Jamie Love over at KEI has brought to light a Wikileaks cable that may be of interest to our readers. In this post, I'll highlight a few of the key IP issues that were discussed in this cable.
The cable, dated Nov 09, 2009 refers to a meeting between United States' Trade Representative Ron Kirk and Anand Sharma, the Cabinet Minister for Commerce and Industry of the Government of India, to reactive the trade policy forum between the two countries. The USTR also expressed their interest in upping India into US' top 10 trading partners from its current 18th position. This trade policy forum included five focus groups, 'innovation and creativity' being the group of our current interest.
Patent Policy - USA's concerns
I am pasting a relevant part of the cable below - emphasis and link added by me.
....on patent and data protection, the discussion focused primarily on U.S. pharmaceutical company Gilead's rejected patent application for incremental innovations. Both sides agreed that it was advantageous to patent incremental innovation and, in Gilead's case, that appropriate procedures, such as review appeal, under the Indian Patent Act would be followed. Both sides also agreed to discuss this issue in the future, including general discussions on the scope of patentable subject matter, Indian Patent Office decisions on cases under Section 3(d) of the Patent Act, and any future issues that may arise.
(It's entirely possible that India's representative mentioned this just as a diplomatic tactic to agree at face value but bring up objections during substantive discussions - For the sake of discussion, I will proceed assuming the alternative, more worrying scenario that this was a genuine comment)
Before commenting on this, I would like to remind our readers of two previous posts on SpicyIP. Firstly, the post regarding the 'lobbying' done by the US Commerce Secretary Gary Locke to Anand Sharma to ensure that Gilead's case receives "fair" consideration in its appeal to the IPAB - whatever that means. The main issues raised in that post were that (i) the IPAB is an independent judicial body, and (ii) who are the US to concern themselves with India's judicial mechanisms! Secondly, the post reporting the legal notice Cipla had served GWU for allegedly allowing the GWU-CII summit be used by Gilead to make representations aimed at influencing Tenofovir's sub-judice patent litigation. Now, coming back to the cable...
Our regular readers will know that S.3(d) of the Indian Patent Act states that patents would not be given for new forms, uses or minor modifications of existing drug patents unless they differ significantly with regard to efficacy. Without considering whether this is normative policy or not, looking at the fact that the legislation considers this valid enough to make into law, I don't see how Mr Anand Sharma can then go on to say that all incremental innovation patents are advantageous. (advantageous to who / what?)
To expand on this slightly:
Incremental innovations (in pharmaceuticals) are essentially of 4 types:
[i] New Chemical Formulation (as opposed to New Molecular Entities - NME)
[ii] New Pharmaceutical Formulation (new dosage forms, rates, etc)
[iii] New combination of NME (new combinations of existing drugs)
[iv] New use of NME.
If you do want to consider normative policy, then, taking a country like India (and the various other countries that India supplies), where access is a very important part of the drug equation - does it make any sense to give a 20 year patent period over a new dosage form of an existing drug, or a new combination pill of existing products? These are simplistic examples of course. To really analyze whether access barriers such as patents are required to bring these incremental innovations into the picture or not, would take a deeper study, but it's certainly unlikely that patents can be justified in this instance. (This debate can go into the 'evergreening' problem - ie, where little or no inventive step is involved; as well as into the problem of a technically sound incremental innovation where the actual social value addition is dismal)
Other USA Concerns
Other issues that were discussed included India's Copyright Amendment Bill and draft Optical Disc legislation. India responded to the Copyright Amendment Bill questions by telling them that they were not allowed to discuss the bill before it is introduced to the Parliament. Regarding the draft OD legislation, India essentially said it was not placed to introduce such legislation right now. USA seemed keen on providing assistance towards this though.
After this, it seems GOI turned the tables and started questioning US about how it was addressing India's IP concerns. The counter pressure is indeed impressive, considering US is the country that is constantly hounding different regimes to fall in line with their own.
(SBU) The GOI raised several issues with the USG including piracy of Indian music and movies, the Google book settlement, the Traditional Knowledge Digital Library (TKDL) access agreement, the misappropriation of the practice of yoga, and the treatment of traditional medicines.
US was offered a list of websites which are used for piracy of Indian music and films, and responded saying they would pass this on to their appropriate law enforcement authorities. As we had posted earlier, the Indian Reprographic Rights Organisation (IRRO) had protested against the Google Book Settlement. US said that they too had some concerns about the settlement and would discuss these issues with India. The TDKL agreement has subsequently been signed by CSIR and the USPTO, with the CSIR to train USPTO staff on how to maximise the use of TKDL tools for research.
There's a line after this point which has left me confused as to what was meant:
Regarding patents for the practice of yoga, the USG was able to show that copyrights granted were for yoga-related products like printed material and equipment, which would not interfere with the practice of yoga in India.
"Patents for the practice of yoga" and "copyrights granted for yoga related products" (in USA) and 'interfere with the practice of yoga in India"? - I can't really comment on who might've said what for this random collection of phrases to come together like this but our long time followers will remember a series of posts that we carried on 'yoga patents' back in 2007 - and the continuous mixing up of the terms 'patents' and 'copyrights' by the media. Those posts may be a good place to visit if you don't understand my confusion with the quoted part.
The Wikileak cable is available in full here for those interested.