Special 301

The USTR’s Special 301 Report has been issued every year beginning in 1989. The Executive Summary of the 2009 report says:

The “Special 301” Report is an annual review of the global state of intellectual property rights (IPR) protection and enforcement, conducted by the Office of the United States Trade Representative (USTR) pursuant to Section 182 of the Trade Act of 1974, as amended by the Omnibus Trade and Competitiveness Act of 1988 and the Uruguay Round Agreements Act (enacted in 1994). This Report reflects the Administration’s resolve to encourage and maintain effective IPR protection and enforcement worldwide.

Past Reports
The following are copies of the USTR Special 301 Report for every year since it’s inception in 1989, as well as selected submissions by PhRMA and IIPA and commentary and submissions by others, followed by selected articles and reports about the Special 301 Report.

• KEI has a Table of each country designations from 1989 to 2024, in View or download in XLSX format.
• USTR has recently provided its own list of the previous Special 301 reports here.

Below are links to each year’s report, as well as selected stakeholder comments or commentary.

2024 Special 301

• April 25, 2024. USTR 2023 Special 301 Report.
• KEI’s January 30, 2024 comments.
• KEI’s post-hearing comments in response to the Special 301 committee’s questions.
• BIO 2024 Special 301 Submission
• PhRMA 2024 Special 301 Submission
• Chamber of Commerce 2024 Special 301 Submission

2023 Special 301

• April 26, 2023. USTR 2023 Special 301 Report
• KEI’s January 30,203 comments.
• The Regulation.Gov docket, which includes comments by several group.
• BIO 2023 Special 301 Submission
• PhRMA 2023 Special 301 Submission
• Chamber of Commerce 2023 Special 301 Submission

2022 Special 301

The 2022 USTR Special 301 report:
2022-Special-301-Report

• 2022. January 31. KEI Comments to the USTR Special 301 Review.
  • 2022. March 8. KEI Follow Up Comments to the Special 301 Review on Trade-related Aspects of Public Goods.
  • 2022. March 8. KEI Follow Up Comments to the Special 301 Review on Compulsory Licensing, Test Data Exclusivity, Fair Use, and Regarding PhRMA’s submission.
• BIO 2022 Special 301 Submission
• PhRMA 2023 Special 301 Submission
• Chamber of Commerce 2022 Special 301 Submission

2021 Special 301

• 2021. April 30. 2021 Special 301 Report
• 2021. January 29. KEI Comments to the USTR Special 301 Review.
• BIO 2021 Special 301 Submission
• PhRMA 2023 Special 301 Submission
• Chamber of Commerce 2021 Special 301 Submission

2020 Special 301

The 2020 USTR Special 301 report:
2020_Special_301_Report

• KEI Special 301 Submission
• BIO 2020 Special 301 Submission
• PhRMA 2023 Special 301 Submission
• Chamber of Commerce 2021 Special 301 Submission

2019 Special 301

The 2019 USTR Special 301 report:
2019_Special_301_Report

• USTR’s Federal Register notice, and links to comments filed by the public
• Industry Comments
  • BIO 2019 Special 301 Submission 56 pages.
  • IIPA 2019 Special 301 Submission 11 pages.
  • PhRMA 2019 Special 301 Submission 220 pages.
  • Chamber of Commerce 2019 Special 301 Submission

• Civil Society NGO Comments
  • 2019. February 8. KEI’s February 7, 2019 Submission to USTR.

2018 Special 301

The 2018 USTR Special 301 report:
2018-Special-301

• USTR’s Federal Register notice, and links to comments filed by the public.
• Industry Comments
  • PhRMA 2018 Special 301 Submission. 183 pages.
  • IIPA 2018 Special 301 Review Comment. 214 pages.
  • CCIA 2018 Special 301 Review Comments
  • Alliance for Fair Trade with India, 2018 Special 301 Comment
  • BSA_2018_Special_301_Review_Comment
  • CropLife_America_2018_Special_301_Review_Comment_
  • 2_8_Final_2018_U_S_Chamber_Special_301_Submission
  • 2_8_Final_U_S_Chamber_International_IP_Index
  • 2018_BIO_301_Submission_Final
  • AAM-Special_301_Letter_02_08_18-Final
  • BSA_2018_Special_301_Review_Comment
  • IA_2018_Special_301_Review_Comment
  • NAM_2018_Special_301_Comments_FINAL
• Civil Society NGO Comments
  • 2018. March 15. Andrew Goldman. 13 NGOs Call on USTR To Support Colombia in Special 301 Following Pressure Over Legal Access to Meds Efforts
  • 2018. March 14. KEI Letter to USTR re Malaysia Special 301
  • 2018. March 12. Kim Treanor. Coalition calls on US and Korea Trade Negotiators to prioritize public health over pharma corporations in trade negotiations
  • 2018. March 8. KEI testimony at March 8, 2018 USTR Special 301 hearing, focusing on US compulsory licensing of patents
  • 2018. March 8. UACT March 8, 2018 Testimony.
  • 2018. February 8.KEI’s February 8, 2018 submission to USTR
  • 2018. February 8. The Union for Affordable Cancer Treatment 2018 Special 301 Comments.
  • 2018. February 8. Public Citizen 2018 Special 301 Comments
  • 2018. February 8. Palmedo_2018_Special_301_Comment
  • 2018. February 2. EFF 2018 Special 301 Comments
• Blogs

