Business Line: Article: Saturday, February 03, 2018.
A Delhi High
Court case shines a light on why public disclosure on working a patent is
critical for compulsory licensing and public health.
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.)
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