Letters, Testimony & Comments

The Honorable Patrick Leahy Chairman Committee on the Judiciary United States Senate Washington, D.C. 20510...
April 2 2014
Stanford McCoy Assistant U.S. Trade Representative for Intellectual Property and Innovation Office of the U.S. Trade Representative...
February 25 2014
Good morning. My name is Lila Feisee, Vice President of International Affairs at the Biotechnology Industry Organization (BIO). ...
February 24 2014
BIO commends the Brazilian Government for its efforts to revisit its policies with the goal of developing a legal framework that...
November 20 2013
BIO appreciates this fourth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory...
October 16 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a...
July 10 2013
Countries across the globe are realizing the significant impact rare diseases have on their populations, and are responding by putting...
June 7 2013
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products....
March 21 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of...
February 22 2013
Biotechnology companies provide unique benefits to the United States and the world. In the health care sector alone, the industry has...
February 8 2013
BIO commends the INPI for their efforts to devise guidelines for examining biotechnology related inventions. Given the technological...
February 1 2013
BIO respectfully submits both questions and comments for the National Health Surveillance Agency’s (ANVISA) consideration on the...
February 1 2013
Given the importance of protections for basic biotechnology inventions to the survival of the biotechnology sector in India, BIO has...
January 18 2013
Draft Guidelines Given the importance of protections for basic biotechnology inventions to the survival of the biotechnology sector in...
November 28 2012
The Biotechnology Industry Organization (BIO) is grateful for the opportunity to provide comments on India’s Draft National IPR...
November 8 2012
Dear Commissioner Hamburg: We are writing on behalf of the following higher education associations in consideration of issues raised...
November 5 2012
BIO supports the President’s decision to include Mexico in the TPP trade negotiations. Providing effective intellectual property...
September 5 2012
I. Agricultural and Animal Biotechnology The Government of Canada has long been a trusted ally to the United States on agricultural...
September 4 2012
The Biotechnology Industry Organization (BIO) appreciates the U.S. Trade Representative's (USTR) query about BIO's views on how...
August 17 2012
The United States Patent and Trademark Office (USPTO) has led the world in providing technical expertise and training to various patent...
July 26 2012
 Dear Chairman Smith and Ranking Member Conyers: On behalf of the Biotechnology Industry Organization (BIO), I am writing to...
July 11 2012
The U.S. Intellectual Property Rights Attaché Program has had significant success and holds immense promise in helping to enhance...
June 28 2012
On behalf of the 23 undersigned industrial, environmental, food and agricultural biotechnology companies, we write to express our...
June 12 2012
  The House Judiciary Committee conducted a hearing on World IP Day on "International Patent Issues: Promoting...
April 26 2012
From BIO’s perspective, Supplemental Examination may have significant benefits, because patents that undergo this process are...
March 26 2012
Selected Excerpts: The vast majority of BIO’s members are small and medium sized enterprises that currently do not have products...
March 7 2012
If a poor patient in Nevada doesn’t have access to an advanced molecular diagnostic test, and right across the border in California...
February 17 2012
BIO has identified the following countries of interest and recommends the following for our 2011 Special 301 submission. Priority...
February 14 2012
  January 30, 2012 Azam Khan Deputy Chief of Staff, Office of the Under Secretary and Director United States Patent and...
January 30 2012
By Electronic Submission To the State Intellectual Property Office, The Biotechnology Industry Organization (BIO) appreciates this...
December 9 2011
By Electronic Submission Ip.policy@uspto.gov Office of Policy and External Affairs United States Patent and Trademark Office...
November 10 2011
By electronic submission Saurabh Vishnubhakat Attorney Advisor, Office of Chief Economist United States Patent and Trademark...
October 27 2011
By electronic submission   Mr. Stan McCoy Assistant USTR for Intellectual Property and Innovation Office of the U.S. Trade...
October 20 2011
The Honorable David Kappos Under Secretary of Commerce for Intellectual Property, Director of the U.S. Patent & Trademark Office...
October 19 2011
Dear Chairman Smith: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our strong support for your...
June 14 2011
Dear Speaker Boehner and Leader Pelosi: We write to express our unified support for Section 22 of H.R. 1249, “The America Invents...
June 13 2011
Dear Secretary Locke: On behalf of the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of...