• PhRMA and BIO request EU be added to USTR Watch List over review of incentives, February 13, 2018.
• PhRMA’s 2018 Special 301 Submission targets Australia, Canada, S. Korea, Japan & others over pricing, reimbursement policies, February 12, 2018

2017 Special 301

• KEI’s 2017 request to testify and written submission.
• PhRMA 2017 Special 301 Submission
• USTR’s 2017 Special 301 Report
• BIO 2017 Special 301 Submission
• Chamber of Commerce 2017 Special 301 Submission

2016 Special 301

• UACT Special 301 March 4,2016
• KEI Special 301 March 4,2016
• 2016 Special 301 Review – PhRMA Comments
• USTR’s 2016 Special 301 Report, here
• BIO 2016 Special 301 Submission
• Chamber of Commerce 2016 Special 301 Submission (Global Intellectual Property Center)

2015 Special 301

The April 30, 2015 USTR Special 301 Report:
/wp-content/uploads/2015-Special-301-Report-FINAL.pdf

As of February 7, 2015, USTR received 40 comments in response to its request for written submissions about the Special 301 Review. The complete list can be found at regulations.gov. Here are some of the important ones.

Industry/trade associations

• PhRMA, February 6, 2015 Submission.
• International Intellectual Property Alliance, February 6, 2015 submission.
• Intellectual Property Owners (IPO) Association, February 6, 2015 submission.
• Biotechnology Industry Organization, February 6, 2015 submission.
• Computer & Communications Industry Association, February 7, 2015 submission.
• Chamber of Commerce 2015 Special 301 Submission

KEI and other public interest groups

• KEI, February 7, 2015 submission.
  • KEI February 24, 2015 Supplement comments, 1 of 3, online pharmacies, parallel trade, counterfeit drugs
  • KEI February 24, 2015 Supplement comments, 2 of 3, Compulsory Licensing not restricted to “Emergencies” or “Measure of Last Resort, and comment on Ecuador
  • KEI February 24, 2015 Supplement comments, 3 of 3, on R&D.
• Public Citizen, February 7, 2015 submission.
• Union for Affordable Cancer Treatment, February 6, 2015 submission.
• Electronic Frontier Foundation, February 7, 2015 submission.

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2014 Special 301

/wp-content/uploads/USTR_2014_Special301.pdf

The USTR docket for the 2014 Special 301 list is here. The PhRMA and IIPA submissions are generally regarded as the most influential.

USTR Videos of February 24, 2014, Hearing on the Special 301 Report

Industry/trade associations

• PhRMA’s 2014 Submission.
• International Intellectual Property Alliance, February 7, 2014 submission.
• Intellectual Property Owners (IPO) Association February 7, 2014 submission.
• BIO 2014 Special 301 Submission
• Chamber of Commerce 2014 Special 301 Submission 

KEI’s comment and commentary

• KEI submission to USTR, February 7, 2014.
• Misc PhRMA quotes from 2014 Special 301 submission. here
• Misc quotes (other than PhRMA) from 2014 Special 301 submission. here
• Trade associations attacking India IPR policies, in Docket USTR-2013-0040. here
• KEI’s additional comments on Special 301, March 7, 2014. These additional comments were quite extensive, and included four long annexes, two on cancer drug prices and two detailing compulsory licenses in the US and EU.
• KEI Comments on Patient Assistance Programs as referenced in the 2014 Special 301 Review Hearing, March 7, 2014.
• KEI Comments on the IIPA oral and written submission to 2014 Special 301 regarding education and research

2013 Special 301

The 2013 Special 301 Report is available here.

• Krista Cox, KEI. Notes on USTR’s 2013 Special 301 Report. May 1, 2013
• PhRMA press release on USTR Special 301, expresses disappointment over language for India, Canada. May 2, 2013.
• Peter Maybarduk, Public Citizen. US Government Special 301 “Watchlist” and Developing Country Use of Compulsory Licenses for Healthcare.Infojustice.Org May 2, 2013.
• BIO’s submission for the 2013 list.
• PhRMA’s submission for the 2013 list.
• Chamber of Commerce 2013 Special 301 Submission 

2012 Special 301

The 2012 Special 301 report was published on April 30, and is available here.

