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Safe Harbor Provision for Genetic Tests in Patent Bill Amendment May Be Scrapped

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – A measure in the House of Representatives that would create a safe harbor from patent infringement for some genetic tests used to confirm an initial diagnosis, but not provided by the patent holder, may soon be scrapped in favor of a study of the issue by the US Patent and Trademark Office.

The safe harbor amendment is attached to a patent reform bill and would have enabled patients to receive diagnostic genetic tests as second opinions from alternate providers by protecting those offering the tests from standard infringement suits, as GenomeWeb Daily News reported Thursday.

Yesterday afternoon, Representative Debbie Wasserman-Schultz (D – Fla.) offered an amendment to the amendment, attached to the America Invents Act (H.R. 1249) in the House Judiciary Committee, to replace the safe harbor proposal with a plan for a study of the best ways to provide second opinion genetic diagnostic tests in the current patent landscape.

The safe harbor plan, which was originally proposed by Wasserman-Schultz and was later adopted into the Judiciary Committee's manager's amendment draft of the bill by Rep. Lamar Smith (R – Tex.), quickly drew sharp criticism from a wide range of advocacy groups.

"The amendment in question would not only fail to resolve second opinion testing issues, but it would not address the many problems with gene patents, including the inhibitions on research, treatment, and scientific progress ," the American Civil Liberties Union said in a letter to House leaders yesterday. "A real solution would not only allow for second opinion testing, but allow hospitals and laboratories to develop and offer testing in the first instance."

A coalition of groups that gathered with ACLU against the amendment includes Breast Cancer Action, Friends of the Earth, the International Center for Technology Assessment, National Women's Health Network, and religious groups.

That coalition said the amendment would allow gene patent holders to continue to challenge second-opinion testing, ignore "the many harms that result from gene patents," such as restrictions on genetics research, and would "allow gene patent holders to argue that Congress has implicitly endorsed the validity of gene patents."

The new amendment offered by Wasserman-Schultz would direct the USPTO to conduct a study of the best ways to provide independent, confirming diagnostic tests in the current environment, which includes gene patents and exclusive licensing for genetic diagnostic tests. This study would look into the effects that the current lack of independent second-opinion testing has on medical care and on innovation for testing and diagnoses practices.

Under the proposal, the USPTO would examine the impact that current exclusive licensing and patents for genetic tests have on medicine, and it would study the role that cost and insurance coverage have on the provision of genetic diagnostic tests.

The report generated by these studies would be presented to judiciary committees in both the Senate and House.

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