A United States health department advisory group this month produced a new draft report on gene patenting and licensing with recommendations suggesting that excessive patenting can limit patients’ access to gene testing and might not foster genetic research. The recommendations were supported by a variety of health professionals but put the biotechnology industry on edge.

The draft report provided by the US Health and Human Resources Secretary’s Advisory Committee on Genetics, Health and Society (SACGHS) obtained by Intellectual Property Watch gave a set of recommendations including the exemption from patent infringement liability “for those who use patent-protected genes in the pursuit of research.” It also called “for anyone making, using, ordering, offering for sale, or selling a test developed under the patent for patient care purposes.” Biotechnology representatives, meanwhile, vehemently reasserted the indispensable role of patents in innovation.

Gene patenting in the US had already been challenged in May when the American Civil Liberties Union (ACLU) with the Public Patent Foundation filed a lawsuit against the patenting of two human genes associated with breast and ovarian cancer. The lawsuit targeted the US Patent and Trademark Office, biotechnology company Myriad Genetics, and the University of Utah, which holds the patents on the two genes. (IPW, Biodiversity/Genetic Resources/Biotechnology, 2 September 2009)

On 30 September, the first hearing in federal court was held on the motions to dismiss the case filed by ACLU. The ruling was expected to be given in October, according to the ACLU website.

Meanwhile, Myriad Genetics announced on 15 October that it now has a “worldwide, exclusive licence” to patents relating to mutations in a gene named PALB2 that allegedly increase a person’s risk to develop pancreatic cancer later in life. Myriad has obtained the licence from Johns Hopkins University (US).

SACGHS advises the US Health and Human Services (HHS) secretary on human health and the potential impact of the development and use of genetic technologies. The committee has been conducting a study on the effects of patents and licensing practices on patient access to genetic tests. The National Institutes of Health Office of Biotechnology Activities manages SACGHS. The SACGHS task force on gene patents consists of government officials, academics and industry representatives.

An updated draft report by the committee, including the results of a public consultation held from March to May 2009, was discussed during an 8-9 October committee meeting. The draft report is being revised further based on the committee deliberations and comments from members of the public received at the meeting and during the prior public consultation process, according to a source.

The process leading to the report started in March 2004 when SACGHS identified gene patents and licensing as a priority issue. In December 2008, an approved public consultation draft report was ready for release.

The committee will reconvene, either at a special meeting in December or at its next regularly meeting in February to review the revised draft report, the source said.

A total of 77 stakeholders submitted comments on the draft report during the comment period. The list of stakeholders is not available to the public. But a wide array of stakeholders submitted comments, according to a presentation (pdf) made by James Evans, chairman of the task force on gene patenting for the SACGHS and a professor of genetics and medicine at the University of North Carolina, during the October meeting. Among them were life sciences companies, healthcare providers, academics, professional associations, industry organisations, health and disease advocacy groups, technology transfer offices, and commercial laboratories.

The Draft Report

The committee sought to “evaluate whether patents induce innovation in the genetics area.” According to the latest draft report, case studies show that “although patents offer an incentive to companies to conduct research and develop genetic diagnostics, exclusive rights are not needed to advance the development of most genetic tests.”

If patents do not appear to raise the price of genetic tests, evidence in some cases shows that patents and licensing practices “have limited laboratories’ ability to perform testing,” it said. Also, quality issues can arise when there is only a single provider of genetic tests.

“Patent claims on isolated genes and association patent claims … have the potential to create a thicket of intellectual property rights that can prevent innovators from creating these multiplex tests or reporting the full extent of results,” said the draft report.

Some recommendations asked for federal efforts to promote broad licensing and patient access and enhanced transparency in patents and licensing. They also asked that the health secretary use “her powers to discourage the seeking, the granting, and the invoking of simple association patent claims.”

The recommendations advocated for 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 the same exemption “for those who use patent-protected genes in the pursuit of research.” Related healthcare and research entities should also benefit from this exemption, the draft report recommendations said.

Medical Associations Opposed to Gene Patents

The Association for Molecular Pathology (AMP) also gave an oral statement during the October meeting. AMP is a lead plaintiff in the lawsuit brought by ACLU, the AMP representative said. “While we have significant concerns about the patenting of DNA, our concern extends beyond that to the negative impact of exclusive and restrictive licensing practices,” she said.

The College of American Pathologists during the meeting said that human health-related gene patents have an inhibitory effect on the ability of pathologists and other laboratory physicians to practice medicine, and that those patents had an impact on the access of patients to important medical testing.

The draft report presented during the October meeting was an updated version to the May report, reflecting comments received after the publication of the first report. “Drawing on (the) comments and all the information obtained throughout the course of the task force’s deliberations, we narrowed the recommendations to those that we felt best fit with the evidence and were more appropriate,” Evans told Intellectual Property Watch.

The recommendations “are not binding to the secretary of HHS,” Evans said. “We hope that our recommendations will be acted upon. We feel they are thoughtfully crafted and relatively narrow in scope and will, if enacted, enhance patient access to genetic tests and spur innovation and research.”

Industry: Committee Shooting at “Wrong Targets”

During the October meeting, comments were made by several stakeholders. In a press release, the Biotechnology Industry Organization (BIO) said that no restriction should be applied to the enforcement of patents and exclusive licences with respect to genetic tests, and argued against some of the SACGHS recommendations.

According to BIO, “if implemented, those recommendations would do far more harm than good to patients.” Benefits of patenting and exclusive licensing practices can foster innovation, particularly of genetic tests for patients with rare disorders, they asserted.

During its oral statement in the meeting, Tom Dilenge, general counsel and vice president for legal and intellectual property at BIO, said that the US lead in biotechnology research and development was largely a result of the system of IP protection. He also praised the Bayh-Dole Act allowing government-funded inventions to be transferred to universities to businesses for development and commercialisation. The research is then “translated into tangible medicines,” and “the critical link in this chain is the availability of patents to protect these investments,” he said.

Dilenge said BIO strongly supported the SACGHS mission, but challenged the conclusions of the draft report, claiming some inconsistencies between case studies provided by the draft report and the conclusions.