Intellectual Property

Earlier this week, BIO submitted a letter and white paper to the U.S. Trade Representative outlining recommendations for policies to pursue with TPP negotiating partners to ensure intellectual property protection for innovative biologic products.

It is imperative that the TPP create a set of strong intellectual property standards – particularly those governing data protection, patents and trade secret protection – that are relevant to biological products.

Using an input output “I-O” approach to estimating the economic impact of academic licensing, and summing over the 15 years of available data for academic U.S. AUTM Survey respondents, the total contribution of these academic licensors to gross industry output ranges from $199B to $836B, in 2005 $US Dollars; contributions to GDP range from $86B to $338B, in 2005 $US Dollars.

This report examines the role played by IPRs in both upstream and downstream phases of the research, development and commercialization of biotechnology products and provides a review and analysis of the existing body of knowledge concerning the role of IPRs.

BIO Ventures for Global Health (BVGH) and the Biotechnology Industry Organization (BIO) have collaborated on a new report that builds upon the findings in BVGH’s previous analysis, Developing New Drugs and Vaccines for Neglected Diseases of the Poor: The Product Developer Landscape.

Hans Sauer tells us why the 2012 BIO International Convention is a can't-miss event if you are interested in issues concerning intellectual property, tech transfer and related topics.

Gene Patents and the Myriad patent case reveal the confusion that often occurs when you mix science, law, politics, and emotion. This article provides a digest of a series of blog posts on Biotech-Now that address common myths in the gene patent debate.

The U.S. Supreme Court issued a favorable decision in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent.

BIO is committed to increased access to biologic medicines for patients throughout the world. 

BIO will be co-hosting an event with the United States Patent and Trademark Office (USPTO) to celebrate the 30th anniversary of the issuance of U.S. patent 4,259,444 to Ananda Chakrabarty following the Supreme Court case, Diamond v. Chakrabarty, which held that Chakrabarty’s bioengineered bacterium was eligible for patenting.

Patent systems can provide an advantage to society by rewarding the development of new inventions, promoting the advancement of technology and protecting the investor.  Patents often are the most important, and sometimes only, asset of a biotech company. Patents and related rights must be obtained in a timely and predictable manner and the ability to enforce those patents is critical.

The Patent Reform Act of 2011 would strengthen and improve our nation’s patent system, spurring innovation and job creation.

The Biotechnology Industry Organization (BIO) will hold its Intellectual Property Counsels Committee Spring Conference and Meeting in Seattle, Washington from April 13-15.

Brenda Herschbach Jarrell and Jennifer Groves present an overview of the IP landscape in China, India, Brazil and Korea.

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.