Delhi HC allows Natco, Alembic to export their versions of Bayer drug for experimental purposes

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. And 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. Nexavar was at that time priced at Rs 2.8 lakh per patient per month, while Natco’s version of the drug was pegged at Rs 8,800.

Explaining the latest Delhi HC verdict, senior advocate Anand Grover told Business Line that multinational companies try to block generic drugmakers from using flexibilities available in the Indian Patents Act. The latest judgement is significant because drug companies will be able to send their version of the innovators drug to another country for experimental or developmental purposes. Grover along with Rajeshwari & Associates appeared for Natco.

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 (API) 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 of Sorafenat 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 Natco to export only 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.

Natco’s counsels argued that it did not infringe Bayer’s rights under Section 48 of the Patents Act, as it was not selling the API for commercial purposes but was exporting it only for development studies to generate data for submission to Chinese authorities which is covered under Section 107-A of the Indian Patents Act. He also argued that Section 107-A is independent of grant of compulsory license.

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.

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