Bayer loses patent battle at Delhi High Court

Bayer has been defeated in a patent battle against India-based drugs companies Alembic Pharmaceuticals and Natco Pharma today.

The ruling, which was handed down at the High Court of Delhi, gave Alembic and Natco permission to export generics of a Bayer drug for research and regulatory purposes.

Natco had been barred from exporting Sorafenat API (sorafenib), a generic of Bayer’s kidney cancer drug Nexavar (sorafenib), but was allowed to produce the drug in India under a compulsory licence.

Bayer had argued that because Natco was under a compulsory licence, Natco was limited to selling the drug in India and should not be allowed to export the drug’s active pharmaceutical ingredients (APIs).

According to the ruling, Natco was manufacturing the product covered by the compulsory licence for export outside of India.

The court has also given Alembic permission to continue exporting generic APIs of blood-thinning drug rivaroxaban for the purpose of research and development (R&D) to the EU.

Bayer, which holds patent rights over rivaroxaban, sought an order to ban Alembic from exporting the drug overseas, including for R&D and regulatory use.

The Indian companies are required to comply with section 107A of the Indian Patents Act, 1970.

Under the section 107A provision, companies can make, use and import a patented invention solely for development reasons.

The provision says: “Importation of patented products by any person from a person shall not be considered as an infringement of patent rights.”