Supreme Court Rules in Mayo v. Prometheus Regarding Patentable Subject Matter

March 20, 2012. The Supreme Court of the US issued its unanimous opinion [28 pages in PDF] in Mayo v. Prometheus, a patent case regarding whether certain processes used by doctors are patentable subject matter.

The Supreme Court held that the claims at issue in the patents in suit cover processes that merely apply laws of nature that are not patentable under Section 101 of the Patent Act.

The underlying patents do not involve information or communications technology (ICT). They involve medical procedure. However, the reasoning of the Supreme Court regarding why the claimed inventions are not patentable subject matter will also be applicable to certain ICT related claims. This opinion, along with the 2010 opinion [71 pages in PDF] in Bilski v. Kappos, impact and limit what is patentable in the context of software. See, story titled "Supreme Court Rules in Bilski" in TLJ Daily E-Mail Alert No. 2,113, July 28, 2010.

35 U.S.C. § 101 provides only that "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title."

Justice Stephen Breyer wrote the opinion for a unanimous court. There were no other opinions.

He wrote that this case "concerns patent claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high. The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects. We must determine whether the claimed processes have transformed these unpatentable natural laws into patent eligible applications of those laws. We conclude that they have not done so and that therefore the processes are not patentable."

He wrote that "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." (Parentheses in original.)

Prometheus is the licensee of U.S. Patent Nos. 6,355,623 and 6,680,302. It sells diagnostic tests that embody the processes the patents describe. It is the plaintiff in the District Court, appellant in the Court of Appeals, and respondent in the Supreme Court.

Mayo announced that it intended to begin using and selling its own test. Prometheus filed a complaint in the U.S. District Court (SDCal) alleging patent infringement. The District Court found infringement, but then granted summary judgment to Mayo. It reasoned that the patents effectively claim natural laws or natural phenomena, and are therefore not patentable.

Prometheus appealed to the U.S. Court of Appeals (FedCir), which reversed the judgment of the District Court. Mayo then filed a petition for writ of certiorari with the Supreme Court, which granted the petition, vacated the judgment, and remanded the case for reconsideration in light of Bilski.

On remand, the Court of Appeals again reversed the judgment of the District Court. See, Court of Appeals' December 17, 2010, opinion. Mayo then filed another petition for writ of certiorari, which the Supreme Court granted.

The Supreme Court, in its just released opinion, reversed the judgment of the Court of Appeals. The claims are not patentable subject matter.

Justice Breyer wrote that "Prometheus' patents set forth laws of nature -- namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm."

He did not discuss software in this opinion. However, it might be noted that some software patents claim, for example, the application an algorithm to accomplish something useful. An algorithm is a law of nature. Hence, the reasoning of the court in this opinion might be applied to challenge some software patent claims. Although, Justice Breyer did not elaborate on this.

This case attracted a large number of amicus curiae briefs. Some came from ICT companies and intellectual property associations with concerns regarding the application of patent law to the tech sector.

For example, Microsoft and Intel submitted a joint amicus curiae brief. They argued that "The now-prevailing mode of Section 101 analysis that allows courts and the PTO to parse claims into the ``underlying invention´´ and ``extra-solution´´ elements based on inherently subjective evaluations of ``significance,´´ misplaced assessments of novelty, or both, is incompatible both with the statutory text and Congress’s expressed intention. The Court, therefore, should reject that analytical framework. Instead, it should reaffirm the historical standard for patent eligibility of process inventions dating back to O’Reilly v. Morse and hold that a process invention is eligible for patenting if it uses ``certain means´´ to create ``a certain useful result.´´"

Verizon and Hewlett Packard filed a joint amicus curiae brief in support of the petitioner, Mayo, in which they argued that Section 101 should be construed to "ensure that patents are limited to concrete structures or processes that are new and useful and that are described and claimed properly. Insisting that patents be circumscribed by these requirements presupposes, at the threshold, that merely adding a recognition of a new property to an old process or product does not create a newly patentable invention."

These are all large incumbent companies. On the other hand, some amicus briefs filed on behalf of start ups and venture capitalists argued in support of the respondent, and affirming the Federal Circuit. See for example, National Venture Capital Association (NVCA) brief and San Diego Intellectual Property Law Association brief.

The Cato Institute, Competitive Enterprise Institute and Reason Foundation filed an amicus curiae brief in support of Mayo in which they argued broadly that patentability law is out of joint, particularly in the context of software patents, and that the Court should use this case to set it right.

They wrote that "Prometheus's patents are two among thousands of abstract process patents which have been improvidently granted since the 1990s. The patents at issue present an opportunity for the Court to restore the original meaning of patentable ``process´´ and reverse an expansion of patentable subject matter that has discouraged innovation and harmed U.S. industries."

They warned that if the Federal Circuit is affirmed, "The effect of abstract process patents on software and financial firms will spread to the healthcare and medical research industries if patents such as Prometheus's are permitted."

They argued that "The term ``process´´ in section 101 is properly limited to processes which aim to have an effect on matter. Although software and business method patents have proliferated over the past two decades, many software and business-method patents, as well as the patents at issue here, should not qualify as patentable subject matter because the purpose of performing the processes is not to have an effect on the physical world."

They argue that something is rotten in the Federal Circuit's expansive interpretation of patentable subject matter. It has had "a net negative economic effect in most industries". It has raised litigation costs to the point that they have "overwhelmed the profits generated from those patents." The state of the law has created an "arms race" in which companies like Google, Microsoft and Apple spend billions to build up their portfolios, and where "Small firms that can't keep up may be run out of business".

Cato's Timothy Lee stated in a release after the opinion that "we would have liked to see Justice Breyer go further". He added that "Mayo v. Prometheus was a step in the right direction, but it was also a missed opportunity to rule on these broader questions".

See, ABA web page with hyperlinks to briefs of parties and amici curaie.

This case is Mayo Collaborative Services, et al. v. Prometheus Laboratories, Inc., Supreme Court of the United States, Sup. Ct. No. 10-1150, a petition for writ of certiorari to the U.S. Court of Appeals for the Federal Circuit, App. Ct. No. 2008-1403. The Court of Appeals heard an appeal from the U.S. District Court for the Southern District of California, D.C. No. 04-CV-1200.