Delhi High Court Judgement On Bolar Exception

By judgement and order dated Mar. 08 2017, a single judge of the Delhi High court interpreted the Bolar provision in India (section 107 A). Whether the language of section 107 A of the Patent Act, 1970 permits exports from India of the patented invention, even if solely for uses reasonable related to the development and submission of information required under any law for time being in force in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product.

The judge held that the word selling under section 107A of the act, includes within its ambit the meaning of the term export.

Background: The above interpretation was issued by the court through common order in cases W.P.(C) 1971/2014  (Bayer v. Union of India) and CS(COMM) No.1592/2016 (Bayer v. Alembic). The Bayer v. Union of India was filed seeking a mandamus to the Customs Authorities to seize the consignments for export containing products covered by Compulsory Licence including Sorafenat ‘ manufactured by Natco Pharma Limited (Natco) and further seeking a direction to all the Customs Ports to not allow exports thereof. The Bayer v. Alemibic was filed by Bayer  to injunct Alembic Pharmaceuticals Ltd. (Alembic) from making, selling, distributing, advertising, exporting, offering for sale and in any manner directly or indirectly dealing in RIVAROXABAN and any product that infringes Bayer‘s patent IN 211300.

Bayer contention was that Natco which is already granted a compulsory license for kidney cancer drug, sorafenib tosylate under section 84, which is subject to condition under section 90(1)(vii) that such license is granted solely for the purpose of making, using , offering to sell and selling the drug covered by the patent within the territory of India.

The court held that the grant of Compulsory Licence would not come in the way of Natco exercising its rights under Section 107A as a non-patentee.

The court also held that the export of Bayer’s blood thinner drug Rivaroxaban by Alembic would be entitled to export the patented invention for the purposes of Section 107A of the Patents Act.

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