This article originally was published byIP Watchdog. Introduction We wrote earlier about the Supreme Court’s renewed interest in patent eligibility and seemingly unintended confusion between the patent eligibility requirements of 35 U.S.C. § 101 and the remaining patentability requirements under Title 35. To paraphrase Judge Rich, whether we lawyers would take advantage of terminology available to us and stop talking nonsense is up to us. Principles of Patentability, Geo. Wash. L. Rev., 28(2), 393-407, 407 (1960).

Absent that, this framework stays as the highest law of our land.”In addition to discussing the current case law, based on her law review article, “Unconstitutional Application of 35 U.S.C. 101 by the U.S. Supreme Court” (included in full with her written testimony), she urged support for the draft bill not only based on the legal analysis, but also on her assertion that R&D on isolated natural products as medicines declined “after Myriad and will continue to stall until Myriad is abrogated.” She concluded in a highly personal manner stating that, as a breast cancer survivor saved by a nature-based antibiotic, “If Mayo/Myriad had been the law years ago, I would not be giving testimony to the subcommittee because I almost certainly would have died.”

And if we only consider final written decisions, the number is 83%.On the appeals side, the latest published appeal data for fiscal year 2022 indicates that the PTAB affirmed examiners 55.6% of the time, and affirmed examiners in part 9.1% of the time. Still, there has been growing anecdotal evidence that appeals of rejections made on grounds of subject matter eligibility -- addressing the requirements of 35 U.S.C. § 101 as interpreted by the courts -- had abysmally low win rates for applicants. Indeed, Professor Dennis Crouch published a short blog post stating that the PTAB affirmed examiners a whopping 92% of the time for § 101 appeals decided in the June/July 2021 time frame.If true, this statistic should give us pause -- applicants should be aware that their chances of winning a § 101 appeal are somewhere around that of the proverbial snowball in Hell.

Ariosa’s Petition: An Accused Infringer’s PerspectiveAs its primary focus, Ariosa’s petition argues that in the 2013 Myriad case, the Supreme Court laid down the clear rule that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Ariosa leads off its introduction section with an entire paragraph devoted to the teaching of Myriad:Seven years ago, this Court held that isolated DNA is not patent eligible under 35 U.S.C. § 101. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580 (2013). The Myriad Court explained that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”

[Co-author: Rebecca Estrada, Ph.D.]Case Summary On March 17, 2020, the Federal Circuit found that patents claiming methods of preparing an extracellular fraction of cell-free DNA that is enriched in fetal DNA were patent eligible and not invalid under 35 U.S.C. §101 even though it was a “natural phenomenon” that this fetal DNA could be separated and amplified based on its size.Best Practices Based on the majority’s reasoning, life sciences claims that would ordinarily be drafted as methods to diagnose or detect disease should be converted to methods of preparing samples or even methods of treatment, if possible, in order to survive invalidity for claiming a natural phenomenon under Section 101.Future Developments Expect continued debate by the Federal Circuit.

The first part of the series – looking at IP issues currently pending before the Supreme Court – can be found below.In this second part of the series, we look at possible developments in the law of patent eligibility under 35 U.S.C. § 101. Since the Supreme Court’s decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), patent eligibility has likely been the single most confounding and controversial issue in the area of patent law.

The first part of the series – looking at IP issues currently pending before the Supreme Court – can be found here.In this second part of the series, we look at possible developments in the law of patent eligibility under 35 U.S.C. § 101. Since the Supreme Court’s decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014), patent eligibility has likely been the single most confounding and controversial issue in the area of patent law.

To Be Patentable Under § 101, a Process Must Be Tied to a Machine or Transform an Article into a Different State or Thing 07-1130 October 30, 2008 Arner, Erika Harmon Decision, en bancLast Month at the Federal Circuit - November 2008Judges: Michel (author), Newman (dissenting), Mayer (dissenting), Lourie, Rader (dissenting), Schall, Bryson, Gajarsa, Linn, Dyk (concurring), Prost, Moore [Appealed from: Board] In In re Bilski, No. 07-1130 (Fed. Cir. Oct. 30, 2008) (en banc), the Federal Circuit affirmed the decision of the Board, finding that the method claims in Bernard L. Bilski and Rand A. Warsaw’s (collectively “Bilski”) patent application were not directed to statutory subject matter under 35 U.S.C. § 101. In doing so, the Court noted that the machine-or--transformation test is the test that should be used to determine whether a process claim is drawn to statutory subject matter.

The hopes of anyone in favor of patent reform targeting 35 U.S.C § 101 have been officially dashed -- or at least put on hold. In an interview with the Intellectual Property Owner's association (IPO) last week, Senator Thom Tillis, Chair of the Senate's Subcommittee on Intellectual Property, indicated that the body would not be completing its work on legislatively addressing patent eligibility.

It is the latter functionality that was the focus of the majority opinion from Judges Prost and Taranto, and the perceived nature of this functionality ultimately doomed the claims.In Alice, the Supreme Court set forth a two-part test to determine whether claims are directed to patent-eligible subject matter under 35 U.S.C. § 101. One must first decide whether the claim at hand involves a judicially-excluded law of nature, a natural phenomenon, or an abstract idea.