The Export Compulsory Licence

In one line

An Indian manufacturer may be licensed to make a patented medicine solely for export to a country that cannot make it for itself.

In the wording a student can write in an exam: section 92A of the Patents Act, 1970 provides that a compulsory licence shall be available for the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided that country has granted a compulsory licence or has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India.

The problem it answers

Chapter 170 works the problem in full. TRIPS article 31(f) required production under a compulsory licence to be predominantly for the supply of the domestic market. A country with no pharmaceutical industry could therefore licence nobody usefully: it had no domestic manufacturer, and a foreign manufacturer could not produce for it under its own country's compulsory licence.

Paragraph 6 of the Doha Declaration recognised the difficulty and instructed the Council for TRIPS to find an expeditious solution. The waiver of 30 August 2003 and then article 31bis, in force 23 January 2017, provided it.

Section 92A is India's expression of the solution, enacted in 2005 before the amendment itself came into force.

The provision itself

Section 92A(1). A compulsory licence shall be available for the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product to address public health problems, provided compulsory licence has been granted by such country, or such country has, by notification or otherwise, allowed importation of the patented pharmaceutical products from India.

Section 92A(2). The Controller shall, on receipt of an application in the prescribed manner, grant a compulsory licence solely for manufacture and export of the concerned pharmaceutical product to such country, under such terms and conditions as may be specified and published by him.

Section 92A(3). Sub-sections (1) and (2) are without prejudice to the extent to which pharmaceutical products produced under a compulsory licence can be exported under any other provision of the Act.

The Explanation. "Pharmaceutical products" means any patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems, and shall be inclusive of ingredients necessary for their manufacture and diagnostic kits required for their use.

Broken down

The importing country must qualify. Insufficient or no manufacturing capacity in the pharmaceutical sector for the concerned product. That is product-specific: a country may be able to make tablets and not vaccines.

And it must have acted. Either it has granted a compulsory licence itself, or it has by notification or otherwise allowed importation from India. Without one of those, section 92A is not engaged.