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Senator Leahy asks for march-in rights to force Myriad to license cancer tests


By David Schwartz
Published: July 24th, 2013

In a letter to the director of the National Institutes of Health Francis S. Collins, Senator Patrick J. Leahy (D.-Vt.) is asking the NIH to use its march-in rights under the Bayh-Dole Act to force Myriad Genetics to license its patents for breast and ovarian cancer tests. “Testimony presented to the USPTO made clear,” writes Leahy, “that many women are not able to afford the testing provided by Myriad.”

The Bayh-Dole Act permits the government to require a patent holder to license if that holder does not sufficiently meet the health or safety needs of the public, but march-in rights have never been used in the 33 years since the law was enacted. Leahy’s request comes on the heels of the Supreme Court’s decision striking down patents based on isolated DNA. Several companies immediately began selling cheaper versions of the breast and ovarian cancer tests, and Myriad filed infringement suits to block them, citing numerous claims that do not rely on isolated DNA as their basis. 

Several observers cast doubt on the likelihood that Leahy’s request would be granted. “A significant percentage of the Myriad patents — both those being asserted now and those at issue in the recently decided Supreme Court case — don’t have an NIH role,” says Arti K. Rai, Duke University Law School professor and a member of the Duke Institute for Genome Sciences and Policy. “And even those that do don’t involve the usual sort of march-in under Bayh-Dole.” For its part, Myriad has pointed out strenuously that it invested a half billion dollars to commercialize the test, above and beyond and federal funding used in the research.

Sean O’Connor, law professor at the University of Washington, while doubting the strength of a march-in argument, sees another route to compulsory licensing. Leahy could request the government take domain over the Myriad patents without authorization, using an argument similar to eminent domain in property cases. “But the tests would have to be performed as a government service,” O’Connor suggests. “And the government would be liable for reasonable compensation for such use to Myriad in the Court of Federal Claims.”

Source: Bloomberg Law

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