PhRMA keeps eye on Indian compulsory licensing activity
This article was originally published in Scrip
Despite its seemingly measured reaction to the latest compulsory licensing application for AstraZeneca's saxagliptin in India, PhRMA (Pharmaceutical Research and Manufacturers of America) appears to be keeping a sharp eye on the developments in the area.
PhRMA, which was critical of India's grant of a compulsory licence (CL) for Bayer's Nexavar (sorafenib) in 2012, said that it continues to have discussions with both the US and Indian governments about the benefits of a "robust and predictable" environment for innovation and how such policies would support the Indian government's goals of fostering a spirit of innovation, entrepreneurship, and R&D growth.
"Certainly, we take the issue of CLs very seriously," PhRMA told Scrip when asked whether it expected to take up the saxagliptin CL issue at various fora or perhaps even with the Indian government.
The Hyderabad-based Lee Pharma recently made a surprise CL application for AstraZeneca's saxagliptin – the third in the Indian pharmaceutical segment after BDR's CL attempt for Sprycel (dasatinib) failed. In March 2012, India approved its first ever CL in the area of medicines for Nexavar, allowing Natco to self-manufacture and sell a version of the product for just over 3% of the price that Bayer sells the drug for in India.
On whether it expects the saxagliptin CL issue to figure, at some point, in the interactions of the high level Indo-US working group on intellectual property, PhRMA said that it hoped such issues would be discussed so that the two governments can work to secure "concrete outcomes" in order to achieve the vision of a transparent and predictable policy environment for fostering innovation put forward by President Obama and Prime Minister Modi.
The establishment of the working group on intellectual property, which operates under the auspices of the US-India Trade Policy Forum, has previously fuelled debate on whether India may just be lowering its guard in an area where the two countries have generally been at odds. Some experts then said that the working group could give the US a ''dedicated forum'' to continue to pressure India to adopt measures that are TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights)-Plus including restrictions on the use of compulsory licenses.
Legitimate health emergencies
PhRMA, however, declined direct comments on the whether or not the saxagliptin CL application was rational, since it was not privy to the case specifics.
On whether local firms may potentially be gaming the CL system in countries like India, as claimed by some industry experts, PhRMA said that legitimate health emergencies that require exceptions to intellectual property rights can be accommodated under international frameworks, but only after "exhausting all other efforts and in extraordinary circumstances."
The head of a leading foreign firm also underscored how Indian firms are using "all clauses" available under the CL route to press their claim. He, however, told Scrip that he reckons that arguments around non-working of a patent in India [broadly construed to imply that the product is not manufactured in India] will not hold water as a ground for a CL. He referred to the Telemecanique and Controls versus Schneider Electric Industries case that reportedly establishes that local manufacture may not be necessary to work a patent. A previous court judgement in the Nexavar CL case also implied that manufacture [by the patent holder] in all cases may not be necessary to establish working in India.
An expert with a leading foreign firm previously maintained that factors like prices of products may have little to do with CL applications and referred to the "lucrative" nature of the market that draws more players trying their luck with the "various allowances" in India's patent law.
Last year, PhRMA claimed, in its Special 301 submission to the US Trade Representative (USTR), that the affirmation in 2013 by India's Intellectual Property Appellate Board of the Nexavar CL based, in part, on a finding that products must be manufactured in India to satisfy India's working requirement is contrary to India's TRIPS commitments (as well as its broader WTO obligations). PhRMA claimed that it also distorted what was intended as a public health exception into an industrial policy by using a CL as a "pretext" to support India's local generic manufacturing industry.
Earlier this year, the USTR's 2015 "Special 301" report kept 13 nations including India, China and Russia on its priority watch list but spared India another immediate out-of-cycle review (OCR) in view of steps initiated by the Indian government indicating that it is "engaged and examining" key IPR issues.
PhRMA also said that it believes that if the "stated goal" of Prime Minister Modi to bring India up to international standards of IP is enacted, it will help bring "certainty" to the IP system and encourage companies to introduce the newest medicines into the Indian market to the benefit of the patients in India.
In April this year, India's Prime Minister Narendra Modi was reported to have referred to the need for India to work towards taking its intellectual property rights in the direction of global parameters, though the seemingly mild reference at the launch of a Global Exhibition on Services in New Delhi set off an avalanche of interpretations (or misinterpretations) on India's IPR position.