Letters, Testimony & Comments

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
Biologics are complex medicines that are manufactured using living organisms.  Due to their size and complexity, biologics are...
July 8 2013
A concerted effort through the TTIP to unleash the potential of biotechnology in the Transatlantic economy and beyond will go a long way...
June 19 2013
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations...
June 19 2013
Countries across the globe are realizing the significant impact rare diseases have on their populations, and are responding by putting...
June 7 2013
Introduction The Biotechnology Industry Organization (BIO) appreciates the opportunity to respond to the Request for Comments issued by...
June 3 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
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
BIO has identified the following countries of interest and recommends the following for our 2011 Special 301 submission. Priority...
February 14 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 Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the...
May 31 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: Participation of Malaysia in the Trans-Pacific Partnership Trade Negotiations Dear Ms. Blue: The Biotechnology Industry...
November 22 2010
Dear Governor Fortuño: In what is currently one of the worst economic recessions to be experienced in our lifetime, the life...
October 24 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
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on India’s Department of Industrial...
September 29 2010
In response to requests from its members, BIO has developed a formal BIO Policy Statement on Options for Increasing Access to Medicines...
May 1 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, This letter is submitted by the Biotechnology Industry Organization (BIO) in response to the request for public comment...
November 3 2009
U.S. Department of State
June 1 2009
Re: DoH Call for Comments 08/2008 Dear Sir or Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
August 25 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
Re: Sugestões ao projeto de lei que dispõe sobre o access tos recursos genéticos e seus derivados Dear Sir/Madam...
February 28 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
COMMENTS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO) ON ISSUES TO BE ADDRESSED BY THE TECHNICAL EXPERTS GROUP ON CONCEPTS, TERMS,...
October 17 2007
The  Biotechnology Industry Organization (BIO) commends the WHO Intergovernmental Working Group on Public Health, Innovation and...
October 3 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
The Biotechnology Industry Organization (BIO) submits these comments on the European Medicines Agency’s (EMEA’s) draft...
May 23 2007
To: Members of the TRIPS Council, World Trade Organization From: The Presidents of the Biotechnology Industry Organization, BIOTECanada...
October 23 2006
Dear Mr. Tian: I am writing on behalf of the Biotechnology Industry Organization (BIO) in response to your request for comments on the...
August 28 2006
To the State Intellectual Property Office of the People's Republic of China
August 28 2006
Comments by BIO; CHMP/437/04
February 28 2005
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
Re: Review of the Declaration of Helsinki   Dear Sir or Madam:   BIO appreciates the opportunity to comment on the World...
Re: European Food Safety Authority (EFSA) Request for public comments on the “Implications of animal cloning on food safety, animal...
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...
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...
October 16 2013
BIO appreciates this fourth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin and we refer you to our previous comments filed to the Colombian Ministry of Health on April 24th 2012, June 12th 2012 and February 21st 2013 for background about BIO and its interest in this Decree. 
July 10 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.
July 8 2013
As the Mexican government looks to establish a pathway to market for biosimilar biological products, BIO offers the following important considerations to ensure patient safety, as well as continued innovation in the life sciences industry.
June 19 2013
The TTIP represents a profoundly important opportunity to advance progress in these areas. The following comments represent BIO’s initial suggestions for the formulation of negotiating objectives relevant to biotechnology.  
November 12 2013
Event brings Western and Chinese life science companies together for partnering and deal making
April 8 2013
Strong Intellectual Property Protection Is Vital For The Life Sciences Industry.
July 23 2012
Groups issue booklet to help biotechnology and pharmaceutical companies identify pipeline medicines with doping potential.
June 6 2012
The report will be released at a Super Session, titled "International Leaders Share Their Worldview: Scientific American's Regional Bio-Innovation Scorecard."
April 5 2012
Centric Health Resources and the National Organization for Rare Disorders (NORD), Co-organizersAlnylam Pharmaceuticals, Genzyme, a Sanofi Company and Millennium: The Takeda Oncology Company, Co-sponsors