May 13 2011
Re: Request for Comments on the Strategy for American Innovation Subject: Innovation Strategy RFI Email: competitiveness@doc.gov Dear...
April 1 2011
March 24, 2011 As our economy begins to improve, job creation remains a critical priority toward ensuring a broad, deep and sustained...
March 24 2011
Patent Amendment (Human Genes and Biological Materials) Bill 2010 Submission to the Senate Legal and Constitutional Affairs Legislation...
February 25 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to participate in the Special 301 process and is hopeful that...
February 15 2011
Re: Microsoft Corp. v. i4i L.P. and Infrastructures for Information Inc., pending in the United States Supreme Court, No. 10-290...
January 13 2011
Re: IPR and Technology discussions at Cancún Climate Change Talks Dear Secretary Clinton and Ambassador Stern: At this very...
December 7 2010
RE: Participation of Malaysia in the Trans-Pacific Partnership Trade Negotiations Dear Ms. Blue: The Biotechnology Industry...
November 22 2010
Re: Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System, 75 Fed. Reg....
November 19 2010
October 14, 2010 To: Members of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing of the Convention on Biological...
October 14 2010
District Court Ruling Exposes Biotechnology to Unprecedented Tort Liability. BIO disputes the District Court Ruling that exposes...
October 14 2010
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on India’s Department of Industrial...
September 29 2010
Biotechnology companies would be less likely to export their products into countries that do not provide meaningful IP and data...
July 26 2010
BIO questions about the utility and expected impact of the proposal, and why patent applicants should be debited with subtractions from...
June 1 2010
Access to Early Capital In the United States and globally, commercial development of biotechnology relies on the continuing...
May 27 2010
The Biotechnology industry Organization appreciates the opportunity to respond to the Request for Information issued by the Office of...
May 25 2010
Intellectual Property Innovation and Chair of the Special 301 Committee Office of the United States Trade Representative Washington, D...
February 18 2010
Dear Ms. Blue: The Biotechnology Industry Organization (BIO) is submitting this letter in response to the request by the United States...
November 1 2009
Recommendations in the Secretary’s Advisory Committee on Genetics, Health and Society draft report on Gene Patenting and Licensing...
October 8 2009
Dear Secretary Vilsack: We are writing today to bring to your attention a court case that has the potential to negatively impact the...
September 9 2009
August 6 2009
  VIEWS AND PROPOSALS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) AND THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF...
July 31 2009
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property...
July 15 2009
U.S. Department of State
June 1 2009
   Written Testimony of The Biotechnology Industry Organization (BIO) Before the United States House of Representatives...
April 30 2009
BIO commends the Senate Judiciary Committee for its success in developing a more consensus-oriented approach to patent reform legislation...
April 2 2009
Office of the U.S. Trade Representative
March 11 2009
 Written Testimony of The Biotechnology Industry Organization (BIO) Before the United States Senate Committee on the...
March 10 2009
Office of the U.S. Trade Representative
February 19 2009
COMMENTS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) AND THE PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) ON...
November 24 2008
BIO responds to a recent report entitled "Toward a New Era of Intellectual Property: From Confrontation to Negotiation" which offered no...
October 13 2008
August 30 2008
The List of Options on Genetic Resources for Consideration by the Intergovernmental Committee on Genetic Resources, Traditional Knowledge...
July 3 2008
Comments of the Biotechnology Industry Organization (BIO) on the Draft Gap Analysis on the Protection of Traditional Knowledge July...
July 3 2008
Dear Chairman Pallone and Ranking Member Deal: On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you...
May 2 2008
Re: Sugestões ao projeto de lei que dispõe sobre o access tos recursos genéticos e seus derivados Dear Sir/Madam...
February 28 2008
Re: Special 301: Identification of Countries Under Section 182 of the Trade Act of 1974: Request for Public Comment, 73 Fed. Reg. 2958 (...
February 11 2008
Office of the U.S. Trade Representative
February 11 2008
BIO commends the IGWG for its work on a global strategy and plan of action that, according to its mandate, will aim at "securing an...
January 1 2008
The Biotechnology Industry Organization Presents a Luncheon Seminar: From Biotechnology Innovation to Global Health Solutions:...
November 5 2007
The Comments of the Biotechnology Industry Organization on the United States Patent & Trademark Office Proposed Rule Changes...
