Category Special 301

Promotion of TRIPS-Plus Intellectual Property Provisions Through the Special 301 Review: How Did It Change During the COVID-19 Pandemic?

[Mike Palmedo] This post introduces my chapter the Special 301 Report in the newly-published book Intellectual Property and Access to Medicines.  The chapter, titled “Unilateral Norm Setting Using Special 301” focuses on Special 301 listings from 2009 to 2020 related to intellectual property policies that can be used to access generic medicines. This post will also describe the Special 301 listings in the 2021 Special 301 Report, which was released after the Covid-19 pandemic had taken hold. There were some differences in the 2021 Report pertaining to specific TRIPS flexibilities useful in the fight against Covid-19. However, much of the 2021 Report was similar to the reports released before the pandemic – the Report still criticized countries for policies that could help the fight against Covid-19.

USTR to Announce 2021 Special 301 Review

The U.S Trade Representative will announce the 2021 Special 301 Review tomorrow. This is the annual review required by the Trade Act which identifies countries that “deny adequate and effective protection of intellectual property (IP) rights or deny fair and equitable market access to U.S. persons who rely on IP protection.” The review is based partially on comments received from "interested parties" to the interagency Special 301 Subcommittee of the Trade Policy Staff Committee.

Sen. Tillis Asks USTR to “Prioritize Strong Intellectual Property Protections” in Agreement with India

Thom Tillis, Chairman of the Senate Judiciary Subcommittee on Intellectual Property, has written U.S Trade Representative (USTR) Robert Lighthizer asking him to "prioritize strong intellectual property protections" in a trade agreement currently under negotiation with India. His letter states that "India has an unusually restrictive market when it comes to biopharmaceutical innovations," and notes that it is regularly included in the Special 301 Report.

Analysis of Special 301 Listings, 2009-2020

Since its inception, the Special 301 Report has been an instrument used by the U.S. Trade Representative (USTR) to pressure foreign nations to change their laws at the behest of American business interests. Policies that allow countries to access lower-priced generic medicines feature prominently in USTR’s allegations of inadequate, ineffective protection of intellectual property. This working paper reviews trends in Special 301 listings over the past 12 years.

United States: An Obsolete Trade Practice Undermines Access to the Most Expensive Drugs at More Affordable Prices

[Maria Fabiana Jorge] Access to affordable drugs is a top policy priority for the United States with real bipartisan support but it increasingly seems to be an unreachable goal, in part, due to conflicting government policies. While the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted the importance of competition to ensure lower drug prices, U.S. trade policy in general, and the Special 301 Annual Review in particular, do exactly the opposite: broaden and lengthen the monopolies granted to pharmaceutical companies thus delaying or deterring the launch of generic and biosimilar drugs and with that, the chances of lowering drug prices.

Special Section 301: US Interference with the Design and Implementation of National Patent Laws

[Carlos Correa] ... This paper examines the patent-related claims made by the USTR in relation to the developing countries on the USTR Priority Watch List. It argues that the regulations and practices identified by the USTR show a legitimate use of the flexibilities provided for by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and that the ignorance of the public interests of the countries concerned (for instance, with regard to access to affordable medicines) has contributed to the discredit (and ineffectiveness) of the Special Section 301.

Overview of 2020 Special 301 Hearing

Last week, the Interagency Trade Policy Staff Committee chaired by the U.S. Trade Representative (USTR) held its hearing for the 2020 Special 301 Review... All of the documents associated with the investigation, including the request for comments, submissions from industries and countries, etc. and hearing statements are available at https://www.regulations.gov/docket?D=USTR-2019-0023. A transcript of the hearing will be posted on the docket within the two weeks. Below are some notes on the hearing.

Testimony to Special 301 Committee, Responding to IIPA’s Request to Place South Africa on the Priority Watch List

IIPA has asked you to list South Africa on the second highest designation – on the Priority Watch List... USTR has not listed South Africa, or any Sub-Saharan African country, on any 301 list dating back to 1999. This should raise two key questions for you. What changed after 1999? What has happened since that would justify USTR altering its judgment?

IIPA Petition Leads USTR to Review South Africa’s GSP Benefits

The U.S. Trade Representative (USTR) has announced an upcoming review of South Africa's eligibility for trade benefits under the General System of Preferences (GSP), a system which allows duty-free imports from developing countries that meet certain criteria. According to the announcement, USTR "is accepting a petition from the International Intellectual Property Alliance based on concerns with South Africa’s compliance with the GSP IP criterion, in the area of copyright protection and enforcement." It will publish a Federal Register Notice requesting comments and announcing the dates of a public hearing.