On June 20, 2011, the United States Supreme Court granted Mayo's petition for certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010), a case addressing patent eligibility under 35 U.S.C. § 101 of certain method claims relevant to personalized medicine. While the issue under consideration here does not relate to whether isolated genes and other alleged “products of nature” are patent-eligible, the Court in Prometheus will likely address whether and how one can claim methods that take advantage of correlations between an individual's personal health/genetic make-up and possible health care options.

As discussed in postings today on Foley's Personalized Medicine Bulletin (http://tinyurl.com/6lg4x5a) and PharmaPatents (http://tinyurl.com/6a9w3t5) blogs, Mayo Collaborative Services filed a second petition for certiorari with the Supreme Court after the Federal Circuit upheld the claims (for a second time) on remand after the Supreme Court's decision in Bilski v. Kappos (2010). Representative claims in Prometheus include:

Claim 1 of U.S. Patent No. 6,355,623:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Claim 46 of U.S. Patent No. 6,680,302:

46. A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathioprine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,

wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the[] amount of said drug subsequently administered to said subject, and

wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

In its December 2010 decision, Federal Circuit held that both the "administering" and "determining" steps were transformative and not merely data-gathering steps. (See Foley's Legal News Alert: Chemical, Biotechnology & Pharmaceutical (http://tinyurl.com/3c6nsm4) and PharmaPatents blog (http://tinyurl.com/62jkrh3).) Specifically, the method claims recited a patent-eligible application of naturally occurring correlations between metabolite levels and efficacy/toxicity, i.e., the treatment of a specific disease by administering specific drugs and measuring specific metabolites. As noted by the court, "[t]he invention's purpose to treat the human body is made clear in the specification and the preambles of the asserted claims." Thus, the method did not wholly preempt all uses of the recited correlations. The methods were not "merely" data-gathering steps or "insignificant extra-solution activity," but rather were part of treatment regimes, and therefore involved "a significant transformative element."

The Supreme Court's decision to grant certiorari today means that the Court may finally provide some additional clarity regarding the best way to pursue and enforce diagnostic method patent claims in light of patent eligibility considerations under 35 U.S.C. §101. In this context, many wonder if Justice Breyer will finally have an opportunity to give precedential force to views he expressed in his dissent in Lab. Corp v. Metabolite, 126 S.Ct. 2921 (2006), suggesting patent ineligibility of certain diagnostic claims.

In fact, on June 6, 2011, Justice Breyer referenced his Metabolite opinion in his dissenting opinion in Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems, Inc., holding that the Bayh-Dole Act does not automatically vest title of federally funded inventions to federal contractors (e.g., universities). (See Foley's Legal News Alert: Intellectual Property (http://tinyurl.com/6jtsowk) and PharmaPatents blog (http://tinyurl.com/6z55t2t).)In the context of his dissent in the Stanford v. Roche case, Justice Breyer states:

[P]atents themselves have both benefits and costs. Patents, for example, help to elicit useful inventions and research and to assure public disclosure of technological advances. [citing Bilski and other cases] . . . But patents sometimes mean unnecessarily high prices or restricted dissemination; and they sometimes discourage further innovation and competition by requiring costly searches for earlier, related patents or by tying up ideas, which, were they free, would more effectively spur research and development.

Citing the Founding Fathers, Justic Breyer continued:

Thus, Thomas Jefferson wrote of "the difficulty of drawing a line between the things which are worth to the public the embarrassment of an exclusive patent, and those which are not." . . . And James Madison favored the patent monopoly because it amounted to "compensation for" a community "benefit."

It is worth noting that claims in Prometheus differ from those in Metabolite. Claim 13 in U.S. Patent No. 4,940,658 is a representative claim at issue in Metabolite:

13. A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:

assaying a body fluid for an elevated level of total homocysteine; and

correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

It is possible that claims at issue in Prometheus differ enough from claim 13 to alleviate Justice Breyer's concerns regarding “the embarrassment of an exclusive patent.” If Justice Breyer believes the claims are not different enough, however, and enough Supreme Court Justices agree with Justice Breyer, and Prometheus is reversed, the impact could be far-reaching, encompassing many personalized medicine and diagnostic method inventions. Because these areas are viewed by many as the next frontier in medical advances and health care, many will believe that such a result would unwisely discourage innovation in this important area by weakening patent rights. On the other hand, those who view patents as an impediment to research will believe that such a Court decision would promote innovation by making the advances open to all.

In short, it remains to be seen what Justices Breyer and Ginsburg, and the rest of the Justices, might do with the claims at issue here in Prometheus. Regardless, this case stands to have a large impact on intellectual property in the personalized medicine space.