Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Hearing was part of a study required by the new patent system to assess the impact of gene patents on obtaining confirmatory tests.

There is an ongoing conflict between genetic diagnostic makers eager to recoup development costs through patent protection and patient groups seeking broader access to the tests. The first of two hearings on this topic, required by the patent law overhaul enacted in September, was held last week by the USPTO.

Leahy-Smith America Invents Act (AIA) requires a study of how to ensure availability of confirming genetic diagnostic tests where gene patents and exclusive licensing for such tests exist. The study, due June 16, must provide recommendations for establishing the availability of independent confirming genetic diagnostic test activity, after addressing:

  • the impact that lack of independent second opinion testing will have on providing “the highest level of medical care” to patients and “inhibiting innovation to existing testing and diagnoses;”
  • the effect of providing independent second opinion genetic diagnostic tests on patent and license holders of exclusive genetic tests;
  • the impact of current exclusive licensing and of patents for genetic tests on practicing medicine including interpretation of results and performance; and
  • the role of cost and insurance coverage on accessing and providing the tests.

During last week’s hearing, held February 16, U.S. Rep. Debbie Wasserman Schultz (D-FL) urged the agency to give patients “as much certainty as we possibly can” by requiring licensing of patents for confirmatory genetic tests. She cited her circumstance of having to decide on seven surgeries, including a double mastectomy, based on one administration of a single test. “No one should ever have to go through that experience without the comfort and the confidence of a second opinion,” Wasserman Schultz said.

Wasserman Schultz was referring to the diagnostic test developed by Myriad Genetics. Myriad is at the center of Association of Molecular Pathology, et al. v. US Patent and Trademark Office, a federal patent case that the Supreme Court is considering hearing. The company seeks to protect seven patents related to BRCA1 and BRCA2 and its method for analyzing those genes for mutations associated with breast cancer.

The U.S. District Court’s Southern District of New York sided with Association of Molecular Pathology (AMP), but the U.S. Court of Appeals for the Federal Circuit overturned most of that decision on appeal, finding Myriad’s gene claims patentable as well as its methods of screening for cancer compounds, but not the company’s claims for the mutation analysis.

Vouching for Gene Patents

Wasserman Schultz authored the AIA section requiring the study as a substitute for an amendment to the patent measure creating safe harbor protection for providers of confirming genetic diagnostic tests from liability for infringement. She withdrew the amendment after the American Civil Liberties Union and medical groups complained the amendment gave test providers too many exemptions.

“Patent rights are property rights. If the proposed provision of the independent second opinion genetic diagnostic testing is enacted, the government would be requiring the owners of already issued patents and patents to issue from pending applications to suffer a permanent invasion of their property,” Thomas J. Kowalski, a shareholder with law firm Vedder Price PC, told USPTO.

“One effect on existing patent and license holders of providing independent second opinion genetic diagnostic testing would be an uncompensated taking, in violation of the Fifth Amendment to the U.S. Constitution,” Kowalski said, adding that the result would include “diminished interest in licensing by companies and diminishing licensing revenues for not-for-profit licensor.”

He cited Canada, which replaced compulsory licensing for patented drugs with adoption of a 2003 World Trade Organization decision limiting licensing to producing generic pharmaceutical products for export to developing countries. Before altering the patent system to promote compulsory licensing of gene patents, Kowalski said, USPTO should assess the impact of such a compulsory licensing rule in the broader context of antitrust law and apply it beyond drugs and diagnostics to all inventions.

Echoing Kowalski was Hans Sauer, Ph.D., deputy general counsel, intellectual property, for the Biotechnology Industry Organization (BIO). “Devaluation of patent assets leads, from our perspective, to reduced incentive for companies to conduct research, development, and commercialization of new biotech products,” Dr. Sauer testified.

He noted that clinical practitioners have told BIO that patients are as unlikely to seek a repeat of an advanced molecular diagnostic test as they are of an MRI scan or x-ray: “What patients ordinarily mean when they ask for a second opinion is a second medical opinion. Independent confirmatory testing as a concept can prolong uncertainty for patients, can give rise to unrealistic hopes, and delay treatment decisions that would otherwise be made.”

One possible alternative would be to allow independent validation of testing procedures and the exchange of samples with outside labs for quality review. “BIO takes no position on such proposals, but we believe they are at least directed at the question raised and would present a much more logical avenue for exploration than going down the patent route,” Dr. Sauer added.

Alternatives to Gene Patents

Opponents of patenting human genes and genotype-phenotype associations told the USPTO the potential harm to patients outweighed the benefits of the technologies. Mary Williams, executive director of the Association for Molecular Pathology (AMP), called for a moratorium on issuing human gene patents.

Williams and AMP—lead plaintiff of 20 plaintiffs challenging Myriad’s patents—want USPTO to base its findings on a 2010 report by the U.S. Department of Health and Human Services (HHS) Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS). “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests” concluded that gene patenting discouraged follow-on research, citing a 2009 Academy of Management Journal study concluding that gene patents decrease public genetic knowledge through effects that included broader patent scope, patent thickets, and fragmented patent ownership.

The report points out that patients are unable to obtain insurance-covered access to a sole provider’s test if the provider does not accept the patient’s insurance and cannot obtain testing from an independent lab to provide a second opinion or to confirm the prior results.

The committee also found that patients had difficulty accessing genetic testing when patent-holders delayed or chose not to develop or license the sequence to develop a genetic test.

AMP found support from Knowledge Ecology International (KEI), a nonprofit, nongovernmental organization that also argued that patenting of genetic tests hurts patients who either cannot afford the cost of a patented diagnostic exam or cannot receive a second opinion on tests found to have high error rates. KEI staff attorney Krista L. Cox cited a 2008 NCI study that showed Myriad’s diagnostic failed to find 20% of known BRAC1 mutations.

“Numerous nonpatent mechanisms exist to induce and reward research and development and represent a superior alternative to the current practice of patenting DNA,” Cox said. She suggested cash prizes for innovation and trade secrets, “although trade secrets are not without their own shortcomings.”

MPEG LA used the first hearing to announce the launch of its web-based catalog of patent rights, Librassay®, as a potential solution. Kristin Neuman, the company’s incoming executive director, told the USPTO that Librassay is expected to launch in the second quarter, when it will be available for nonexclusive licensing “on reasonable, transparent, and nondiscriminatory terms.”

“The Librassay many-to-many licensing model will be particularly useful and valuable in connection with multiplex genetic testing, where patent rights belonging to many different owners may be needed to support a single multiplexed genetic test,” Neuman said. “We are in the process now of concluding agreements with the world’s leading universities and research institutions to include their patents upon launch, and the Librassay website store is in beta test as I speak.” MPEG LA reportedly has more than 6,000 patents in 74 countries, over 130 licensors, and 5,000 licensees.

Librassay and other patent alternatives could eventually expand the availability of genetic tests. However, it will be difficult to force them upon industry, even for the admirable goal of enhancing public health. Deprived of patenting’s greater return-on-investment, industry is likely to mount a property-rights challenge and win, based on recent higher-court decisions like the Myriad case.

USPTO may fare better, instead, by encouraging test developers to license their technologies in return for incentives such as longer patent duration or quicker review processes, with greater rewards for licensing to nonprofits such as healthcare providers or increasingly clinically focused research institutes.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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