HZNP Fin. Ltd. v. Actavis Labs. UT, Inc.

Decision Date25 February 2020
Docket Number2017-2149, 2017-2152, 2017-2153, 2017-2202, 2017-2203, 2017-2206
Citation950 F.3d 867 (Mem)
Parties HZNP FINANCE LIMITED, Horizon Therapeutics USA, Inc., Plaintiffs-Appellants v. ACTAVIS LABORATORIES UT, INC., Defendant-Cross-Appellant
CourtU.S. Court of Appeals — Federal Circuit

ON PETITION FOR REHEARING EN BANC

Per Curiam.

ORDER

A petition for rehearing en banc was filed by appellants HZNP Finance Limited and Horizon Therapeutics USA, Inc. A response to the petition was invited by the court and filed by cross-appellant Actavis Laboratories UT, Inc. The petition for rehearing was first referred to the panel that heard the appeal, and thereafter, the petition for rehearing en banc and the response were referred to the circuit judges who are in regular active service. A poll was requested, taken, and failed.

Upon consideration thereof,

IT IS ORDERED THAT :

1) The petition for panel rehearing is denied.
2) The petition for rehearing en banc is denied.
3) The mandate of the court will issue on March 3, 2020.

Lourie, Circuit Judge, with whom Newman, O’Malley, and Stoll, Circuit Judges, join, dissenting from the denial of the petition for rehearing en banc.

I respectfully dissent from the court’s decision not to rehear this case en banc. I believe the panel majority, affirming the district court, has erroneously misconstrued the "consisting essentially of" language in evaluating the definiteness requirement of 35 U.S.C. § 112.

The petition for rehearing asserts that the panel erred in holding that the claims reciting "consisting essentially of" are indefinite because the basic and novel properties that the specification indicates the claimed composition possess are indefinite. I agree with the petition.

It is not disputed that "consisting essentially of" generally means that the composition not contain, in addition to its enumerated components, materials that materially affect the basic and novel properties of the invention. PPG Indus. v. Guardian Indus. Corp. , 156 F.3d 1351, 1354 (Fed. Cir. 1998). The majority here, affirming the district court, concluded that the claim was indefinite because of inconsistencies in the meaning of "better drying time."

However, better drying time is not in the claim, and it is the claims that the statute requires be definite. Claim 49 of U.S. Patent 8,252,838 ("the ’838 patent"), at issue, certainly is definite on its face. It reads:

49. A topical formulation consisting essentially of:
1–2% w/w diclofenac

sodium;

40–50% w/w DMSO;

23–29% w/w ethanol;

10–12% w/w propylene glycol;

hydroxypropyl cellulose; and

water to make 100% w/w,

wherein the topical formulation has a viscosity of 500–5000 centipoise.

’838 patent col. 30 ll. 60–67. It recites diclofenac

, the main active ingredient of the composition, three other specific excipients, all with precise and definite quantity ranges; one more excipient with no range; and the remainder consisting of water. Drying time is not recited.

The "consisting essentially of" language connotes that those specified are the claim’s essential ingredients, but it is not closed to others. The word "essential" is key. The possibility of inclusion of others, implied by the language at issue here, does not make what is recited and essential indefinite.

The utility of the claimed invention, recited in the specification, is as an anti-inflammatory, or analgesic, because those are the principal properties of diclofenac

, the main ingredient of the composition. The specification also indicates that the advantages of the claimed composition are better drying time, higher viscosity, increased transdermal flux, greater pharmacokinetic absorption, and favorable stability. ’838 patent col. 4 ll. 22–27. This disclosure informs the public about the nature of the claimed invention and may satisfy other requirements of § 112 as well as the utility requirement of § 101. These advantages are certainly relevant to showing that an invention has utility and may be important in overcoming a rejection for obviousness. But it is the language of the claims that must not be indefinite, not the understanding or clarity of an advantage of the invention. The advantages of the invention, its utility and its basic and novel properties, are not in the claims.

Aside from the specifics of "better drying time" in this case, the issue is of broader importance. Advantages of an invention recited in the specification or in the prosecution history, but not in the claims, are not part of the claims. Certainly the written description should be consulted to interpret claims, as they are drafted to be read together. See 35 U.S.C. § 112 (2010) ("The specification shall contain a written description of the...

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1 books & journal articles
  • Chapter §2.04 Claim Definiteness Requirement
    • United States
    • Full Court Press Mueller on Patent Law Volume I: Patentability and Validity Title CHAPTER 1 Basic Principles
    • Invalid date
    ...As detailed infra, Circuit Judge Lourie would later raise the same objection. See HZNP Medicines LLC v. Actavis Labs., Inc., 950 F.3d 867, 869 (Fed. Cir. 2020) (Lourie, J., dissenting from denial of rehearing en banc).[403] The HZNP majority cited two earlier Circuit decisions as additional......

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