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Patent Bill Could Make Some Gene Tests Safe from Infringement Suits

By Matt Jones

NEW YORK (GenomeWeb News) – A new amendment to the patent reform bill in the US House of Representatives would enable patients to receive second opinions on the results of patented diagnostic genetic tests from alternate providers by enabling those testers to use the intellectual property and be protected from standard infringement suits.

The measure would create a safe harbor specifically for testing that provides independent confirmation of the results of genetic tests for certain uses, but not in others, although the details of what types of tests the measure includes are vague and may still be in development.

The amendment to The America Invents Act (H.R. 1249), a separate version of which passed the Senate on a 95-5 vote but did not contain the genetic testing measure, was originally introduced by Rep. Debbie Wasserman-Schultz (D – Fla.), a breast cancer survivor with a personal interest in genetic testing. A modified version has been added to a manager's amendment to the Act that includes a number of other amendments.

Both versions of the America Invents Act would move the US to a first-inventor-to-file (FITF) system from its current policy of awarding patents to the first inventors. The House version with the safe harbor proposal is currently awaiting further consideration in the House Judiciary committee.

The safe harbor rule was not designed to reflect the views of the Congress on the issue of whether gene patenting is constitutional, legal, or moral, the Wasserman-Schultz amended amendment makes clear, in order to avoid conflict with a future court ruling, such as one from the ongoing lawsuit against Myriad Genetics by the American Civil Liberties Union and others who hold that gene patenting is unconstitutional.

The manager's amendment currently says that such confirmation tests would be safe from certain types of infringement claims, but it would not include tests for monitoring or reconfirming medical status over time, for therapeutic treatment selection, or determining responsiveness to treatment, and for other purposes.

The range of potential ramifications of the proposal, if it passed, are difficult to predict and ripe for speculation. Would it weaken intellectual property related to genetic testing? Would second opinion genetic testing create new business opportunities for some test providers, or would there not be enough economic incentive for such providers to offer these tests? To what extent would confirmation providers still be vulnerable to infringement claims?

There also are questions about how this proposal covers tests that are used to make medical decisions, as the language covering such use is still in development; Wasserman-Schultz has posted an amendment to the manager's amendment dealing with that issue.

"While we heartily support the goal of the amendment – to provide patients with more medical options – this amendment would be ineffective in achieving that result while increasing the risk that patent holders would claim the amendment provides support for their continued monopolistic practices," the ACLU said in a letter to House leadership today.

"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. 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," the ACLU letter advised.

The amendment is likely to be scrapped in favor of a study that may be conducted by the USPTO. See the follow-up article for more details.

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