[UNITAID Press Release, Link] UNITAID is concerned about the expiry of the ‘pharmaceuticals exemption’ for least-developed countries (LDCs) which originates from the Doha Declaration on the TRIPS Agreement and Public Health. Due to this exemption, least developed countries (LDCs) are not obliged to grant or enforce patents and data protection for pharmaceuticals.
[Cross posted from Heesob’s IP Blog, Link] One of the controversies in implementing the KorUS FTA is whether biological products are subject to the patent linkage obligation of the KorUS FTA. The debate was provoked by the Korean government’s proposal which applies the patent linkage to biologics. But it is unclear if the FTA text imposes such an obligation.
Chapter 18 (IPRs) has no definition of pharmaceutical products for the patent linkage, only the provision of patent term extention defining a “new pharmaceutical product” as “a product that at least contains a new chemical entity that has not been previously approved as a pharmaceutical product in the territory of the Party.” See Article 18.8:5 FN21. In contrast, Chapter 5 (Pharmaceuticals and Medical Devices) makes clear that “pharmaceutical product or medical device means a pharmaceutical, biologic, medical device, or diagnostic product.”
Mexico’s PRI has introduced legislation, dubbed “Ley SOPITA” by some observers, that aims to “stop or prevent, in the digital environment, the commission infringements of intellectual property rights.” It would give the Mexican Institute of Industrial Property the ability to inspect business, collect data, and make interim orders that aim to stop infringement.
A news story in El Economista quotes the Red Collective in Defense of Digital Rights R3DMX: “The Parliamentary Group of the PRI in the House of Representatives intends … to empower the Mexican Institute of Industrial Property (IMPI ) to order censorship of content, and even entire Internet sites, under the pretext of protecting copyright.” [Google-translated quote]
Summary: Intellectual property (IP) protections proposed by the United States for the Trans-Pacific Partnership Agreement (TPPA) have sparked widespread alarm about the potential negative impact on access to affordable medicines. The most recently leaked draft of the IP chapter shows some shifts in the US position, presumably in response to ongoing resistance from other countries. While some problematic provisions identified in earlier drafts have been removed or mitigated, major concerns remain unresolved.
This week, the 16 Asian and Pacific countries negotiating the Regional Comprehensive Economic Partnership (RCEP) are meeting in Thailand. This trade agreement will include Australia, Brunei, Cambodia, China, India, Indonesia, Laos, Malaysia, Myanmar, New Zealand, Japan, the Philippines, Singapore, South Korea, Thailand, and Vietnam. According to the RCEP’s Guiding Principles stated at the beginning of the negotiations in 2012, the agreement will include an intellectual property chapter to promote “cooperation in the utilization, protection and enforcement” of IPR.
Japan’s proposed intellectual property text, which was leaked and has been posted online by KEI, includes numerous TRIPS Plus provisions. (South Korea is reported to be advocating for TRIPS-Plus provisions too.) Many of the provisions would be especially harmful to the Indian generic industry, which supplies the majority of medicines used by people in developing countries.
[Médecins du Monde press release, Link] Today, Doctors of the World – Médecins du Monde (MDM) has filed a European patent challenge against the Hepatitis C virus (HCV) drug, sofosbuvir. In recent months, Médecins du Monde and its partners have raised the alarm around the problems caused by the cost of new treatments against hepatitis C and of sofosbuvir  in particular. The U.S.-based pharmaceutical company Gilead holds a monopoly for sofosbuvir and is marketing a 12-week course treatment at extremely high prices – 41 000 euros in France and 44 000 euros in the United Kingdom – thereby hindering access to the drug for People Living with HCV.
Last week the Obama Administration released its Budget for the upcoming fiscal year, which includes a number of policy proposals designed to save money for both the government and taxpayers. Its proposal to shorten the monopolies granted to brand name biologic drugs – and thereby hasten generic competition – would directly clash with the provisions the Administration seeks in the Trans Pacific Partnership.
Prepared statements from Chairman Orin Hatch, Ranking Minority Leader Wyden, and Ambassador Froman, and video of the full hearing are here. Actually, most of the hearing is on the video, but the committee edited out the protestors who disrupted the hearing. Democracy Now has the video and transcript of the protest here.
During Q&A, many of the Senators brought up enforcement of trade agreements as a very important area for USTR to focus its energies. Two Senators, in particular, indicated they wanted the U.S. to be been more active in trade disputes over intellectual property, through either FTA frameworks or bilateral measures:
[Updated Jan 5] The U.S. International Trade Commission has released its report on Indian trade, investment and industrial policies, including but not limited to intellectual property rights. The full report is here and the the press release is here.
The report was based on “a survey of U.S. companies doing business in India; a quantitative analysis of the effects on the U.S. economy; and qualitative research, including a hearing and fieldwork, to produce case studies and examples that help illustrate effects of the policies on particular companies or industries.”
Two departments within India’s Ministry of Science and Technology, the Department of Biotechnology (DBT) and the Department of Science and Technology (DST) have released a new Open Access Policy. Under the new policy, researchers who receive funding or use resources from from these departments can still publish in any journals they wish, but they will need to deposit copies of the final papers and supporting data in institutional repositories where the information can be accessed by the public:
[International Federation of Library Associations, Link, (CC-BY)] IFLA’s response to the Synthesis Report of the UN Secretary-General on the Post-2015 Development Agenda: “The Road to Dignity by 2030: Ending Poverty, Transforming All Lives and Protecting the Planet”
Access to information…Intellectual Property reform…access to open data…affordable access to ICTs. These are some of the important issues IFLA and those of us in the greater library and information community are grappling with in a variety of ways.
IFLA has been working with the international library community—as well as civil society and member states—to develop its position and help ensure that crucial elements such as access to information are included in the UN post-2015 Development Agenda. Throughout this process, it is important that libraries are seen as being part of the conversation.
President Obama gave a talk on the stat of the economy last week at the Business Roundtable, group of American CEOs that promotes pro-business public policies. The full transcript of his talk, including questions and answers is here.
As part of a longer answer to a general question on the global economy, Obama mentioned bilateral talks with China. He said that his administration is “pushing hard” on China to strengthen intellectual property, and asked the member companies of the Business Roundtable to “help us by speaking out when you’re getting strong-armed.”