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Vectura Limited v. Glaxosmithkline LLC

United States District Court, D. Delaware

October 1, 2018

VECTURA LIMITED, Plaintiff,
v.
GLAXOSMITHKLINE LLC and GLAXO GROUP LIMITED, Defendants.

          Kelly E. Farnan, Christine D. Haynes, RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Dominick A. Conde, Christopher B. Borello (argued), Brendan M. O'Malley (argued), Michael P. McGraw, Damien N. Dombrowski, FITZPATRICK, CELLA, HARPER & SCINTO, New York, NY. Attorneys for Plaintiff.

          Jack B. Blumenfeld, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Martin J. Black, Kevin M. Flannery (argued), Robert Ashbrook, Sharon K. Gagliardi, DECHERT, LLP, Philadelphia, PA; Blake B. Greene (argued), DECHERT LLP, Austin, TX. Attorneys for Defendants.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE:

         Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent Nos. 8, 303, 991 ("the '991 patent") and 8, 435, 567 ("the '567 patent"). The Court has considered the Parties' Joint Claim Construction Brief. (D.I. 82). The Court heard oral argument on May 21, 2018. (D.I. 106 ("Tr.")). The Court heard expert testimony on September 10, 2018. ("Exp. Tr." (transcript not yet docketed)).

         I. BACKGROUND

         The patents-in-suit "relate to pharmaceutical compositions for inhalation and methods of making them." (D.I. 82 at 1).

         The parties originally presented claim construction disputes for U.S. Patent No. 8, 956, 661 ("the '661 patent"). (D.I. 82 at 1 n.l). However, Plaintiff has since stated that it will not assert the '661 patent. (D.I. 117 at 1). Plaintiff nonetheless indicates that several terms which appear in the '661 patent "may remain in the case depending on the Court's construction of the claim terms in" the '991 and '567 patents. (Id. at 2).

         The '991 and '661 patents share a specification, and derive from the same parent application. (D.I. 82 at 1 n.l). The '567 patent contains a distinct specification, and derives from a different parent application. (Id.).

         Independent claim 1 of the '991 patent is representative, and reads as follows:

1. Composite active particles for use in a pharmaceutical composition for pulmonary administration, each composite active particle comprising a particle of active material and particulate additive material on the surface of that particle of active material, wherein the composite active particles have a mass median aerodynamic diameter of not more than 10 urn, and wherein the additive material promotes the dispersion of the composite active particles upon actuation of a delivery device.

('991 patent, claim 1) (disputed terms italicized). Claim 1 of the '567 patent is representative:

1. Microparticles for use in a pharmaceutical composition for pulmonary administration, comprising particles of an active substance having, on their surfaces, particles of a hydrophobic material suitable for promoting the dispersal of the active particles on actuation of an inhaler and suitable for delaying the dissolution of the active substance, wherein the hydrophobic material comprises one or more materials selected from the group consisting of hydrophobic amino acids, metal stearates, a C10 to C22 carboxylic acid, phospholipids, and derivatives thereof.

('567 patent, claim 1) (disputed terms italicized).

         II. LEGAL STANDARD

         "It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal quotation marks omitted). '"[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources 'in light of the statutes and policies that inform patent law.'" Soft View LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324) (alteration in original). When construing patent claims, a court considers the literal language of the claim, the patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed. Cir. 1995) (en banc), affd, 517 U.S. 370 (1996). Of these sources, "the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (internal quotation marks omitted).

         "[T]he words of a claim are generally given their ordinary and customary meaning. . . . [Which is] the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1312-13 (citations and internal quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). "In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words." Id. at 1314.

         When a court relies solely upon the intrinsic evidence-the patent claims, the specification, and the prosecution history-the court's construction is a determination of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015). The court may also make factual findings based upon consideration of extrinsic evidence, which "consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19. Extrinsic evidence may assist the court in understanding the underlying technology, the meaning of terms to one skilled in the art, and how the invention works. Id. Extrinsic evidence, however, is less reliable and less useful in claim construction than the patent and its prosecution history. Id.

