What is the line dividing nature and patentable invention in life sciences and biotechnology? On January 13, 2020, the U.S. Supreme Court refused to answer this question by denying all pending petitions concerning patent eligibility.[i]
Under 35 U.S.C. § 101, patent eligibility is defined as “any new and useful process, machine, manufacture, or composition of matter,” but excludes discovery concerning the laws of nature, physical phenomena, as well as newly discovered naturally occurring plants and minerals from patent protection.[ii] Section 101’s impact on the future of biotechnology and life sciences sparked interest after a string of recent cases by the Supreme Court invoked this exclusion, and when Federal Circuits invalidated the vast majority of patents challenged for their subject matter eligibility.[iii] In 2012, the Supreme Court found in Mayo Collaborative Services v. Prometheus Laboratories, Inc. that a method of determining the proper and optimized dosage of a drug was patent-ineligible since it pertained to “the underlying laws of nature themselves.”[iv] Subsequently, the Court articulated a two-part test for determining patent eligibility in Alice v. CLS Bank.[v] According to the test, the Court must first examine whether the claim was directed to a patent-ineligible concept. If so, the Court then determines “whether the additional elements ‘transformed the nature of the claim’ into a patent-eligible application.”[vi]
Mayo and Alice established the precedent that patents involving a naturally-occurring phenomenon must produce something the court classifies as non-natural.[vii] Following these cases, the Supreme Court and Federal Circuits have progressively narrowed the types of claims which are patentable under Section 101[viii], despite groundbreaking and life-saving discoveries in the industry.[ix],[x] Such decisions risk invalidating thousands of diagnostic methods and DNA-related claims.[xi] In fact, the impact of these decisions was revealed when USPTO rejected 35% of such applications based on the Mayo precedent alone.[xii]
It is not surprising that biotechnology is especially susceptible to such invalidation, due to its close relationship to the natural phenomena and laws of nature that they rely on. In the biotechnology and life science industry, compositions of matter are unavoidably entangled with laws of nature.[xiii] The parameters of innovation derived from naturally existing circumstances are, therefore, uncertain.[xiv] Uncertainty surrounding what constitutes eligible subject matter have led to difficulty in applying the Supreme Court’s legal framework at the Federal Circuit and lower courts.[xv]
Many had hoped the Supreme Court would revisit and clarify the issue in recent pending cases such as Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc., and Athena Diagnostics, Inc. v. Mayo Collaborative Services. Vanda also addressed patent eligibility of claims, similar to Mayo, regarding a method of treating schizophrenia based on genotyping, but reached a different conclusion. Both Vanda and Mayo dealt with optimizing a patient’s dosage based on their ability to metabolize the drug. However, the Federal Circuit held the claims in Vanda patent-eligible because they “recite[ed] more than the natural relationship between the [gene] and the risk.[xvi] What exactly does this mean? According to the Federal Circuit, there was “an application of the relationship . . . [requiring] a treating doctor to administer iloperidone,”[xvii] unlike the claims in Mayo which merely recognized a need to alter the dose based on drug metabolism, without requiring doctors to use the natural relationship between drug metabolism and dosage.[xviii] Therefore, the Federal Circuit created a precedent that diagnostics may be patent-eligible as long as they include a method of treatment step.[xix] In Athena Diagnostics, Inc. v. Mayo Collaborative Services, the court considered a method of diagnosing a medical condition.[xx] The Federal Circuit was split on the application of Section 101 under Mayo.
Both cases received a great degree of attention among experts, and the United States Solicitor General filed an amicus brief urging the Supreme Court to deny certiorari in the case.[xxi] However, he agreed that the recent Supreme Court decisions departed from patent eligibility jurisprudence and urged the Supreme Court to review recent decisions and clarify the law as to patent eligibility, in a different case where the guidance would have a material effect on the outcome of the Section 101 analysis.[xxii]
However, while the Supreme Court followed the Solicitor General’s advice and denied certiorari in Hikma Pharmaceuticals USA Inc. v. Vanda Pharmaceuticals Inc., the Court also denied certiorari for all the major cases involving patent eligibility, including Athena Diagnostics, Inc. v. Mayo Collaborative Services. It seems that the Court is unwilling to settle the question of patent eligibility despite the uncertainty in the biotechnology and life sciences industry. Currently, there is little clarity and guidance on Section 101. For now, the Court’s message is clear; the responsibility is on Congress to clarify anything, if they so choose.
* Averyn Lee is an Associate Editor on the Michigan Technology Law Review.
[ii] Rebecca Lindhorst, Two-Stepping Through Alice’s Wasteland of Patent-Eligible Subject Matter: Why the Supreme Court Should Replace the Mayo/Alice Test, 69 Case W. Res. L. Rev. 731, 738 (2019).
[iii] Hallie Wimberly, The Changing Landscape of Patent Subject Matter Eligibility and Its Impact on Biotechnological Innovation, 54 Hous. L. Rev. 995, 1005 (2017). https://houstonlawreview.org/article/3928-the-changing-landscape-of-patent-subject-matter-eligibility-and-its-impact-on-biotechnological-innovation
[v] Mike Sikora, Mayo, Myriad, and A Muddled Analysis: Do Recent Changes to the Patentable Subject Matter Doctrine Threaten Patent Protections for Epigenetics-Based Inventions?, 102 Minn. L. Rev. 2229, 2234-35 (2018).
[vi] Alice Corp. Pty. Ltd., v. CLS Bank Int’l, 134 S. Ct. 2347, 2352 (2014).
[vii] Wimberly, supra note 3, at 1007.
[viii] Madison R. LeDuc, Patent Eligibility of Natural Products: A Growing Problem, 66 DRAKE L. REV. 229, 241 (2018); BRCA1 v. Ambry Genetics Corp., 774 F.3d 755, 763 (Fed. Cir. 2014).
[ix] Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).
[x] Sequenom, Inc. v. Ariosa Diagnostics, Inc., 136 S. Ct. 2511, 2511 (2016).
[xiii] Nicole Tudhope, Misunderstanding Biotechnology: Separating Laws of Nature from Underlying Technological Developments, 54 Willamette L. Rev. 587, 590 (2018).
[xv] Id. at 1015.
[xvi] Vanda Pharm. Inc. v. W.-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 1136 (Fed. Cir. 2018).
[xvii] Lindhorst, supra note 2, at 756.
[xviii] Lindhorst, supra note 2, at 756.