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Feb 08, 2010
 |  BioCentury  |  Politics, Policy & Law

Gene patent debate heats up

The courts, an HHS advisory committee and Congress are all considering calls to bar gene patenting in the U.S. Despite all of the attention, not much is likely to happen.

Last week, a federal court heard arguments in a case seeking to invalidate gene patents, while an HHS advisory committee finalized a report recommending legislation to exempt genetic tests from liability for infringement of gene patent claims.

Meanwhile, two members of Congress are moving forward with legislation that seeks to eliminate or weaken gene patents.

It is far from clear, however, that any of this activity will result in changes to patent law or practice, or that the contemplated changes would be as far-reaching as opponents or proponents of gene patents assert.

Patent lawyers are skeptical that the American Civil Liberties Union (ACLU), which presented arguments last week on behalf of the Association for Molecular Pathology and other plaintiffs in a suit against Myriad Genetics Inc. and the U.S. Patent and Trademark Office (USPTO), will convince the courts that isolated gene sequences can never be patented.

Even if the ACLU wins, the case may not produce the result it seeks - which is to place all genetic tests in the public domain - because test manufacturers can invoke other kinds of patent claims.

Nor is it likely that the report finalized last Friday by the HHS Secretary's Advisory Committee on Genetics, Health, and Society (SAGHS) will attract much attention from White House policy makers.

The report recommends that the administration urge Congress to create "an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care purposes."

Anyone who gets past the recommendations to the meat of the report will see that the committee found little evidence that patents are inimical to public health, and a great deal of evidence that they are powerful incentives for innovation. In any case, it is unlikely that the Obama administration will expend its shrunken political capital on an attempt to nullify gene patents.

Two pieces of legislation that could affect the...

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