Gene Patenting

A new federal recommendation could hinder innovations from biotechnology R&D by limiting gene patents and licenses.

A patent case winding its way through U.S. District Court has the potential to hinder biotechnology R&D if the judge hearing the case rules in favor of the plaintiffs, led by the American Civil Liberties Union.

On February 4th, BIO hosted a media briefing on how efforts to restrict gene patenting and licensing would threaten advances in public health and harm the national economy.

Genetic disorders known as Lysosomal Storage Diseases, including Gaucher disease, Fabry disease and Pompe disease, continue to be an area of high unmet medical need.

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).

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 14 2014
Dear Chairman Terry and Ranking Member Schakowsky: On behalf of the Biotechnology Industry Organization (BIO), I write in support of H.R. ___, the Targeting Rogue and Opaque Letters (TROL) Act of 2014, and urge the Subcommittee to pass this legislation. It is critical that legislation that seeks to reign in abuses by patent trolls does so in a way that preserves and enhances the incentives necessary to sustain our nation’s global leadership in biotechnology innovation and to spur the creation of high-wage, high-value jobs throughout the country. Improving our patent system can help America retain its global competitive advantage in biotechnology and other innovative industries, and will spur more investment and job creation at a time when both are sorely needed. We commend Chairman Terry and Members of the Subcommittee on Commerce, Manufacturing, and Trade for creating a balanced approach that will address the issue of false or deceptive patent demand letters without impeding the ability of legitimate patent owners to enforce their patents by sending patent-related communications made in good faith.
February 1 2013
BIO commends the INPI for their efforts to devise guidelines for examining biotechnology related inventions. Given the technological advances and the innovation that spurs it are the primary drivers of economic growth in the modern era, it is critical that patent laws and practices properly motivate and reward innovation.
June 11 2012
On behalf of the 23 undersigned industrial, environmental, food and agricultural biotechnology companies, we write to express our concerns over the pending appeal in the case of Association for Molecular Pathology et al. v. Myriad Genetics et al (AMP) before the U.S. Court of Appeals for the Federal Circuit.
February 17 2012
If a poor patient in Nevada doesn’t have access to an advanced molecular diagnostic test, and right across the border in California a similar patient has access to the same test, there’s obviously something wrong with that, but how can that be a patent problem?

Press Releases

March 3 2015
BIO supports the STRONG Patents Act of 2015 and will continue to advocate for passage of legislation to curb abusive patent practices.
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.
November 1 2010
The brief, filed jointly with the Association of University Technology Managers (AUTM), supports the patentability of isolated DNA molecules, noting that invalidating the patentability of these molecules would discourage future biotechnological innovation.
March 30 2010
BIO is pleased that the Court dismissed the far-reaching claims regarding the constitutionality of patenting gene-based inventions. Disputed allegations that patents supposedly stifle research or impede patient access were explicitly excluded from consideration.
February 5 2010
BIO was  joined on the letter by the Association of University Technology Managers (AUTM), Genetic Alliance, the Wisconsin Alumni Research Foundation (WARF), and more than 20 other stakeholders in urging Secretary Sebelius to reject the Committee’s recommendations and to ensure that the fundamentals of the innovation system put in place nearly 30 years ago through the Bayh-Dole Act are preserved.