Four Judges Dissent from CAFC Denial of Rehearing in Generic Osteoarthritis Drug Case

“Advantages of an invention recited in the specification or in the prosecution history, but not in the claims, are not part of the claims…. The advantages of an invention and disclosure of how to make and use an invention are not to be incorporated into claims for purposes of evaluating their indefiniteness.” – CAFC Judge Lourie dissent

denied - U.S. Court of Appeals for the Federal Circuit (CAFC) today denied HZNP Medicines LLC’s (Horizon’s) request for rehearing in HZNP Medicines LLC v. Actavis Laboratories UT, Inc., with Judges Newman, O’Malley, Stoll and Lourie dissenting. Judge Lourie, writing for the dissent, said that the Court “has erroneously misconstrued the ‘consisting essentially of’ language in evaluating the definiteness requirement of 35 U.S.C. § 112” and that rehearing en banc should have been granted.

In October, the CAFC affirmed the U.S. District Court for the District of New Jersey’s findings of invalidity and noninfringement of certain claims of some of the asserted Horizon patents, as well as the district court’s finding of nonobviousness of one claim of another Horizon patent. Judge Newman dissented in that decision, saying that “The majority’s new ruling sows conflict and confusion” and that it could “cast countless patents into uncertainty.”

The October decision meant that  Actavis, owned by generic drug maker Teva Pharmaceuticals, was enjoined from engaging in the commercial use, offer for sale, or sale of its product covered in its Abbreviated New Drug Application (ANDA) until the expiration of U.S. Patent No. 9,066,913 (the ‘913 patent) in 2027.

In its analysis, the CAFC addressed the district court’s ruling of indefiniteness of Horizon’s claims. Under Nautilus, Inc. v. Biosig Instruments, Inc., the Supreme Court determined that a claim is invalid for indefiniteness if its language, read in light of the specification and prosecution history, fails to reasonably inform those skilled in the art about the scope of the invention.


In this case, the CAFC said in part that the phrase “consisting essentially of” referenced in Claim 49 of Horizon’s U.S. Patent No. 8,252,838, which demonstrates the use of the asserted claims of the formulation patent group, was indefinite because the patent listed two methods to achieve better drying time with inconsistent results, therefore preventing the POSITA from having reasonable certainty about the scope of the basic and novel properties of the invention, and thereby rendering the term “consisting essentially of” indefinite under the Nautilus standard.

The Court referenced PPG Industries and AK Steel in holding that courts evaluating claims that use the phrase “consisting essentially of” may ascertain the basic and novel properties of the invention at the claim construction stage, and then consider if the intrinsic evidence establishes what constitutes a material alteration of those properties. Therefore, if a POSITA cannot ascertain the bounds of the basic and novel properties of the invention, there is no basis upon which to ground the analysis of whether an unlisted ingredient has a material effect on the basic and novel properties.

In the dissent issued with today’s order, Judge Lourie wrote: “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.”

He continued:

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 invention . . . [and] shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”). But the advantages of an invention and disclosure of how to make and use an invention are not to be incorporated into claims for purposes of evaluating their indefiniteness. It is the language of the claims that determines their definiteness.

Ultimately, said Lourie, “the principle of importing an uncertainty in measuring an advantage of an invention could have unintended potential effects well beyond this particular case. It should not be sound precedent.”

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Join the Discussion

2 comments so far.

  • [Avatar for EG]
    February 27, 2020 07:14 am

    Hey Gene,

    The dissent and Judge Newman are correct that the term “consisting essentially of” has a well-established meaning. That the rest of the Federal Circuit says otherwise is a disgrace.

  • [Avatar for TFCFM]
    February 26, 2020 11:27 am

    I can’t decide whether I’d side with the majority or the dissent in this particular instance.

    On the one (majority) hand, if “drying time” is the one variable that corresponds to the property that must not be affected by a composition “consisting essentially of” the listed ingredients in order to infringe, then the majority is clearly right that if there is no way to determine “drying time,” then the claim has no determinable meaning and is indefinite.

    One the other (dissenting) hand, the majority’s analsys is valid ONLY if “drying time” is the One True Determinative Property that so distinguishes infringing compositions from non-infringing ones. I have not delved deeply enough into the case to determine whether I agree that “drying time” is the One-And-Only Truly Relevant Variable, and I do not plan to.

    Regardless, the point of this comment is that the entire dispute could have been avoided through better application preparation. When one plans to (or plans potentially to) rely on a claim that includes a “consisting essentially of” transition, YOU SIMPLY KNOW that the this issue threatens to arise. Unless you’re trying deliberately to be vague as to what is and is-not your invention, specify which property(ies) of a composition that you will claim make it your invention, as well as ensuring that their either is an art-established way of unambiguously determining those property(ies) or that you have clearly specified such a way.

    Client schedules and budgets surely sometimes limit the care that can be lavished on an application. Nonetheless, this seems a fundamental point for practitioners who practice in arts in which ‘partially-open’ claim transitions are common. Support in one’s specification for “what does ‘consisting essentially of’ mean” (whether explicit or easy-to-recognize-even-though-implicit) ought to be present in every such application.