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Business News/ Politics / Policy/  Delhi HC allows export of patented drugs for specific purposes
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Delhi HC allows export of patented drugs for specific purposes

The Delhi HC ruling came on two pleas filed by Bayer Corp. Ltd, which had moved against two companies for a cancer drug and a blood thinner, respectively

Delhi high court directed that the export of drugs can happen for the purposes of development, clinical trials and regulatory clearances. Photo: Pradeep Gaur/ MintPremium
Delhi high court directed that the export of drugs can happen for the purposes of development, clinical trials and regulatory clearances. Photo: Pradeep Gaur/ Mint

New Delhi: The Delhi high court on Wednesday allowed generic drug manufacturers to export patented drugs for the purposes of development, clinical trials and regulatory clearances.

The ruling came on two pleas filed by manufacturer Bayer Corp. Ltd, which had moved against Natco Pharma Ltd and Alembic Pharmaceuticals Ltd for a cancer drug and a blood thinner, respectively.

Justice Rajiv Sahai Endlaw allowed Natco Pharma and Alembic to export the active pharmaceutical ingredient (API) Sorafenib and Rivaroxaban for development purposes and regulatory clearances.

The two generic drug makers have furnished undertakings that exports of patented drugs will not be for purposes other than those in Section 107A.

Section 107A of the Patents Act explains what will not constitute infringement of a patent, and includes selling of a patented invention for the purposes of development.

The court said that sale under Section 107A, even if for profit, cannot be prevented.

The court rejected Bayer’s argument that only data can be exported.

“The court has reiterated that the growth of the pharmaceutical industry in India cannot be stunted in this manner by stopping exports for regulatory purposes which is a well recognized exception under trips. This judgment would dissuade and prevent frivolous litigation being filed against Indian generics," lawyer Prathiba Singh said, who represented Alembic in the case.

The court further said that no suit prohibiting exports of a patented invention would be available.

Bayer had moved the high court to restrain Natco Pharma from selling Sofranet abroad, since it’s a compulsory licence granted for sale within India. It filed a similar case against Alembic.

The court was to determine whether the provisions of the Patents Act allows exports and if so how the same are to be regulated so that they are within the confines of Section 107A.

The court had in March 2014 restrained the sale of Sofranet covered by the compulsory licence overseas. The court allowed Natco Pharma to export a small quantity, of less than 15 grams, for the purposes of clinical trials. Later, in November 2014, the court ruled that Natco Pharma could export 1 kilogram of the API Sorafenib for the purpose of clinical trial.

Alembic wants to export to Brazil and Palestine for regulatory clearances.

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Published: 08 Mar 2017, 12:34 PM IST
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