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Stakeholders Continue to Spar on Need For Confirmatory Genetic Test Legislation

Monday, January 14, 2013
After a third public roundtable Jan. 10 on a Congress-mandated study, the Patent and Trademark Office is no closer to a consensus on recommendations for easing patient access to a second opinion genetic diagnostic test that is patented.

With 20 speakers at the PTO's Alexandria, Va., headquarters roughly equally split between those who want a ban on all patents claiming genetic material and patent-owning interests demanding the legislators “do no harm” to the patent system, the PTO will have difficulty finding a compromise position.

The PTO's report on the issue was due June 16. PTO officials told BNA after the session that Congress received but did not respond to a letter from the agency explaining the delay, and has not set a new due date.

Report Overdue
Section 27 of the AIA asked the PTO to submit the report by June 16, but the PTO missed the deadline for publishing its conclusions.

The report must cover four questions posed by Congress. Two questions are specific to second opinion testing, one on the impact on patient care and the other on the effect on patent and license holders. The other two questions ask about genetic testing generally. Question 3 is on how exclusive licensing and patents affect the practice of medicine and Question 4 is related to insurance coverage.

Section 27 was actually a fallback option, inserted at the end of the patent reform debate to replace a proposal submitted by Rep. Debbie Wasserman Schultz (D-Fla.) to exempt infringement by a “genetic diagnostic tester or … related health care entity with respect to such confirming genetic diagnostic test activity.”

The PTO issued a request for comments in January 2012 (77 Fed. Reg. 3,748; (16 PTD, 1/26/12), and conducted hearings on the issue in February in Alexandria, Va. (33 PTD, 2/21/12), and in March in San Diego.

In a later message to Congress explaining its reason for missing the deadline, the agency said that the issue was compounded by two post-roundtable decisions by the Supreme Court, referring to the 35 U.S.C. §101 patent eligibility ruling in Mayo Collaborative Services v. Prometheus Laboratories Inc., and its vacating and remanding of the isolated DNA patentability case, Association for Molecular Pathology v. Myriad Genetics Inc. (60 PTD, 3/29/12).

The PTO had actually asked for additional comments from stakeholders after those events, and it ended up considering a total of 27 sets of written comments and testimony from 18 witnesses. Apparently, it was unable to reconcile the differences among the comments in time to meet the June 16 deadline.

The office's Aug. 28 letter to the House and Senate Judiciary Committee leadership said, “Given the complexity and diversity of the opinions, comments and suggestions provided by interested parties, and the important policy considerations involved, we believe that further review, discussion and analysis are required before a final report can be submitted to Congress.”

It subsequently set up the third “Roundtable on Genetic Diagnostic Testing” (77 Fed. Reg. 71,170). The notice asked the presenters to subsequently supply written comments within 30 days of the roundtable, but otherwise did not seek additional input from other stakeholders.

Government March-In Rights at Best a 'Nudge'
The four-hour discussion began with a short introduction to the issue by Teresa Stanek Rea, deputy director of the office. Though the agency remains noncommittal about its views, Rea gave at least one indication that the PTO will not simply tell Congress to do nothing. The AIA made “an explicit acknowledgment that innovations of tomorrow cannot take root in the patent system of the past,” she said.

The first two presenters represented the government: Henry N. Wixon, chief counsel at the National Institute of Standards and Technology, Gaithersburg, Md., and Mark L. Rohrbaugh, director in the Office of Technology Transfer at the National Institutes of Health, Bethesda, Md. Each focused on the ability of the government to exercise--when it is an owner or co-owner of a patent--“march-in rights” under the Bayh-Dole Act, 35 U.S.C. §203, and thus eliminate a licensee's exclusivity.

Arti K. Rai, a law professor at Duke University, Durham, N.C., discounted the likelihood that the government would actually exercise those rights with respect to genetic testing patents, but still contended that march-in rights could be effective “as a nudge” to push exclusive licensees who are arguably not acting in the public interest. She said that the rights could be “surgically calibrated” and would be particularly effective if the test could be easily conducted by individual doctors.

Is the Issue Verification Use or Research Use?
Rai's colleague at the Duke Institute for Genome Sciences & Policy, Robert Cook-Deegan, was the first presenter to distinguish two different legislative solutions that could be considered, depending on what Congress was actually trying to address. An exemption for verification use, he said, could be considered if the “second opinion” desired is to have the patented test repeated but by a different laboratory. On the other hand, an exemption for research use addresses whether the goal is to devise an alternative test altogether.

The verification concern--confirmation of either a positive or negative first test result--would suggest a legislative concern equivalent to Wasserman Schultz's original proposal: Congress could expand 35 U.S.C. §287(c), which currently exempts from infringement liability “a medical practitioner's performance of a medical activity,” such that it also covers professionals in the genetic counselling field from performing related diagnostic tests.

