Definitely Consisting Essentially Of: Basic and Novel Properties Must Be Definite Under 35 U.S.C. §112
| November 15, 2019
HZNP Medicines, LLC, Horizon Pharma USA, Inc. v. Actavis Laboratories UT, Inc.
October 15, 2019
Before: Prost, Reyna and Newman; Opinion by: Reyna; Dissent-in-part by: Newman
Summary: Horizon appealed a claim construction that the term “consisting essentially of” was indefinite. The district court evaluated the basic and novel properties under the Nautilus definiteness standard and found that the properties set forth in Horizon’s specification where indefinite. Horizon maintained this was legal error. The CAFC found that having used the phrase “consisting essentially of,” Horizon thereby incorporated unlisted ingredients or steps that do not materially affect the basic and novel properties of the invention. They asserted that a drafter cannot later escape the definiteness requirement by arguing that the basic and novel properties of the invention are in the specification, not the claims. Newman dissents, noting that no precedent has held that “consisting essentially of” composition claims are invalid unless they include the properties of the composition in the claims and that the majority’s ruling “sows conflict and confusion.”
Details:
- Background
HZNP Medicines, LLC, Horizon Pharma USA, Inc (“Horizon”) owns a series of patents directed to a methods and compositions for treating osteoarthritis. Actavis Laboratories UT, Inc (“Actavis”) sought to manufacture a generic version. Horizon sued Actavis for infringement in the District of New Jersey. Most of Horizon’s claims were removed by Summary Judgment on multiple issues. One claim survived to trial and was found valid and infringed. The CAFC taking up the appeal and cross-appeal on a number of issues (induced infringement, obviousness of a modified chemical formula and indefiniteness) affirmed the District Court.
This paper focuses on the ruling that Horizon claims using the “consisting essentially of” transitional phrase where invalid based on the basic and novel properties being indefinite under 35 U.S.C. §112.
- The CAFC’s Decision
Several of the claims in the Horizon patents recited a formulation “consisting essentially of” various ingredients. Claim 49 of the ’838 patent was used as the example.
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.
The claims had been found invalid by the District Court under Summary Judgement following a Markman hearing. The parties’ dispute focused on the basic and novel properties of the claims. The CAFC agreed with the District Court that these properties are implicated by virtue of the phrase “consisting essentially of,” which allows unlisted ingredients to be added to the formulation so long as they do not materially affect the basic and novel properties.
The district court held that the specification of the patents identified five basic and novel properties: (1) better drying time; (2) higher viscosity; (3) increased transdermal flux; (4) greater pharmacokinetic absorption; and (5) favorable stability. Further, the district court reviewed the characteristics and found that at least “better drying time” was indefinite because the specifications provided two separate manners of determining drying time which were inconsistent. Based thereon, they concluded that the basic and novel properties of the claimed invention were indefinite under Nautilus.
The CAFC evaluated whether the Nautilus definiteness standard applies to the basic and novel properties of an invention. Horizon had argued that the Nautilus definiteness standard focuses on the claims and therefore does not apply to the basic and novel properties of the invention. The majority found this argument to be “misguided” and asserted that by using the phrase “consisting essentially of” in the claims, the inventor in this case incorporated into the scope of the claims an evaluation of the basic and novel properties.
The use of “consisting essentially of” implicates not only the items listed after the phrase, but also those steps (in a process claim) or ingredients (in a composition claim) that do not materially affect the basic and novel properties of the invention. Having used the phrase “consisting essentially of,” and thereby incorporated unlisted ingredients or steps that do not materially affect the basic and novel properties of the invention, a drafter cannot later escape the definiteness requirement by arguing that the basic and novel properties of the invention are in the specification, not the claims.
They supported this position by noting that a patentee can reap the benefit of claiming unnamed ingredients and steps by employing the phrase “consisting essentially of” so long as the basic and novel properties of the invention are definite.
In evaluating the district courts finding of indefiniteness, the CAFC maintained that two questions arise when claims use the phrase “consisting essentially of.” The first focusing on definiteness: “what are the basic and novel properties of the invention?” The second, focusing on infringement: “does a particular unlisted ingredient materially affect those basic and novel properties?” The definiteness inquiry focuses on whether a person of ordinary skill in the art (“POSITA”) is reasonably certain about the scope of the invention. If the POSITA cannot as-certain the bounds of the basic and novel properties of the invention, then 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. Keeping with this logic, the CAFC maintained that to determine if an unlisted ingredient materially alters the basic and novel properties of an invention, the Nautilus definiteness standard requires that the basic and novel properties be known and definite.
