In a significant ruling for generic drug companies, the Delhi High Court has allowed Hyderabad-based Natco to export its version of Bayer’s patented drug sorafenib tosylate for experimental purposes.
An advanced kidney cancer drug, sorafenib tosylate is marketed by Bayer as Nexavar. The issue touches a raw nerve for foreign drug companies as Nexavar is the first and only drug in India on which a compulsory license had been issued.
In March 2012, India had issued a CL on Nexavar allowing Natco to make its chemically-similar version of the drug for the local population, on the payment of royalty to Bayer.
Senior advocate Anand Grover told
Bayer could not be reached for comment on whether it would appeal the Court ruling. The German drugmaker had received a patent on the drug in March 2008.
Natco was exporting the Active Pharmaceutical Ingredient of sorafenib tosylate to China to run bioequivalence and bioavailability studies (to prove their product is similar to the innovator product) for regulatory approval in China. But in March 2014 Bayer approached the Delhi HC asking that export consignments be seized and Natco’s NOC (no objection certificate) for export of the drug be refused on the grounds that it infringed Bayer’s patent rights. The CL allowed Natco to sell only in India, Bayer said.
Natco did receive interim relief in May 2014, when the Delhi HC allowed it to export 15 grams of the drug. In another order in November 2014, the Court allowed Natco’s application seeking permission to export one kg of the API of sorafenib mesylate.
In another case involving Alembic Pharma, the Court held that the export of Bayer’s blood thinner drug Rivaroxaban by Alembic wouldn’t infringe the patentee’s right, a lawyer familiar with the development said.
What is Section 107-A
Section 107-A is also known as the Indian version of the Bolar exemption. It makes certain acts (that could be seen as an infringement of a patentee’s rights) to be a non infringement during the subsistence of the patent. Such acts under Section 107-A includes use of the patented invention solely for uses related to the development and submission of information.
(source: Lawyers Collective)