Tomorrow USTR will hold an open hearing as part of the 2012 Special 301 Review, in which it identifies countries that “deny adequate or effective intellectual property protection or deny fair and equitable market access to United States persons that rely upon intellectual property protection.”  This year, there will be fewer big businesses and trade associations at the hearing than in previous years, though USTR has received written comments from them.  The witness list – containing three country representatives, three IP owner representatives, and six NGO/academic speakers – is available here.  To view the written comments received by USTR for this year’s 301 review, go to regulations.gov and enter the search code “ustr-2011-0021.”

This blog highlights the main points made by a coalition of civil society NGOs, PhRMA, and IIPA in  written comments to USTR.

Last year’s Submission of International Health NGOs to USTR argued:

  • Using Special 301 to promote restrictions on public health flexibilities in TRIPS violates international law and administration policy
    • TRIPS flexibilities are integral to the TRIPS Agreement
    • Past USTR Efforts to Restrict TRIPS Flexibilities Violated the Doha Declaration
    • PEPFAR Depends on Access to Generic Medicines
    • Threatening Trade Sanctions through Special 301 Violates the WTO Dispute Settlement Understanding
  • The 2010 report showed a continued failure to respect access to medicines
    • The 2010 Report Fails to Fully Endorse and Honor the WTO Doha Declaration
    • The 2010 Report Includes Numerous Listings of Countries for Taking Advantage of TRIPS Flexibilities that Promote Access to Medicines.
      • Data Exclusivity
      • Restrictions on Compulsory Licensing
      • Patent Extensions
      • Patentability Criteria
      • Disclosure of Origin Requirements
      • Vague Definitions of “Counterfeit” Pharmaceuticals
      • Vague Criticisms of Pharmaceutical Patent Practices
      • Enforcement Requirements
  • The 2010 Report Fails to Promote Best Practices in Innovation Policy
  • USTR Should Continue to Improve Transparency and Due Process Within Special 301
    • Adequate Notice and Right of Reply
    • Neutral Arbiter and Right of Appeal
    • Objective and Transparent Standards
    • Public Interest Representation
    • Allowing Testimony Delivered via Teleconferencing or Web Conferencing
    • Inclusion of Relevant U.S. Government Agencies

 

[This year, civil society submissions came from Public Knowledge, Consumers International, Knowledge Ecology International, Essential Inventions, and the Brazilian Network for the Integration of Peoples Working Group on Intellectual Property.  Comments from individuals and academics included a submission from Sean Flynn and I, and another from Brooks Tueting of the University of Wyoming College of Law Center for Internationatl Human Rights Law and Advocacy.]

The main top priorities of the Pharmaceutical Research and Manufacturers of America, as identified in the introduction to this year’s detailed comments to USTR, are:

  • Patents
    • Scope of patentability
    • Patent backlogs and approval delays
    • Patent enforcement
    • Early resolution of IP disputes and marketing approval
    • Use of compulsory licensing and other mechanisms that undermine IP rights for domestic industrial purposes
  • Preferential trade policies that limit US companies’ abilities to compete globally and undermine IP
    • Local manufacturing requirements as conditions for market entry
    • De facto bans on imports
  • Protection for pharmaceutical test or other regulatory data

 

The top priorities of the International Intellectual Property Alliance (a coalition of trade associations representing IP owners), according to their summary of their detailed comments, are:

  • The need for deterrent enforcement responses to copyright piracy
  • Internet piracy
  • Enterprise (including government) end-user piracy of software and other copyright matierials
  • Unauthorized loading onto PCs (hard-disk Loading) and mobile device piracy
  • Circumvention of technological protection measures (TPMs)
  • Illegal camcording of theatrical motion pictures
  • Piracy of books and journals
  • Optical disk and game cartridge piracy
  • Pay TV piracy and signal theft
  • Using FTAs to improve global standards copyright protection and enforcement
  • Implementation of the WCT and WPPT
  • Market Access Barriers