A report by a United States health department advisory group issued last week presents recommendations aimed at preventing patents on genes and licensing practices in the US from negatively impacting patient access to genetic tests that would allow patients to establish their genetic dispositions and identify potential illnesses.

Industry lobbyists were quick to voice concern about what they called the impairing effect of those recommendations, if implemented, on research and the prospects for new treatments. But the report found instances of enforcement by industry patent-holders to the detriment of patients, a finding supported by concerns of consumer groups.

The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) final report was approved by the committee on 5 February, following a draft report issued at an October committee meeting that came after a round of public consultations.

The final version of the “Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests” [pdf] was posted yesterday on the SACGHS website. It shows revisions from the earlier draft based on committee deliberations and additional public comments.

The report will be sent forward to US Secretary of Health and Human Services Kathleen Sebelius for further consideration.

“A near perfect storm is developing at the confluence of clinical practice and patent law,” the committee concluded in its final report. The technology is offering a wealth of possibilities for improving health, whether by increasing physicians’ ability to identify patients’ genetic predispositions or because genetic information can help pharmaceutical and biotechnology companies develop new treatments, it said. But the “trends in patent law appear, however, to pose serious obstacles to the promise of these developments” as patents now cover not only commercial products, but also “foundational research discoveries.”

The committee issued a list of six recommendations, the first of which is to support the creation of exemptions from infringement liability, proposing two statutory changes. It proposed: “The creation of an exemption from liability for infringement of patent claims on genes for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care purposes, and the creation of an exemption from patent infringement ability for those who use patent protected genes in the pursuit of research.”

The second recommendation is about access for patients to genetic technologies, and asks to “promote adherence to norms designed to ensure access.” The third recommendation suggests to “enhance transparency in licensing,” so that the public can know “the type of license and the field of use for which rights were granted.” The fourth recommendation advises that an advisory body be established on the health impact of gene patenting and licensing practices.

In its fifth recommendation, the committee advises that the United States Patent and Trademark Office be provided with needed expertise, and in its sixth and last recommendation, the committee urges that equal access be provided to clinically useful genetic tests for patients.

Industry Sees Fight for Status Quo

The draft report set off reaction from industry, who although claiming support for the independent mission of SACGHS, said that the conclusions of the committee were not always supported by the evidence of case studies provided in the report (IPW, Public Health, 29 October 2009).

On the eve of the SACGHS meeting, the Biotechnology Industry Organization (BIO) issued a letter to Sebelius, urging her to reject SACGHS recommendations. [Clarification: BIO was one of 26 co-signatories to the letter]

In the letter [pdf], BIO said it had “grave concerns about certain recommendations” of the report, which could threaten the fundamentals of the US innovation system and the Bayh-Dole Act.

The Bayh-Dole Act implemented in 1981 promotes government-funded inventions to be transferred to the private sector for commercialisation.

According to the letter, the US current patent system fosters the innovative collaboration between universities and companies, helping create high-paying jobs in the US, and a policy change is not desirable. The letter’s signatories claim that SACGHS “ignored the public comments by organisations with experience in patenting and technology transfer,” resulting in unprecedented recommendations “based on limited anecdotal experiences,” that could threaten public-private partnership and the “commercialisation of publicly-funded research.”

BIO argues that by “undermining the value of gene-based patents, these recommendations would chill future investments and innovation,” and “would unfairly upset the investment-backed expectations of current patent owners and licensees.” According to BIO, the restriction of patents and licensing practices for federally-funded inventions would be a step back in time, canceling the benefits brought by the Bayh-Dole Act.

Public Interest Defenders, Courts, Tackle the Issues

Meanwhile, several cases are being examined by US courts. One such case is the Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al., which was filed on 12 May 2009 in the US District Court for the Southern District of New York, against the USPTO, Myriad Genetics and the University of Utah Research Foundation. The foundation holds the patents on the genes BRCA1 and BRCA2, associated with breast and ovarian cancer.

In the first hearing about the patentability of human genes in federal court on 3 February, the American Civil Liberties Union (ACLU) and the Public Patent Foundation asked the court “to rule that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid,” according to an ACLU press release.

During the hearing, ACLU attorney Chris Hansen said that “patenting human genes is like patenting e=mc2, blood or air.” He also said that “allowing patents on genetic material imposes real and severe limits on scientific research, learning and the free flow of information,” according to the release.

According to the SACGHS report, some case studies found that exclusive rights had been enforced by patent holders to prevent clinical laboratories from offering testing. For example, Myriad Genetics and Athena Diagnostics have enforced their exclusive rights to stop alternative providers for testing, one for breast cancer, the other one for Alzheimer’s disease. Miami Children’s Hospital also enforced a patent on Canavan disease in order to have other laboratories either stop the testing or pay royalty fees.

The Association for Molecular Pathology (AMP) on 4 February also issued a position paper [pdf] on the SACGHS report. AMP “strongly endorses the SACGHS report,” it said, considering that “if implemented, the committee’s recommendations would be a significant step forward to reverse years of policy that has hindered innovation, restricted patient access to test, and constrained the widespread clinical application of biomedical research.”

Although recognising that intellectual property rights are essential to encourage investment and reward “true acts of invention such as new therapeutics, diagnostics, or technology platforms,” a single gene or a sequence of the genome, not being a product of nature, should not be patentable, said the AMP.

The SACGHS report downplayed industry concerns, stating that even if ACLU and the associated plaintiffs were to prevail, the decision “would not necessarily lead to the automatic invalidation of all existing patents on genes and associations.”

One of the obstacles that patents are bringing to research is the difficulty to “invent around” patent claims on genes, according to the report, because “inventing around a technology involves making an invention that accomplishes the same thing as the original patented invention but that does not infringe the patented inventions.”

International Consequences of Potential Legal Changes

According to the SACGHS report, recommended changes in US legislation regarding the patenting of human genes would not go against the US international trade obligations. As a member of the World Trade Organization, US patent laws have to be consistent with the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

The committee found that “there is ample authority in the agreement to support changes that promote access to, and research on, genetic testing,” because, in particular, countries can exclude from patentability diagnostic methods for the treatment of humans, plants, and animals other than microorganisms under WTO Article 27.3.b.

According to the committee, TRIPS also allows members to define what constitutes an invention. “Applying this principle, Argentina, Bolivia, Brazil, Colombia, Ecuador, Peru and Venezuela have chosen to classify isolated gene molecules as discoveries rather than inventions,” the report said.