Make pharmaceutical patents work in the public interest

The Indian Patents Act contains a rather unique provision not found in most other patent regimes. It requires that every patentee disclose how they have worked their patented invention. Violation of this statutory mandate is punishable with fine and other criminal penalties.

Working a patent means that the patented invention must be used or deployed in some way, either as a commercial product or through licences to enable third parties to make such products.

In fact, patent working lies at the heart of a robust innovation ecosystem, for if patents are simply hoarded and not commercialised it can have perilous effect on this environment. More importantly, an ‘abusive’ working of patents in the pharmaceutical sector (such as charging excessive prices or not making a critical drug available to the patient population) can have deleterious public health consequences. Therefore, the requirement that the extent to which a patent is commercially worked be disclosed to the general public.

Patent working disclosure also serves as a necessary quid pro quo for the 20-year monopoly granted to the patentee; in helping assess whether or not the patentee has served the larger public interest through the patent. And it is here that the Indian patent system scores over the allegedly more advanced patent systems of the United States and European Union.

Unfortunately, this disclosure requirement is not taken seriously by the Patent Office or patentees. I, therefore, filed a public interest petition in the Delhi High Court in 2015 praying that the Patent Office be directed to take action against errant patentees who fail to submit this information. I filed details of a survey conducted by me along with my research associates showing that between 2009-2012, around 35 per cent of patentees sampled simply failed to submit this information at all.

In an extremely lucid order, the Delhi High Court agreed with our broad contentions and noted that patent working information is not “confidential” and must necessarily be submitted by patentees. However, a final order on this petition is still due and the matter is now listed for February 5. Patent working norms are particularly important during compulsory licensing cases, to help establish whether the patentee has fulfilled the reasonable requirements of the public by selling the patented product at an affordable price.

Patent working information played a critical role in the famous Bayer vs Natco compulsory licensing (CL) dispute, with Natco using Bayer’s working information to help demonstrate that Nexavar (a very expensive patented drug for kidney/liver cancer) was available to hardly 2 per cent of the patient population.

Under the CL order, Natco was directed to submit periodic information on the sales of its own generic product, Sorefenat. This information is absolutely critical, since the very premise of the CL is that Natco would work the patent better than the patentee by making it more available to a larger cross-section of the patient population. In fact, the Patents Act stipulates that if, despite the CL, the patented invention is still not fully worked to satisfy the public requirements, the patent could be revoked.

In response to our RTI queries, the Patent Office indicated that Natco had not filed this critical information. We, therefore, highlighted this in our petition and the Court made note of it in its order. Subsequently, Natco appeared in Court to suggest that they did file this with the Patent Office and it was the latter’s fault for not disclosing it.

At the next hearing, one hopes that the Court hands down a landmark order directing the Government and patentees to take the disclosure requirement more seriously. For patent working is central to a robust innovation ecosystem and furthers the public interest in more ways than one.

The writer is the Honorary Research Chair Professor of IP Law at Nirma University and founder of the blog SpicyIP. Views expressed are personal.

Shamnad Basheer is the Honorary Research Chair Professor of IP Lawat Nirma University and founder of the blog

SpicyIP. Views expressed are personal.