Members Of Congress: India's Pharma Industry 'Protectionism' Is Harming US Pharma Industry's Abuse Of Patent System

Patents

from the towards-a-forceful-homogenization-of-worldwide-IP-law dept

We recently discussed the US Chamber of Commerce’s incredibly strange statement on the state of India’s IP protection (or lack thereof). The CofC first applauded the success of India’s Bollywood industry, achieved without strong IP protection, before insisting the only way it would survive was by implementing strong IP protection. This, of course, was the CofC advancing its own agenda, despite being faced with evidence to the contrary.

It’s the sort of doublespeak frequently deployed by IP-reliant industries in the US in their attempt to force the world to align their laws with ours. The argument always seems to be for more “protection,” even if foreign industries are thriving without it.

In a Congressional letter sent to the administration by 170 “concerned” members of Congress, India’s IP laws come under attack again. This time it’s the pharmaceutical industry being defended from India’s supposedly inadequate protections.

Under the umbrella of claiming that policies of the Government of India favor domestic producers over U.S. Exporters – in other words, that India is protectionist – the Members of Congress claimed that “the intellectual property (IP) climate has become increasingly challenging in India.”

What’s so challenging about it? Well, it seems that India actually practices some sort of quality control on patents, much to the dismay of American pharmaceutical companies looking to exploit the system the way they do domestically.

Under the WTO TRIPS Agreement, India has every right to define standards of patentability so long as they satisfy minimum standards of patentability set forth in TRIPS, namely novelty, inventive step, and industrial activity. India has elected to define and apply standards of patentability rigorously. When this rigorous standard is applied in India, it prohibits patents on secondary patents involving new uses of existing medicines or minor modifications of existing medicines/active ingredients that do not significantly enhance therapeutic efficacy.

This raises the bar for American companies, who are finding it harder to extend patents past the 20-year exclusivity through evergreening (or as pharma companies refer to it: “patent lifestyle management”). While a majority of patents run through the process smoothly, some just don’t meet the Indian standard.

Although Members of Congress and Big Pharma executives, including those from Novartis and Pfizer, condemn an Indian decision denying a patent on secondary form of the anti-cancer medicine Glivec, they neglect to acknowledge that both Novartis and Pfizer have received hundreds of patents on medicines in India in the past 8 years and that it is only the frivolous or unworthy patents that are being screened out.

This rejection, and the more rigorous patentability standards India adheres to, suggest there will be more of the same in the future. That’s simply not acceptable for pharmaceutical companies, who are used to extending patents for decades at a time. Also upsetting is the government’s issuance of compulsory licenses on lucrative imported drugs, something India is legally allowed to do by the TRIPS agreement.

Using fully lawful compulsory licensing procedures, India did issue a compulsory license on an overpriced Bayer cancer medicine, citing three justifications in a 60-plus page decision: excessive pricing, failure to supply the market, and refusal to produce locally. As a result of this license, the cost of the cancer medicine has now fallen more than 97%, showing the excess mark-up that Bayer imposes on patients. Rather than acting arbitrarily, the legal system in India allows a court review of the compulsory license decision, which Bayer is now pursuing.

The members of Congress and the corporations behind him have decided to portray these actions as evidence the Indian government skews its protections in favor of domestic producers, a claim that’s rather audacious in its hypocrisy.

It is deeply ironic when the world’s biggest wolf cries wolf. Any objective examination of U.S. trade policy, including that represented in the current negotiations of the Trans-Pacific Partnership Agreement, would conclude that the U.S. is relentless in its pursuit of heightened standards of patentability, data protection, and enforcement in order to protect the interests of Big Pharma and other IP-intensive domestic industries. Over 600 industry representative sit on advisory committees to the U.S. Trade Representative having privileged access to otherwise secret trade agreement proposals…

It’s an insult to our collective intelligence when Members of Congress misleadingly condemn alleged “protectionism” in India while tolerating monopoly encroachment globally and doing so to protect “jobs and investments” in the United States.

The industries propelling these secret trade agreements love protectionism, and want to extend this “home field advantage” to as many foreign markets as possible. This is aided greatly by making these agreements contingent on US-directed overhauls of existing IP law. The lesson is: if you want to do business with the US, you’ll play the rules — our rules. It’s an agenda set by favored industries and executed by our legislators, both of whom seem more than willing to undermine successful foreign industries simply because it doesn’t fit with the “strong IP protection creates jobs” narrative.

Filed Under: india, patents, pharma, protectionism