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Myriad Spurs Call for PTO Moratorium on Gene Patents

By Mari Serebrov
Washington Editor

The 800-pound gorilla in the Patent and Trademark Office (PTO) hearing on genetic diagnostic tests was Myriad Genetics Inc. – even though the Salt Lake City-based company wasn't on the agenda.

Using Myriad's exclusive license to patents on the BRCA1 and BRCA2 genes as Exhibit A, the Association for Molecular Pathology (AMP) called for a PTO moratorium on gene patents, including process claims, while the issue undergoes full legal and legislative consideration.

Industry bristled at the suggestion, with Hans Sauer, associate general counsel for intellectual property at the Biotechnology Industry Organization, expressing outrage that the gene patents of all biotech companies would be questioned based on the reported marketing practices of one company.

According to the AMP, Myriad has refused to sublicense the patents, which it licensed from the University of Utah, and has actively protected them with "cease-and-desist" letters.

Because of the price of Myriad's BRCAnalysis, many payers refuse to cover the diagnostic, even though it's the only one available for BRCA mutations.

Taking a "be-careful-what-you-wish-for" stance, Kevin Noonan, a molecular biologist and partner at McDonnell Boehnen Hulbert & Berghoff LLP, warned of the consequences of a moratorium on gene patents. When it comes to genetic-based diagnostics and therapies, most of the low-hanging fruit has already been picked, he said.

Subsequently, future advances in personalized medicine will be much more complex, involving more than one gene. That level of complexity is extremely difficult to reverse engineer, Noonan said. Without patents and their required disclosures, companies would be more likely to protect their innovations into perpetuity through trade secrets. In such a scenario, getting secondary diagnostics or therapies would be even more difficult.

Thursday's hearing was the PTO's first step in meeting a congressional mandate to prepare a report on ways to develop independent, second-opinion tests in light of patented genetic diagnostics. The PTO will hold a second hearing on the issue March 9 and accept written comments through March 26. It must submit its report to Congress by June 16. (See BioWorld Today, Feb. 6, 2012.)

Coincidentally, the hearing was held on the eve of the Supreme Court's conference session in which it will decide whether to grant cert to the Association for Molecular Pathology v. Myriad Genetics Inc. In a split decision last year, the U.S. Court of Appeals for the Federal Circuit upheld the patents on the BRCA genes, mutations of which are associated with breast and ovarian cancers. (See BioWorld Today, Aug. 2, 2011, and Feb. 16, 2012.)

In opening the PTO hearing, Teresa Stanek Rea, deputy director of the PTO, said the purpose of the study is to look at how exclusive licensing and patents on genetics affect the practice of medicine.

Questions that must be considered, she said, are how the evolving patent system is keeping pace with delivering patient care and how to balance patients' interest in accessing information about their own health with the interest of patent holders.

"The innovations of tomorrow cannot take root in the patent system of the past," she said.

Rep. Debbie Wasserman Schultz (D-Fla.), appearing by video, shared her experience with Myriad's BRCAnalysis. The test indicated she had the genetic mutation, but no other tests were available to confirm those results. And for many women, the Myriad test is inconclusive, she said.

The congresswoman also pointed out that in 20 percent of genetic diseases, only one lab test is available because of patents, so patients are denied the right to a second, independent opinion.

But creating an entitlement to a second diagnostic test won't automatically translate into a patient benefit, Sauer said. When it comes to second opinions, patients rarely seek another MRI, CAT scan or diagnostic test. What they want is a second doctor to interpret the results, he added.

Such an entitlement also would significantly increase health care costs and could delay life-saving treatment, he said.

It's About Reimbursement

Besides, the lack of secondary tests is about reimbursement, not patents, Sauer continued. To prove his point, he showed two maps of the U.S. that indicated payment under Medicare and Medicaid for a specific molecular test. People covered by Medicare could get the test covered regardless of where they lived. But Medicaid coverage was only available in a few states.

The fact that a Medicaid patient in Nevada can't get the test but one living across the border in California can shows this is not a patent issue, Sauer said.

Several people speaking at the hearing took issue with the implications of the PTO study required by the America Invents Act (AIA).

Thomas Kowalski, a shareholder and patent attorney with Vedder Price, called the study a congressional "do over" of the Federal Circuit's Myriad decision and part of a broader agenda to deny patents for DNA. He noted that Wasserman Schultz was unsuccessful in attaching an amendment to the AIA to do that.

In the alternative, if the government were to force patent holders to grant licenses to their patented DNA for the purpose of developing second tests, it would amount to an "unconstitutional, uncompensated, compulsory license," Kowalski said. Doing that would diminish the value of the patents, he added, which would result in less investment for research.