Intellectual Property

What happens in Washington influences biotechnology progress every bit as much as what happens on Wall Street or in the lab.

The theory claiming that the over-patenting of biotechnology research hinders the research and development of new treatments is not supported by empirical evidence.

On July 23rd, the House passed by voice vote an amendment on human patenting offered by Dave Weldon (R-Fla.) as part of the Commerce-Justice-State appropriations bill (H.R. 2799).

In the early weeks of the 108th Congress, two Senate bills, S. 54 and S. 7, were introduced that embrace the "Greater Access to Affordable Pharmaceuticals Act of 2003" (GAAP), formerly known in the 107th Congress as S. 812

On October 24th the FDA published proposed regulations that affect implementation of the Hatch-Waxman law. These changes in part respond to recommendations in a July 2002 Federal Trade Commission (FTC) report and a Citizen Petition filed with the FDA by the FTC in May 2001.

Last week, the Senate Health, Education, Labor and Pensions (HELP) Committee marked-up legislation - The Edwards/Collins substitute to S. 812 - The "Greater Access to Affordable Pharmaceuticals Act of 2001" - that raises serious concerns for members of the Biotechnology Industry Organization (BIO).

Letters, Testimony & Comments

March 21 2013
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products....
February 22 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of...
February 8 2013
Biotechnology companies provide unique benefits to the United States and the world. In the health care sector alone, the industry has...
February 1 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...

Press Releases

May 2 2013
Washington, D.C. (May 2, 2013) The Biotechnology Industry Organization (BIO) today expressed concern over specific...
April 8 2013
Washington, D.C. (April 8, 2013) –  The Biotechnology Industry Organization (BIO) issued the following...
February 11 2013
  WHAT: An inside look at two cases facing the Supreme Court of the United States: Bowman v....
January 15 2013
Washington, D.C. — The Biotechnology Industry Organization (BIO) and the American Seed Trade Association (ASTA...
June 21 2012
Washington, D.C. (June 21, 2012) – The Biotechnology Industry Organization (BIO) released a report on the...