On IPR, Major US Trading Partners In Firing Line Of US Industry, While Cancer Patients Ask For Access 09/02/2018 by Catherine Saez, Intellectual Property Watch 1 Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Every year at this time, the Office of the United States Trade Representative collects comments from stakeholders for its review of how well US trading partners are behaving when it comes to protecting and enforcing the intellectual property rights of US companies. Pharmaceutical companies and an alliance of rights holding industries came prepared with a list of countries to be put on special watch lists, including Canada, Brazil, India, Malaysia, and Switzerland. A patient group, on the other hand, asked that trade interests not supersede access to medicines worldwide. The annual USTR “Special 301” report identifies “a wide range of concerns that limit innovation and investment,” according to the USTR website. It defines which countries, in its opinion, are adequately protecting US IP rights, and singles out countries which it finds to be renegade. The report looks at the lack of IP protection and enforcement measures taken by countries, if trade secrets are misappropriated, “troubling” indigenous innovation policies disadvantaging US rights holders in foreign markets, copyright piracy and counterfeit trademarked products on the internet, market access barriers, and IP rights enforcement issues at borders. Stakeholders provide comments to the report, which comes out later in the spring and typically closely reflects industry views. A number of them have submitted requests to the 2018 Special 301 Review. Being placed on a Special 301 list could ultimately lead to loss of US trade benefits [clarified], but rarely ever does, serving more as a guide to issues USTR is likely to raise bilaterally with countries. Pharma Industry: Pricing Policies, Compulsory Licence The Pharmaceutical Research and Manufacturers of America (PhRMA), for its part, asked that the USTR take “immediate action to address serious market access and intellectual property barriers in 19 overseas markets.” Of particular concern for PhRMA, as stated in their press release, are Canada, South Korea, and Malaysia, which according to PhRMA should be designated as “Priority Foreign Countries”. The pharmaceutical industry also calls for Japan and 11 other countries on the “Priority Watch List.” PhRMA Senior Vice President for International Advocacy Brian Toohey said, “Discriminatory pricing policies in Canada, Korea and Japan and compulsory licensing in Malaysia are threatening American jobs and exports.” He added, “Countries that blatantly disregard trade rules to benefit their own domestic industries are undermining investment in new treatments and cures for patients around the world.” In PhRMA’s submission, Canada is targeted by PhRMA for having intellectual property and pricing environment which have “created significant instability for U.S. innovative biopharmaceutical companies.” South Korea, according to the release has pricing policies which “severely devalue U.S. intellectual property and favour Korea’s own pharmaceutical industry.” Malaysia announced a compulsory licence “for the patent that protected an innovative U.S. medicine,” PhRMA said, but did not explain how the use of compulsory licencing, a protected practice under international trade rules, was in disregard of trade rules. International IP Alliance: Streaming Devices, Disturbing Legal Trends An even larger number of countries were suggested by the International Intellectual Property Alliance (IIPA) for inclusion on special watch lists, “because of harmful records on protection, enforcement or market access for U.S. innovators and creators.” Some 19 countries are targeted, according to an IIPA release [pdf]. Argentina, Chile, China, India, Mexico, Russia, Taiwan, Ukraine, and Vietnam are recommended for placement on USTR’s priority watch list, the release said. Additionally, Brazil, Canada, Colombia, Ecuador, Indonesia, Peru, Switzerland, South Africa, Thailand, and the United Arab Emirates, should be placed on USTR’s watch list, the IIPA said. Of concern is the “global proliferation of illicit streaming devices,” the stream-ripping services, “disturbing trends in national copyright law amendments,” lack of legal framework adapted to meet the challenge of online piracy, and the “dismantling” of market access barriers, it said. The IIPA full report is here. Cancer Patients: Medicine Not a Bargaining Chip The Union for Affordable Cancer Treatment (UACT) asked to testify at the Special 301 hearing on 27 February and denounced the US trade sanctions or threat of trade sanctions against countries whose policies are identified as running contrary to US companies’ interests. According to their comment, the UACT underlines the consequences on such trade sanctions on cancer patients. “Medicine should not be treated as bargaining chips to be traded as other commodities,” it said. “It is time the USTR recognize fully and respect the words as well as the spirit of the Doha Declaration,” (the Doha Declaration on the TRIPS [World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights] Agreement and Public Health). “The USTR has a role to play in protecting U.S. interests, but has options other than to advocate for higher drug prices around the world,” the comment said. “Given the repeated promises by President Trump to give people relief from high drug prices, it is time for USTR to rethink its objectives in trade policy,” it concluded. Knowledge Ecology International also made a submission, available here. KEI made some notable assertions: “Thus far the USTR has published 29 Special 301 lists. The criteria for being included on the list is notoriously vague. Canada has appeared on list 27 times, despite having high legal standards and lower rates of copyright infringement than the United States. Several other countries are on the list almost every year, without much to distinguish their policies and practices from their less frequently listed neighbors. One factor that seems to be highly significant to inclusion on the list is how large the GDP or GNI of a country is relative to others. In fact, more to the point, this is a list driven by lobbyists for the right holders, many of whom are former employees of USTR, other federal agencies, or Congress.” “It would more interesting and useful for USTR to develop and outline the policies and norms that it wants to promote through the Special 301 list and its follow-on enforcement actions, without having every talking point framed by PhRMA, IIPA members and other right holder groups,” it added. [Update:] KEI has posted many of the submissions from various parties, here. [Update:] The Indian Pharmaceutical Alliance, in its submission, made a case for removal of India from the USTR Priority Watch List, where it was placed in 2017. The submission cited several actions taken by the Indian government for improving the IP rights environment and enforcement. The IPA submission is a detailed rebuttal to concerns and charges made by US pharmaceutical industry groups. For example, the group, which includes 20 pharma companies in India, took issue with concerns about the possibility of use of compulsory licensing despite the fact that only one such licence has been issued in India, back in 2012. IPA argued that India’s law on use of compulsory is not broader than that in many Western European nations, and that international bodies have reinforced the right of World Trade Organization members to decide for themselves when to use this authorised tool. It also argues against claims about patent backlog, enforcement, litigation. Other comments may be added to this story as they become available. William New contributed to this report. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Catherine Saez may be reached at firstname.lastname@example.org."On IPR, Major US Trading Partners In Firing Line Of US Industry, While Cancer Patients Ask For Access" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.