Biotechnology companies depend on comprehensive and consistent global patent rights for biotechnology inventions. Biotechnology inventions include but are not limited to modified living organisms and genetic materials. Many BIO member companies seek IP protection globally. Enhanced international cooperation in patent procurement and enforcement will provide greater incentives for the expansion of the biotechnology industry in the global market place.

BIO believes a key factor in the future progress of biotechnology is the harmonization of patent laws and standards throughout the world. BIO is an active participant in the discussions on a possible patent law harmonization treaty within the World Intellectual Property Organization (WIPO) and has been an active participant in the World Trade Organization (WTO) TRIPS process. BIO is also actively engaged in the deliberations of the Intergovernmental Committee on Folklore, Traditional Knowledge and Genetic Resources of the World Intellectual Property Organization and in various forums within the Convention on Biological Diversity (CBD).

Patent Law Harmonization

• Patent Law Harmonization (June 22, 2007)
  BIO Letter to the Patent and Trademark Office.
  Read the letter (525 KB PDF)
• Letter to Mr. Nicholas Godici (238 KB PDF), Acting Undersecretary of Commerce and Acting Director of the United States Patent and Trademark Office Regarding Patent Law Harmonization
• Letter to James Rogan (273 KB PDF), Under Secretary of Commerce for Intellectual Property and Director of the USPTO on Patent Harmonization (May 6, 2002)
  • PTO response (1.2 MB PDF) to Carl Feldbaum on International Patent Harmonization Efforts

Trade and Intellectual Property

• BIO Comments to Brazilian Bill (February 28, 2008)
  BIO submitted comments in response to the public consultation requested by the Office of the President, Subsector for Legal Affairs (Casa Civil da Presidência da República, Subchefia para Assuntos Jurídicos), regarding the draft bill of law covering the collection of biological material, access to genetic resources and their derivatives for scientific or technological research, remittance and transport of biological material, access to and protection of the associated traditional knowledge and rights of farmers and the sharing of benefits.
  Read the letter (160 KB PDF)
• Identification of Countries involving the Special 301 provisions (February 11, 2008)
  BIO's letter to the Office of the U.S. Trade Representative
  Read the letter (181 KB PDF)
• On the Resumption of the Doha Development Round Negotiations (March 8, 2007)
  BIO's letter to the Office of the U.S. Trade Representative
  Read the letter (143 KB PDF)
• Identification of Countries involving the Special 301 provisions (February, 2007)
  BIO's letter to the Office of the U.S. Trade Representative
  Read the letter (664 KB PDF)
• Convention on Biology Diversity and Patent Disclosure Requirements (October 23, 2006)
  Letter from BIO, EuropaBIO, BIOTECanada and CropLive International to the TRIPS Council, World Trade Organization
  Read the letter (76 KB PDF)
• China's Compliance with WTO Commitments (September 18, 2006)
  BIO's letter to the Office of the U.S. Trade Representative
  Read the Letter (293 KB PDF)
• Patent Law of the People's Republic of China (August 28, 2006)
  Letter from BIO to the State Intellectual Property Office of the People's Republic of China
  Read the Letter (361 KB PDF)
• The Russian Federation and the WTO (June 9, 2006)
  Letter from BIO to the U.S. Trade Representative (62 KB PDF)
  Letter from BIO to Conressional Leaders (92 KB PDF)
• US-Malaysia Free Trade Agreement
  Written comments to the USTR
  Read the letter (201 KB PDF)
• Special 301 submission
  Letter to USTR on continuing concerns.
  Read the letter (57 KB PDF)
• US-Korea Free Trade Agreement
  Written comments to the USTR touching on Intellectual Property Rights, Biosafety Protocol Implementation, Adventitious Presence, and Labeling. (March 24, 2006)
  Read the comments (188 KB PDF)
• 2005 Special 301 submission from the Biotechnology Industry Organization (97 MB PDF) (Feb. 11, 2005)
• 2004 Special 301 submission from the Biotechnology Industry Organization (75 KB PDF) (Feb. 13, 2004)
• BIO Letter to the Hon. Robert Zoellick, U.S. Trade Representative, in support of CAFTA (126 KB PDF) (Dec. 10, 2003)
• BIO's Comments to the USTR (12.1 MB PDF), identifying countries of concern as per the Trade Act of 1974 (Feb. 14, 2003)
• Concerns with Trade-Related Aspects of Intellectual Property (TRIPS) (2.32 MB PDF), Letter to The Honorable Robert Zoellick, US Trade Representative (Jan. 29, 2003)
• Concerns with Trade-Related Aspects of Intellectual Property (TRIPS) (98 KB PDF), Letter to The Honorable Robert Zoellick, US Trade Representative (Nov. 27, 2002)
• Letter to the United States Senate (371 KB PDF) Supporting the Passage of Trade Promotion Authority Without Accompanying Amendments (May 6, 2002)

