Delhi High Court permits Natco, Alembic to export drugs for R&D

By: | Published: March 9, 2017 5:16 AM

The Delhi High Court has allowed Natco Pharma and Alembic Pharma to export Sorafenat bulk drug active pharmaceutical ingredients (APIs) and Rivaroxaban for use in research and development and experimental purposes.

German drug major Bayer AG had sought an injunction from exporting Sorafenat in 2014. Sorafenat is manufactured by Natco Pharma under compulsory license (CL) for Bayer’s patented drug Nexavar, used for kidney cancer.

The Delhi High Court has allowed Natco Pharma and Alembic Pharma to export Sorafenat bulk drug active pharmaceutical ingredients (APIs) and Rivaroxaban for use in research and development and experimental purposes.

German drug major Bayer AG had sought an injunction from exporting Sorafenat in 2014. Sorafenat is manufactured by Natco Pharma under compulsory license (CL) for Bayer’s patented drug Nexavar, used for kidney cancer.

Bayer had said compulsory license is only for sale of the drug in India and Natco should not be allowed to export the drug’s active pharmaceutical ingredients.

Natco sought to export samples of the drug’s API to generate clinical trial data for submitting to regulators of various countries.

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An official from Natco Pharma said that the company is yet to study the full order but the operative portions of the orders are export permitted, no conditions for R&D and can be exported for experimental purposes as the company was clear that it was not exporting for any other purposes.

Earlier, Natco Pharma had said that the Special Leave Petition (SLP), preferred by Bayer Corporation was dismissed by the Supreme Court of India. The SLP was filed by Bayer against Union of India, Natco Pharma and others for the grant of CL to Natco for Bayer’s product Nexavar, used for liver and kidney cancer.

German drug major Bayer AG had challenged in Bombay High Court on 5th July, 2014. Earlier, it had challenged the Intellectual Property Appellate Board’s (IPAB’s) order of CL issued to Natco Pharma in the Bombay High Court and has sought the court’s intervention to protect its rights over patented cancer drug Nexavar. In March 2012, Natco Pharma announced the granting of a CL under the provisions of Section 84 of the Indian Patents Act, 1970 for Sorafenib Tosylate having the brand name as Nexavar and owned by Bayer Corporation.

Nexavar is the first-line treatment for liver and kidney cancer.

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