Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

Supreme Court has to decide whether to reverse previous stance upholding two of Prometheus’ method patents.

The U.S. Supreme Court will hear oral arguments today in one of several cases closely watched by molecular diagnostics companies seeking guidance on what intellectual property they can and cannot patent. Mayo Collaborative Services (doing business as Mayo Medical Laboratories) and Mayo Clinic Rochester have urged the justices to overturn a decision made by the Court of Appeals for the Federal Circuit last December upholding two diagnostic method patents owned by Prometheus Laboratories.

At issue in Prometheus Laboratories, Inc. v. Mayo Collaborative Services et al. are patents covering the methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases. The methods were designed to account for the context of a treatment regimen based on the individual patient’s metabolism.

Prometheus sued Mayo in U.S. District Court in 2004, alleging that an announced (but never marketed) Mayo Medical Laboratories diagnostic test infringed two Prometheus patents by measuring the same metabolites as Prometheus’ test; Mayo’s test used different levels to determine toxicity of the two metabolites. Mayo has countered that Prometheus’ patents include claims based on unpatentable natural phenomena—the correlations between thiopurine drug metabolite levels and efficacy and toxicity—and that the claims wholly preempt use of the natural phenomena.

Hans Sauer, Ph.D., deputy general counsel, intellectual property at the Biotechnology Industry Organization (BIO), told GEN the Supreme Court will consider issues of patentability under 35 U.S.C. § 101, which can set a broad precedent across the life sciences and beyond.

“If this particular patent falls, all kinds of other patents will fall with it,” Dr. Sauer said. “We think that personalized medicine patents, like the kinds of patents that generate important information for decisions, these are implicated as a category of patents by this case. Depending on how it decides this particular case, the Supreme Court actually sets the switches for the patentability of things that companies actually invest a lot of money in—biomarker research and the like.”

Making the Case for Maintaining Past Ruling

In amicus curiae filings Mayo won support from associations of physicians, researchers, medical educators, and other providers of healthcare-related services as well as several public interest groups, two clinical laboratory companies, and two high-tech companies outside the life sciences.

Life sciences parties siding with Prometheus include BIO, Pharmaceutical Research Manufacturers of America (PhRMA), the Association of University Technology Managers, and Myriad Genetics; Myriad is at the center of another important case for the diagnostic community, and its outcome may hinge on Prometheus v. Mayo.

In its amicus filing, BIO disputed Mayo’s contention that Prometheus’ patents disclosed natural phenomena. Yet it also argued that patent claims could be upheld if based on applications of a natural phenomenon, law of nature, or idea. BIO urged the Supreme Court to consider patent claims as a whole, rather than segment them to eliminate portions deemed known or insignificant.

“Petitioners seem to advance a rule whereby not only natural phenomena and laws of nature would be excluded from patent-eligibility but also some ill-defined subset of applications of those laws of nature or natural phenonema,” BIO stated. “The Court should squarely reject this rule and reaffirm its prior precedents. Holding otherwise would interpose insurmountable obstacles to securing patent protection in the field of life sciences, as virtually all inventions in this field draw upon biological systems or seek to exploit or affect their function.”

Those precedents, PhRMA noted in its amicus, include the high court’s decision in Diamond v. Diehr (1981), which upheld as patentable the execution of a process controlled by a computer program that applied a math formula that by itself was not patentable. That “machine-or-transformation” test was upheld by the Federal Circuit in In Re: Bilski (2008) but watered down by the Supreme Court in Bilski v. Kappos (2010), when it cautioned that the standard should not be the sole test but “a useful and important clue” of patentability.

“A personalized medicine process may, and often will, draw upon known steps or components to yield an overall process that is important, valuable, and deserving of patent protection,” BIO added. “Known biomarkers and known correlations are frequently used in novel processes for beneficial treatment or diagnostic purposes.”

