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SACGHS Gene Patent Report Stirs Pushback

NEW YORK (GenomeWeb News) – A Department of Health and Human Services committee that is considering recommending bold changes in how current US patent laws apply to claims on genes has stirred up sharp opposition, most particularly over the report's suggestion that genes should be exempt from certain infringement claims.

The unfinished genetic patenting draft report developed by a Secretary's Advisory Committee on Genetics Health and Society task force — the product of a five-year process — advises HHS to consider making those offering genetic tests and researchers exempt from infringement claims, discourage the granting of genetic association patents, promote broad licensing practices, and enhance transparency of information on genetic patents and licenses. The report was presented last week in Washington, DC, at a meeting of the task force.

While criticism of such a policy approach was expected from industry organizations, a particularly scathing critique of the "Draft Report on Gene Patents" came from inside the committee's task force from ad hoc adviser Brian Stanton, a molecular oncologist who worked in intellectual property and technology transfer policy for the National Institutes of Health and for the US Patent and Trademark Office.

Stanton explained in a dissenting letter to the committee that the draft paper was "based on flawed assumptions" and that the recommendations it currently proposes were derived from misinterpreted data and that they were "presented in a biased manner."

The report explains that the task force found through its investigations of case files, studies, and public comments that patents and the financial incenting process may not lead to more innovation of important and useful medical technologies than without the patents. Patents actually may stifle such innovations, according to the report, because they can lead to restricted use of genetic tests, can make it difficult for researchers to access information about the genes or to use them in research, according to the report.

For Stanton, the report is largely "confused" and "illogical." The evidence it builds on fails to support the recommendations, and it over-reaches beyond the assignment with which the committee was initially charged, he said.

"After years of study and effort, the data demonstrates no evidence that intellectual property laws or licensing practices are the cause of general harm, a lack of technology development, or any systemic lack of public access to genetic testing," Stanton wrote.

"The report fails to present and represent the input of public comments in a proportional and fair manner," he added, and it includes "inconsistent findings and flawed logic." Stanton, who describes himself as an acknowledged supporter of IP incentives, also said that the report "fails to explore the benefits" of the patent system.

The Biotechnology Industry Organization, which represents more than 1,200 biotech companies, said in a statement that it "strongly" disagrees with the conclusions the task force drew from their findings, and sees them as a source of potential danger, on the grounds that they would hinder innovation and would not expand access to genetic tests.

"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," BIO President and CEO Jim Greenwood said in a statement.

Echoing Stanton's complaint, BIO argued that the list of recommendations the SACGHS task force drafted were based on conclusions that were not supported by the committee's findings or by the case studies it reviewed.

Greenwood said that the overall patent, licensing, and technology transfer system in the US is "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," Greenwood added. "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."

In remarks delivered to the SACGHS committee last week, BIO General Counsel Tom Dilenge argued that some of the committee's findings "show how patenting and exclusive licensing practices can, indeed, be necessary to foster the development of [genetic 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."

Dilenge also described as "seriously off the mark" the task force's suggestion that exempting certain activities relating to genetic testing from patent infringement liability would be supported by precedent.

Restricting or prohibiting "association" patent claims "would likely sweep in many valuable and appropriate claims and have a chilling effect on research and technology transfer," Dilenge said.

Michael Remington, who serves as counsel for the Wisconsin Alumni Research Foundation and who delivered comments to the committee, called the proposed set of recommendations "stunning" in their lack of understanding of the "substantial flexibility" needs of licensing practices.

Remington, who previously was Chief Counsel of the House Judiciary Committee's Subcommittee on Intellectual Property, also chided the report for not providing support for its policy options, and for focusing too much on regulation without considering possible incentives.

Remington also said that the report presents "meager" evidence of 'patent thickets', dense layers of overlapping rights claims on certain genes or associations, which were mentioned in the report and could cause difficulties for patient access and for researchers.

Remington's position on patent thickets finds support in a new study called "Legal Uncertainty in the Area of Genetic Diagnostic Testing," which found that only around three percent of gene-related patent claims occupy a blocking position that would indicate a patent thicket.

That study, conducted by two researchers at the Catholic University of Leuven, in Belgium and published in the most recent issue of the journal Nature Biotechnology, also found that most genetic diagnostic patents originate from the US, and that three-fifths of identified applications on gene-related patents came from the non-profit sector, including universities and institutes.

Most of the gene patent claims were directed towards genetic diagnostic methods, the study found.

The authors of the study propose that because there are not many 'blocking' gene patents, proposals that would ban patents on human genes "do not provide a plausible solution, unless the ban would be on patents for broad genetic diagnostic methods."

The authors also suggested that more attention should be paid to ensuring that licensing practices are conducted in responsible ways.

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