[Ip-health] Alert - Working of Patents requirement under review in India – relevance to the pharmaceutical sector

leena menghaney leenamenghaney at gmail.com
Wed Mar 21 04:50:28 PDT 2018

Please find below information on developments relating to the patent
working requirement in India, which may be of interest to the community
working on access to medicines and the use of health safeguards in patent

A patent working requirement (“working requirement”) is a component of
India’s national patent system. Patentees need to submit Form 27 to
disclose the full extent of working of their patent.

In the context of pharmaceuticals, patentees have mostly ignored this duty
and disclosures are deliberately vague and in other cases just not
fulfilled particularly as fines and penalties are not imposed by the Indian
Patent Office.

In the context of access to affordable medicines, the importance of
disclosures under section 146 are clearly evidenced during the compulsory
licensing proceedings (2011-2012) on the patented anticancer drug Sorefanib
Tosylate where not only the exorbitant pricing (Rs 2.8 lakhs per month
about USD 5000) but the data on the patentees failure to make it available
was also based on form 27 disclosures including no importation in certain
years and in other years import was grossly inadequate to meet the needs of
patients who could have benefited from the drug (hardly 2%).

In 2017, public interest groups highlighted that Otsuka has not initiated
the process of making delamanid available in India and that patents are not
granted merely to enable the patentee to enjoy a monopoly, yet more than
eight years since delamanid was first granted a patent in India the drug is
still not available/accessible to patients with XDR-TB. The drug had become
available in the European Union in 2014. Otsuka while not directly
responding to the letter filed for registration of the drug before the
Indian drug regulatory authority.  See letter here

In 2015 a public interest petition was filed in the Delhi High Court
praying that the Patent Office be directed to take action against errant
patentees who fail to submit this information. See documents here

Also see The Hindu, 2 February, 2018, Make pharmaceutical patents work in
the public interest;

The final decision in the matter is awaited and the concerned government
department – the Department of Industrial Policy & Promotion (DIPP) – has
called for submissions from stakeholders. Comments from stakeholders can be
submitted by the 23rd of March (deadline extended from 16th March)

See Comments on Issues relating to Working of Patents - Public Notice No.
CG/Meeting-Circular/DIPP/2018/14 dated March 1, 2018 available at


Leena Menghaney
Mobile: 9811365412

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