On March 21, 2017, the New York Times published a letter signed by Dr. Elias Zerhouni, defending the proposed Sanofi monopoly on the US Army patents to the Zika virus. The letter is available from the NYT from the following link, and also reprinted here, followed by commentary.
To the Editor:
Re “Trump Should Avoid a Bad Zika Deal” (Op-Ed, March 11):
On March 20, 2017, the Maryland House of Delegates approved a prescription drug price gouging bill by a vote of 137-4. A copy of the bill, as it passed the House, is attached.
This is a March 20, 2017 Report by Erin Cox, published in the Baltimore Sun:
Maryland's attorney general could sue drug companies for price gouging under a bill approved by the House of Delegates Monday.
Attached is a March 15, 2017 note by Switzerland on the India EFTA TEPA IP Chapter.
The EFTA is the The European Free Trade Association. The EFTA member states are Iceland, Liechtenstein, Norway and Switzerland. The document refers to a proposed "Trade and Economic Partnership Agreement," or TEPA, between India and the four members of the EFTA. The EFTA page on this negotiation is here.
Patients, Members of Congress Ask Chilean Government to Issue Compulsory Licenses on Prostate Cancer and HCV Drug Patents
21 MARCH 2017
FOR IMMEDIATE RELEASE
Santiago, Chile — Members of the Chilean Congress and a group of 6 patients visited the Chilean Ministry of Health yesterday to ask that the government use its authority under Chilean law to end patent monopolies on the prostate cancer drug enzalutamide (U.S. brand name Xtandi) and on sofosbuvir-based combination drugs for the treatment of hepatitis C virus (HCV).
The patients and members submitted a petition that outlined the legal authority and public policy rationale for the grant of compulsory licenses on the patents for the drugs described in the petition. Those compulsory licenses would allow prescription drug manufacturers to produce affordable generic versions of the drugs, subject to a reasonable royalty.
The Regional Comprehensive Economic Partnership (RCEP) is a proposed trade agreement involving 16 countries in the Asia/Pacific region, that have a combined population of 3.5 billion persons, and about 30 percent of world GDP. They include the members of the Association of Southeast Asian Nations (ASEAN) (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam), and six additional countries: Australia, China, India, Japan, South Korea and New Zealand.
14 March 2017 - Senate Finance Committee grills Robert Lighthizer (USTR nominee) on trade and IPR policies
On 14 March 2017, the U.S. Senate Finance Committee held confirmation hearings for Robert Lighthizer, President Donald Trump's appointee for United States Trade Representative. During the Reagan administration, Lighthizer served as Deputy US Trade Representative with the rank of Ambassador (Source: http://www.presidency.ucsb.edu/ws/?pid=41174). Prior to his tenure as Deputy USTR, from 1981 to 1983, Lighthizer served as Chief Counsel for the U.S. Senate Finance Committee. Currently, he is a partner at Skadden Arps.
James Love and Andrew Goldman represented KEI on March 16, 2017, in a working group meeting of a subcommittee of the Maryland General Assembly House of Delegates Health & Government Operations Committee, where they testified on HB666/SB437, a bill that would establish transparency of R&D costs for prescription drugs sold in Maryland.
Vincent DeMarco of at Health Care for All! and Dr. Reshma Ramachandran of the Johns Hopkins Bloomberg School of Public Health also testified at the hearing.
HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals' Spinraza
The Department of Health and Human Services Office of Inspector General (OIG) informed KEI that it would not move forward with an investigation into whether Isis Pharmaceuticals, now known as Ionis Pharmaceuticals, failed to report federal funding in patents on Spinraza.
In a letter dated March 13, 2017, Matthew Charette, the Special Agent in Charge of the Investigations Branch of OIG, explained that OIG counsel believes that OIG has limited authority, and that the obligation to "monitor invention reporting and remedy noncompliance" "rests with NIH's Office of Policy for Extramural Research Administration (OPERA)."
