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).

Letters, Testimony & Comments

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.
April 23 2015
BIO has filed a friend of the court brief at the Federal Circuit in the Amgen v. Sandoz case.
February 9 2015
The Biotechnology Industry Organization (BIO) appreciates the opportunity to participate in the Special 301 process and is hopeful that our contribution will assist the United States Trade Representative’s (USTR) efforts in preserving strong intellectual property protections for United States’ companies internationally. BIO appreciates the opportunity to comment on 2015 Special 301 Review: Identification of Countries Under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing.

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.