A new federal recommendation could hinder innovations from biotechnology R&D by limiting gene patents and licenses.
In February, the Health and Human Services Secretary’s Advisory Committee on Genetics, Health and Society approved a report that includes such limitations. In response, BIO and several other organizations sent a letter to HHS Secretary Kathleen Sebelius urging her to reject certain recommendations in the report.
SACGHS’ Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests contains recommendations that restrict gene patenting. More than 20 organizations including the Association of University Technology Managers, Genetic Alliance and the Wisconsin Alumni Research Foundation joined BIO in stressing that such restrictions would threaten advances in public health and harm the national economy.
The biotech industry has created several million U.S. jobs. This growth is largely attributed to the patent system and passage of the Bayh-Dole Act. Former Sen. Birch Bayh spoke at a BIO press conference on Feb. 4 at the National Press Club in Washington, D.C., about the legislation that bears his name. The Bayh-Dole Act allows universities to patent and license with flexibility. Such freedom generated a large surge in commercialization of federally funded research, which rarely happened before the legislation was passed in 1980.
“By undermining the value of gene-based patents, these recommendations would chill future investment and innovation, and would undermine the investment-backed expectations of current patent owners and licensees,” says BIO President and CEO Jim Greenwood.
The SACGHS proposals would create an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, offering for sale or selling a test developed under patient-for-patient care purposes. Restricting gene patenting will harm patients by impairing the R&D and commercialization of the medicines and diagnostic tests of tomorrow, BIO believes.
BIO noted in the letter to Sebelius that the United States’ success in genomic research has spurred the creation of biotech hubs around the globe. Given this global competition, the United States must protect its R&D engine, Greenwood says.
“The United States must preserve incentives for investment and innovation, particularly given the current state of the economy,” he says. “It is not the time to undertake or recommend policy changes that would undermine the foundations of American life sciences innovation.”