxaban for purposes other than those under section 107A. Prathiba Singh told India Business Law Journal that by clearing Alembic of patent infringement “the court has categorically held that for the purposes of regulatory approvals in other countries, it is permissible for companies to export the patented product”.

Kapur told India Business Law Journal that the ruling, which “recognizes the Bolar exemption as enacted under the Indian patent law … is in consonance with the intent of the legislature that a non-patentee is allowed to take steps in order to ensure that it is ready to manufacture and market pharmaceutical products from the very moment of expiry of term of patent”.

Appeals were expected in both matters. Pravin Anand told India Business Law Journal that his client “will certainly be appealing the order”. In a note summarizing the case he said: “the ruling allows generics to export the patented invention without any regulation by merely declaring that the export is for regulatory purposes”.