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
Biologics are complex medicines that are manufactured using living organisms.  Due to their size and complexity, biologics are...
July 8 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
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
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
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
  January 30, 2012 Azam Khan Deputy Chief of Staff, Office of the Under Secretary and Director United States Patent and...
January 30 2012
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
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
   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
 Written Testimony of The Biotechnology Industry Organization (BIO) Before the United States Senate Committee on the...
March 10 2009
BIO responds to a recent report entitled "Toward a New Era of Intellectual Property: From Confrontation to Negotiation" which offered no...
October 13 2008
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
September 16 2005
May 13 2005
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
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
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
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
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
Dear Senators Reid and McConnell: On behalf of the more than 430 undersigned organizations representing American innovation from all 50...
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.
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 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
We understand the challenges that India faces with respect to healthcare and the innovative biotechnology industry stands ready to work with India to help address them.  
June 7 2013
BIO applauds the government of Brazil for taking steps towards developing regulatory requirements to ensure patients suffering from rare diseases have access to treatment.   
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.
May 14 2013
BIO welcomes the unanimous Supreme Court decision in Bowman v. Monsanto, in which the Court confirms that biotechnology seed is entitled to the same protections as other inventions under the patent law.
September 8 2011
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the passage of The Leahy-Smith America Invents Act, H.R. 1249, by the U.S. Senate.
June 23 2011
BIO President and CEO Jim Greenwood released a statement on the passage of The Leahy-Smith America Invents Act, H.R. 1249, by the House of Representatives.