Posts Tagged: "India"

Over the past two years, India has invalidated or otherwise attacked patents on 15 drugs produced by innovative pharmaceutical firms. While the claim is that this promotes lower prices and expanded access to medicines, in truth this is industrial policy not health policy. The clear beneficiaries are local generic manufacturers, not Indian patients. The majority of Indians do not need Nexavar, or any of the other patented drugs being considered for compulsory licenses. They need doctors, nurses, clinics, and hospitals. Put simply, a functioning healthcare infrastructure. Basic health statistics clearly illustrate the real problem, India currently accounts for one-third of the deaths of pregnant women and close to a quarter of all child deaths.[3] The battle for health in India will not be won with compulsory licenses. It will be won with investments of resources on the ground in local communities.

Over the past few months, a groundswell of voices in the U.S. business community and U.S. Government has arisen to express frustration with India’s IPR policies. In May, USTR’s annual Special 301 Report highlighted India for the 24th consecutive year, citing growing challenges to IPR protection which raise “serious questions regarding the future condition of the innovation climate in India across multiple sectors and disciplines.” In June, the Alliance for Fair Trade with India was launched by over a dozen leading U.S. business associations, including the National Association of Manufacturers and the U.S. Chamber of Commerce’s Global Intellectual Property Center, to bring attention to India’s discriminatory trade practices, including the erosion of IPR in India. In July, Vice President Joe Biden cited IPR protection as an obstacle to expanded U.S.-India trade. Following a hearing on how India’s industrial policies are hurting U.S. companies, House Energy & Commerce Trade Subcommittee Chair Lee Terry (R-NE) introduced legislation in September to block duty-free access to U.S. markets for countries without adequate protection for intellectual property.

Innovation provides new therapies and breakthrough treatments that extend and enhance life. The scientific and financial resources required for these advances are an investment worth making and an important precedent for global health. Patents encourage those innovations, making cutting-edge treatments a reality. Patents give innovation life. Current efforts to amend existing intellectual property legislation to “fix” the patent system will only undermine the incentives that encourage innovation. All innovation, both breakthrough discoveries and incremental improvements, is valuable and should be protected and rewarded. India, Brazil, South Africa and other emerging economies should take note. Their proposed changes, aimed at weakening intellectual property rights protections, are misguided and potentially very damaging to public health.

As many following India IP issues are well-aware, in 2012 India issued the 1st compulsory license (CL) to Natco for Bayer’s anti-cancer drug Nexavar. The granting of this CL was further upheld by the Intellectual Property Appellate Board in Spring 2013, leading to great concern and condemnation in the international IP community, especially by those in the Pharma field. Also in Spring 2013, BDR Pharmaceuticals, Ltd. filed the 2nd Indian application for a CL (still pending) for Dasatinib, Bristol Meyers Squibb’s blockbuster anti-cancer drug. Thus it appears to be the beginning of a trend for Indian pharma companies to request CLs, and I believe that this trend will continue and likely increase.

In a recent article in the New England Journal of Medicine, Amy Kapczynski argues that the Supreme Court of India’s strict interpretation of the country’s new patent law provides a model to be followed by other countries. Kapczynski applauds this “Patent Law 2.0” and argues that it will enhance access to medicines and may improve pharmaceutical innovation. Unfortunately she is wrong on both counts. Section 3(d) of the Indian Patent Act forbids the patenting of new forms of known drugs unless the new form significantly enhances efficacy and yields therapeutic benefits. Accordingly, much of the incremental innovation that is done on existing treatments will no longer be patentable under the so-called Patent Law 2.0. These are not issues considered by Kapczynski. Astonishingly, she interprets the impact of this law as follows, “Provisions like Section 3(d) can help reverse this effect [prioritizing incremental innovation over breakthrough drug discovery] and encourage companies to undertake the riskier and more expensive research that is required to generate breakthrough drugs.” Her analysis is strikingly naïve. It is laughable to think that weaker intellectual property rights (IPR) protection will incentivize innovative pharmaceutical firms to expend more resources and take on greater risk.

Newly implemented policies, compulsory licensing practices, and recent court decisions have heightened concern about IPR in India. Congressmen Erik Paulsen and John Larson expressed their worries with India’s intellectual property violations in a letter written to President Obama. Over 170 members of Congress, consisting of a bi-partisan support, signed the letter. During their speeches at the GIPC, the Congressmen emphasized that this bi-partisan support demonstrates the grave concern of IPR in India and the importance of persuading India to comply with global practices. The Congressmen sent the letter just prior to a visit to India by Secretary of State, John Kerry.

India’s booming $26 billion generic drug industry and public health sector rejoiced over the Indian Supreme Court’s recent decision to reject a patent filed by the Swiss pharmaceutical giant, Novartis for their landmark leukemia drug, Gleevec. Novartis received a patent for an earlier variation of Gleevec in 40 countries including Russia, China, and Taiwan. However, India’s troubled IP regime applies an ambiguous standard to patentability, the so-called “enhanced efficacy” for new forms of known substances. India only applies their “efficacy” requirement to the chemical and pharmaceutical drug industry as a protectionist measure. India codified the efficacy requirement in section 3(d) of their patent code and this may contravene with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) as set forth by the World Trade Organization (WTO).

The fact that the outsourcing of patent searches and the preparation of patent applications violates U.S. law only makes perfect sense, particularly when you factor into consideration the requirements of 35 U.S.C. 181 (re: national security) and 35 U.S.C. 184 (re: foreign filing licenses). By openly and willingly tolerating the outsourcing of preparation work of patent applications the clear intention of 35 U.S.C. 181 is subverted. What good does a secrecy order make if the the information relative to the invention has already been sent overseas?

For 2010 the US Trade Representative reviewed 77 trading partners for this year’s Special 301 Report, and placed 41 countries on either the Priority Watch List, Watch List, or the Section 306 monitoring list. The Priority Watch List for 2010 names the following countries:China, Russia, Algeria, Argentina, Canada, Chile, India, Indonesia, Pakistan, Thailand and Venezuela.