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.
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.
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.
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:
“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.
Anti-legislation presenters included:
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.
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:
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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