Patent Eligibility Remains Uncertain — Especially for the Life Sciences — Even After Recent Federal Circuit Decisions and Efforts By the USPTO to Bring Clarity

Section 101 specifies four categories of inventions or discoveries that are eligible for patent protection: processes; machines; manufactures; and compositions of matter. 35 U.S.C. §101. In its earlier decisions, the Supreme Court explained that "[i]n choosing such expansive terms … modified by the comprehensive 'any,' Congress plainly contemplated that the patent laws would be given wide scope[,]" and a categorical rule denying patent protection for "inventions in areas not contemplated by Congress … would frustrate the purposes of the patent law." Diamond v. Chakrabarty, 447 U.S. 303, 308, 315 (1980). But in its subsequent ground-breaking decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), follow-up cases involving DNA — such as, Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and more recently, Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), cert. denied, 136 S. Ct. 2511 (June 27, 2016) — the Supreme Court has changed course on the scope of patentability and generated substantial controversy and uncertainty. The resulting conflict between incentivizing invention and setting boundaries on eligible subject matter has resulted in uncertainty for all participants in the patent system.

Six Years After Mayo, Uncertainty Remains.

In the life sciences area, Alice/Mayo have created a "bumpy road ahead for pharmaceutical and diagnostic inventors in obtaining patent protection for their discoveries." Megan Thobe, A Call To Action: Fixing The Judicially-Murkied Waters Of 35 U.S.C. §101, 50 Ind. L. Rev. 1023, 1048 (2017). "[T]he broad application of the newly created exceptions to patentability has damaged many innovators[,] … provoked uncertainty in entire industries[,] … [and] 'seems to lead to the reduction ad absurdum that most biotechnology processes are patent-ineligible.'" Naira Rezende Simmons, Why The Supreme Court Should Use Ariosa v. Sequenom To Provide Further Guidance On 35 U.S.C. §101 Patent Eligibility, 16 Chi.-Kent J. Intell. Prop. 112, 115-116 (2016). The trend after Alice/Mayo has placed patent rights at risk, while reducing the incentives and capital needed for innovation. Paul R. Michel, The Impact of Bad Patents on American Business, Testimony, House Judiciary Committee at 5 (July 13, 2017). Uncertainty "is choking off funding for bio-tech firms just when they are on the cusp of breakthrough discoveries that would revolutionize human health and longevity." Id. "[T]he law has created unacceptable chaos for inventors, innovators, business, and investors. Legal chaos is the exact opposite of what the U.S. economy needs." Paul R. Michel, The Impact of Bad Patents on American Business, Supplemental Testimony, House Judiciary Committee at 18 (Sep. 12, 2017). And by excluding important and life-saving discoveries, the current Section 101 jurisprudence may chill innovation to the detriment of scientific development and public health needs. Bilski v. Kappos, 561 U.S. 593, 613 (2010) (Stevens, J., concurring).

After Mayo, courts struggled to apply Section 101, particularly in the life sciences. In Smart Sys. Innovations, LLC v. Chicago Transit Authority, 873 F.3d 1364, 1377 (Fed. Cir. 2017) (Linn, J., dissenting), Judge Linn lamented that the Section 101 test "is indeterminate and often leads to arbitrary results." He cautioned that "the danger of getting the answers to these questions wrong is greatest for some of today's most important inventions in computing, medical diagnostics, artificial intelligence, the Internet of Things, and robotics, among other things." Id. at 1378; see also, BASCOM Global Internet Servs., Inc. v. AT&T Mobility LLC, 827 F.3d 1341, 1353 (Fed. Cir. 2016) (Newman, J., concurring) ("[T]he emphasis on eligibility has led to erratic implementation in the courts.").