Natco Pharma, Alembic Win Legal Battle Against Bayer; Allowed To Export Select Drugs For R&D
The Indian drugmakers were fighting a case with Germany’s Bayer AG.
In what comes as a relief to Natco Pharma Ltd. and Alembic Pharmaceuticals Ltd. engaged in a legal battle with Germany's Bayer AG, the Delhi High Court on Wednesday allowed both drugmakers to export select active pharmaceutical ingredients (APIs) for research and development (R&D) purposes.
The court had barred Natco from exporting kidney cancer drug Sorafenat API in 2014. Sorafenat is manufactured by the Indian company under compulsory licence for Bayer’s patented drug Nexavar.
Bayer had argued that compulsory licence is only for sale of the drug in India and Natco should not be allowed to export the drug’s API. Natco sought to export samples of the drug’s API to generate clinical trial data for submitting to regulators of various countries.
The court also allowed Alembic Pharmaceuticals Ltd. to export Rivaroxaban API for R&D. Bayer has patent over Rivaroxaban, a blood thinner, and sought a restraining order on Alembic from exporting the drug for R&D and/or regulatory use overseas.
“The court has re-iterated that pharma industry growth cannot be stunted in this manner. This judgement will dissuade frivolous litigation for or against Indian generic makers,” said senior advocate Pratibha Singh, who represented Alembic.
Rejecting Bayer's plea that only data should be exported, the court said exporting products is a constitutional right of Indian companies, Singh told reporters after the hearing. The judgment was passed by Justice RS Endlaw.
The Natco Pharma stock rose as much as 3.17 percent to Rs 792, while Alembic Pharmaceuticals stock jumped as much as 5.98 percent to Rs 623.5 after the court’s verdict.