An international intellectual property association filed an amicus curie brief urging the U.S Supreme Court to dismiss the dispute and issue presented in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 131 S.Ct. 3027 (2011), arguing that the district court and Federal Circuit lacked subject matter jurisdiction. The amici argued that for reasons that are not clear, the district court and the Federal Circuit unapplied, misapplied, or simply overlooked Congress’ legislative efforts to achieve a globally-desired limitation of exclusive patent rights.

A Brief History of the Dispute

Earlier this year, the Supreme Court granted Mayo Collaborative Laboratories’ (“Mayo”) petition for review of the Federal Circuit’s decision Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010).  The issue before the Supreme Court is whether the disputed patent claims fall within the ambit of patentable subject matter under 35 U.S.C. § 101. Briefly, the diagnostic claims under consideration relate to methods for optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder by administering a prodrug of 6-thioguanine to a patient and then determining the level of 6-thioguanine in blood isolated from the patient.

The Federal Circuit had determined that the claims did satisfy the patent-eligibility requirement of 35 U.S.C. § 101 because both the “administering” and “determining” steps of the claims were transformative and not merely data-gathering steps. Our previous Personalized Medicine Bulletin post discussed the Federal Circuit decision.

AIPPI Urges Elimination of the Entire Patent Dispute

The AIPPI finds support for its argument in 35 U.S.C. § 287(c) that is argued to exclude methods of medical treatment, such as the claims under consideration. None of the exceptions to the infringement exception, noted in the statute, are argued to apply.

35 U.S.C. § 287(c)  recites in pertinent part:

“(c)(1) With respect to a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271(a) and (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

(2) For the purposes of this subsection:

(A) the term “medical activity” means the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

(B) the term “medical practitioner” means any natural person who is licensed by a State to provide the medical activity described in subsection (c)(1) or who is acting under the direction of such person in the performance of the medical activity.

(C) the term “related health care entity” shall mean an entity with which a medical practitioner has a professional affiliation under which the medical practitioner performs the medical activity, including but not limited to a nursing home, hospital, university, medical school, health maintenance organization, group medical practice, or a medical clinic.

(D) the term “professional affiliation” shall mean staff privileges, medical staff membership, employment or contractual relationship, partnership or ownership interest, academic appointment, or other affiliation under which a medical practitioner provides the medical activity on behalf of, or in association with, the health care entity.

(E) the term “body” shall mean a human body, organ or cadaver, or a nonhuman animal used in medical research or instruction directly relating to the treatment of humans.

(F) the term “patented use of a composition of matter” does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method. … “

The AIPPI notes that only the United States and Australia allow the patenting of medical methods and the United States’ Congress, by enacting Section 287 (c)(1), had pronounced that at least some medical activities should be outside of, and free from, interference from the patent system. The activities within the scope of the disputed claims are within the infringement exclusion. Thus, the AIPPI reasoned, because Section 287 (c)(1) applies, the courts lack subject matter jurisdiction to hear a specified class of claims of patent infringement against specified classes of potential infringers.

Reference was also made to Laboratory Corp. of America Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006), where certiorari had been granted and then dismissed as improvidently granted. The AIPPI argues that Justices Breyer, Stevens, and Souter wrote that “special public interest considerations” are implicated by the technology covered by the claims because allowing such patent claims would inhibit doctors from using their best medical judgment and divert resources from healthcare tasks to the legal task of searching patent files.

In conclusion, the AIPPI recognized that the issue of whether subject matter jurisdiction was present was not briefed, or even seriously briefed at any stage of the proceedings at the district court or Federal Circuit.

The AIPPI

The amicus brief was filed by the Association Internationale Pour la Protection de la Propriete Intellectuelle (AIPPI) and the International Association for the Protection of Intellectual Property (AIPPI-U.S.), collectively the “AIPPI”. The parties describe their charter as the development, improvement, and legal protection of intellectual property. The AIPPI is self-described as politically neutral, non-profit organization headquartered in Switzerland having over 9000 members representing over 100 countries. The brief was submitted in support of neither party.