Biodiversity and Bioprospecting

• Letter to the Secretariet of the Convention on Biologocal Diversity (November 30, 2007)
  Letter from BIO suggesting agenda items for discussions at the next (6th) meeting of the working group on Access and Benefit Sharing in Geneva.
  Read the notification (677 KB PDF)
  Read the letter (49 KB PDF)
• Convention on Biology Diversity and Patent Disclosure Requirements (October 23, 2006)
  Letter from BIO, EuropaBIO, BIOTECanada and CropLive International to the TRIPS Council, World Trade Organization
  Read the letter (76 KB PDF)
• US-Korea Free Trade Agreement (March 24, 2006)
  Written comments to the USTR touching on Intellectual Property Rights, Biosafety Protocol Implementation, Adventitious Presence, and Labeling.
  Read the comments (188 KB PDF)
• Fourth Meeting of the Ad Hoc Open-Ended Working Group on Access and Benefit-sharing, Granada, Spain (January 30, 2006 ñ February 3, 2006)
• Bioprospecting Guidelines
  Cover Memo for Bioprospecting Guidelines
  Bioprospecting Guidelines
• BIO's statement to IGC on genetic resources and patent disclosure requirements (Nov. 5, 2004) BIO is participating in the deliberations of the Intergovernmental Committee on Folklore, Traditional Knowledge and Genetic Resources of the World Intellectual Property Organization. The text of BIO's statement on genetic resources and patent disclosure requirements can be found here. Read the response (80 KB PDF)
• Response to Swedish Questionnaire (Sep. 7, 2004) BIO's response to a Swedish questionnaire regarding genetic source origin disclosure requirements in patent applications. Read the response (197 KB PDF)
• Response to "Notice 227 Patents Amendment Bill, 2004" (Mar. 18, 2004) Read the response (359 KB PDF)
• Letter regarding the Conference of the Parties of the Convention on Biological Diversity (Feb. 5, 2004) Read the Letter (365 KB PDF)
• Existing national access regimes and status regarding CBD implementation

IP and Global Health

• Comments to the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) (January 2008)
  BIO's comments on the Revised Draft of Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.
  Read the comments (641 KB PDF)
• Comments to the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (“IGWG”) (October 3, 2007)
  BIO's comments regarding drawing up a global strategy and plan of action on public health innovation and intellectual property for developing countries.
  Read the comments (312 KB PDF)
• BIO hosted a Seminar entitled “From Biotechnology Innovation to Global Health Solutions: Solutions for Diseases Affecting Developing Countries” during the second meeting of the World Health Organization's (WHO) Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), November 5-10, 2007 in Geneva, Switzerland.
  
  Seminar speakers included (with presentations):
• Diran Makinde, Network Director, NEPAD Biosciences, West Africa Biosciences Network (WABNet), Senegal - Presentation (PDF 5.89 MB)
• Mark Rohrbaugh, Director, Office of Technology Transfer, National Institutes of Health (NIH), US Department of Health & Human Services, USA - Presentation (PDF 404 KB)
• Ted Roumel, Vice President for Research Innovation & Commercialization at the University of Maryland Biotechnology Institute, USA - Presentation (PDF 130 KB)
• Janna Tom, Assistant Director, Office of Technology Transfer, University of California; Vice President for Public Policy, Association of University Technology Managers (AUTM), USA - Presentation (PDF 216 KB)
• Eileen Yen, former Director, Sarawak Biodiversity Centre, Malaysia - Presentation (PDF 1.42 MB)