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Life Sciences: Strategies for Overcoming Early Litigation Challenges to Patent Eligibility

April 27, 2022 (3 min read)

By: Michael Furrow and Shannon Clark, Fitzpatrick, Cella, Harper & Scinto                                               


Section 101 of the Patent Act provides: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101. The Supreme Court has held that this section contains an important implicit exception for laws of nature, natural phenomena, and abstract ideas. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014); see also Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 70 (2012).

The U.S. Court of Appeals for the Federal Circuit has expressed that patent eligibility is a threshold issue of law that may be amenable to resolution through an early dispositive motion, thereby minimizing unnecessary burdens on the parties and the court. See, e.g., Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373–75 (Fed. Cir. 2015); Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 717–19 (Fed. Cir. 2014); OIP Techs., Inc. v., Inc., 788 F.3d 1359, 1364 (Fed. Cir. 2015) (Mayer, J., concurring).

This article considers strategies that you as the patentee may utilize when facing patent eligibility challenges early in litigation. Although much of the content is generalizable, special attention is given to inventions in the life sciences. When § 101 challenges arise in the life sciences arena, the claims commonly in focus are those directed to methods or tools for analysis of biological samples, compositions of matter based on naturally occurring materials, or methods of treatment using compositions that are asserted to be naturally occurring.

Two-Step Alice Framework

Following the Supreme Court’s decision in Alice Corp., there has been a significant increase in the number of patents challenged under § 101. Courts follow a two-step framework when “distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those claiming patent-eligible applications of those concepts.” 134 S. Ct. at 2355 (citing Mayo, 566 U.S. at 77–80). At step one, courts must determine “whether the claims are directed to one of those patent-ineligible concepts.” Id. If they are, courts must consider the elements of each claim both individually and “as an ordered combination” to determine whether additional elements transform an abstract idea into a patent-eligible invention. Id. This second step is equated with “a search for an ‘inventive concept’—i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself’.” Id. (citing Mayo, 566 U.S. at 72–73).

To read the full practice note in Lexis Practice Advisor, follow this link.

Michael Enzo Furrow is a partner with Fitzpatrick, Cella, Harper & Scinto. His experience with and understanding of the challenges innate to discovery in the pharmaceutical and biotechnology fields fuel his passion to enforce and defend life sciences patents. He has represented innovators across these industries in high-stakes patent disputes both in Federal Court and before the U.S. Patent and Trademark Office, concerning drugs or biologics for treating HIV/AIDS, Alzheimer’s disease, breast cancer, prostate cancer, bacterial infection, epilepsy, and various endocrine, vascular and gastrointestinal diseases, as well as genetically modified animals. Shannon Clark is an associate with Fitzpatrick, Cella, Harper & Scinto.

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