Abstract: In April 2014, the United States Trade Representative (USTR) listed India on its Special 301 Priority Watch List, following India’s refusal to grant a patent over the leukemia drug Gleevec and its compulsory licensing of the cancer drug Nexavar. USTR also undertook an out-of-cycle review of India’s intellectual property laws, to determine whether or not to upgrade India to the more serious Priority Foreign Country status, which would potentially trigger retaliation through withdrawal of GSP benefits.
The White House Office of the Intellectual Property Enforcement Coordinator (IPEC) has issued a request for comments to inform the drafting of the next Joint Strategic Plan on Intellectual Property Enforcement. The notice “invites public input and participation in shaping the Federal Government’s intellectual property enforcement strategy for 2016–2019.” The Federal Register notice is here, and IP Czar Danny Marti’s post about it is here. Comments are due October 16, 2015.
The Office of the U.S. Trade Representative has issued a request for comments for the 2016 National Trade Estimate (NTE) report on Foreign Trade Barriers. This is an annual report in which USTR seeks to identify “significant barriers to U.S. exports of goods, services, and U.S. foreign direct investment.” The notice suggests that “commenters should submit information related to one or more of the following categories of foreign trade barriers … (4) Lack of intellectual property protection (e.g., inadequate patent, copyright, and trademark regimes);”
Comments are open to the public, and should be submitted electronically by October 28, 2015. See the Federal Register Notice for instructions. The NTE report is typically released in the spring of each yearm, and the 2015 NTE is available here.
[Médecins Sans Frontières press release, Link] At the International AIDS Society (IAS) Conference today, the international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) warned that middle-income countries (MICs), which will be home to 70% of people living with HIV by 2020, face increasing threats to their ability to access affordable generic medicines, which are crucial to countries’ ability to reach the global UNAIDS 90/90/90* targets.
The 2015 Special 301 Report continues a trend, beginning last year, of scrubbing a lot of language that long graced previous reports threatening other countries about WTO TRIPS and other international treaty violations. (See Special 301, A Historical Primer). This could be seen as an acknowledgment that such threats violate the World Trade Organization dispute settlement understanding. The WTO clearly states:
[Joint Letter from 12 American NGOs] We write as American organizations in advance of your trip to India this month to ask you to support India’s central role in providing high-quality, low-cost generic medicines—which are essential for health care around the world. Recent U.S. policy stances have sought to topple parts of India’s intellectual property regime that protect public health in order to advance the interests of multinational pharmaceutical corporations in longer, stronger, and broader exclusive patent and related monopoly rights. India’s laws fully comply with the WTO TRIPS Agreement. Millions around the world depend on affordable generic medicines that would disappear if India acceded to these proposals, including many beneficiaries of US-funded programs. Instead of using your trip to promote the narrow interests of one segment of the pharmaceutical industry, we ask you to support the interests of people who need affordable medicines, whether they live in the U.S., in India, in Africa or elsewhere. Our world is safer and healthier because of India’s pro-health stance and we ask you to say so publicly while you are there.
[Federal Register Notice from the office of the U.S. Trade Representative, Link] …USTR is hereby requesting written submissions from the public concerning foreign countries that deny adequate and effective protection of intellectual property rights or deny fair and equitable market access to U.S. persons who rely on intellectual property protection…
Dates/Deadlines: The schedule and deadlines for the 2015 Special 301 review are as follows:
[Lawyers Collective, India] As you know, transnational pharmaceutical companies and the US Government are putting pressure on the Indian Government to change India’s IP laws especially the Indian Patents Act, which will make medicines unaffordable to millions of people in India and other developing countries.
Peoples’ groups, patients’ networks and civil society organizations have come together in one voice to ask the US government to stop pressuring India against use of its legitimate rights to protect public health. The petition asks the US Government to stop pressuring India. The petition also urges the Indian Government to hold its ground and not give in to the pressure.
[Swaraj Paul Barooah, SpicyIP, reposted from with author’s permission] In a very welcome and quick response to USTR’s Special 301 Out of Cycle Review (OCR) process for India that opened for comments a couple of days ago (October 14th), the Government of India has told the American authorities that they will not be cooperating with this unilateral process, writes Nayanima Basu in the Business Standard.
[Gabriel Michael, ‘To Promote the Progress?’ Blog, Link (CC-BY-SA)] My previous post discussed how Special 301′s enforcement mechanism has rarely been used, and is even less likely to be used in the future. But the frequency with which an enforcement mechanism is used is not a measure of effectiveness. We don’t measure the effectiveness of criminal justice systems by the number of people in jail (at least, we shouldn’t). Perhaps Special 301 is effective in accomplishing its goals even without resort to its enforcement mechanism.
On April 30, the United States Trade Representative released the 2014 Special 301 Report, which fulfills its mandate under the Trade Act (19 U.S.C. § 2242) to identify countries that “deny adequate and effective protection of intellectual property rights, or deny fair and equitable market access to United States persons that rely upon intellectual property protection.” The report is based partially on input including the public comments and hearing statements that are available on regulations.gov, and partially on other inputs such as meetings with other government agencies. Below are six observations:
In the weeks leading up to today’s publication of the Special 301 report, Indian officials were reportedly ready to file a challenge to the program in the World Trade Organization. That threat seems to have been avoided by the USTR refusing industry calls to list India as a “priority foreign country.” This follows USTRs decision to suspend a 301 investigation of Ukraine because of the political situation in that country. This leaves the 2014 list again with no priority foreign countries listed.