Patent Reform

Danny Levine of the Burrill Report conducted a podcast with BIO President & CEO Jim Greenwood today on BIO's public priorities for 2010.

Economists have long recognized that the development and spread of economic innovations are the most powerful factors affecting how fast the U.S. economy grows and how much the incomes of most Americans will rise.

Certain groups are calling for serious overhaul of the nation‟s patent system.

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).

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.