The Biotechnology Industry Organization (BIO) provided comments yesterday to the Secretary's Advisory Committee on Genetics, Health and Society regarding its draft report on Gene Patenting and Licensing and Their Impact on Patient Access to Genetic Tests.

According to the group, the report makes several recommendations that would restrict the ability to obtain or undermine the enforceability of patents and exclusive licenses with respect to genetic tests.

"While BIO and our member companies strongly support the mission of the Committee and its goal of improving patient access to genetic tests, we must strongly disagree with its recommendations," said BIO President and CEO Jim Greenwood. "If implemented, these recommendations would do far more harm than good to patients, particularly the patients of tomorrow who will rely on biotech innovation to bring the promise of personalized medicine to reality."

In its comments, BIO took issue with many of the draft report's recommendations, which were not supported by the Committee's own findings and case studies. Those findings and case studies show how patenting and exclusive licensing practices can be necessary to foster the development of valuable genetics tests for patients, particularly those with rare disorders, and that they have other positive impacts - such as incentives to promote physician and patient education, broader insurance coverage, and improved compliance. Those real benefits were largely ignored by the Committee in proposing its over-reaching and restrictive recommendations.

"The patent, licensing, and tech transfer system in this country is, by any objective measure, working quite well overall. The evidence shows that decisions about what patents to seek and how best to license them are decisions that are best made by the researchers and their commercial partners, who have the greatest incentives to achieve widespread patient access to their discoveries," concluded Greenwood. "Enacting these recommendations would risk thousands of jobs across the country by stifling university-industry partnerships and undermine the country's global leadership in biotech innovation."