KEI Commentary (following publication)

• James Love, USTR’s 2012 Special 301 Report, focuses on largest developing country markets, and Canada. May 1, 2012.
• Krista Cox, More notes on the USTR 2012 Special 301 List, May 2, 2012.

Other post publication commentary and reports

• Rashmi Ragnath, The 2012 Special 301 Report Continues to do the Bidding of the Content Industry, Public Knowledge, 30 April 2012
• Mike Masnick, USTR Releases Ridiculous ‘Naughty’ Special 301 List For Countries Who Don’t Pass Silly Laws Hollywood Wants, 30 April 2012, TechDirt
• Colin Mann, MPAA’S Dodd commends IP protection report, Advanced Television, 1 May 2012/
• USTR retains PHL in IPR watchlist, Zambo Times, 1 May 2012
• U.S. Chamber Releases Statement on USTR’s 2012 Special 301 Report, 1 May 2012, The Financial
• William New, Some Major Trading Partners Are Biggest IP Violators, USTR Says, 1 May 2012, IPWatch
• Jeremy Malcolm, 2012 USTR Special 301 Report blind to weaknesses of IP regime, 1 May 2012, a2k Network
• USTR 301 Report surprisingly restrained on Bayer CL decision, 2 May 2012, SpicyIP

Pre-Publication Public Submissions

• The public submissions on the Special 301 are here. These include several industry, and some academic and NGO submissions, including submissions by MSF and Public Knowledge.
• The February 21, 2012 KEI and Essential Inventions submissions are available here.
• The two most important right-holder submissions are the February 21, 2012 comments by PhRMA and IIPA.
• Lawmakers must work with consumers, or risk further global copyright protests, 23 April 2012, Consumers International
• BIO 2012 Special 301 Submission
• Chamber of Commerce 2012 Special 301 Submission 

2011 Special 301

/wp-content/uploads/2011_Special_301_Report.pdf

KEI Post publication commentary

• Size Matters: PhRMA’s Special 301 picks for South America.
• BIO 2011 Special 301 Submission
• PhRMA 2011 Special 301 Submission

2010 Special 301

The 2010 Special 301 report was published on April 30, 2010 and it is available here. This year there were more than 700 submissions to the USTR.

KEI pre-publication submissions and commentary:

• KEI blog PhRMA’s asks regarding pharmaceutical test data
• KEI blog on IIPA’s criticism of mandates for open source or software of domestic origin
• KEI 2010 February 18, 2010 submission on Special 301

Selected Industry submissions:

• Submission of PhRMA
• Submission of BIO
• Submission of IIPA
• Submission of CCIA

Selected NGO submissions:

• Joint Submission Oxfam America, Health Gap (Global Access Project), Center For Policy Analysis On Trade And Health, Knowledge Ecology International, Forum On Democracy And Trade, Universities Allied For Essential Medicines, Ip Justice, Redge – Red Peruana Por Una Globalización Con Equidad (Peru) (Peruvian Network For Globalization With Equity), Fundación Misión Salud (Colombia), Health Mission Foundation, Justice, Peace & Integrity Of Creation Missionary Oblates, Salud Y Farmacos (International Society Of Drug Bulletins)
• Joint Submission of Public Knowledge and EFF
• Submission of MSF
• Submission of Oxfam
• Submission of Health Gap
• Submission by the Indian NGO: Lawyers Collective
• Submission by the Brazilian civil society: Brazilian Working Group of Intellectual Property/GTPI/REBRIP
• Submission of Jon Ungphakorn, AIDS Access Foundation, a Thai NGO.
• Submission of Free Software Foundation
• Submission of Center for Policy Analysis on Trade and Health (CPATH)

2009 Special 301

• USTR’s April 30, 2009 Report.
• PhRMA’s 2009 Submission
• IIPA’s 2009 submission
• BIO 2009 Special 301 Submission
• Chamber of Commerce 2009 Special 301 Submission
• March 12, 2009 blog on PhRMA’s submission on the Philippines.
• March 12, 2009 blog on the PhRMA submission on Thailand.
• April 30, 2009, Tweeting the 301 announcement.
• April 30, 2009, Response of public health groups to the 2001 USTR Special 301 report.
• May 2, 2009. Consumers International response to 2009 USTR 301 Report
• May 4, 2009, PhRMA’s statement on the Special 301 list.

