The Indian Pharmaceutical Alliance (IPA), a representative body of 20 research-based pharmaceutical companies in India, has called on the government to effectively use public health safeguards in Indian Patents Act.
Subsections (c) to (g) which were added by the Patents (Amendment) Act, 2002 with effect from 20 May 2003 were clearly intended to safeguard public health, prevent abuse of patent rights and ensure that patents contribute to the transfer and dissemination of technological knowledge. They were also intended to strike a balance between the grant of monopoly rights to incentivize innovation and the imperatives of public health, consistent with the Doha Declaration and the TRIPS Agreement.
So far, the government has issued only one compulsory licence and it was issued to Natco Pharma to manufacture Bayer's anti-cancer drug Nexavar. Barring this, the government has hardly used a compulsory licence to ensure availability of patented drugs in the country at affordable prices, said DG Shah, secretary general, IPA.
When medicines are under patent, it is imperative that patents are adequately worked. Compulsory licences are a powerful mechanism to ensure adequate availability at reasonable prices. Contrary to general perception, the use of compulsory licencing is not unusual. A recent study shows that there were 100 instances of compulsory licences (including for public non-commercial or government use) for pharmaceutical products between 2001 and 2016, and six of these instances were in developed countries. These licences were largely for HIV (73), but were also issued for cancer (12) and other diseases (15), Shah said.
Based on an analysis of Form 27 filings (working of patent) between 2009 and 2012 in three fields – pharmaceutical drugs, telecommunications and publicly funded research – it is observed that about a third of the patentees did not disclose the status of patent working and even for the disclosures made, about a third were defective and incomplete.
If a patentee fails to provide details on working of patent in Form 27, the patent is susceptible to a compulsory licence.
The industry body in a submission to Controller General Patents, Designs & Trade Marks has advocated retaining the requirement of "working of patents" as per the Indian Patents Act and the same should not be compromised under any circumstances.
The submission is in response to Circular dated March 1, 2018 calling for comments on Section 146 and 122 of the Patents Act, 1970 and Rule 131 and Form 27 of the Patents Rules, 2003 relating to the working of patents.
IPA said that the requirements prescribed by the section 146 are justified and should be continue as the association believes that the requirement of working of patent is important in order to achieve balance between promoting innovation in one hand and accessibility of invented product to the public at large at the other hand. It is in consistent with the Doha Declaration and the TRIPS Agreement.
Section 146 (1) calls on patentees and licensees to furnish such information or periodical statements that may be specified on the extent to which a patent has been worked on a commercial scale for specified period(s), Section 146(2) requiring the submission as prescribed (currently at annual periodicity in Form 27) by every patentee and licensee of statements on the extent to which the patented invention has been worked on a commercial scale in India and Section 146(3) that the Controller may publish information received by under subsections (1) and (2).
The Patent Office may consider routinely digitising all Form 27 filings and placing them in a searchable database designed to permit convenient analysis and scrutiny by all persons, said Shah.
Talking about amendment to Form 27 which requires declaration of product value, he said “ The Controller and Government should decide on what best serves their purpose, taking into consideration the views of all stakeholders regarding the criticism from several quarters on the contents of the Form viz., lack of clarity on what should be the definition of ‘quantum’ and on the manner of computation of value, Sl. No. 3 of the Form (‘public requirement’, ‘met partly/adequately’, ‘reasonable price’), Confidentiality of commercial information relating to quantum, value and licensees.”