The U.S. Supreme Court delivered a unanimous blow to Prometheus Laboratories by saying that its methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases are ineligible for patenting. In a decision written by Justice Stephen G. Breyer, the high court overturned the decision by the Court of Appeals for the Federal Circuit last December. The Federal Circuit had upheld the two diagnostic method patents, which covered the methods designed to take into account the context of a treatment regime based on the individual patient’s metabolism.
“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,'” the court stated. “It must limit its reach to a particular, inventive application of the law.”
Prometheus’ patents failed that test, according to the court: “We conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves. The claims are consequently invalid."
Through the ruling, Breyer answered the question he posed to attorneys for both sides during oral arguments in December: “What has to be added to a law of nature to make it a patentable process?”
The court cited precedents in several cases including Gottschalk v. Benson (1972), where a process claim based on a numerical algorithm was held unpatentable if it “would wholly pre-empt the mathematical formula;” Parker v. Flook (1978), in which an invention using a mathematical algorithm was ruled patent-eligible only if its implementation were novel and unobvious; Diamond v. Diehr (1981), 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 as applied in the telegraph though the use of electromagnetic force was deemed too broad to patent.
“The process claims at issue here do not satisfy these conditions. In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.
The Prometheus case started in June 2004 when Prometheus sued Mayo in U.S. District Court, alleging that an announced (but never marketed) Mayo Medical Laboratories diagnostic test infringed two Prometheus patents. Mayo’s test measured the same metabolites as Prometheus’ test, but Mayo’s test used different levels to determine toxicity of the two metabolites.
Mayo countered that Prometheus’ patents were invalid and unenforceable because the claims were based on subject matter that is unpatentable as they impermissibly claimed natural phenomena—the correlations between, on the one hand, thiopurine drug metabolite levels and, on the other hand, efficacy and toxicity—and that the claims wholly preempt use of the natural phenomena.
The case spent more than six years winding through the judicial system. In December 2010, the Federal Circuit sided with Prometheus, by stating that the firm’s claims passed a revised In re Bilski machine-or-transformation standard. Prometheus’ claims, the circuit court ruled, recited specific treatment steps, not just correlations themselves, and involved a specific application of natural correlationism, namely the treatment of a specific disease by administering specific drugs and measuring specific metabolites.
The Supreme Court disagreed, siding with Mayo. “Because the laws of nature recited by Prometheus’ patent claims—the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—are not themselves patentable, the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. The three additional steps in the claimed processes here are not themselves natural laws but neither are they sufficient to transform the nature of the claims,” the court ruled.
“There is a danger that granting patents that tie up their use will inhibit future innovation, a danger that becomes acute when a patented process is no more than a general instruction to ‘apply the natural law,’ or otherwise forecloses more future invention than the underlying discovery could reasonably justify. The patent claims at issue implicate this concern,” the court concluded.
Prometheus v. Mayo was one of two cases being watched closely by molecular diagnostics companies looking for answers about what intellectual property they can patent and what they can’t. In the other case, Myriad Genetics is seeking to protect seven patents related to breast cancer susceptibility genes 1 and 2 (BRCA1 and BRCA2) and its method for analyzing sequences of those genes for mutations associated with breast cancer. Myriad's patents are being challenged by several medical associations and individual doctors, assisted by the American Civil Liberties Union and Public Patent Foundation.
The court decision in Prometheus may also shape the USPTO’s study, due in June, of how to ensure the availability of confirming genetic diagnostic tests where gene patents and exclusive licensing for primary genetic diagnostic tests exist. The study was required by the Leahy-Smith America Invents Act, the patent-law overhaul enacted by President Barack Obama in September, and USPTO recently concluded a pair of hearings seeking public input on the issues raised.