Indian court clears export of patented Bayer drugs for research
The Delhi High Court has cleared two Indian drug companies to export a cancer drug and blood thinner, both patented by Bayer, for the purposes of development and clinical trials for regulatory clearances.
The judgment, issued on Monday, April 22, settled two appeals brought by Bayer against the 2017 decision of a lower Indian court to approve the export of its patented drugs by Alembic Pharmaceuticals and Natco Pharma for research purposes.
Natco had been seeking to export sorafenib, the active ingredient in Bayer’s renal cancer drug Nexavar.
Bayer obtained a patent for sorafenib and sorafenib tosylate in 2012.
While the patent application was pending, Natco obtained a compulsory licence for the drugs from the Indian Patent Office solely for the Indian market.
Natco then produced the drug for export outside the Indian market, but argued that it did not export “to any party outside India for [a] commercial purpose”.
Alembic, meanwhile, had sought to export rivaroxaban, the active ingredient in Bayer’s blood thinner Xarelto.
The Indian companies cited Section 107 of the Patents Act which they argued allows the sale of a patented invention for development purposes.
In Monday’s judgment, the Delhi High Court affirmed the ruling of the lower court that the drugs could be exported for research purposes.
The sale of a patented drug “both within the country and abroad is authorised and legal provided the seller ensures that the end use and purpose of sale/export is reasonably related to research and development”, the High Court said.
The High Court also ruled, however, that the lower court would have to reconsider whether these drugs were, in fact, being sold for research purposes.
In the 2017 ruling, the court had found that the proposed quantities were too small to be for commercial purposes. The High Court has now found that this reasoning alone was insufficient to establish “reasonable use”.
The High Court outlined a list of criteria to be considered in such cases, including among others the type of patent at issue and the nature of the products, as well as the quantity.
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