         "A claim construction is persuasive, not because it follows a certain rule, but because it defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Osram GMBH v. Int'l Trade Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007) (citation omitted).

         III. TERMS FOR CONSTRUCTION

A. "composite active particle(s)" ('991) and "microparticles" ('567); "on the surface (of)" ('991) and "on their surfaces" ('567); "each composite active particle comprising a particle of active material and particulate additive material on the surface of that particle of active material" ('991) and "comprising particles of an active substance having, on their surfaces, particles of a hydrophobic material" ('567)[1]
1. Plaintiff's proposed construction ("composite active particles "): "[a] single particulate entit[y/ies] made up of a particle of active material to which one or more particles of additive material are fused"
2. Plaintiff's proposed construction ("each composite active particle comprising a particle of active material and particulate additive material on the surface of that particle of active material"): "where a composite active material is a single particulate entity made up of a particle of active material to which one or more particles of additive material are fused"[2]
3. Defendants 'proposed construction ("composite active particle(s) "): "particulate entities formed by milling a uniform blend of only additive particles and active particles (with or without liquid) using sufficient energy and duration to ensure sufficient break-up of agglomerates of both constituents, dispersal, and even distribution of additive over the active particles"
4. Defendants 'proposed construction ("each composite active particle comprising a particle of active material and particulate additive material on the surface of that particle of active material"): "each composite active particle comprising a particle of active material and particles of additive material irreversibly bound by fusing to the surface of the active particle, thereby forming a continuous coating or a discontinuous coating covering, on average, at least 50% of the total surface area of the active particles"
5. Court's construction ("composite active particles"): "[a] single particulate entit[y/ies] made up of a particle of active material to which one or more particles of additive material are fixed such that the active and additive particles do not separate in the airstream"
6. Court's construction ("each composite active particle comprising a particle of active material and particulate additive material on the surface of that particle of active material"): "where a composite active material is a single particulate entity made up of a particle of active material to which one or more particles of additive material are fixed such that the active and additive particles do not separate in the airstream"

         The parties agree that a "composite active particle" is "made up of a particle of active material to which one or more particles of additive material are fused." (D.I. 82 at 5). However, Defendants seek to read several additional limitations into the disputed limitations and seek to define the term "fused." (Id).

         First, Defendants argue that the intrinsic record establishes that Plaintiff clearly injected a "milling" requirement into the "composite active particles" limitation. (D.I. 82 at 11). Ordinarily, courts should not read process steps such as "milling" into composition claims. However, "process steps can be treated as part of a product claim if the patentee has made clear that process steps are an essential part of the claimed invention." Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1375 (Fed. Cir. 2007).

         Here, Defendants argue that Plaintiff made "milling" an essential part of the claimed invention by disclaiming non-milling processes for making "composite active particles" in both the patent specification and prosecution history. (D.I. 82 at 11-13).

         Plaintiff stated in the '991 patent Abstract, "The invention relates to a method for making composite active particles . . ., the method comprising a milling step .... The invention also relates to compositions for inhalation prepared by the method." (See, e.g., '991 patent at 1:9-12, 2:3-12, 2:35-44). But the disputed claims do not include a milling requirement. Rather, the milling method is separately claimed in the '661 patent, which shares a specification with the '991 patent. ('661 patent, claim 1). Defendants analogize Plaintiffs statements in the Abstract to statements made in Medicines Co. v. Mylan, Inc., 853 F.3d 1296 (Fed. Cir. 2017). (D.I. 82 at 13). There, the Federal Circuit concluded that a product claim requires the use of a process "because the specification's definition of [the claim term] by itself injects a ... process as a limitation in the asserted claims." Medicines, 853 F.3d at 1304. Here, on the other hand, the Abstract does not provide a "definition" of "composite active particles" that includes "milling." Rather, the patent plainly establishes that the relevant "invention" is a composition: "composite active particles for use in a pharmaceutical composition." ('991 patent at 11:44-55). Given that this specification enables both composition and method claims, ...


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