On January 18, 2017, KEI submitted a 22-page letter to OIG containing evidence that the patents on Spinraza benefited from federal grants. KEI did not just ask OIG to investigate Isis' alleged failure to report this funding, in violation of the Bayh-Dole Act and federal regulations, but also urged the OIG "to investigate whether the National Institutes of Health failed to conduct proper oversight in administering its grants" and to "recommend appropriate action to remedy the situation in line with the statute and prior decisions with regard to failure to disclose a subject invention."
On March 10, 2017, KEI filed our 3rd set of comments with the U.S. Army Medical Research and Material Command (USAMRMC) on their proposed grant of an exclusive license on Zika virus vaccine patents to the French pharmaceutical company Sanofi.
On March 9, 2017, KEI was scheduled to testify before the Maryland House Committee on Health on HB 666, a bill that would require an annual report on R&D costs from drug companies that sell high-priced medicines in the state of Maryland.
In advance of the hearing, I prepared a note that summarizes provisions in both transparency and pharmaceutical price gouging legislation that would require the disclosure of the costs associated with research and development. This note is a less detailed version of this 2016 summary.
This year, so far, legislators in 13 states have introduced 21 bills that would require some degree of transparency.
On 8 March 2017, the Permanent Representative of Portugal, Ambassador Pedro Nuno Bártolo, made a powerful intervention at the Human Rights Council's panel discussion on access to medicines. Portugal stressed that access to medicines is a fundamental element of the right to health and highlighted how the high prices of hepatitis C and cancer medicines made them unaffordable to large segments of the population in industrialized countries.
On 8 March 2017, the European Union (EU) delivered the following statement to the Human Rights Council's panel discussion on Access to Medicines. As the Human Right Council imposed a strict two minute limit on interventions, the EU was not able to raise the following two questions contained at the end of its intervention.
I have two questions for the Panel.
Could the panellists suggest further measures to promote a holistic approach to access to medicines?
On 8 March 2017, the World Trade Organization delivered the following statement at the Human Rights Council's panel on Access to Medicines.WTO statement – Antony Taubman
It’s an honour for the WTO Secretariat to join this distinguished panel. Today’s discussion is a welcome step forward in the journey together towards the shared goal of access to medicines for all, and promoting the development of urgently needed new medicines, recognizing the centrality of the human rights perspective for this collective effort.
On 8 March 2017, Kate Gilmore, United Nations Deputy High Commissioner for Human Rights, delivered this opening address to the Human Rights Council's panel on Access to Medicines. Deputy High Commissioner Gilmore identified the following challenge posed by intellectual property rights:
Today, KEI submitted written testimony on SB 793 — a bill that is designed to allow the Oregon Department of Consumer and Business Services to investigate price increases for prescription drugs — in advance of a hearing before the Oregon Senate Committee on Health Care at 1:00 P.M. (PST) on March 9, 2017.
Wednesday, March 8, 2017, the Office of the United States Trade Representative (USTR) will hold the first Special 301 Hearing of the Trump administration. This year, USTR received 63 submissions in advance fo the hearing from governments, civil society organizations, and industry groups.
This blog post pulls out interesting selections from the various submissions, and includes as attachments the submissions of selected organizations.
On 8 March 2017, the Human Rights Council will convene a three hour Access to Medicines panel which will take place from 3 PM to 6 PM in Room XX of the Palais des Nations in Geneva. This panel is mandated by resolution 32/15 which passed at 32nd session of the Human Rights Council (June/July 2016). The resolution directed the Human Rights Council to convene an access to medicines panel at its 34th session in March 2017.
