Patent Claims "consisting Essentially Of"

• Jurisdiction: United States,Federal
• Citation: Vol. 45 No. 2
• Publication year: 2020
• Author: D. Benjamin Borson
• topic: Patent law,Federal,Civil Procedure

Patent Claims "Consisting Essentially Of"

D. Benjamin Borson

Borson Law Group P.C.

NZNP MEDS. LLC V. ACTAVIS LABS, UT, INC. 940 F.3D 680 (FED. CIR. 10 OCTOBER 2019), AND HZNP FINANCE LIMITED, HORIZON THERAPEUTICS USA, INC. V. ACTAVIS LABORATORIES UT, INC. SLIP. OP. 2017-2149, 2017-2152, 2017-2153, 2017-2202, 2017-2203, AND 2017-2206 (FED. CIR. 25 FEBRUARY 2020).

Introduction

These two decisions stem from a series of twelve patents assigned to Horizon Pharmaceuticals USA, Inc. ("Horizon"). In the first case, (940 F.3d 680), Horizon appealed from the U.S. District Court for the District of New Jersey's judgment of invalidity of the claims, and non infringement by Actavis Laboratories UT, Inc. ("Actavis") who had filed an Abbreviated New Drug Application (ANDA) under Hatch-Waxman. The patents in question relate to methods and formulations for treating osteoarthritis, and can be divided into two groups, methods claims and formulation claims. The method claims are of lesser importance to this article, and therefore, the focus of this article is on the formulation claims, and the denial of en banc review by the Fed. Cir. (Slip. Ops).

The formulation claims include claim 49 of U.S. Pat. No. 8,252,838 (the '838 patent) as shown below. Other formulation claims contain the "essentially consisting of" connector.

49. A topical formulation consisting essentially of:

1-2% w/w diclofenac sodium;
40-50% w/w DMSO;
23-29% w/w ethanol;
12-12% w/w propylene glycol;
hydroxylpropyl cellulose; and
water to make 100% w/w, wherein the topical formulation has a viscosity of 500-5000 centipoise.

After a Markman hearing, the district court found three terms in the asserted formulation claims to be indefinite, the one being important to this article is "consisting essentially of." After holding the term to be indefinite, the district court ruled in favor of Actavis and granted their motion for summary judgment.

Federal Circuit Decision

On appeal to the Fed. Cir., Judges Prost, Newman, and Reyna filed their decision. Writing for the majority of the panel, Judge Reyna stated:

The district court found that the term "consisting essentially of" was indefinite. In that regard, the district court began by recognizing that the phrase "consisting essentially of," when used in a formulation patent, reflects that the recited formulation includes (a) the listed ingredients that follow the phrase, and (b) unlisted ingredients that do not materially affect the basic and novel properties of the invention (citing PPG Industries v. Guardian Industries Corp. 156 F.3d 1351, 1354 (Fed. Cir 1998). Because the parties disputed the basic and novel properties, the district court determined that in this case identification of those properties was required. The district court therefore concluded that "because the basic and novel properties of an invention are part of the construction of a claim containing the phrase "consisting essentially of," the Nautilus standard applies to the assessment of an invention's basic and novel properties (citing Nautilus, Inc. v. Biosig Instruments Inc. 572 U.S. 898, 910 ("Nautilus" 2014); 940 F.3d at 684-685; emphasis added.

Citing Judge Reyna's comments, under the Nautilus standard, "a claim is invalid for indefiniteness if its language, read in light of the specification and prosecution history fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention." 572 U.S. 898, 901; emphasis added.

Because the basic and novel properties are important to the claim construction, Judge Reyna explained:

[Page 16]

[T]he district court noted that the specification identified five properties: (1) better drying time; (2) higher viscosity; (3) increased transdermal flux; (4) greater pharmacokinetic

...