Pharmaceutical patents in India - new and old compulsory license provisions cast doubt on their value

Pharmaceutical products are now patentable subject matter in India thanks to the Patents (Amendment) Act, 2005, which is the statutory mechanism by which India met the deadline for bringing its patent law into full TRIPs compliance.

The legislation was intensely debated for several months, by both domestic and foreign interests, including the pioneering companies of the international pharmaceutical industry and developing and undeveloped nations.

Why do developing and undeveloped countries care about patent law in India?  Many of these nations rely on the Indian pharmaceutical industry to provide inexpensive copies of patented pharmaceutical products and feared that this supply would disappear over night upon enactment of the new law.

The final law accommodates the interests of these developing nations with the following special compulsory license provision:

92A. (1) Compulsory license shall be available for 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 license has been granted by such country or such country has, by notification of otherwise, allowed importation of the patented pharmaceutical products from India.

Explanation — For the purposes of this section, “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.

Note that the “Explanation” is part of the statute.  The emphasis is mine.

This compulsory license provision is incredibly vague.  What exactly is a “public health problem?”  For that matter, what is “insufficient manufacturing capacity?”  And look at its breadth — compulsory licenses granted under this provision can extend to ingredients and diagnostic kits.

Indian patent law already includes a compulsory license provision that can be invoked under certain circumstances, including a lack of working the patent in India.  This provision extends to all patents and presumably includes patents on pharmaceutical products.  Considering this, the new compulsory license provision appears to be a direct product of lobbying by developing nations.

So now you can seek and obtain patent protection on pharmaceutical products in India.  But, with two compulsory license provisions in the law, the value of pharmaceutical patents remains to be determined.