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Clinical Laboratories and Pathology Groups

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Court case will directly affect future development of new pathology and molecular tests

In New York’s Southern District Court, a trial is underway that tests the legality of patenting genes. In Association for Molecular Pathology, et al v. U.S. Patent and Trademark Office 09-civ-4515, pathologist groups, patient advocacy groups, and the American Civil Liberties Union (ACLU) are challenging patents for the BRCA I and BRCA II genes which are held by the University of Utah and licensed exclusively to Myriad Genetics, Inc., of Salt Lake City, Utah.

Many experts believe this lawsuit has the potential to produce new case law that addresses the ability of individuals and companies to hold patents on human genes. A ruling in favor of either party in the lawsuit will directly affect the clinical laboratory testing industry and diagnostic tests that utilize gene-based technologies.

ACLU Challenges University of Utah and Myriad patent.

The lawsuit was filed in May 2009 by the American Civil Liberties Union and the Public Patent Foundation at Benjamin N. Cardozo School of Law. It named as defendants the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah Research Foundation.

In recent weeks, on February 3, Judge Robert W. Sweet heard testimony regarding the two sides’ motions for summary judgment. This testimony revealed the basis for each side’s position in the suit. Christopher Hansen of the American Civil Liberties Union, lead attorney for the plaintiffs, argued that the University of Utah had patented a part of the human body and a law of nature, both of which have previously been ruled as not patentable.

The attorney for the University of Utah and Myriad Genetics is Brian M. Poissant of Jones Day. He countered that the process of extracting the BRCA genes altered them chemically, making the genes patentable. “This is not nature’s handiwork. This is an invention of man,” he argued.

The plaintiffs further asserted that the patents were unconstitutional because they stifled the free flow of information protected under the First Amendment. In response, Assistant U.S. Attorney Ross Eric Morrison, representing the patent office, argued that no court has ever upheld a first amendment challenge to a patent.

The two sides in the suit do not dispute the facts of the case, only their interpretation. That is why legal experts believe it is likely that Judge Street will make his ruling without a trial.

By the ACLU’s estimation, more than 20% of the human genome is currently patented by a variety of companies. The ACLU singled out Myriad Genetics for the suit challenging the BRCA patents because Myriad Genetics has resorted to court action more than nine times to stop what it considered to be patent infringement. This aggressive use of the courts made Myriad a prime target for those who believe that gene patenting is illegal and unethical.

Myriad controls all testing related to BRCA1 and BRCA2 through a licensing agreement with the patent holder, the University of Utah. According to the plaintiffs, this control prevents researchers from developing new laboratory tests for cancer and gives a monopoly to Myriad that allows it to maintain a fee, reportedly $3,000, that puts the test out of reach for many cancer patients. It also restricts patients’ ability to get a second opinion from a non-Myriad clinical laboratory.

The American College of Medical Genetics (ACMG), one of the plaintiffs in the suit, has stated that Myriad’s monopoly not only removes consumer choice and competitive incentives, it also represents a major impediment to developing laboratory tests that simultaneously study large groups of genes.

“Gene patenting creates an obstacle course that will make true genomic analysis not only cost-prohibitive but impossible, given that no single laboratory will ever own the rights to offer comprehensive testing,” remarks Bruce R. Korf, M.D., Ph.D., President of ACMG.

This is not the first time that Myriad’s control of the BRCA genes has been challenged. In 2004, a European court limited Myriad’s patent protections in the European Union, and Cancer Research, a charitable organization, was granted the European patent on the BRCA2 gene. The firm allows free use of the patent by clinical pathology laboratories in Europe.

With the steady growth in the number of genetic and molecular diagnostic tests which utilize multiple genes in a single assay, the pathology profession is concerned that obtaining patent rights for the tens, hundreds, and thousands of genes that make up a single clinical laboratory test would prove prohibitive. That alone would inhibit advances in the use of genetic and molecular technologies for diagnostic testing.

Because any ruling by the judge is likely to be appealed, the final resolution to this court case may be years away.

Related information

Key phase of gene-patent lawsuit in judge’s hands: Myriad Genetics, biotech industry defend research rights.

ACLU Challenges Patents On Breast Cancer Genes: BRCA

Hearing Held in Breast Cancer Gene Patent Lawsuit

The Dark Report laboratory intelligence

The Executive War College 2010 Agenda: “Fast-Moving Legal Issues”