Biotechnology Patent Law Top Ten of 2018 - Broad Wins, Sovereignty Loses, and Patents Dance
60 Pages Posted: 10 Jul 2019 Last revised: 6 Aug 2019
Date Written: 2019
In this article, we discuss what we consider to be the ten important and influential biotechnology patent law judicial decisions of 2018. These hinged on a variety of patent doctrines. An abbreviated new drug application (ANDA) for the multiple sclerosis drug Ampyra set the stage for the Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2018) decision, in which the Court of Appeals for the Federal Circuit (Federal Circuit) provided guidance on how to conduct an obviousness analysis (35 U.S.C. §103). The Berkheimer v. HP Inc. (Fed. Cir. 2018) decision, although addressing a software invention, provided valuable insight into how to determine if inventions fall within patent-eligible subject matter (35 U.S.C. §101). Widely-anticipated by the branded and generic pharmaceutical industries, sovereign Native American nations, and consumers alike, the Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2018) decision held that tribal sovereign immunity could not be used to shield patents covering the drug Restasis in an inter partes review (IPR) proceeding before the Patent Trial and Appeal Board (PTAB). In Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018), the Federal Circuit found there to be no interference-in-fact between patents and patent applications covering CRISPR gene editing owned by the Broad Institute and the University of California. The United States Supreme Court (Supreme Court), in Oil States Energy Services, LLC. v. Greene’s Energy Group, LLC (2018), held that IPR proceedings violate neither Article III nor the Seventh Amendment of the United States Constitution, and, in SAS Institute Inc. v. Iancu (2018), further elaborated the law of IPRs by requiring the United States Patent and Trademark Office (“USPTO”) to produce a final written decision (FWD) on all claims challenged by a petitioner in an IPR petition. How to apply the written description requirement (35 U.S.C. §112) to patent claims covering monoclonal antibodies, as well as the requirements for granting a permanent injunction against infringing medicines or other therapeutic agents, were both the subject of the decision in Amgen Inc. v. Sanofi (Fed. Cir. 2017). The Supreme Court gave its first interpretation of the Biologics Price Competition and Innovation Act (BPCIA) for the approval of biosimilar drugs in Sandoz, Inc. v. Amgen, Inc. (2017), addressing, among other things, the disclosure and information exchange provisions of the statute, commonly known as the “patent dance” over Sandoz’ biosimilar of Amgen’s biologic, Neupogen. In contrast to cases where the Supreme Court deigned to act, the Court decided not to act in Regeneron Pharmaceuticals v. Merus (2018), denying a petition for certiorari to consider the law of inequitable conduct. In a decision of considerable importance, the Supreme Court considered, in Life Techs. Corp. v. Promega Corp. (2017), whether the supply of a single component, Taq polymerase, of a multi-component toolkit for genetic testing by DNA amplification, for combination abroad, violates 35 U.S.C. § 271(f)(1), reversing the Federal Circuit’s decision that it does, and remanding the case for further proceedings. Biotechnology patent law evolved in 2018 across a number of frontiers, and will certainly continue its doctrinal evolution in 2019.
Keywords: biotechnology, biotech, patent, obviousness, patentable subject matter, sovereign immunity, inter partes review, CRISPR, biosimilar, patent dance, inequitable conduct, infringement, combination invention
JEL Classification: K00, K11, K19, K20, K21, K23, K29, K32, K39, K40, K41, K42, K49, D42, I18, O3, O30, O31, O32, O33, O
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