Indian Patent Law specifies a provision for submission of information in Form 27 regarding the details of ‘working of a patent’ granted in India, which is a statutory requirement.
The information sought by the IPO in Form 27 can be summarized as follows:
A. For not ‘working of patent’: the reasons for not working and steps being taken for ‘working of the invention’ to be provided by the patentee.
B. In case of establishing ‘working of a patent’, the following yearly information needs to be provided:
1. The quantity and value of the invention worked; which includes both local manufacturing and importation.
2. The details to be provided if any licenses and/or sub-licenses have been granted for the products during the year.
3. A statement as to whether the public requirements have been met partly/adequately to the fullest extent at a reasonable price.
• A fine of up to (USD $25,000 may be levied for not submitting or refusing to submit the required information by the IPO.
• Providing false information is a punishable offence attracting imprisonment of up to 6 months and/or a fine.
What would amount to ‘Local Working of Patent’ in India?
Obviously, the question will arise what then would constitute ‘working of patent’ in the country. It is generally believed that ‘commercial exploitation’ of patented products in India will mean local ‘working of patent’ in the country.
This is still a controversial issue as some experts claim that ‘local working of patent’ can be established only through local manufacturing and thus importation of such products will not be considered as ‘local working of patent’ in India.
However, other groups of experts opine, as a signatory of article 21 (1) of TRIPS, India is under clear obligation to accept importation of a locally patented product as ‘local working of patent’.
How affordable is affordable?
Besides, ‘local working of patent’ issue, section 84.1 of the patent Act 2005 under ‘Compulsory licenses’ says:
“At any time after the expiration of three years from the date of the (grant) of a patent, any person interested may make an application to the controller for grant of compulsory license on patent on any of the following grounds, namely:
a. that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or
b. that the patented invention is not available to the public at a reasonably affordable price, or
c. that the patented invention is not worked in the territory of India.”
The question, therefore, will arise, who will determine whether a patented product is available to the public at a reasonably affordable price or not? Moreover, what will be the measure, formula or yard to stick to decide reasonably affordable price? The next question could be – reasonably affordable price for whom … for the rich minority… or for around 300 million middle class population of the country… or for another 713 million lower middle class or poorer section of the society?
How ‘affordable’ then will be considered as ‘affordable’ in such cases?
Whatever may be the case, it would be interesting to know, how the Indian patent Office (IPO) would deal with these details. In any case, such information will not remain a secret. ‘The Right to Information Act’ will help ferret all these details out in the open.
Thus, when the ‘moment of truth’ comes, one will be quite curious to note how the proponents of ‘compulsory licensing (CL)’ would try to push their envelope hard enough on this score to establish their view points… And on the other hand how would the innovator companies establish that the price is indeed a function of the value that the product would offer… and in that process would gear themselves up with relevant and credible, possibly ‘Health Technology Assessment (HTA)’ details to establish the price premium of patented products in India to meet the ‘unmet needs of the ailing patients.’
Striking a right balance in this matter by the IPO between rewarding fruits of expensive, risky and time consuming innovation, on the one hand, and help improving access to affordable modern medicines to a vast majority of the population of the country, on the other, will indeed be a daunting task.
By Tapan Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.