At the March 2017 session of the WTO TRIPS Council, Brazil delivered the following statement on copyright and e-commerce.Copyright and e-commerce
Statement from Brazil
ADVANCED?MANUFACTURING COALITION FOR
TECHNOLOGY & INNOVATION /
ALLIANCE FOR CLEAN TECHNOLOGY INNOVATION
December 7, 2015
The Honorable Michael Froman
Office of the United States Trade
600 17th Street, NW
Washington, DC 20508
Fax: (202) 395-4549
The Honorable Penny Pritzker
United States Department of Commerce
1401 Constitution Ave., NW
Washington, DC 20230
Fax: (202) 482-2741
The Honorable John Kerry
United States Department of State
2201 C Street, NW
Washington, DC 20520
Fax: (202) 647-2283
Re: U.S. IPR and the COP21 Climate Negotiation
Dear Secretary Kerry, Ambassador Froman, and Secretary Pritzker:
As the COP21 UNFCCC meeting in Paris progresses, we ask for your continued
leadership in rejecting the ongoing demands of a small group of foreign governments and NGOs
that UNFCCC member governments weaken the protection of climate change-related patents and
other Intellectual Property Rights (IPR), or that they agree to measures or provisions that would
otherwise undermine existing global IPR standards. Any such outcome would not only
undermine previously agreed global IPR standards as reflected in the WTO Agreement on Trade-
Related Intellectual Property Rights (TRIPS) in particular, but would be counterproductive from
a perspective of addressing the effects and underlying causes of global climate change (for which
innovation and continued dissemination and deployment of clean technologies is needed), and
have serious negative consequences for U.S. industry, U.S. exports, and U.S. jobs.
Over the years, several countries and NGOs have sought to insert references to IPR in
UNFCCC decisions and other negotiating outcomes. This has ranged from overt schemes like
compulsory licensing, veiled references to “flexibilities” and “balancing” IPRs, to proposals to
create UN- or foreign government-led bodies to buy up and effectively redistribute American
and other IPRs and their related technologies.
We urge you to avoid all references to IPR, positive or negative, in the agreement or
decision text. This is particularly critical with respect to references that relate to IPR and
finance, which could be viewed as an institutional mechanism to engage in compulsory
There are several reasons why these and other IPR-related proposals are so harmful:
? First, U.S. firms are currently among the world’s leaders in the development and production
of cleaner, more efficient technology, goods, and services. Enhancing this leadership
position will help create and maintain high-paying jobs in America and sustain future U.S.
economic growth, exports, and trade. Failing to do so means losing the battle for
competitiveness and jobs to China, India, and other nations, all of whom are investing in
these key growth markets and have aggressive industrial policies in place that are targeted at
U.S. technology and U.S. innovation. Continued strong global IPR protection is key.
? Second, failure to protect clean technology IPR would also undermine the very climate
change action that the Administration (and the UNFCCC) is aiming to pursue. The evidence
shows, for example, that strong IPR protection encourages private sector investment in new
technologies and innovation, helps companies market and thus monetize their competitive
technological edge, yet at the same time rewards the sharing of knowledge and inventions,
rather than inhibiting or punishing it.1 A wide body of economic and policy literature also
confirms that IPRs help facilitate both the development of new clean technology solutions,
and their adoption and deployment on the ground.2 As such, patents and other forms of IPR
protection are a tried-and-tested tool to achieve global climate change-related objectives, as
well as sustainable development and investment in some of the world’s poorest and most
vulnerable nations. Indeed, in most developing countries it is not the existence of IPR
protection that is the problem, but rather its absence.
Finally, no matter how carefully crafted, failure to keep IPR issues out of a UNFCCC or
other UN climate change or sustainable development agreement or decision will result in
significant legal, institutional and practical confusion precisely because such IPR issues are
already well-regulated at the WTO and elsewhere. Even worse, any kind of compromise
language on or references to IPR in a climate change or other UN agreement or decision,
risks undermining this Administration’s own recent negotiating efforts in the Transpacific
Trade Partnership (TPP) Agreement and elsewhere, and would send mixed signals to our
negotiating partners around the world. It would send a confusing signal and be harmful not
just for the U.S. economy, innovation, exports, and jobs, but for the very climate changerelated
objectives that the UNFCCC COP21 negotiation is purporting to pursue.
1 See, e.g., PriceWaterhouseCoopers, Innovation: Government’s Many Roles in Fostering Innovation (2010).
2 See, e.g., Kristina M. Lybecker and Sebastian Lohse, WIPO Global Challenges Report, Innovation and Diffusion
of Green Technologies: The Role of Intellectual Property and Other Enabling Factors, WIPO: Geneva (2015); U.N.
Conference on Trade and Development, Foreign direct investment, the transfer and diffusion of technology, and
sustainable development (2011), available at http://unctad.org/en/docs/ciiem2d2_en.pdf.
