The biotech community’s relief over the USPTO’s recission of Bush-era patent rules may be short-lived. New recommendations from the Task Force on IP and Genetic Testing could weaken patent protection for genetic research. The 300-page task force report, “Final Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests,” was submitted to the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS), which voted to accept the recommendations and pass them on to Kathleen Sebelius, secretary for Health and Human Services. The recommendations focus specifically on genetic tests that often are associated with diagnostic work on cancer, heart, and neurological conditions. The report advocates exempting genetic tests for cancer and other diseases from patent protection — meaning that anyone could use genetic diagnostic research from any university without obtaining licenses, according to Andrew Cohn, who spearheads lobbying efforts on behalf of the Wisconsin Alumni Research Foundation (WARF). “They are making reckless policy recommendations,” Cohn says. “This is an incredible precedent — a bad precedent.”

The report inflames the debate between adherents of the patent system and those who argue that the 20-year monopoly afforded by a patent can limit the use of medical breakthroughs. The task force argues that patent ownership of genetic science creates single commercial providers of such genetic tests, forcing physicians to send blood and tissue samples to specific providers for analysis and creating a patchwork of testing labs — some without agreements from Medicare or Medicaid to pay for the work. “As we did the report, we had one major constituency in mind, and that was patients,” says James Evans, MD, PhD, director of adult genetics services at the University of North Carolina at Chapel Hill, who chaired the task force. The study examined how the system could be narrowly adjusted to enhance patient access to new technologies, according to Evans. But “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,” says Jim Greenwood, president of the Biotechnology Industry Organization (BIO).

The report includes a second recommendation that encourages Sebelius to explore whether her department has the authority to compel universities and companies that use federal funding for technology research to license their inventions freely to as many users as possible. The idea, Evans says, is to limit the use of exclusive license arrangements that keep medical innovations in the hands of a few. But WARF’s Cohn calls the recommendation a “cookie cutter” approach that has “the potential to gut the Bayh-Dole act.” Both WARF and BIO contend the report fails to substantiate that patent protection limits the use of genetic testing and research. Patent attorney Gene Quinn, founder of the web site IPWatchdog.com, agrees, criticizing the “shocking and surprisingly unfounded conclusion” that patents do not serve as incentives for genetics research. Quinn posted on his web site a minority opinion written by Brian Stanton, an ad hoc member of the SACGHS task force and principal author of the USPTO’s 2001 utility examination guidelines. According to Stanton, the report is “fundamentally flawed” and its suggestions could significantly harm medical innovation. Years of study have produced no evidence that IP laws or licensing practices cause general harm, lack of technology development, or systemic lack of public access to genetic testing, Stanton points out, yet the report suggests otherwise. He urges the full SACGHS to halt the current line of inquiry; return the current draft report to the task force for revision, further study, and reconsideration; or disband the task force and convene a new study group with a balanced membership of IP, industry, academic, and medical experts. “Unfortunately, the report is ill-conceived and fatally flawed to such an extent that it serves no purpose,” Stanton writes. “Further, the suggestions contained in the report are inconsistent with the evidence obtained, redundant to other IP management efforts, and fail to identify any endemic problems or issues. I therefore formally dissent from its content, conclusions, and suggestions.”

Sources: Milwaukee Wisconsin Journal Sentinel and IP Watchdog

Posted October 14th, 2009 under Tech Transfer

Write a comment