ACLU patent case could have far-reaching consequences

NEW YORK—Should biotech companies like Salt Lake City, Utah-basedMyriad Genetics be allowed to patent a pair of genes closely linked to breastand ovarian cancer? Myriad claims it "owns" the genes and argues that withoutthe right to patent and profit, biotechnology as we know it would vanish.

But Christopher A. Hansen, an American Civil Liberties Union(ACLU) lawyer, argues, "Patenting a gene is unconstitutional."

This is the crux of what could become a national debate in2010, with deep ramifications to the biotechnological, genetic, pharmaceutical,medical and healthcare industries far into the future.

In The Association for Molecular Pathology, et al. v.U.S. Patent and Trademark Office, et al.,the plaintiffs challenged the right to patent genes in a lawsuit filed May 12,2009. A hearing was held in the U.S. District Court for the Southern Districtof New York, with Judge Robert Sweet presiding. Sweet is expected to make adecision within 60 days. If the case goes to trial, the fate of Myriad and allcompanies holding gene patents would be in the hands of a jury.

The lawsuit was filed on behalf of breast cancer and women'shealth groups, individual women and scientific associations representingapproximately 150,000 researchers, pathologists and laboratory professionals,says Hansen, lead counsel.

The named defendants include Myriad Genetics and theUniversity of Utah Research Foundation, which hold the patents on the genesBRCA1 and BRCA2, which are associated with breast and ovarian cancer. Thelawsuit charges that patents on human genes violate the First Amendment andpatent law because genes are "products of nature," and therefore, cannot bepatented.

"Allowing patents on genetic material imposes real andsevere limits on scientific research, learning and the free flow ofinformation," Hansen says. "Patenting human genes is like patenting e=mc2,blood or air."

Mutations along the BRCA genes are responsible for mostcases of hereditary breast and ovarian cancers, according to the lawsuit. Manywomen with a history of breast and ovarian cancer in their families opt toundergo genetic testing to determine if they have the mutations on their BRCAgenes before deciding on a treatment plan which includes undergoing preventivemastectomies or ovary removal.

The patents granted to Myriad provides the exclusive rightto perform diagnostic tests on the BRCA1 and BRCA2 genes, Hansen says, and heargues that Myriad's "monopoly" on the genes makes it impossible for women toaccess alternate tests, or even get a second opinion about their results.Furthermore, one diagnostic test costs as much as $3,700—which is out of reachto women without the means to pay for it.

Myriad is hardly alone. Approximately 20 percent of allhuman genes are patented, including genes associated with Alzheimer's disease,muscular dystrophy, colon cancer, asthma and many other illnesses, Hansen says.

Co-counsel Daniel B. Ravicher says, "Patents on human genesshould never have been granted in the first place. Genes are identified, notinvented."

The U.S. Patent and Trademark Office (PTO) has grantedthousands of patents on human genes—in fact, about 20 percent of our genes arepatented, Hansen says. A gene patent prevents anyone from studying, testing oreven looking at a gene that limits scientific research and genetic testing.

Several major organizations, including the American MedicalAssociation, the March of Dimes, the American Society for Human Genetics andNobel Prize winners Joseph Stiglitz and Sir John Sulston, have filedfriend-of-the-court briefs in support of the ACLU and the Public PatentFoundation's (PUBPAT) case.

"Without the patents, there wouldn't have been the financialincentive to create the tests," says Richard M. Marsh, Myriad executive vicepresident and general counsel.

Parties who have filed amicus briefs in support of Myriadinclude the Biotechnology Industry Organization (BIO); BayBio; Celera;Coalition for 21st Century Medicine; Genomic Health; the Genetic Alliance;Rosetta Genomics; and George Mason University.

"We believe we have a compelling argument that our isolatedDNA claims are patent-eligible under the Patent Act, and our method claims arealso patent-eligible based on the recent Federal Circuit Court decision in Mayov. Prometheus," Marsh says. "This case has little to do with thecost of testing. While Myriad is currently profitable, we spent many yearsincurring substantial operating losses, and finally, in the twilight of ourpatent term, we are finally recouping our investment.

"However, this is exactly how the patent system works,"Marsh adds. "It gives companies an incentive to spend vast capital dollars(which would not be done but for patent protection), to promote the underlyingscience and progress of the invention, and hopefully, by the end of the patentterm, the patent holder has been able to obtain a return on its investment."

Once the patent expires, society then gets the collectivebenefit of all of the efforts to promote and increase general research,insurance coverage, patient and physician knowledge and understanding aboutpredisposition testing for hereditary cancers, he says.

"One thing Myriad is proud of is the fact that due to ourefforts, 90 percent of our testing is now covered by insurance, so the test hasbecome accessible and affordable to patients," Marsh says. "For those withoutinsurance and who cannot afford testing, Myriad has a financial assistanceprogram providing free testing."

The issue of gene patents took the national stage Feb. 4,when 26 organizations representing innovations in American life sciences sent aletter to Kathleen Sebelius, secretary of the U.S. Department of Health andHuman Services, "to express grave concerns about certain recommendations in theSecretary's Advisory Committee on Genetics, Health and Society's (SACGHS)Report on Gene Patents and Licensing Practices and Their Impact on PatientAccess to Genetic Tests.

While the controversial report indicates that gene patentsand licensing practices concerning such patents have not had an adverse impacton patient access to genetic tests, it nevertheless includes a controversialproposal to exempt gene patents from infringement liability.

"By undermining the value of gene-based patents, theserecommendations would chill future investment and innovation in this area, andwould unfairly upset the investment-backed expectations of current patentowners and licensees," the letter states.

At a press conference held in Washington, D.C., on Feb. 3, BIO Presidentand CEO Jim Greenwood stood with former Sen. Birch Bayh, co-author of theBayh-Dole Act; Dr. Brian Stanton, a member of the SACGHS Task Force; Dr. JimDavis, executive vice president, general counsel an secretary of Human GenomeSciences Inc.; and Dr. Jon Soderstrom, managing director of the Office ofCooperative Research at Yale University. Greenwood said the recommendation toexempt gene patents "would undermine the U.S. patent system, and the Bayh-Doletechnology transfer system … would discourage investment in biotech innovation,hobble the transfer of federally-funded research, undermine university researchprograms and harm patients who are waiting for life-saving therapies anddiagnostics yet to be developed."