As the COP21 enters its final stages, we urge you to continue standing up for American
jobs, American exports, and American innovative businesses and entrepreneurs and to continue
rejecting any and all references to IPR in a COP21 agreement or decision, including more
indirect references or openings for future discussions about IPR, such as those mentioned above
and previously discussed with your teams.
We recognize the evolving nature of these negotiations and urge you continue to support
an environment where IP rights facilitate technology development and dissemination. We will
continue to communicate with your representatives on the ground in Paris from State, USTR, and
Commerce as a follow up to this letter.
Alliance for Clean Technology Innovation
Biotechnology Industry Association
Business Council for Sustainable Energy
Corn Refiners Association
Information Technology Industry Council
National Association of Manufacturers
National Foreign Trade Council
Northeast Clean Energy Council
U.S. Chamber of Commerce
United States Council for International Business
CC: The Honorable Michelle Lee
United States Patent and Trademark Office
USPTO Madison Building
600 Dulany Street
Alexandria, VA 22314
Fax: (571) 273-8300
CC: Ms. Caroline Atkinson
The White House
1600 Pennsylvania Avenue, NW
Washington, DC 20006
Fax: (202) 456-2461
CC: The Honorable Stefan Selig
United States Department of Commerce
1401 Constitution Ave., NW
Washington, DC 20230
Fax: (202) 482-2741
Oral Statement at World Intellectual Property Organization copyright committee (sccr 31)
Millions of consumers in Europe and the United States represented by TACD are in favour of the role public libraries in providing access to knowledge, research and preservation.
Recently we have commemorated 800 years of the Magna Carta and the Charter of the Forest that safeguarded the use and access of the common good from unreasonable, private enclosure. It limited the power of the monarchy to exercise its complete power over its properties. Today we are facing many attempts to enclose the digital and cultural sphere to prevent access to what should be the immaterial knowledge commons. International instruments for exceptions and limitations could prevent this.
Preservation of our cultural heritage should be a global public good and a part of our global knowledge commons.
Archives provide researchers with copies, aid scientific endeavors and preserve our cultural legacy. To ignore that we are in a digital age that can reinforce and enrich common knowledge is neither rational nor morally acceptable. It is not an alternative to impose cumbersome and expensive licensing schemes.
The right to reproduction is also needed for supplying copies for use, repair, lending and sharing between libraries and for individuals. Why deny exceptions and create barriers to this public non-profit service that helps many and hurts no one? There is no empirical objective evidence of substantial “negative unintended consequences.” by library activities.
It is quite surprising that the European Union that has recently presented a proposal for a reform of its copyright laws, with clear proposals for exceptions and limitations for text and data mining, disabilities and other areas but at the same time it is not willing to extend these initiatives to the rest of the world.
EU´s new copyright proposal that has just been released to reform the existing 2001 Information Society Directive. It states:
“The EU exception authorizing libraries and other institutions to allow on-screen consultation of works for research and private study only applies to terminals on the libraries’ physical premises, which does not take into account today’s technological possibilities for remote consultation. Lastly, the EU exception on preservation activities by cultural heritage institutions also needs attention, notably because Member States often do not take digital formats into account when implementing the exception at national level.25 The Commission will take action to ensure that the EU framework on exceptions that is relevant for access to knowledge, education and research is effective in the digital age and across borders.
To allow public interest research organizations to carry out text and data mining of content they have lawful access to, with full legal certainty, for scientific research purposes;
? provide clarity on the scope of the EU exception for ‘illustration for teaching’, and its application to digital uses and to online learning;
? provide a clear space for preservation by cultural heritage institutions, reflecting the use of digital technologies for preservation and the needs of born-digital and digitized works;
? support remote consultation, in closed electronic networks, of works held in research and academic libraries and other relevant institutions, for research and private study; “
Why can´t the EU enter into a parallel discussion here at WIPO about similar exceptions and limitations could be enacted for the libraries of the world?
What is acceptable for the European Union needs to be extended to the rest of the world for universal access to culture, education and science.