The Federal Circuit in HZNP Meds. LLC v. Actavis Labs. UT, Inc., 940 F.3d 680 (Fed. Cir. 2019) reiterated that the term “consisting essentially of” permits inclusion of components not listed in a claim, provided that they do not materially affect the basic and novel properties of the invention. Id. at 693. Importantly, the Federal Circuit also found that it was permissible for a District Court to both define the basic and novel properties of a formulation, and then to find that the term “consisting essentially of” was indefinite at the claim construction phase. Id. at 698-99. Thus, opening a viable avenue for indefiniteness challenges to claims for which the basic and novel properties are not specifically defined in the patent specification. Whether the District Courts will pick up the mantle set in HZNP Meds. waits to be seen. However, District Judge Brian R. Martinotti, of the District of New Jersey, recently deferred ruling on the indefiniteness of “consisting essentially of” during claim construction so that the parties could develop a more complete record. Par Pharm., Inc. v. Sandoz, Inc., 2020 U.S. Dist. LEXIS 39776 (D. N.J. March 9, 2020). Sandoz even consented to this approach during the Markman hearing. Id. Judge Martinotti’s decision suggests that Sandoz should provide expert testimony in support of its assertion that the term “consisting essentially of” as used in claim 1 of U.S. Patent No. 9,375,478 is invalid as indefinite under 35 U.S.C. § 112, because the specification of does not disclose the basic and novel properties encompassed by claim. This ruling further implies that the claim construction phase of a Hatch-Waxman litigation, due to the potential need for expert testimony, is not the most opportune time to press a § 112 defense. And, as a practical matter, page limitations for a brief during claim construction also counsel that indefiniteness may be a fight better fought elsewhere. It seems likely, however, that the capacity for making out an indefiniteness defense at the claim construction phase of a case will depend on the specific claim and specific term.

ABOUT LYNN TERREBONNE

Lynn.Terrebonne@offitkurman.com | 267.338.1332

Lynn M. Terrebonne focuses her practice on complex patent litigation. She is an experienced first-chair trial attorney and leads Offit Kurman’s Hatch-Waxman Litigation Team. Lynn has led Hatch-Waxman teams in numerous cases many of which settled on favorable terms prior to trial. She also represents clients in litigations involving design patents, trademark and copyright infringement and the theft of trade secrets. Lynn has a unique combination of experience in both intellectual property and science. She spent eleven years carrying out interdisciplinary research at the University of Alabama at Birmingham (UAB) covering the fields of platelet physiology, protein chemistry, immunochemistry, and enzymology. Additionally, while at UAB she participated in the working group that discovered the gene responsible for Cystic Fibrosis.

ABOUT MICHAEL HOGAN

Michael.Hogan@offitkurman.com | 267.338.1333

Mike Hogan is a principal in Offit Kurman’s Philadelphia office and a member of the firms’ Intellectual Property Group. He practices intellectual property litigation and concentrates on complex patent litigation, primarily in the pharmaceutical and life science areas. Mike’s litigation experience has spanned other technology areas including biotechnology, medical and mechanical devices, and consumer electronics. He has also litigated design patent, trade secret, and copyright cases. Mike’s practice incorporates non-litigation components, including the freedom to operate, patent analysis and complex opinion work, all facilitated by bringing a litigation perspective to such patent scope, validity, and prosecution matters.

ABOUT PEI-RU WEY

PeiRu.Wey@offitkurman.com | 267.338.1337

Pei-Ru Wey’s primary focus is on patent prosecution and intellectual property (IP) litigation. In patent prosecution, Pei-Ru works closely with inventor-scientists to understand and realize the full potential of their inventions. Her experience spans medical, diagnostic, pharmaceutical, nutraceutical, chemical, and consumer product technologies.

Pei-Ru is also an experienced IP litigator, with a focus on Hatch-Waxman litigation. As a pharmacist-attorney, Pei-Ru combines her scientific knowledge and patient counseling experience to break down complex technology and IP legal concepts to target audiences.

Pei-Ru’s practice further includes patentability, freedom-to-operate, invalidity and noninfringement opinions across a range of technologies.

ABOUT R. TOUHEY MYER

touhey.myer@offitkurman.com | 302.351.0908

R Touhey Myer focuses his practice on litigating complex patent matters before the United States District Court for the District of Delaware. Additionally, Touhey practices before the USPTO, prosecuting patent, and trademark matters. Touhey has particular experience evaluating the market value of patent portfolios to determine the viability of litigation campaigns for his clients. Before joining Offit Kurman, Touhey served as an Assistant Solicitor for Montgomery County, Pennsylvania and Managing Partner of the Delaware Office for a boutique patent firm based in Philadelphia. An active member of the local intellectual property community, Touhey serves as the President-Elect for the Philadelphia Intellectual Property Law Association (PIPLA).

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