By contrast, while a research use exemption could also be implemented legislatively, quite a few of the presenters suggested a blunter legislative instrument: a ban on gene patents as excluded statutory subject matter under 35 U.S.C. §101.

These presenters almost to a person cited Myriad Genetics Inc., the holder of the isolated DNA patents in the case now back at the Supreme Court and likely to be scheduled for oral argument in April (231 PTD, 12/3/12), as the prototypical example of the problem with patents on the composition itself, as opposed to specific tests.

The claim--which Myriad's General Counsel Richard M. Marsh denied--is that Myriad threatened infringement proceedings against researchers looking to devise an alternative test. That is, purportedly, Myriad had asserted that the scope of its isolated DNA patent claims prevented a researcher from using the relevant genetic material, such that development of an alternative test would be an infringing act.

Anti-gene patent presenters were:


  • Sapna Kumar, a law professor at the University of Houston;

  • Debra G. B. Leonard, a professor of pathology at Cornell University, New York, representing the College of American Pathologists, Northfield, Ill.;

  • Beth N. Peshkin, a professor of oncology at Georgetown University, Washington, D.C., and representing the National Society of Genetic Counselors, Chicago;

  • Roger D. Klein of the Cleveland Clinic Foundation, representing the Association for Molecular Pathology, Bethesda, Md.;

  • Lisa Schlager, vice president of community affairs and public policy at Facing Our Risk of Cancer Empowered (known as “Force”) Tampa, Fla.; and

  • Jaydee Hanson, policy director at the International Center for Technology Assessment, Washington, D.C.


Several of these presenters also projected upcoming problems with gene patents for potential holdup in developments of whole genome sequencing.

“The days of single gene testing are numbered,” Peshkin said. “We are on the cusp of a major paradigm shift in medicine … coming from whole genome testing.” She complained that genetic patenting “stops the free flow of information” that will allow the new technologies to succeed.

Patent System Defenders Defend
Defenders of the status quo generally argued that the innovations for which the detractors want to eliminate patent protection may never have come about without the patent incentive.

Anti-legislation presenters included:


  • Hathaway P. Russell of Foley Hoag, Boston, speaking on behalf of the Coalition for 21st Century Medicine, Arlington, Va.;

  • Linda Bruzzone, founder and executive director of Lynch Syndrome International, Vacaville, Calif.;

  • Karen S. Canady of Canady Lortz, San Marino, Calif., representing the American Intellectual Property Law Association, Arlington, Va.;

  • Lori Pressman, representing the Association of University Technology Managers, Deerfield, Ill.;

  • Hans Sauer, associate general counsel for intellectual property for the Biotechnology Industry Organization, Washington, D.C.;

  • Kristin H. Neuman, executive director of Librassay, a Chevy Chase, Md.-based service of patent-standards portfolio licensor MPEG LA; and

  • Leonard R. Svensson of Birch Stewart, Kolasch & Birch, representing Biocom, San Diego, Calif.;


Sauer was foremost among many in questioning whether Congress set a clear goal when it asked the questions it did in the context of the AIA. For example, he pointed to studies showing that only one in 10 errors associated with a genetic test occur in the laboratory conducting the test. Thus, a solution that makes a second test more cost effective leaves 90 percent of the errors still to be dealt with, he said.

Neuman offered Librassay as a private sector solution that already exists and would negate the need for legislation. As is the case with its parent organization, Librassay would aggregate patents genetic material patent holders and market a portfolio of patent rights nonexclusively. She said it would offer a royalty-free license for basic research and educational purposes as well.

Insurance Does Not Cover
Svensson added on to Sauer's arguments about whether the patent system was the problem. “Any patient concerns raised in this debate are not really patent concerns,” he said. “They are insurance issues.”

However, Force's Schlager said lack of insurance coverage was a “significant burden on the patient community.” Two other presenters focused on that AIA Question 4 as well:


  • Charis Eng, professor of genetics at Case Western Reserve University, Cleveland, Ohio; and

  • Russell's colleague, Bruce Quinn, a senior health policy advisor at Foley Hoag, Boston, also representing the Coalition for 21st Century Medicine;


Each agreed that Medicare will not cover a second lab conducting the same genetic test.

However, Myriad's Marsh suggested, based on the company's experiences with trying to get payment, that coverage is improving.

He further tried to argue that patients rarely ask Myriad for the name of a second test supplier in any case, so even the insurance problem may not be so big. But Schlager rejected that argument.

“Most people don't ask because it's common knowledge that only one company does the testing,” she said.

By Tony Dutra


PTO information on the study is available at http://www.uspto.gov/aia_implementation/aia_studies_reports.jsp.

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