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HHS Committee Opens Public Comment on Gene Patents

NEW YORK (GenomeWeb News) – A National Institutes of Health task force has released a draft report on its findings about the effects of gene patenting on medicine, research, and business, and has issued a set of potential policy options for public consideration as part of the report.

The Secretary's Advisory Committee on Genetics, Health, and Society, which meets this week to discuss a number of other genomics-related issues, will seek public comments until May 15, 2009, on the findings and policy options drafted by its task force.

The SACGHS task force worked with Duke University's Center for Genome Ethics to draft policy options based on a variety of findings from case studies of certain tests, companies, illnesses, and research areas.

The group reviewed a number of these case studies to draw conclusions about how gene patents affect pricing, access to and availability of genetic tests, new innovations and research related to genes, and other areas.

The case studies did not show "widespread overpricing" of genetic diagnostic tests that were patented and exclusively licensed relative to those that are unpatented or non-exclusively licensed.

So far, the panel found, patents covering genetic tests and related licensing practices do not appear to be impeding patient or clinical access to the tests. Although several cases were found in which patient access to genetic tests may have been impeded, these cases were mostly resolved and access to the tests is not an issue now.

The committee also found that patents may not serve as powerful incentives, but rather a minor stimulus, for either genetics research in the diagnostic arena or development of genetic tests. Most academic scientists are driven to conduct research "by a mix of motives," the committee suggested, including advancing their careers, adding to knowledge, and developing treatments.

While the case studies showed patented discoveries that were developed into tests, unpatented genetic discoveries also were "routinely developed into clinical genetic tests," suggesting that "patents are not needed for development of these tests."

If regulatory oversight of genetic testing evolves to require "some type of costly independent review before marketing, patent protection may be needed for companies" to feel the risk and expense is worthwhile, according to the committee. In addition, "Concerns about the quality and validity of genetic tests may be best addressed by enhancing the oversight system for laboratory developed tests," the group proposed.

These and other findings outlined in the draft report led the committee to propose a number of potential options. But it has not developed these into final conclusions and will await completion of the public comment phase before it makes recommendations to the Secretary of Health, which it expects to do in October.

SACGHS said that a set of principles and guidance documents should be developed that engage stakeholders over issues regarding patenting and licensing strategies for genetic diagnostic tests.

In order to optimize patient access for genetic tests, "stakeholders should work together to develop a code of conduct to encourage broad access to such technologies," the group found.

In cases where multiple stakeholders have collaborated to identify genetic mutations and to develop a diagnostic test, they should determine whether to seek patent protection and how to disseminate, utilize, and license such technology in a manner that balances their proportional contributions.

A forum could be used to discuss technology development strategies among research collaborators, the committee suggested. In addition, they said strategies should be pursued that balance protecting IP rights associated with discoveries such as diagnostic tests with appropriate patient and physician access.

Transparency in patents and licensing could be enhanced, and federal agencies should adopt policies to increase that transparency by encouraging patent holders to make license information available, it said. The National Institutes of Health also should change its best practices for genomic licensing to encourage licensors and licensees to include in their contracts a provision allowing each party to disclose some information about the license.

The Food and Drug Administration and the Centers for Medicare and Medicaid Services could require DNA-based tests to display on its packaging or on websites any issued patent and published numbers that the company believes covers their patents.

More information is needed about the gene patenting and licensing arrangements that are used to commercialize genetic tests, according to SACGHS. To remedy that, the Secretary of HHS should establish an advisory board that provides ongoing advice about the public health impact of gene patenting and licensing practices. To assess whether gene patents or licensing arrangements may be negatively affecting patient access to genetic tests, HHS and other agencies should develop a reporting system to encourage researchers and medical practitioners who order, use, or perform genetic tests to report those effects, the committee recommended.

The data that the committee believes might be most useful include whether or not the licensor of the invention granted the licensee the rights to make and sell a test or to provide a service, the nature of that agreement, the patent number and licensing timelines, date of the first sale of a genetic test on the market, and some measure of the volume of sales.

SACGHS also is considering if there should be federal efforts to promote broad licensing and patient access, and proposes that licensing policies governing federally funded research facilitate access to gene tests.

It also said that there should be studies of the federal implementation of intellectual property laws, and that the US Patent and Trademark Office's policies covering genetic tests should be clarified and improved.