Posts Tagged: "TRIPS"

Canada is not the first country that comes to mind as a threat to U.S. trade. After all, Canada is our largest goods trading partner, with $632 billion in total goods traded bilaterally during 2013. . . Over the last decade U.S. pharmaceutical companies have faced trade challenges in the form of a narrow interpretation of patent eligibility in Canada. Canada’s patent utility provisions are a serious threat to U.S. innovative industries, and therefore are legitimately being raised in NAFTA’s dispute settlement system.

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.

Employers often spend considerable resources recruiting, hiring and training key talent, only to face potential disaster when those trusted employees quit to join a competitor, often taking sensitive files on their way out the door. Even if they don’t act in bad faith, departing employees carry critical, confidential information inside their heads, which can’t be deleted. Fortunately, various remedies may be available for the former employer, from confidentiality and non-competition agreements, to lawsuits for actual or threatened misappropriation of trade secrets and the doctrine of inevitable disclosure. But there’s a conflict. Employers have a legitimate interest in preventing misappropriation of trade secrets, while employees have a legitimate interest in utilizing knowledge and skills gained through work experience and working for employers of their choosing.

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.

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).

To all those who can read the Constitution it has to be clear that the Supreme Court’s decision in Golan v. Holder is absurd. It is a ridiculous decision that lacks intellectual honesty and defies common sense. Further, the facts of this case provide ample ground for the suspicions of many who wonder why it is that the United States is so interested in losing its identity and compromising Constitutional principles in order to facilitate some ill conceived plan to join the world community. Simply stated, treaties and international law cannot trump the Constitution. With all due respect to the six Justices who ruled in favor of stripping works from the public domain, the Constitution does not support this decision and any attempts to argue to the contrary are insulting and show a contemptuous understanding of the history and role of intellectual property in America.

Earlier this week the United States Supreme Court granted the petition for a writ of certiorari filed by lawyers from Stanford Law School’s Fair Use Project (FUP) and Wheeler Trigg O’Donnell LLP and will review the constitutionality of a federal statute that has removed thousands of foreign works from the Public Domain and placed them under copyright protection. The case presents a two-pronged constitutional challenge to the 1994 law passed by Congress, which amended the Copyright Act. The case will test whether Congress has the authority to remove works from the Public Domain under the “Intellectual Property Clause” of the United States Constitution and whether the 1994 law violates the First Amendment rights of those who performed, adapted, restored and distributed works which had previously been in the Public Domain.

Yesterday I had the honor of spending 30 minutes interviewing Francis Gurry, the Director General of the World Intellectual Property Organization (WIPO). The Director General spoke substantively about issues facing the Patent Offices of the world, as well as some possible solutions. Gurry also discusses harmonization attempts, work-sharing agreements and the crushing worldwide backlog of patent applications that could lead to irrelevance of the system. As you read the interview you will also see that he thinks it is possible that the rest of the world will adopt a US-like grace period.