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Special 301: BIO Highlights Challenges in India

February 26, 2014
BIO recently testified before the U.S. government on the intellectual property challenges our members face in various markets around the world. Among other matters, BIO recommended that the U.S. government designate India as a Priority Foreign Country, a designation that would lead to the consideration of trade sanctions for treaty violations. Specifically, BIO testified:
“In the healthcare space, only a few dozen innovative and patent protected medicines are on the market in India. Yet, in the last two years more than a dozen patents have been revoked, compulsory licensed or threatened to be compulsory licensed, or otherwise rendered unenforceable. In addition, several biotechnology inventions in the health and agricultural fields have been denied patent protection; these same products have been granted patents in many other jurisdictions around the world. There are perhaps other anti-IP actions that we do not yet know about. The fact that these same patents are valid around the world in both major and emerging markets reveals a clear lack of concern for protecting innovators in India, presumably for the benefit of India’s industry. The Indian government claims that it is taking these steps to keep the prices of medicines down and improve access to medicines. However, we contend that these actions are in reality a form of industrial policy designed to improve local commercial interests at the expense of U.S. biotechnology companies. These steps by the Indian government benefit in a very tangible manner its domestic pharmaceutical industry. The medicines being targeted, such as Bayer’s Nexavar, Pfizer’s Sutent, BMS’ Sprycel, Roche’s Tarceva, and Novartis’ Glivec, are highly specialized anti-cancer medicines that benefit a small fraction of India’s patient population, and only those who can already afford the highly specialized medical talent and facilities to properly diagnose and treat the relevant forms of cancer. Yet, to our knowledge, only one of these medicines (Glivec) appears on India’s National List of Essential Medicines.

"No amount of patent revocations, compulsory licenses, enhanced efficacy requirements, or other methods to render patent rights unenforceable will address any of the systemic healthcare problems plaguing India. The real tragedy underlying the anti-IP rhetoric is not simply that it diverts attention away from the real problems of access to health care that many millions of Indians face, but that it undermines India’s goal of becoming a healthcare and science innovator. There are companies around the world interested in collaborating in research, science and the development of medicines in India. These measures make it difficult, and often impossible, for such deals to happen. In our view, this is a problem for innovators in India as the deals will simply go to other countries with more respect for IP rights. Nonetheless, a number of our member companies continue to strive to be successful and to help the Indian poor through patient assistance programs which provide the medicine for free or even below generic price to the poor, creative licensing strategies to allow Indian generic companies to manufacture medicines to reduce cost, technology improvements to enhance storage life of medicines to survive the lack of infrastructure in India, and many more initiatives that contribute to addressing the healthcare burden in India. Yet, American companies cannot fix this problem alone. And the current set of IP policies impedes them from doing more. The government of India spends around 1% of the country’s GDP on healthcare. That is lower than all other emerging economies and even lower than several heavily indebted nations. India’s vast economic growth over the last decade has clearly not been matched by an equivalent increase in public spending by the government.

"While it may not be our place to set priorities for the Indian government, we wish to point out both the significant costs of its current approach in undermining its potential as a global biotech innovator, and observe that the benefits to healthcare in India, to the extent they exist at all, would not appear to offset these costs.”

Read the full testimony

Read the full submission highlighting IP challenges in various markets around the world.