In an April 29, 2017 executive order, President Trump directed USTR and the Department of Commerce to submit within 180 days a report that reviews trade agreement performance, identifies trade abuses, and pursues trade remedies.
Abstract: The pharmaceutical industry extensively relies on the patent system. It actively lobbies for the strengthening of patent protection of its medical products and the results of its efforts may be found in the majority of bilateral and multilateral agreements, including the TRIPS and the most recent TPPA, augmented by private patent strategies pursued by pharmaceutical companies. However, some recent developments show the emerging tendency of implementing different business models by pharmaceutical companies that may mark the beginning of transformation of this industry. Among these developments is an ‘open innovation’ model, which has increasingly been followed by some research institutions and pharmaceutical companies aiming at facilitating the creation of new and affordable medicines, as well as providing transparency in order to enhance safety and efficacy of drugs. This article will discuss these two current developments in the pharmaceutical industry, i.e. strong IP protection against open innovation.
Joint letter signed by 43 civil society organizations
Dear Ministers: As organisations representing health professionals and health advocates from countries that are signatories to the Trans-Pacific Partnership Agreement (TPP), we write to convey our deep concerns about reports that some of the remaining TPP parties are considering resurrecting the TPP following the U.S. withdrawal, and to reiterate concerns raised with you previously regarding its negative impacts on people’s right to health, access to affordable medicines, and the ability of governments to regulate health-damaging activities of corporations.
There is increasing attention in international trade and copyright forums to the question of how international law should protect and promote copyright user rights. I presented the following options at this year’s Creative Commons Global Summit as examples of provisions that (at least partially) promote the organization’s mission of promoting “nothing less than realizing the full potential of the Internet — universal access to research and education, full participation in culture — to drive a new era of development, growth, and productivity.”
Existing models included in trade and other international agreements primarily serve two ends –
- protecting rights of countries to enact “fair use” rights, e.g. from the challenge that such exceptions could be held to violate the Berne “3-step test” as not being sufficiently tailored to “specific” cases, and
- affirmatively promoting user rights in copyrights systems, either through broad mandates to achieve “balance” or through mandatory exceptions for some categories of use.
Japan has become the US in drag, asserting its commitment to implementing the TPPA no matter what and pushing TPPA positions (and sometimes worse) even in areas it initially opposed in those negotiations, such as SOEs and intellectual property. Presumably this is to impress Trump in the hope the TPPA can be resurrected or a bilateral US Japan deal can rise from its ashes, with Japan surrendering once again to the American superpower.
Australia and New Zealand continue their mantra that RCEP must be a ‘high quality’ agreement and continue to demand massive commitments from developing countries. They got a lot of pushback this week.
This note comments on each provision of the leaked RCEP IP chapter (dated October 2015) in brief. Patent is omitted, where I defer to others with expertise in that area of international IP law. It argues that like so many negotiating (and unfortunately, final) texts of recent IP chapters in trade agreements, there are proposals here that would, if adopted, constitute a radically unbalanced text promoting strong rights while providing little or no protection for other stakeholders in the IP system. Like the TPP text, provisions that suggest a degree of balance are mostly optional/exhortatory, where provisions for the benefit of right holders are mostly mandatory. An exception is the enforcement provisions which are, consistent with other agreements, mostly put in terms so as to require authority to make certain orders or grant certain remedies, rather than a requirement to actually make orders.
Joint letter from 316 civil society groups based in countries negotiating RCEP [Printable PDF]
Dear Trade Ministers & Negotiators from the RCEP countries: This is an urgent call by 316 civil society organisations from across the Asian and Pacific countries negotiating the Regional Comprehensive Economic Partnership (RCEP), which includes the 10 ASEAN Member States with China, Japan, South Korea, India, Australia and New Zealand.
This letter comes at a very important political moment, when in the aftermath of the US elections it seems clear that the Trans-Pacific Partnership Agreement (TPP) will not be ratified by the USA, in spite of its big push since February 2016 when the agreement was signed by the 12 countries.
Authors: Hazel Moir, Brigitte Tenni, Deborah Gleeson & Ruth Lopert
Abstract: In the Trans Pacific Partnership (TPP) Agreement negotiations, the USA successfully pursued intellectual property (IP) provisions that will affect the affordability of medicines, including anti-retrovirals (ARV) for HIV. Vietnam has the lowest GDP per capita of the 12 TPP countries and in 2013 provided ARVs for only 68% of eligible people living with HIV. Using the current Vietnamese IP regime as our base case, we analysed the potential impact of a regime making full use of legal IP flexibilities, and one based on the IP provisions of the final, agreed TPP text.
[AFTINet Press Release, Link] “The Australian government should reject the push from US Republican Congress members to increase biologic medicine monopolies by seven years, even more than the extra three years which has already been agreed in the TPP text,” Dr Patricia Ranald, Convener of the Australian Fair Trade and Investment Network said today.
Dear President Obama: As organizations that represent millions of Americans, including consumers, retirees, and patients, and that provide medical care globally, we are concerned about recent reports that your Administration is working behind the scenes to craft Trans-Pacific Partnership (TPP) implementing legislation and possibly enter into side letters that would mean even more lengthy monopoly protections for biologics than the already onerous provisions in the TPP agreement. It is our understanding that this could bind the United States to a 12-year market exclusivity period for biologics and block the U.S. and other countries from reducing the amount of time expensive biologic drugs are protected from competition from less expensive biosimilar drugs.
Abstract: The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving twelve countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines.
Senior copyright industry experts described the Trans Pacific Partnership and other recent free trade agreements as likely setting a “high water mark” for intellectual property commitments in trade agreements. The statements came as part of a symposium last week on Trading in IP: Copyright Treaties and International Trade Agreements sponsored by Columbia Law School’s Kernochan Center for Law, Media, and the Arts.
Steve Metalitz, Partner at Mitchell, Silberberg & Knupp LLP and long-time Counsel to the International Intellectual Property Alliance, kicked off the discussion