In a press conference on February 4, the Washington, DC-based Biotechnology Industry Organization (BIO) expressed concern about recommendations in the report “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests,” issued by the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). The committee is charged with advising the U.S. Secretary of Health and Human Services on human health and societal issues raised by the development and use of genetic technologies. Although the SACGHS report indicates that gene patents and licensing practices have not had an adverse impact on patient access to genetic tests, the committee is nevertheless making recommendations that “would undermine the U.S. patent system and the Bayh-Dole technology transfer system that have served our nation so well,” noted BIO president and CEO Jim Greenwood. The committee’s recommendations “would discourage investment in biotech innovation, hobble the transfer of federally funded research, undermine university research programs, and harm patients who are waiting for life-saving therapies and diagnostics yet to be developed,” he added.
SACGHS task force member Brian Stanton, PhD, a consultant on IP management and policy, former director of the Division of Policy at the National Institutes of Health’s Office of Technology Transfer, said the committee’s report shows “no evidence of harm, and yet it still calls for changes.” The change that has garnered the most attention is a proposal to exempt gene patents from infringement liability. While Stanton acknowledged that the task force identified isolated instances of harm that need to be addressed, it also determined that “the court systems and the systems of checks and balances that are built into the fabric of the patent system were more than capable of addressing problems on a case-by-case basis.” He also observed that the report contains a letter of dissent from the only three members of the full committee who have direct experience in business and law with respect to IP and private sector development of products and services.
The Bayh-Dole Act “transformed the entire way that we, as universities, interact with the commercial sector,” and helped to create a whole new industry, added Jon Soderstrom, PhD, managing director of the Office of Cooperative Research at Yale University. According to its annual survey, Association of University Technology Managers (AUTM) members have gone from issuing dozens of licenses before passage of the Act to issuing thousands of licenses each year — more than 5,000 licenses in 2009 alone, according to Soderstrom. Over the past 20 years, patents licensed by AUTM members have led to the development of more than 10,000 new products, he added. Prior to Bayh-Dole, not a single drug was developed using Yale’s patented technology. Since passage of the Act, five drugs based on Yale patents have made it to market and 18 more are in clinical trials. The SACGHS recommendations could set the clock back, creating “essentially a reconstitution of the world as is it existed before 1980,” Soderstrom warned. BIO has made a podcast of the press conference available here.
Source: Patent Docs