Unanimous Supreme Court decision invalidates Prometheus diagnostic test patents and reverses Federal Circuit decision

In a major patent ruling today, the Supreme Court of the United States issued a unanimous decision in Mayo v. Prometheus Laboratories. The case, heard twice before the Federal Circuit (once before the Supreme Court's ruling in Bilski and once after), has been closely followed because of its impacts on personalized medicine and potential implications for the Myriad Genetics case on the BRCA genes. The Supreme Court reversed the Court of Appeals for the Federal Circuit and held that Prometheus' patents-at-issue were not eligible for patent protection.

The facts of the case are as follows. Prometheus Laboratories was the sole and exclusive licensee of the patents and sold diagnostic tests based upon these patents. The patents concern the use of thiopurine drugs to treat autoimmune diseases, such as Crohn's desease or ulcerative colitis. The body metabolizes thiopurine drugs and causes metabolites to form in a patient's bloodstream. Because metabolization varies from patient to patient, different doses are necessary in order to reduce side effects but still maintain effective treatment levels. The patents at issue emobody findings that certain concentrations indicate the dosage was too high, whereas other concentrations indicated too low of a dosage. After using the Prometheus diagnostic tests, Mayo subsequently announced that it would begin using and selling its own test. Prometheus then brought action against Mayo for patent infringement.

The District Court in the case granted summary judgment in Mayo's favor, but the Federal Circuit reversed. Mayo filed a petition for writ of certiorari with the Supreme Court granted, but then vacated and remanded for further consideration in light of Bilski. The Federal Circuit then reaffirmed its earlier decision and Mayo again filed for certiorari which was again accepted.

Justice Breyer wrote the opinion which can be found here.

In holding that the patents-at-issue were not patentable, the Court found that more than one must do more than a mere application of a law of nature to render such a law patent eligible. It stated that a patent that describes the relation set forth in natural law does does not do enough to permit a patent.

Providing instructions on applying natural laws does not transform "unpatentable natural laws into patent eligible applications of that laws." The case focused, in large part, on Section 101 of the Patent Act which the Court noted includes an implicit exception that laws of nature are not patentable subject matter.

The Court focused its decision, in part, on the reasoning for the implicit exception and implications patents can have on future innovation. Citing past precedent in Gottschalk v. Benson, 409 U.S. 63 (1972), the Court noted that phenomena of nature and abstract principles are "basic tools" of science and "monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it." The Court also noted that the claimed processes involved "upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries." Repeatedly, the opinion emphasizes the "concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature" and that

there is a danger that the grant of patents that tie up their use will inhibit future innovation permised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to 'apply the natural law,' or otherwise forecloses more future invention than the underlying discovery could reasonably justify.

In addition to its concerns regarding future research and development, the Court also noted that the process claimed by Prometheus involved activity already well-understood and utilized by the scientific community:

To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regulations.

The opinion rejected the US Government's position that "virtually any step beyond a statement of a law of nature" transforms an unpatentable law into an patent-eligible application. In rejecting this position, the Court found that such an approach would make the implicit law of nature exception to Section 101 a "dead letter."

Finally, the Court made one important clarification regarding its 2010 decision in In re Bilski. Although the Federal Circuit found that the "machine or transformation" test is an "important and useful clue" to patent eligibility under the guidance of the Bilski decision, the Supreme Court noted here that "we have neither said nor implied that the test trumps the 'law of nature' exclusion."

It also cited the differing of opinion, recognizing that patent protection is a "two-edged sword." Although amici on Prometheus' side claimed need for patent protection to encourage discoveries, amici for Mayo, including the American Medical Association, the American College of Medical Genetics, the American Hospital Association, the American Society of Human Genetics, the Association of American Medical Colleges, and the Association for Molecular Pathology, among others, argued that

"claims to exclusive rights over the body's natural responses to illness and medical treatment are permitted to stand, the result will be a vast thicket of exclusive rights over the use of critical scientific data that must remain widely available if physicians are to provide sound medical care."

Expanding on amici's point, the Court's opinion takes note that the exclusivity of a patent

can impede the flow of information that might permit, indeed spur, invention, by, for example, raising the price of using the patented ideas once created, requiring potential users to conduct costly and time-consuming searches of existing patents and pending patent applications and requiring the negotiation of complex licensing arrangements.

The case could have implications for American Molecular Pathology v. Myriad Genetics. The arguments against the patent eligibility of the BRCA1 and BRCA2 genes rest on some of the same case law and principles cited by the Supreme Court in Prometheus. The issues of application of well-understood research tools, field preemption and implications for further innovation are all major factors in the Myriad case. Additionally, the Court relied on the same precedent cited in favor of AMP, including Gottschalk v. Benson, Diamond v. Diehr, Diamond v. Chakrabarty and Funk Brothers Seed Co. v. Kalo Inoculant Co.

I would expect that the Supreme Court will ask the Federal Circuit to re-hear the Myriad case and to decide it in light of the Prometheus ruling (much as the Federal Circuit re-heard Prometheus after the Supreme Court decided Bilski). Based on the guidance of the Supreme Court in Prometheus, the Federal Circuit could reverse its ruling in Myriad. Alternatively, if the Federal Circuit comes down on the same side and upholds Myriad's patents, the case could be appealed again to the Supreme Court.

Additional coverage of the case is available via Pharmalot.

Prior coverage, including court documents and briefs are available at SCOTUSBlog.