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Lawsuits test boundary rights of medical patents

The cases come at a time of renewed interest by the U.S. Supreme Court in patent law and could have ramifications for medical research.

By Amy Lynn Sorrel — Posted June 29, 2009

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Some physicians are taking aim at what they say are overly broad medical patents that could stifle innovation and access to care.

A lawsuit challenging the validity of Myriad Genetics' patents on a pair of genes associated with breast and ovarian cancer was filed in May by the Assn. for Molecular Pathology, American College of Medical Genetics and several other medical organizations, researchers and patients. In April, the American Medical Association, ACMG and five other medical associations filed a friend-of-the-court brief in a federal appeals court case questioning Prometheus Laboratories Inc.'s patent on a test linking patients' metabolite levels to a drug's efficacy.

Physicians say such patents violate legal precedent that forbids the patentability of laws of nature, natural phenomena and abstract ideas. If upheld, the monopolies threaten to interfere with the practice of medicine and limit treatment options, said ACMG President Bruce R. Korf, MD, PhD.

"Doctors are going to see things that could make a difference in medical care, and they're not going to be able to share that information" without first getting permission from patent owners for research or interpretation of patients' test results, he said.

But stakeholders on the other side of the debate, including the biomedical industry and patent lawyers, say such patents are not only legal but also necessary to spur the investment needed for expensive research and development.

Legal precedent has recognized that naturally occurring phenomena can be transformed into something else or applied in a new context, said Hans Sauer, PhD, associate general counsel of intellectual property at the Biotechnology Industry Organization. The trade group filed a friend-of-the-court brief in Prometheus v. Mayo.

"There has been a long discussion and recognition that patents are important in the development of medicine," Sauer said. If courts go too far to rein in patent protections, "it would step on other valuable and bona fide inventions in an unjustifiable way," he said.

What is patentable?

The physician community agrees that patents serve a legitimate purpose, for example, in the creation of new drugs or a specific testing process.

But gene patents cover a basic element of human biology used regularly to diagnose and treat patients for common medical conditions, Dr. Korf said. "We only have one BRCA-1 gene, and if that happens to be responsible for breast cancer, there's no inventing around that."

In addition, Myriad has enforced its gene patents aggressively, said Daniel B. Ravicher, president and executive director of the Public Patent Foundation. The group, which advocates for stricter patent policy, helped file the case, along with the American Civil Liberties Union. Myriad licenses a single lab to conduct testing, Ravicher said.

As a result, patients could not get a second opinion on their cancer tests, confirm inconclusive results or afford Myriad's $3,000 test, according to the lawsuit, filed in the U.S. District Court for the Southern District of New York. Also, several research institutions received cease-and-desist orders from Myriad for analyzing the genes, the complaint states.

Prometheus sued Mayo Collaborative Services Inc. for infringing on its patent on a test that measures patients' metabolite levels after those patients have taken thiopurine drugs, then correlates those levels with the drug's efficacy or toxicity so doctors can gauge dosing. Mayo developed a different testing method for detecting such effects.

In 2008, a federal trial court invalidated the patent, finding that it covered a natural relationship. Prometheus appealed the decision to the U.S. Court of Appeals for the Federal Circuit, where the case is pending.

Doctors say discoveries of basic scientific principles are meant to be shared -- not monopolized -- to promote cost-effective quality care and medical advances.

"If patent licenses are required for physicians merely to consider newly discovered implications of well-established diagnostic tests, and if laboratories become contributory infringers merely by educating doctors about those implications, it's hard to imagine how the medical diagnostic community will continue to serve the goal of quality patient care," states the brief by organized medicine groups.

Myriad declined to comment for this story, as did the U.S. Patent and Trademark Office, also a named defendant in the case. The patent office has recognized that genes can be patented if they are isolated from their natural state and purified.

Prometheus also declined comment but argued similarly in legal briefs that the metabolites covered by its patent do not occur naturally in the human body because they are transformed by man-made drugs and other processes under Prometheus' testing method.

The bigger picture

Experts say the cases come at a time of renewed interest by the courts in the scope of patentability.

In June, the U.S. Supreme Court accepted a closely watched case, In re Bilski, likely to influence the issues at stake in the suits against Myriad and Prometheus. The high court will decide whether certain methods -- which often involve abstract or natural principles -- are patentable.

"The court is going to clarify [the scope of patentability] one way or another. The problem is, instead of fixing the system, there's a risk the court could cut back," which could limit medical progress, said Michael D. Bednarek, a patent lawyer and partner with Paul Hastings in Washington D.C.

"But there may be some middle ground that has to do with how these patents are enforced," he said. Patent law in other countries, for example, exempts research activities from liability for infringement.

The ACMG's Dr. Korf agreed that stakes are high for the future of patient care as developments in genomic analysis and personalized medical treatments become the norm. "The issues are only going to get bigger."

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ADDITIONAL INFORMATION

Cases at a glance

Are genes or certain diagnostic tests involving naturally occurring substances patentable?

Courts at the trial and appellate levels are being asked to decide the issue.

Impact: Physicians say that overly broad patents on medical discoveries could stifle research and interfere with routine patient care. Patent lawyers and biomedical industry representatives say investment and development will be diminished if the courts interpret patent law too narrowly.

Assn. for Molecular Pathology et al. v. U.S. Patent and Trademark Office et al., U.S. District Court for the Southern District of New York; Prometheus Laboratories Inc. v. Mayo Collaborative Services, U.S. Court of Appeals for the Federal Circuit

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