October 30 2007
The Biotechnology Industry Organization (BIO) appreciates this opportunity to provide the perspective of its members on the role of...
October 24 2007
COMMENTS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) ON ISSUES TO BE ADDRESSED BY THE TECHNICAL EXPERTS GROUP ON CONCEPTS, TERMS,...
October 17 2007
Attention: Kathleen Fonda Comments to Notice of Proposed Rulemaking Entitled: Examination of Patent Applications That Include Claims...
October 9 2007
The Biotechnology Industry Organization (BIO) appreciates this opportunity tp provide the perspective of its members on the Bayh-Dole Act...
August 27 2007
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on the U.S. Council for International...
August 16 2007
I'm writing on  behalf of the Biotechnology Industry Organization (BIO) in response to your invitation for public comments on...
June 22 2007
Chairman Leahy, Ranking Member Specter, and Members of the Committee, I am pleased to testify before you today on the critically important...
June 6 2007
The Statement of the The Biotechnology Industry Organization On H.R. 1908, The Patent Reform Act of 2007 The United States House of...
April 26 2007
Office of the U.S. Trade Representative
March 8 2007
RE: Identification of Countries Under Section 182 of the Trade Act of 1974: Request for Public Comment, 72 Reg. 1033 (January 9, 2007)...
February 1 2007
To: Members of the TRIPS Council, World Trade Organization From: The Presidents of the Biotechnology Industry Organization, BIOTECanada...
October 23 2006
Perhaps no other industry is as dependent upon patents as is the biotech industry.  In 2004 alone, more than 10% of the PTO's...
October 6 2006
Office of the U.S. Trade Representative
September 18 2006
Attention: Hiram H. Bernstein Comments to Proposed Rulemaking Entitled: Changes to Information Disclosure Requirements and Other...
September 9 2006
To the State Intellectual Property Office of the People's Republic of China
August 28 2006
Dear Ambassador Schwab: The Russian Federation's accession to the World Trade Organization (WTO) would be an important step forward...
June 9 2006
Letter to USTR on continuing concerns.
March 31 2006
Comments to the USTR touching on Intellectual Property Rights, Biosafety Protocol Implementation, Adventitious Presence, and Labeling.
March 24 2006
December 6 2005
September 16 2005
September 14 2005
May 13 2005
March 11 2005
February 11 2005
Janna Tom, Assistant Director, Office of Technology Transfer, University of California; Vice President for Public Policy, Association of...
November 20 2004
Intervention of BIO Agenda Item 7 Patent Disclosure Requirements relating to Genetic Resources Thank you Mr. Chairman. The...
November 5 2004
Dear Mr. Simon: I write on behalf of the Biotechnology Industry Organization (BIO) in response to your request for views of European...
September 7 2004
February 13 2004
December 5 2003
Dear House Leadership: On behalf of the Biotechnology Industry Organization (BIO), I urge you to seek prompt passage of H.R. 1561, the...
October 24 2003
Earlier this year both the House and Senate passed their versions of a Medicare reform bill /1. Included in both the House and Senate...
September 8 2003
Chairman Bilirakis and Members of the Committee, I am pleased to testify before you today regarding technology transfer issues as they...
July 10 2003
Identifying countries of concern as per the Trade Act of 1974
February 14 2003
Letter to The Honorable Robert Zoellick, US Trade Representative
January 29 2003
Letter to The Honorable Robert Zoellick, US Trade Representative
November 27 2002
The Honorable Mitchell E. Daniels, Jr. Director, Office of Management and Budget Dwight D. Eisenhower Executive Office Building, #252...
October 24 2002
Dear Senator Daschle: The Biotechnology Industry Organization (BIO) strongly supports the Conference Agreement on the Department of Justice...
October 2 2002
Letter from BIO to the U.S. House of Representatives strongly urging members not to sign the discharge petition (H. Res. 517) offered by...
September 20 2002
July 22 2002
Expressing strong concerns regarding S. 812 (McCain/Schumer- Edwards/Collins)
July 15 2002
The Honorable Thomas A. Daschle 509 Hart Senate Office Building Washington, DC 20510 Dear Majority Leader Daschle:   ...