Weighing In for Overturning the Decision

In their pro-Mayo amicus, Arup Laboratories and Laboratory Corp. of America said Prometheus’ patents are tantamount to “exclusive rights over the process of administering a drug and observing the results. This is improper. If claims like the ones at issue are sustained, such tests may be blocked by patents on the law of nature on which they are based. This is especially harmful given the nature of modern medicine,” Arup and LabCorp asserted.

The medical-healthcare coalition added that Prometheus’ claims “involve utterly conventional applications of unpatentable natural phenomena, scientific conclusions, and mental processes.” Such patents, the coalition asserted, hinder physicians’ ability to provide top-flight patient care by hindering their use of pre-existing lab tests and stifling innovation.

“Even a claim limited to a specific disease, however, significantly preempts research into whether treatment of that disease should be personalized based on individual patient characteristics such as age or gender or on the results of complementary tests,” the coalition said.

The medical-healthcare coalition also said such patents impede the obligation of physicians to share medical knowledge with patients and other physicians. Coalition members include the American College of Medical Genetics, American Medical Association, American Hospital Association, American Society of Human Genetics, Association of American Medical Colleges, Association for Molecular Pathology, Association of Professors of Human and Medical Genetics, College of American Pathologists, Florida Hospital Association, Minnesota Hospital Association, and Minnesota Medical Association.

Will Prometheus Prevail?

A Prometheus amici said the company’s patents involve more than a law of nature or observation. Juhasz Law Firm PC argued that subject matter patentability under 35 U.S.C. §101 can be determined by the existence of either a physical link or virtual link to physical or tangible objects.

Paul R. Juhasz, president of Juhasz Law, told GEN the physical-virtual standard was supported by two Supreme Court cases: Diamond v. Diehr; where software that manipulated a specific physical object was patentable; and O’Reilly v. Morse (1853), where the Morse code dot and dash signs were patentable to the extent they were applied in the telegraph, since they represented the change in state of physical objects from switches to clicks; one Morse claim, though—use of electromagnetic force—was deemed too broad to patent.

Diamond was cited in two Federal Circuit life science cases: Myriad’s lawsuit (Association for Molecular Pathology v. US Patent and Trademark Office) and Classen Immunotherapies v. Biogen Idec, where a Federal Circuit majority on August 31 upheld two of three Classen patents. “Classen is a case that, in my view, addresses the concern of the Supreme Court with regard to extra-solution activity” expressed in Bilski v. Kappos, Juhasz said.

In Classen the court maintained that while a transformation to gather data toward a body of knowledge was not patentable, a transformation “putting this knowledge to practical use” is. Classen’s physical-virtual standard also complements the transformative-step standard applied by a three-judge Federal Circuit panel that earlier this year upheld Myriad’s gene claims and methods of screening for cancer compounds as patentable– but not claims for mutation analysis.

Myriad seeks to protect seven patents related to breast cancer susceptibility genes 1 and 2 and its method for analyzing sequences of those genes for mutations associated with breast cancer against a legal challenge by several medical associations and individual doctors, aided by the American Civil Liberties Union (ACLU) and Public Patent Foundation.

The ACLU weighed in on Prometheus v. Mayo via amicus, arguing that the case “raises fundamental issues regarding freedom of thought and scientific inquiry centering around First Amendment values. What Prometheus seeks to monopolize through its patents is the right to think about the correlation between thiopurine drugs and metabolite levels and the therapeutic consequences of that correlation. Granting Prometheus or any other patent holder a monopoly on abstract ideas is incompatible with a constitutional regime that protects freedom of thought.”

Three tech giants—Microsoft, Intel, and EMC—urged the Supreme Court to affirm a “basic standard for patent eligibility focusing on the use of certain means to create a useful practical result in the physical world” but not technology-based or “rigid” standards such as machine-or-transformation.

The high court will likely set that “basic standard.” If Bilski v. Kappos is any guide, the court’s standard can be expected not to rely on the rigidity of a single test but on some combination of tests grounded in precedent and designed to advance life science innovation.

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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