2008 Special 301

• USTR’s 2008 Special 301 Report.
• IIPA’s 2008 submission
• BIO 2008 Special 301 Submission

2007 Special 301

• USTR’s 2007 Special 301 Report.
• IIPA’s 2007 submission
• BIO 2007 Special 301 Submission
• KEI’s submission on pharmaceutical test data
• KEI Statement on USTR 301 list reference to Thailand, Apil 30, 2007
• May 13, 2007 KEI Statement on IPR/Health aspects of bipartisan “New Trade Policy“

2006 Special 301

• USTR’s 2006 Special 301 Report.
• IIPA’s 2006 submission
• CPTech Response to 2006 PhRMA “Special 301” Submission for Chile

2005 Special 301

• USTR’s 2005 Special 301 Report.
• IIPA’s 2005 submission
• PhRMA’s 2005 Submission to the USTR for the 301 List: PhRMA “Special 301” Submission. Appendix C: U.S. Government Needs To Take Action To Address Foreign Price Controls

2004 Special 301

• USTR’s 2004 Special 301 Report.
• IIPA’s 2004 submission

2003 Special 301

• USTR’s 2003 Special 301 Report.
• IIPA’s 2003 submission
• PhRMA 2003 Special 301 Submission

2002 Special 301

• USTR’s 2002 Special 301 Report.
• IIPA’s 2002 submission

2001 Special 301

• USTR’s 2001 Special 301 Report.
• IIPA’s 2001 submission
• PhRMA 2001 Special 301 Submission

2000 Special 301

• USTR’s 2000 Special 301 Report.
• Submission of PhRMA for the “Special 301” Report on Intellectual Property Barriers – Feb. 18, 2000
• Submission Of The Pharmaceutical Research And Manufacturers Of America (PhRMA), For The National Trade Estimate Report On Foreign Trade Barriers (NTE) 2000, December 3, 1999
• January 29, 2000, Letter from Dr.Jakkrit Kuanpoth and Dr. Jiraporn Limpananont to Ambassador Barshefsky in response to PhRMA’s submission (for Thailand) to the 2000 USTR NTE Report
• May 10, 2000, Executive Order 13155, Access to HIV/AIDS Pharmaceuticals and Medical Technologies

1999 Special 301

• USTR’s 1999 Special 301 Report.
• Among the many objectional items in the 1999 Report, was this:
  

  During the past year, South African representatives have led a faction of nation’s in the World Health Organization (WHO) in calling for a reduction in the level of protection provided for pharmaceuticals in TRIPS.

• CPTech’s May 7, 1999 Annotated USTR 301 report against South Africa.
• October 6, 1999 Letter from Ralph Nader, CPTech and Essential Action to USTR Charlene Barshefsky.

1998 Special 301

• USTR’s 1998 Special 301 Report.

1997 Special 301

• USTR’s 1997 Special 301 Report.
• January 15, 1997, USTR Press Release USTR-Designate Barshefsky Announces GSP Sanctions Against Argentina for Continuing IPR Problems.
• February 4, 1997 letter to President Clinton regarding trade sanctions against Argentina for policies on health registration data and political activity.
• June 9, 1997 Letter by James Love and Ralph Nader to US Trade Representative Charlene Barshefsky
• July 29, 1997 Letter from Ralph Nader, James Love and Robert Weisman to Vice President Gore regard U.S. policy toward South Africa pharmaceutical policies.

1996 Special 301

• USTR’s 1996 Special 301 Report.

1995 Special 301

• USTR’s 1995 Special 301 Report.
• October 9, 1995. Ralph Nader and James Love letter to Michael Kantor on Health Care and IPR

1994 Special 301

• USTR’s 1994 Special 301 Report.

1993 Special 301

• USTR’s 1993 Special 301 Report.

1992 Special 301

• USTR’s 1992 Special 301 Report.

1991 Special 301

• USTR’s 1991 Special 301 Report.
• January 25, 1991. Roger A Brooks from PhRMA writes to International Subcommittee of the Patent Committee, US Department of Commerce, stating that PhRMA “is in the process of formulating a Section 301 petition against Thailand for lack of intellectual property protection.” He asks that the Subcommittee “evaluate the proposed changed in the current Thai Law” in view of the comments made by Pfizer, which he encloses.

1990 Special 301

• USTR’s 1990 Special 301 Report.

1989 Special 301

• USTR’s 1989 Special 301 Report.

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Misc documents and studies

• Foreign Affairs As The New Copyright Law, Part 2 of 3, June 2, 2009. This is a history of the Special 301 Report.
• IIPA report on the placement of countries on 301 list, from 1989 to 2004.
• Geist, Michael, “The Sound and the Fury of the USTR Special 301 Report,” KEStudies, Vol. 1 (2007).
• Dexin Tian, The USTR Special 301 Reports: an analysis of the US hegemonic pressure upon the organizational change in China’s IPR regime, Chinese Journal of Communication, Volume 1, Issue 2 October 2008 , pages 224 – 241