June 14 2002
Under Secretary of Commerce for Intellectual Property and Director of the USPTO on Patent Harmonization
May 6 2002
Summary The biotechnology industry is the most research and development intensive and capital-focused industry in the world. The United...
April 11 2002
Ranking Member of the House Judiciary Committee
March 21 2002
Chairman of the House Judiciary Subcommittee on Courts, The Internet, and Intellectual Property
March 21 2002
Ranking Member of the House Judiciary Subcommittee on Courts, The Internet, and Intellectual Property
March 21 2002
The biotechnology industry is the most research and development intensive and capital-focused industry in the world. As such, it is very...
February 26 2002
Regarding funding for the U.S. Patent and Trademark Office
November 15 2001
November 5 2001
Outling BIO opposition to generic biologic and pediatric rule codification amendments on pediatric exclusity bill.
October 1 2001
Outlining BIO opposition to generic biologic and pediatric rule codification amendments on pediatric exclusivity bill
October 1 2001
The Honorable Michael Harris, M.P.P. Premier of Ontario Legislative Assembly of Ontario Room 281 Legislative Building Toronto,...
September 26 2001
Honorable Michael Bilirakis Chairman Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives 2125...
July 26 2001
Executive Summary The Biotechnology Industry Organization (BIO) supports amendment of the current reexamination authority to enhance patent...
May 10 2001
Acting Undersecretary of Commerce and Acting Director of the United States Patent and Trademark Office Regarding Patent Law Harmonization
May 4 2001
WASHINGTON, D.C. (July 13, 2000) -- Executives from two Biotechnology Industry Organization (BIO) member companies testified today...
July 13 2000
Executive Summary The Biotechnology Industry Organization (BIO) supports reforms of the Hatch Waxman Act that will provide full day-for-...
July 1 1999
Executive Summary BIO supports amendments to the patent law that, above all, ensure that diligent patent applicants are not penalized...
March 25 1999
RE: Notice of Public Hearing Concerning China's Compliance with WTO Commitments Written Comments (Federal Register Vol. 71, No. 145...
Every Year... -of the 57 million people who die, 10.5 million are children under 5 years and 1.5 million are children between the ages...
Government's role in developing solutions for diseases that disproportionately affect developing countries Introduction: -...
National Institutes of Health: An International Perspective NIH Mission: To uncover new knowledge that will lead to improved public...
Innovation And The Global Research Enterprise WORLD HEALTH ORGANIZATION GENEVA—NOVEMBER 2007 THEODORE J. ROUMEL VICE PRESIDENT...
Dear Senators Reid and McConnell: On behalf of the more than 430 undersigned organizations representing American innovation from all 50...
Dear Representative Issa: I write on behalf of the Biotechnology Industry Organization (BIO) to commend your sponsorship of, and...
October 14 2014
The Biotechnology Industry Organization (BIO) appreciates this fifth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin.
April 2 2014
BIO joins coalition letter to Chairman Patrick Leahy and Ranking Member Chuck Grassley expressing serious concerns with the direction of patent legislation.
February 25 2014
BIO appreciates the opportunity to participate in the Special 301 process and is hopeful that our contribution will assist the United States Trade Representative’s (USTR) efforts in preserving strong intellectual property protections for United States’ companies internationally. BIO appreciates the opportunity to comment on 2014 Special 301 Review: Identification of Countries Under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing.
February 24 2014
Lila Feisee, Vice President of International Affairs testified on behalf of BIO and its 1100 members who innovate in the healthcare, agriculture, industrial, and environmental sectors. 
November 20 2013
BIO welcomes the opportunity to provide the views of its members on facilitating access to genetic resources and traditional knowledge and the sharing of benefits from their use...
May 21 2014
BIO applauds Chairman Leahy’s decision to remove the controversial patent bill from the Senate Judiciary Committee’s agenda until greater stakeholder consensus can be achieved.
February 26 2014
Transparent communication important for Patients and Physicians
December 4 2013
BIO and the American Seed Trade Association (ASTA) announced today that the Data Use and Compensation Agreement (DUCA) is open for signature. 
December 3 2013
BIO issued the following statement regarding the Innovation Act (H.R. 3309), as reported by the House Judiciary Committee.
June 13 2013
The SCOTUS decision represents a departure from judicial and PTO precedent supporting patentability of DNA molecules. The decision could create business uncertainty for a range of inventions.