Hence, the CAFC concluded that the district court did not err in considering the definiteness of the basic and novel properties during claim construction.
The majority then looked to the specific finding of indefiniteness by the district court regarding the basic and novel property of “better drying time.” They noted that the specification discloses results from two tests: an in vivo test and an in vitro test. The district court had found that the two different methods for evaluating “better drying time” do not provide consistent results at consistent times. Accordingly, CAFC affirmed the district court’s conclusion that the basic and novel property of “better drying rate” was indefinite, and consequently, that the term “consisting essentially of” was likewise indefinite.
In sum, we hold that the district court did not err in: (a) defining the basic and novel properties of the formulation patents; (b) applying the Nautilus definiteness standard to the basic and novel properties of the formulation patents; and (c) concluding that the phrase “consisting essentially of” was indefinite based on its finding that the basic and novel property of “better drying time” was indefinite on this record.
However, they noted that the Nautilus standard was not to be applied in an overly stringent manner.
To be clear, we do not hold today that so long as there is any ambiguity in the patent’s description of the basic and novel properties of its invention, no matter how marginal, the phrase “consisting essentially of” would be considered indefinite. Nor are we requiring that the patent owner draft claims to an untenable level of specificity. We conclude only that, on these particular facts, the district court did not err in determining that the phrase “consisting essentially of” was indefinite in light of the indefinite scope of the invention’s basic and novel property of a “better drying time.”
Judge Newman’s Dissent
Judge Newman dissented. She asserted that the majority holding that “By using the phrase ‘consisting essentially of’ in the claims, the inventor in this case incorporated into the scope of the claims an evaluation of the basic and novel properties” is not correct as a matter of claim construction, it is not the law of patenting novel compositions, and it is not the correct application of section 112(b).
First, she noted that there is no precedent that when the properties of a composition are described in the specification, the usage “consisting essentially of” the ingredients of the composition invalidates the claims when the properties are not repeated in the claims.
Second, in regard to the specifics of “drying time” for the case at hand, she noted that whatever the significance of drying time as an advantage of the claimed composition, recitation and measurement of this property in the specification does not convert the composition claims into invalidating indefiniteness because the ingredients are listed in the claims as “consisting essentially of.”
The role of the claims is to state the subject matter for which patent rights are sought. The usage “consisting essentially of” states the essential ingredients of the claimed composition. There are no fuzzy concepts, no ambiguous usages in the listed ingredients. There is no issue in this case of the effect of other ingredients…
Noting that there was no evidence that a POSITA would not understand the components of the composition claims with reasonable certainty, Newman concluded that since in the current case there are no other components asserted to be present, no “unnamed ingredients and steps” that even adopting the construction taken by the majority the claims are not subject to invalidity for indefiniteness.
Takeaways:
Added caution must be taken by patent prosecutors when electing to use the transitional phrase “consisting essentially of”. The specification needs to be clear as to what the basic and novel properties are and how they are determinable.
When using “consisting essentially of” incorporating the properties that are considered to be basic and novel into the claim language may help prevent ambiguity.
Tags: 35 U.S.C. §112 > basic and novel properties > consisting essentially of > definiteness
The Definiteness Standard for AIA Trials is Still Undecided
| June 7, 2018
Tinnus Enterprises LLC v. Telebrands Corp.
May 30, 2018
O’Malley, Wallach and Hughes. Opinion by O’Malley.
Summary:
This case is an appeal from a final decision from the PTAB in a Post-Grant Review (“PGR”) finding that the claims in U.S. Patent No. 9,051,066 are indefinite applying the In re Packard standard for definiteness. Tinnus Enterprises LLC (“Tinnus”) argued that the Nautilus standard for definiteness is the proper standard, but that the claims are definite under either standard. The CAFC declined to decide which definiteness standard is correct for a PGR at the USPTO. The CAFC instead held that the claims are definite under either standard, and thus reversed the PTAB’s decision of invalidity due to indefiniteness.
