Today, U.S. Trade Representative Robert Lighthizer formally notified Congress of its intent to renegotiate the North American Free Trade Agreement (NAFTA), via a letter to Congressional leadership. The letter is less detailed than last March’s draft notification, and unlike the March draft, it includes no specific negotiating objectives. Rather, the letter that was sent today notes “our aim is that NAFTA be modernized to include new provisions to address intellectual property rights, regulatory practices, state-owned enterprises, services, customs, procedures, sanitary and phytosanitary measures, labor, environment, and small and medium enterprises.” The letter also says that the Administration will develop negotiating positions that are consistent with the objectives found in Section 102 of the Trade Priorities and Accountability Act.
[Initiative for Medicines, Access & Knowledge press release, Link (CC-BY)] In a move that could strike down barriers to treatment for the exploding hepatitis C epidemic that kills 700,000 people every year, attorneys and scientists from the Initiative for Medicines, Access & Knowledge (I-MAK) filed a legal challenge against Gilead’s (NASDAQ:GILD) remaining patent for the hepatitis C medicine sofosbuvir in China. Branded as Sovaldi®, this patent covers the sofosbuvir base compound and is founded on previously published techniques, and does not meet the legal criteria for a patent. This new filing follows another legal challenge filed by I-MAK in 2015, which helped result in a rejection in June 2015 by China’s State Intellectual Property Office (SIPO) on the other critical patent application on sofosbuvir. SIPO found that this patent, covering the prodrug that activates the otherwise inactive base compound in the body, did not deserve a patent under the law.
Here is the Trump administration’s draft notice of intent to renegotiate NAFTA, which was put out by Inside U.S. Trade. The administration says many elements of the agreement as it currently stands are “clearly outdated,” and that FTA provisions on intellectual property rights have been “improved in newer trade agreements.”
A few excerpts of interest to readers of this blog follow. These are what are listed in the letter as “specific negotiating objectives.”
NAFTA dispute panel arbitrators are reported to have issued a decision in the dispute brought by Eli Lilly against the government of Canada, though the decision has not been made public yet. Lilly had alleged that Canada’s patentability requirements had an overly high standard of what was considered ‘useful’, causing it to lose patent cases, and that this had violated NAFTA’s requirement that each country grant patents on inventions that “are new, result from an inventive step and are capable of industrial application.”
On March 29, PIJIP will team up with the American University International Law Review and a number of other organizations to host a one-day conference: Globalizing Fair Use: Exploring the Diffusion of General, Open and Flexible Exceptions in Copyright Law.
9:00 – 3:30: An academic symposium co-hosted by PIJIP and the American University International Law Review will exploring new directions in domestic and international copyright law promoting adoption of general copyright exceptions that are open and flexible. Click here for the symposium agenda.
Delivered March 8, 2017 at the Open Hearing that USTR conducted as part of the 2017 Special 301 Review
Thank you for the opportunity to testify at this hearing. My name is Mike Palmedo, and I work for American University Washington College of Law’s Program on Information Justice and Intellectual Property (PIJIP). We are an academic research program that promotes the public interest in IP policy. Much of my recent research at PIJIP has involved the comparison of copyright limitations in different countries, and the examination of outcomes associated with different copyright limitation structures.
[Natalia Mileszyk, Communia Association, Link (CC-0)] The Rapporteur Marc Joulaud of the Committee on Culture and Education (CULT) recognises the problem with proposed article 11 regarding protection of press publications concerning digital uses – it can threaten hyperlinking and various ways users use content online. In Communia’s opinion the Commission’s proposal to introduce a right for press publishers is poorly aligned to the objective of modernising the EU copyright framework and adapting it to the challenges of a fast-evolving digital environment. In the light of the above we believe that the only solution is to remove the whole idea from the directive. This is not the approach shared by CULT – instead 3 problematic changes were proposed:
Twenty trade associations have written the House and Senate leadership urging Congressional engagement on the trade relationship between the U.S. and India. Their letter identifies intellectual property protection as an “ongoing challenge.” It highlights diplomatic structures where the countries have discussed IP and other issues, then notes that “WTO dispute settlement has played and should continue to play a key role in ensuring that India follows through on its international commitments.”
Abstract: The U.S. Constitution grants Congress the power “to Promote the Progress of Science and the Useful Arts” by granting copyrights and patents to authors and inventors. Most courts and scholars understand this language to entail a utilitarian or consequentialist approach to intellectual property (IP) law. Unlike IP systems in other parts of the world, U.S. IP law generally eschews so-called “moral” or deontological considerations such as justice and fairness. Yet while there is considerable consensus regarding U.S. IP law’s philosophical orientation, there has been little discussion of its deeper normative goals. Most courts and scholars agree with the idea that IP law should provide incentives to creators, but there has been almost no analysis of why creativity and innovation are good. What, exactly, are the interests that IP law should promote?
[Joint press release from six civil society groups, Link] The six candidates for Director-General of the World Health Organization (WHO) – of whom one will be elected this May – have published responses to an open letter asking them to make clear their plans for the future of the WHO’s work in promoting a new system of equitable drug R&D. The original open letter was signed by 18 civil society organizations, and titled “Will you support a patient-centred R&D agreement?“. The WHO Executive Board convenes today to begin 9 days of meetings during which the candidates will be interviewed, and up to 3 of the 6 shortlisted for a final vote in May 2017.
The candidates recognised that urgent problems exist in the current system of drug R&D. Dr Douste-Blazy (France) wrote that “past failures to invest in research and development are killing millions today”. Dr Nishtar (Pakistan) recognised “the failure of market mechanisms to incentivise innovation” and asserted that the “WHO already has a strong mandate for action”. Dr Bustreo (Italy) noted that “high prices of health technologies and lagging innovation […] impede people’s access to quality health care”.
The U.S. Trade Representative has requested comments for the 2017 Special 301 Report, in which it lists countries that it alleges “deny adequate and effective protection of intellectual property rights (IPR) or deny fair and equitable market access to U.S. persons who rely on intellectual property protection.” The content is based on written comments (mostly those submitted IP owners and business associations), testimony at a hearing, and on consultations with other governmental departments.
Any interested party may submit comments, and any interested party may testify at the open hearing. The deadline for submissions and requests to testify is February 9; the hearing is February 28; and the Special 301 Report will be released “On or about April 30.” See the Federal Register notice for further details and submission instructions.
The Australian Government Productivity Commission has released its final report on ‘Intellectual Property Arrangements,’ which recommends a number of reforms to IP law, including changes to the law on patents, copyrights and enforcement.
Regarding copyright and related rights, the Australian Government Productivity Commission warns that the scope of works eligible protection is too broad and the term of protection is too long, forcing copyright users face higher costs. It recommends clarifying the law on geoblocking and allowing parallel trade in books in order to expand access to works. The report recommends “Introducing a system of user rights, including the (well-established) principles–based fair use exception.”