Patent

Patent Pledge: Caving in on Compulsory Licensing?


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Caving in on compulsory licensing? And pledging away public health safeguards? If the Indian governments’ alleged under-the-table assurance to USIBC (and other US industry groups) that it will not invoke compulsory licenses (CL’s) anymore (save for public non-commercial use) is truly true, then we have a lot to worry about!

Particularly since a compulsory licensing determination vests largely in the control of the Controller (of Patents), a functionary fully beholden to the government…..those that struck a different chord such as Bullet Kurian got the boot in no time!

My rant in the Indian Express (reproduced below). Where I make the argument that we need to constitutionalise the Patent Office, and ensure that it is vested with enough adjudicatory competence and independence. As also put in place a mechanism for gathering more health/drug data, rather than leaving the onus on compulsory licensing applicants. The piece below benefited greatly from discussions with Balaji Subramanium, Rupali Samuel, Vaneesha Jain, Prashant Reddy and Vivek Reddy. So many thanks to all of them!

Anyway, here goes:

Patents over Patients

“In a dramatic development, US industry groups recently claimed the Indian government offered them a “private” assurance that compulsory licences will not be issued, save in emergencies and for non-commercial purposes.

Needless to state, such an assurance flies in the face of the Patents Act and the public health safeguards enshrined in it. Illustratively, Section 84 mandates that a compulsory licence be granted in favour of third parties, if the patented invention (such as a drug) is excessively priced or not available sufficiently. Relying on this, Natco, an Indian generic manufacturer, applied for India’s first compulsory licence some years ago and convinced the patent office that Bayer’s patented drug for kidney cancer, Sorafenib Tosylate, was excessively priced and available to hardly 2 per cent of patients. In sharp contrast to Bayer’s Rs 2.8 lakh per month price tag, Natco offered to sell its version of the drug at Rs 8,800 per month.

The controller of patents granted a licence upon the payment of a 6 per cent royalty rate to Bayer, ensuring this was not a zero-sum game but one that could potentially benefit the patent owner as well, given Natco’s knack of selling in markets beyond the ordinary purview of the high-priced patented drug. Upon appeal by Bayer, the patent office decision was validated, with some minor modifications in royalty rates. Unfortunately, despite this excellent start to the invocation of an important public health safeguard, no other licence has been granted since.

World over, compulsory licensing is largely a matter of government discretion to be invoked at the government’s pleasure. However, in India, Section 84 makes clear it’s a legal entitlement that cannot be pimped away through private assurances to foreign friends. Rather, the government is obliged to adjudicate each application on merit, donning its robe as a quasi-judicial authority. The patent office must, therefore, be equipped with personnel vested with a fair degree of adjudicatory competence and independence. Unfortunately, the functioning of regulatory authorities, such as the Drug Controller General of India (DCGI), suggests our government’s record in ensuring its statutory agencies’ independence has been far from fair.

In view of the fact that our government is yet to issue a public clarification on this private assurance, one is not sure if it intended to cover compulsory licensing as a whole. Or meant to restrict it to Section 92, a provision enabling the government to notify compulsory licences (of its own accord) on grounds of national emergency, extreme urgency or public non-commercial use. As such, this licensing is distinct from Section 84, and vests the government with considerably more discretion. However, “discretion” doesn’t mean the government can choose to ignore circumstances that warrant the exercise of discretion.

Unfortunately, while the first kind of licence (Section 84) was granted at least once in the past, the government has yet to issue any notification under Section 92. Even as the health ministry appeared keen on triggering this safeguard for a range of cancer cures, the commerce ministry played spoilsport. It sent a long list of questions asking for “data” on various aspects of the cancers/ numbers of patients, etc.

This seemingly sound list belies a glaring gap in our public health machinery. A lot of health data is difficult to come by, given that they reside in the sole possession of private parties like hospitals, pharmacies and drug companies. Consider cancer, a near epidemic now. Till date, there’s no Central law mandating disclosure of data on patients, treatment methods, drug pricing, etc.

Interestingly, the same data deficit was used by the government to deny the most recent compulsory licensing application under Section 84 to Lee Pharma, which bid for a licence against AstraZeneca’s Saxagliptin, a patented anti-diabetic drug. One finds it paradoxical that the only authority with the legal legitimacy to collect and publish health data transfers this onus to private applicants.

If serious about its constitutional commitment to good health, the government must immediately formulate a legal framework to compel private parties to disclose drug and disease data. More importantly, it must ensure quasi-judicial authorities (the patent office) remain relatively independent and are infused with sufficient training to ensure a fair, impartial and competent dispensation of justice.

Unfortunately, this government appears more keen on the private than the public, preferring trade to health, nepotic control over regulatory independence, and American patents over Indian patients. It’s a trade-off likely to only create more misery in India.”

ps: For more reading on this, see Amit Sengupta’s powerful and well researched piece here.

pps: Image from here.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

2 comments.

  1. Avatarsuvro roy

    Dear Author ,

    The article makes very pertinent noise about the “transparency” that ought to be publicised from the health regulators and the Central Government . It appears that of late this forum is making un-necessary allegations without going into the merits of that issue. It is legally and practically irrelvant to pay any attention to question what a private lobby group is saying and we should not attribute their statements as being official policy of a sovereign government . often discussions held by national government, their officials, foreign service corps involves understandings and discussions which gives a assessment of point of view , not necessarily a policy declaration then and there.

    I believe it is futile to question the Central Government always on the negotiations that they hold with US agencies , pressure groups , lobby firms on IP . Nothing favorable to US has been granted till now , however the pitch within the blogging contributors in spicyip leads to the belief that this government has already sold our souls on a platter to a foreign government.

    Reply
  2. Shamnad BasheerShamnad Basheer Post author

    Not sure where to start. Read up perhaps? On the close nexus between industry lobby groups and government…particularly in the US where campaign contributions play a huge role in policy making! Big pharma is a telling example. So yes, one is well placed to logically deduce that often times the attack by big pharma and industry lobbies on Indian IP is also mirrored by their home governments. And that this government appears a wee bit more keen on keeping the US happy. So to ignore industry statements would be fairly foolhardy. And did you see the government clarification. So mild in tone simply denying in the most delicate of manners, without ever sounding worried that an industry lobby group dragged its name to the mud by alleging a “secret” private deal/assurance. Alas–governments can only sell their souls when they have one to begin with. As the age old maxim in property law goes: you cannot give away that which you don’t have! (or some such thing).

    Reply

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