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Delhi High Court allowed Indian drug manufacturers to export patented medicines for approval

 

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The Delhi High Court allowed the Indian companies Alembic and Natco Pharmaceuticals to export - for research and regulatory purposes - generic versions of two life-saving drugs developed by Bayer Germany.

The government had granted Natco a license to make the generic version of Nexavar in 2012 before the expiration of its patent - a decision confirmed by the Supreme Court in 2014 when Bayer appealed the measure. In the case of Natco, Bayer said license for Sorafenat had been granted for the sale of drugs in India. Natco requested court authorization to send samples of active ingredients abroad for testing and production of clinical trial data for submission to authorities.

Bayer had approached the court in 2016 to prevent Alembic from exporting its generic version of Xarelto (Rivaroxaban), used to prevent and treat dangerous blood clots. The company also sued the government in 2014 to stop Natco's export of Sorafenat, a generic copy of Bayer's drug Nexavar (Sorafenib), used to treat liver and kidney cancers.

Both companies stated that their exports were purely for research and regulatory purposes. In addition, Natco stated that it has never exported the finished product outside of India for commercial purposes.

 

"I judged that their exports were allowed," said Judge Rajiv Sahai Endlaw. Alembic and Natco are under an obligation not to export drugs for purposes other than those provided for in Section 107A of the Patents Act 1970. Endlaw stated that supporting what Bayer argues would be contrary to the natural, literal or textual interpretation of section 107A.
"Any export by a non-patentee of a patented invention shall be deemed to be for that purpose and, only if proved otherwise, may render the exporter responsible for the consequences thereof in an appropriate legal proceeding, it added.

"The court reiterated that the growth of the pharmaceutical industry can not be stunted in this way by halting exports for research and regulatory purposes which is an exception recognized under the Agreement on Trade Intellectual property rights, Pratibha M Singh, said Alembic's counsel.

According to Rajeshwari H, counsel for Natco, the judgment interprets for the first time the scope of section 107A, including the fact that exports are permitted under this section. "...

This judgment makes it clear for the first time that, as long as the material is exported in good faith for regulatory submissions, it can not constitute an infringement (of a patent)," she told.

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