Prometheus v. Mayo: Limited Implications for Section 101 Jurisprudence

• Jurisdiction: United States,Federal
• Publication year: 2013
• Citation: Vol. 8 No. 5

Washington Journal of Law, Technology and Arts Volume 8, Issue 5 Spring 2013

Prometheus v. Mayo: Limited Implications for § 101 Jurisprudence

Jessica Belle(fn*)© Jessica Belle

ABSTRACT

The United States Supreme Court recently confirmed the importance of the patent eligible subject matter inquiry under 35 U.S.C. § 101 when assessing whether a claimed invention ("claim") is patentable in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The Court also stressed that patents will not be issued to a claim that simply recites a law of nature unless there are additional steps that ensure the claim is sufficiently tailored to not preempt further use of the natural law. The Court's decision shocked the patent law community. However, decisions by lower courts since have demonstrated that prometheus has not dramatically altered the landscape of patent eligibility analysis, though it has deeply impacted cases involving diagnostic medical therapeutic techniques. While the Court of Appeals for the Federal Circuit remains split as to how narrowly it will read prometheus, its forthcoming en banc opinion in CLS Bank Int'l v. Alice Corp. Pty. Ltd. will likely unify its interpretation of the case. In the meantime, following the lower court cases is the best approach to understanding how the patent law landscape has changed since the landmark case.

TABLE OF CONTENTS

Introduction..................................................................................556

I.Mayo Collaborative Services v. Prometheus Laboratories, Inc...................................................................558

A.History of the Case..........................................................558

B.The Supreme Court Finds Prometheus's Claim Patent Ineligible under § 101......................................................560

C.Dictum: Refusing to Change § 101 Jurisprudence...........561

II.Revolutionizing Patent Law or Confirming

Existing Cases?.....................................................................563

A."Machine or Transformation" Test and Additional Analysis Reaffirming Prior Precedent.............................565

B.How to Assess Patent Eligibility under § 101..................566

C.Redefining Patentability for Diagnostic Medical Method Claims................................................................569

Conclusion...................................................................................571

Practice Pointers...........................................................................571

INTRODUCTION

The United States' patent system incentivizes investment in discoveries that will benefit our society by ensuring that rightful inventors possess "the exclusive Right to their respective . . . Discoveries" for a certain period of time.(fn1) However, patent laws are also crafted to prevent patents from being granted when such patents would stifle scientific and technological progress. For that reason, a claimed invention must consist of patentable subject matter(fn2) and be novel,(fn3) nonobvious,(fn4) and fully and particularly described.(fn5)

Under 35 U.S.C. § 101, a patentable innovation is "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."(fn6) The United States Supreme Court has held that the use of "any" to modify such broad terms in § 101 demonstrated that Congress had "contemplated that patent laws would be given [a] wide scope."(fn7 )Arguably the united states patent and Trademark office has previously considered § 101 to be a mere formality(fn8) and this provision has seldom been the basis for rejecting a patent application, unless one of the judicially created exceptions applied.(fn9) Indeed, the judicially created exceptions to § 101-for claims that seek to patent "laws of nature, natural phenomena, and abstract ideas"(fn10)-have historically been the sole basis for rejecting a claim under § 101. Granting a patent to a claim falling within any of these three categories would "impede innovation more than it would tend to promote it" by preventing the free use of basic scientific and technological tools.(fn11)

In March 2012, however, the Supreme Court held in Mayo Collaborative Services v. Prometheus Laboratories, Inc. that a § 101 patentability analysis is the threshold inquiry in any determination of whether a patent is valid, and that a claim must contain a patent eligible concept to pass this threshold inquiry. Despite initial apprehension among commentators and practitioners that Prometheus would radically alter patent law, opinions by lower courts indicate that the case is being read narrowly so as to simply reiterate prior Supreme Court jurisprudence. The question remains open whether the united States Court of Appeals for the Federal Circuit will embrace or cabin the Prometheus holding. Section I of this Article summarizes the case history and the Supreme Court's reasoning in Prometheus. Section II discusses how lower courts' interpretations of Prometheus have affected the patent eligibility landscape.

I. MAYO COLLABORATIVE SERVICES V. PROMETHEUS LABORATORIES, INC.

In Prometheus, the Supreme Court considered whether a method for optimizing the dosage of a drug constituted patentable subject matter and found that in this particular case it was not. After reaching this conclusion, the Court reaffirmed that the "machine or transformation test" previously espoused by the Federal Circuit was not solely determinative of patent eligibility, and rejected attempts by the patent law community and the U.S. government to render § 101 a mere formality in assessing a claim.(fn12) As will be discussed below, it is debatable whether this analysis was pertinent to the holding or merely dictum.

A. History of the Case

At issue in the case were Prometheus's patent claims directed to a method of optimizing the dosage of thiopurine drugs, which are used to treat Crohn's disease.(fn13) The claims first directed a medical professional to administer the thiopurine drug to the patient.(fn14) Then, they suggested that the medical professional measure the level of thioguanine metabolites in the patient's blood.(fn15) Finally, in light of the level of the thioguanine metabolites found in the patient's blood, the claims directed that the dosage of thiopurine be adjusted according to Prometheus's guidelines to achieve an optimal dosage.(fn16) Mayo Clinic Rochester and Mayo Collaborative Services used Prometheus's patented test until 2004 when it announced its intention to sell its own, slightly different version of the test.(fn17) Prometheus subsequently sued for patent infringement.(fn18)

The district court agreed with Mayo that Prometheus's patent was ineligible because it sought to patent laws of nature, specifically the correlation between metabolite and the efficacy and dangers of thiopurine dosages.(fn19)

The Federal Circuit reversed, finding that the claim satisfied the "machine or transformation" test and was sufficiently narrow in scope.(fn20) Courts have traditionally applied the "machine or transformation test" to determine if a claim was patent eligible. Under this test, a claimed process satisfies § 101 "if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing."(fn21) In this case, Prometheus's claim "involve[d] the transformation of the human body or of blood taken from the body."(fn22)

The Supreme Court granted certiorari and then remanded the case to the Federal Circuit for consideration of the Court's recent holding in Bilski v. Kappos.(fn23) In that case, the Supreme Court held that the "machine or transformation" test is merely an important consideration in the § 101 inquiry that is to be used as a secondary tool only after assessing the claim in light of prior precedent.(fn24 )Even in light of Bilski, the Federal Circuit again found Prometheus's claim to be patent eligible because it did "not encompass laws of nature or preempt natural correlations."(fn25) The Supreme Court then granted certiorari once more in Prometheus..(fn26)

B. The Supreme Court Finds Prometheus's Claim Patent Ineligible under § 101

The Supreme Court began its opinion with two premises that underlie the patent system. First, judicially created exceptions for laws of nature, physical phenomena, and abstract ideas are implicit in 35 U.S.C. § 101.(fn27) Claims that fall under these categ8ories are "'free to all men and reserved exclusively to...