The Delhi High Court on Wednesday allowed two Indian pharmaceutical companies — Natco and Alembic — to export generic versions of German drug major Bayer’s patented invention Sorafenib, used in treatment of kidney cancer, and Rivaroxaban, which is a blood thinner, for research and development purposes.
The court ruled that Indian generic drug makers have the fundamental right to make, sell and export patented medicines for purposes of regulatory approval and clinical trials and said that the same did not amount to infringement of the German company's patent.
The court also held that a company cannot be barred from manufacturing and exporting a drug merely because there is no law to ensure that the patented product is used in the destination country for the same purpose for which it is exported.
‘Fundamental right’
“The right of manufacturers/producers of medicines and of fine chemical producers, to make, construct and sell including by way of export, a patented invention, for the purposes prescribed in Section 107A (of Patents Act) is a fundamental right protected by Article 19(1)(g) of the Constitution and the sale cannot be curtailed except by express law,” Justice Rajiv Sahai Endlaw said.
While allowing the Indian drugmakers to export the patented products versions, the court imposed a rider that they, during the life of the respective patent, will not export the respective patented invention for any purpose other than those specified in Section 107 Patents Act (for development/ research purposes).
‘No permission’
Bayer had objected to Natco making, importing, selling, offering for sale Sorafenib, a generic version of Bayer's cancer drug 'Nexavar'.
Natco had contended that it was exporting the same only for developmental purposes, while Bayer contended that the Indian firm had permission only for sale within India.
Bayer had also objected to Alembic manufacturing and exporting Rivaroxaban, a generic of its Xarelto, to the European Union.
Alembic had claimed that it had not launched the drug commercially while Bayer had said the export of 90 kg of drug worth ₹3 crore by Alembic could not be for clinical purposes.
Both firms submitted that their exports are intended only for research and development and to obtain the drug regulatory approvals in those countries.
