May 29, 2012 Top Story

Prometheus's Patent Ruled a Myth

Supreme Court finds diagnostic test an unpatentable law of nature

Katerina E. Milenkovski

By unanimous decision, the United States Supreme Court recently held that a patent on a diagnostic medical test was invalid and that essentially, the application merely attempted to patent a “law of nature.” The decision brings into question the validity of a number of similar medical and biotechnical patents.

Overview of Claims

The patent in question in Mayo Collaborative Services v. Prometheus Laboratories, Inc. covers a blood test that helps doctors determine the proper dosage for a drug that is used to treat certain autoimmune illnesses. Prometheus Laboratories, Inc., is the exclusive licensee of the patents in question and sells diagnostic tests that employ the processes the patents cover.

The Mayo Clinic had used the tests before developing a test of its own. Prometheus sued the Mayo Clinic, alleging patent infringement.

The U.S. District Court for the Southern District of California granted summary judgment to the Mayo Clinic. The trial court reasoned that the patent claims were unpatentable statements of natural laws and phenomena.

The U.S. Court of Appeals for the Federal Circuit reversed, pointing out that the patent identified a series of steps that met the “machine or transformation test.” According to the Federal Circuit, this transformed the law of nature into a patentable claim.

The Supreme Court Weighs In

The Supreme Court granted certiorari, vacated the lower court judgment, and remanded the case for reconsideration in light of Bilski v. Kappos. Bilski held that the “machine or transformation test” is not a definitive test of patent eligibility, but merely a consideration.

On reconsideration, the Federal Circuit upheld the patentability on other grounds. Again the Supreme Court granted certiorari and, upon review, issued its recent decision finding the claims were not patentable.

“To transform an unpatentable law of nature into a patent­ eligible application of such a law, a patent must do more than simply state the law of nature while adding the words ‘apply it,’” wrote Justice Stephen Breyer for the Court. “We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid.”

Patent Eligibility and Patentability

Laws of nature, along with physical phenomena and abstract ideas traditionally have not been considered patent eligible subject matter under Section 101 of the Patent Act. An application of a law of nature, however, can be entitled to a patent if the additional steps of the process add enough to meet the patentability criteria of Sections 102 and 103 of the Patent Act.

“With the Supreme Court, the trend has been to limit patentability, so it is not surprising that this case does the same,” observes Kim R. Jessum, Philadelphia, cochair of the ABA Section of Litigation’s Distance CLE Committee and a patent attorney. “However,” she adds, “Section 101 is not commonly used by patent examiners to reject claims and has not been used as effectively as Sections 102 and 103 to invalidate claims in patent cases.”

The key to deciding if subject matter is patent-eligible, according to the Court in Prometheus, is “whether . . . the patent claims add enoughto their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that applynatural laws.” Thus, the key inquiry was whether, apart from the law of nature, the claim included additional steps that were themselves novel. As Justice Breyer notes, “A process that focuses upon the use of a natural law must also contain other elements or a combination of elements, sometimes referred to as an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.”

Court Cites Prior Opinion Yet Strays From Its Holding 

In an earlier case, Diamond v. Diehr, the Supreme Court held that courts must consider a patent claim as a whole and not dissect or examine the individual elements. Despite quoting heavily from Diehr in its Prometheus analysis, the Supreme Court nevertheless did exactly what Diehr instructed not to do, according to Robert M. Asher, Boston, cochair of the Patents Subcommittee of the Section of Litigation’s Intellectual Property Litigation Committee.

“All patents that have method claims may be subject to the same analysis the Court used here, namely the dissection of claims to remove the portions that define laws of nature and then a consideration of whether the remaining parts of the claim were known in the art,” says Asher.

Far-Reaching Implications

“While the case dealt with biotech, it has far broader ramifications, especially for business methods cases,” predicts Asher. “Prometheus leaves a lot of room for litigation of Section 101, which may become a threshold issue for many cases.”

“There are many existing patents on diagnostics in the pharmaceutical and biotechnology industries,” adds Jessum, “so this case will have a major impact on enforceability of those patents.” Specifically, she says, “[b]y eliminating patent protection on diagnostics, there will be less financial incentive to invest a lot of research dollars in diagnostics. Other investment in R&D should not be affected for now, but some may be worried that there may be further limitations on patentable subject matter in the near future.”

The patent bar should not panic just yet, according to Asher. “While Justice Breyer implied that non-obviousness or novelty played a role in patentability, Diehr was quite explicit that you don’t look at the novelty of individual steps. Breyer made no attempt to overrule Diehr. Thus, I believe Diehr is still good law. I also think it’s premature to raise alarms about this decision quashing R&D,” says Asher. “That’s an overreaction at this point. The Myriad case will be much more telling in terms of its impact on R&D and biotech.”

Consequences of Prometheus 

The patents at issue in Association for Molecular Pathology (AMP) v. Myriad Genetics, Inc., coverisolated DNA molecules and related methods useful for assessing risk of developing breast cancer.

The U.S. District Court for the Southern District of New York found gene patents to be invalid. On appeal, the Federal Circuit rejected much of the district court’s reasoning. Just a few weeks after the Prometheus decision, the Supreme Court vacated the Myriad decision and sent it back to the Federal Circuit for consideration in light of Prometheus. “Industry needs to hope that the Myriad decision will calm fears,” says Asher.

“One take away from the Prometheus decision is the importance of drafting claims that cover the invention in different ways, if possible. [This way], if one type of claim becomes invalid, then the patent owner can rely on the other claims for enforcement,” instructs Jessum.

Katerina E. Milenkovski is an associate editor for Litigation News.

Keywords: patents, biotech, Supreme Court, patentability, law of nature

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