An Unethical and Unwarranted Assurance

Source: Economic & Political Weekly| Vol. 51, Issue No. 12, 19 Mar, 2016

The Government of India gives “private assurances” to its friends in Big Pharma in the United States. 

The compulsory licence is the definitive instrument in the amended Patents Act of 2003 that ensures that there is a way out in case patented products go out of reach of the sick and the needy. Specifically, compulsory licence provisionsaward manufacturing rights to Indian pharma companies if a patent on a medicine is not worked in India, or if the medicine is expensive, and/or if the patent holder is not able to meet the reasonable requirements of those needing the medicine in India. The Indian manufacturer, Natco, got a compulsory licence awarded to it for Bayer’s sorafenib tosylate, used in certain kinds of renal and liver cancers, in accordance with these provisions.At the time, Bayer’s price for this drug in India was Rs 2,88,425 per person per month while Natco’s was Rs 8,800 per person per month. Novartis was selling its anti-cancer drug imatinib mesylate at a high price of Rs 1.2 lakh per month per patient (Rs 40,000 per 10 tablets) during the days it was arguing before the Indian courts on the drug’s patent worthiness. The patent was denied on considerations of Section 3(d) of the Patents Act. The Rajasthan Medical Services Corporation’s recent procurement price of imatinib 400 mg tablets is almost 1,400 times less at Rs 29 per 10 tablets.

These developments are not welcome tidings for bodies like the US–India Business Council (USIBC). Its president famously has declaimed in his report of February 2016 that feeds into this year’s Special 301 review of the United States Trade Representative (USTR):

…Despite compulsory licensing denials, Industry continues to be concerned by the potential threat of compulsory licensing. The Government of India has privately reassured India [sic] it would not use Compulsory Licenses for commercial purposes. USIBC would be further encouraged if the Government of India made a public commitment to forego using compulsory licensing for commercial purposes and in public emergencies only, which would greatly enhance legal certainty for innovative industries.

In the same report to the USTR, the USIBC describes its mission “is to serve as the primary interlocutor between business and Government leaders, resulting in increased trade and investment to strengthen ties between the two nations.” In other words, this cabal of Indian and American big business representatives would like to determine what is “ease of business” for them in India. Forget slogans like “Make in India.” The council would like to determine what and how India makes what it does in India, even if this may mean the unmaking of the Patents Act provisions like those on compulsory licences, Section 3(d), etc, aided and abetted by Special 301—that imprimatur of the US government that sorts out, against all World Trade Organization norms, what is not free in the free markets of the world. It is sad that those associated in this sordid enterprise are many determined, if misguided, suits of Indian origin in the USIBC (and even in the USTR), acting as instruments in badgering the Government of India into giving private assurances that take away hard-won policy wiggle room.

This cabal, along with the USTR, manufactures the narrative on who and what is kosher in the Indian judiciary. In the same report to the USTR, the USIBC president pronounces:

The Government of India also has helped to improve judicial precedent and law by upholding decisions that have improved IPR [intellectual property rights]. These positive decisions include the Delhi High Court’s decisions in MSD (Merck) v Glenmark and Roche v Cipla. These decisions also reflected the increased capacity and competency of Indian judges to resolve patent infringement cases, assess damages, and order injunctive relief.

If a pharma multinational corporation (MNC) wins a patent dispute, India’s judges have “increased capacity and competency.” If the MNC, or specifically American companies lose, India’s patent laws and IPR protection are weak. To further ensure that the Indian patent systems are not “weak,” the USIBC, a group that receives funding from pharma companies, conducts training for India’s patent examiners, a move that orients the patent examiners to the narrative of Big Pharma.

With the recent passage of the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Bill, intellectual property disputes on pharmaceutical patents will be heard by these commercial courts. It is anybody’s guess whether these courts are equipped with a world view of patents that takes into account concerns of access to medicines, public health and human rights. Moves like fast track clearing of patents, even in the absence of adequate access to information on the patent thickets over a particular product, may end up riding roughshod on efforts of concerned citizens, especially patient groups, to file pre- and post-grant oppositions.

The unsaid message to the executive is that complying strictly with India’s patent laws, rejecting patent applications and awarding compulsory licences, is enthusiasm that the Government of India does not approve of. Will the Government of India tell us this is not so and that our rights to compulsory licences and access to medicine will not be bartered away, and that the alleged unwarranted assurances were not given, or if given, will not be implemented?

 

This entry was posted in Compulsory Licensing, Uncategorized, USTR 301 report. Bookmark the permalink.

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