Intellectual Property

This side-event, organized by the Biotechnology Industry Organization (BIO) and cosponsored by the Association of University Technology Managers (AUTM), provided an overview on the key elements at play in establishment an enabling environment for transfer of technology to support the full implementation of CBD objectives and priorities.

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.

Attached please find "Guidelines for BIO members engaging in Bioprospecting". The Guidelines are a set of general principles and practices that BIO, as an organization, believes are appropriate to follow when an entity engages in bioprospecting activities.

Guidelines for The Biotechnology Industry Organization Members Engaging in Bioprospecting

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).
July 27 2015
A coalition of 79 house members have requested significant improvement upon language within H.R. 9, the Innovation Act, in order to preserve the effectiveness of Hatch-Waxman and the Biologics Price Competition and Innovation Act.
April 14 2015
Dear Chairmen Grassley and Goodlatte and Ranking Members Leahy and Conyers, We write as leading agricultural companies and producer organizations to urge caution as the Congress considers changes to the U.S. patent system. There is a concern that the Innovation Act, as currently drafted, will discourage investment in modern agricultural tools important to rural America by making patent rights more difficult to enforce and more challenging for companies and universities to cross-license agricultural technologies.
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.
December 10 2014
A coalition of industry and university representatives, including BIO, submitted a letter to Chairman Goodlatte, Chairman Leahy, Rep. Conyers, and Senator Grassley address concerns related to harmful patent enforcement practices.

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 25 2015
BIO released the following statement on the decision by the U.S. Patent and Trademark Office rejecting challenges to two patents held by Acorda Therapeutics...
August 20 2015
BIO issued a statement regarding the United States Patent and Trademark Office’s (PTO) proposed changes to the rules governing the Patent Trial and Appeal Board (PTAB) inter partes review (IPR) proceedings...
April 15 2015
BIO supports the efforts of the House Judiciary Committee to curb abuse of the patent system by those seeking to use the system for personal financial gain rather than to promote innovation. However, we are concerned that H.R. 9, the Innovation Act of 2015, goes beyond targeting abusive practices, including with respect to its excessive pleading requirements, mandatory stays of discovery, and mechanisms for joinder of third-party investors, licensors, and collaborators in all patent-related cases.