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 MICHAEL HOGAN
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 R. TOUHEY MYER
email@example.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).
ABOUT OFFIT KURMAN
Offit Kurman is one of the fastest-growing full-service law firms in the United States. With 14 offices in seven states, and the District of Columbia, and growing by 50% in two years through expansions in New York City and Charlotte, North Carolina, Offit Kurman is well-positioned to meet the legal needs of dynamic businesses and the individuals who own and operate them. For over 30 years, we’ve represented privately held companies and families of wealth throughout their business life cycles.
Whatever and wherever your industry, Offit Kurman is the better way to protect your business, preserve your family’s wealth, and resolve your most challenging legal conflicts. At Offit Kurman, we distinguish ourselves by the quality and breadth of our legal services—as well as our unique operational structure, which encourages a culture of collaboration and entrepreneurialism. The same approach that makes our firm attractive to legal practitioners also gives clients access to experienced counsel in every area of the law.
Find out why Offit Kurman is The Better Way to protect your business, your assets and your family by connecting via our Blog, Facebook, Twitter, Instagram, YouTube, and LinkedIn pages. You can also sign up to receive LawMatters, Offit Kurman’s monthly newsletter covering a diverse selection of legal and corporate thought leadership content.
DELAWARE | MARYLAND | NEW JERSEY | NEW YORK | NORTH CAROLINA | PENNSYLVANIA | VIRGINIA | WASHINGTON, DC