Bayer’s woes with compulsory licences

During the pendency of this suit, Natco approached the Indian patent controller for the grant of a compulsory licence for sorafenib and sorafenib tosylate.

The following year, the patent controller granted Natco a compulsory licence to patent number 215758 (sorafenib).

In 2014 Bayer obtained an order holding that consignments from India containing Sorafenat, Natco’s version of sorafenib, could not be exported.

Natco submitted that it had the required drug licences and consent of Bayer’s counsel to export the drugs in no more than 15mg quantities for clinical studies.

Natco again applied for a licence to allow the export of 1kg of the drug to China for clinical studies and trials. This was then contested by Bayer.

Bayer had also instituted a suit against Alembic Pharmaceuticals, claiming that it had exported 90kg of the drug to Brazil and Palestine.

Bayer’s counsel submitted that section 107A of the Patents Act 1970 did not contemplate the export of products. Bayer argued that section 107A envisages that the patented invention can be used only in India for conducting trials and that the regulatory information generated from the said trials can be given to the concerned authorities in a country other than India.

Bayer also argued that the rights under section 107A stemmed from section 84(4) of the Patents Act and that the word “selling” under section 107A referred to the sale of the drugs in India alone—and did not include the export of such drugs.

These arguments were countered by Natco’s counsel who argued that the drugs were exported to China solely for research and development and that the regulatory regime in China requires clinical trials to be conducted in that country.

Natco’s counsel also argued that the company didn’t have any commercial reason to export the drugs.

Bayer’s counsel alleged that experimentation, and research and development into the patented product was prohibited as it would lead to commercial exploitation.