A PIL in Delhi HC has sought for better disclosure of ‘local working requirements’ for pharma patents in India through ‘Form 27’ .
This might open another avenue for ‘compulsory licensing’ of products and also facilitate innovation in the country.
What is the spirit of patenting legislations in India?
Countries like India signed up to the intellectual property bandwagon to maximise opportunities for technology transfer.
Part of this exercise involves allowing local firms to compete and improve innovation, especially on life-saving pharmaceuticals.
Patents are not for the benefit of companies but for the promotion of research and betterment of the health metrics of the public.
There is hence no wisdom in enacting patent laws that mainly enable foreign companies to import products, without helping in our scientific progress.
What is Form 27?
A PIL was filed before the Delhi High Court – stressing the importance of “Working requirements” in the patents Act, 1970 (mainly drugs & medicines)
In essence, it stressed the need for making ‘Form 27’ (that seeks to ensure working of patented invention on a commercial scale) more rigorous.
Patented invention needs to cater to the demands of the public and this is also mandated in the patent law (and Form 27 merely verifies compliance to this).
If the demand is not met, then it can be a ground for ‘compulsory licensing’ of the product within India for enhancing supply and protecting public health.
Under a compulsory license, an individual or company seeking to use another's intellectual property can do so without seeking the rights holder's consent.
While patent owners usually have the right to decide on granting licenses for their products, compulsory licensing route is an exemption to the general rule.
A licence fee is paid to the rights holder as fixed by the licence granting authority (Controller General of Patents – under the Ministry of Commerce).
What is ‘working requirement’ of patents?
Patent law grants to the patentees the privilege of enjoying a limited monopoly in order to achieve the objective of public benefit.
As part of the disclosures, patentees are required to disclose if they are locally working their patented invention in exchange for the conferred benefits.
Patents are granted to encourage inventions and to secure that the inventions are worked in India on a commercial scale to the fullest practicable extent.
Hence, it needs to be stressed that the monopoly granted to the patentees is not merely to import the invention but to make them locally too.
Historically, India has considered that “working” the invention is important for enjoying monopoly and non-working could enable compulsory licensing.
Will the working requirement violate WTO’s TRIPS?
In streamlining the local working requirement, especially in the field of pharmaceuticals, India is in line with its international trade obligations.
In fact, Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides flexibilities to contries in honouring trade commitments.
Doha Declaration also outlines the right of national governments to compulsorily license patents as per their sitational needs and discretion.
Thus, lack of local working of a patent can be grounds for granting a compulsory licence, along with others such as high prices and lack of supply.
Doha Declaration hence allows the exercise of sovereign rights to define when patent rights could be curtailed to achieve a larger public interest result.
What needs to be done?
The country is obligated to protect the right to life of its citizens under Article 21, and this duty is heavier than its commitements to the patentees.
As monopoly holders, patentees shold contribute to the promotion of technological innovation and balance their rights and obligations.
Indian Patents Act through Form 27 requires a patentee (or licensee) to furnish statements of how the invention is been commercially worked in India.
But as the Form is bereft of crucial details, there is a need to revice it to ensures the spirit of patenting is observed and innovation is promoted.
Conversly, ‘Controller General of Patetnts’ also has the right to publish the information received in the public domain.
