Letters, Testimony & Comments

Dear Shri Aggarwal:   At the outset, the Biotechnology Industry Organization (BIO) greatly appreciates the opportunity to...
December 15 2015
The Biotechnology Industry Organization (BIO) appreciates this opportunity to submit comments on the United States Patent and Trademark...
October 29 2015
June 4, 2015 Honorable Charles E. Grassley Chairman Committee on the Judiciary Honorable Patrick J. Leahy...
June 5 2015
Honorable Charles E. Grassley Chairman Committee on the Judiciary   Honorable Patrick J. Leahy Ranking...
June 4 2015
BIO has filed a friend of the court brief at the Federal Circuit in the Amgen v. Sandoz case. Because this case is the first test of the...
April 23 2015
Executive Summary:   The Biotechnology Industry Organization (BIO) appreciates the opportunity to participate in the Special 301...
February 9 2015
The Honorable Patrick Leahy Chairman Committee on the Judiciary United States Senate Washington, D.C. 20510...
April 2 2014
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 25 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...

Letters, Testimony & Comments

February 8 2016
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the 2016 Special 301 Submission. 
December 15 2015
The Biotechnology Industry Organization (BIO) greatly appreciates the opportunity to provide comments/suggestions of the stakeholders on the Draft Patents (Amendment) Rules 2015 published by the Ministry of Commerce & Industry.
October 29 2015
The Biotechnology Industry Organization (BIO) appreciates this opportunity to submit comments on the United States Patent and Trademark Office’s (USPTO) July 2015 Update on Subject Matter Eligibility (Guidance).
June 5 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.
June 4 2015
BIO submitted a letter to members of the Senate Judiciary Committee regarding the Managers Amendment to PATENT Act.

Press Releases

September 28 2015
"It is disappointing that the PTO’s Patent Trial and Appeal Board (PTAB) failed to properly assess the important issues raised by this motion. This cursory and erroneous ruling reinforces the immediate need for Congress and the PTO leadership to take clear and decisive action to prevent any further misuse and abuse of the Inter Partes Review process by hedge funds, extortionists and other questionable entities seeking to undermine it for their own financial benefit." 
September 3 2015
The Biotechnology Industry Organization (BIO) today released the following statement regarding the recent IPR challenges filed by hedge fund manager Kyle Bass.
August 3 2015
BIO announced the appointment of Jeanne Haggerty as Senior Vice President of Federal Government Relations.
June 11 2015
BIO continues its continued opposition to The Innovation Act (H.R.9) as amended and reported by the House Judiciary Committee today.