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Galderma Laboratories L.P. v. Teva Pharmaceuticals USA, Inc.

United States District Court, D. Delaware

September 7, 2018

GALDERMA LABORATORIES L.P., GALDERMA S.A., and NESTLE SKIN HEALTH S.A., Plaintiffs,
v.
TEVA PHARMACEUTICALS USA, INC., Defendant.

          Jeremy A. Tigan, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Michael Wilson (argued), Jamil N. Alibhai (argued), Kelly P. Chen, and Chad Ray, MUNCK WILSON MANDALA, LLP, Dallas, TX Attorneys for Plaintiffs.

          Nathan R. Hoeschen, SHAW KELLER LLP, Wilmington, DE; Leora Ben-Ami (argued) and Justin Bova, KIRKLAND & ELLIS, LLP, New York, NY; Kristen Reichenbach (argued), KIRKLAND & ELLIS, LLP, San Francisco, CA. Attorneys for Defendant.

          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, 815, 816 (the '"816 Patent"), 8, 362, 069 (the '"069 Patent"), 9, 089, 587 (the '"587 Patent"), 9, 233, 117 (the '"117 Patent"), 9, 233, 118 (the '"118 Patent"), and 9, 782, 425 (the "'425 Patent"). (D.I. 110 at 1).

         The Court has considered the Parties' Joint Claim Construction Brief. (D.I. 110). The Court heard oral argument on August 22, 2018. (D.I. 120 ("Tr.")).

         I. 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) (citation 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.'" SoftView 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, 979-80 (Fed. Cir. 1995) (en banc), aff'd, 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.

         "[T]he words of a claim are generally given their ordinary and customary meaning. . . . [This 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. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 1321. "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 on 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 on 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.3dat 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).

         II. BACKGROUND

         Plaintiffs assert six patents from three patent families against Defendant. (D.I. 110 at 1). The '587 Patent, the' 117 Patent, the' 118 Patent, and the '425 Patent are members of the Jacovella patent family. (Id.). The patents relate generally to methods and compositions for topical treatment of rosacea with ivermectin.

         The parties dispute terms in claims 1 and 7 of the '069 Patent. This patent relates to "pharmaceutical compositions based on a compound of the avermectin family." ('069 Patent at 1:22-23). The following claim of the '069 Patent is representative:

1. A pharmaceutical/dermatological emulsion which comprises at least one fatty phase, at least one aqueous phase and at least one avermectin compound, said at least one fatty phase comprising at least one oily solvent other than a mineral ox plant oil, said avermectin compound being solubilized in said at least one oily solvent to form an active phase, said active phase being devoid of any solvent for said avermectin compound distinct from said at least one oily solvent; said emulsion consisting essentially of:
a. first fatty phase which is a solvent for the at least one avermectin compound, in an amount of from 0.01% to 25% by weight, said first fatty phase consisting essentially of at least one oily solvent selected from the group consisting of diisopropyl adipate, PPG 15 stearyl ether, octyl dodecanol, C12-C15 alkyl benzoate and mixtures thereof;
a second fatty phase which is not a solvent for the at least one avermectin compound, in an amount of up to 20% by weight, said second fatty phase consisting essentially of at least one member selected from the group consisting of silicone oils, mineral oils, stearyl alcohol, cetyl alcohol, waxes, butters and mixtures thereof;
at least one avermectin compound;
at least one emulsifier, in an amount of 1% to 8% by weight;
a gelling agent, in an amount of up to 5% by weight;
an aqueous phase, in an amount of from 50% to 75% by weight; and one or more additives selected from the group consisting of humectants, preservatives, anti-irritants, moisture regulators, pH regulators, osmotic pressure modifiers, UV-A and UV-B screens and antioxidants.

('069 Patent, claim 1) (disputed terms italicized).

         The parties dispute terms in claims 1, 2, and 11 of the '816 Patent. This patent relates to "formulation of ivermectin into topical pharmaceutical compositions useful for the treatment of rosacea." ('816 Patent at 1:50-53). The following claim of the '816 Patent is representative:

1. A method for treating rosacea, common acne, seborrheic dermatitis, perioral dermatitis, an acneform rash, transient acantholytic dermatitis or acne necrotica milliaris, comprising topically applying onto the affected skin area of an individual in need of such treatment, a topical pharmaceutical emulsion which comprises: a thus effective amount of ivermectin; an oily phase; at least one surfactant-emulsifier selected from the group consisting of polyoxyethylenated fatty acid esters and sorbitan esters; a mixture of solvents and/or propenetrating agents for the ivermectin, said solvents and/or propenetrating agents being selected from the group consisting of propylene glycol, ethanol, isopropanol, butanol, N-methyl-2-pyrrolidone, DMSO, polysorbate 80, phenoxyethanol, glyceryl triacetate and oleyl alcohol; one or more gelling agents but excluding aluminum magnesium silicate/titanium dioxide/silica; and water; said emulsion having lamellar layers of liquid crystals and being chemically stable over a period of 8 weeks.

('816 Patent, claim 1) (disputed terms italicized).

         The parties dispute terms in claims 1, 2, 7, 8, 10, 15, 23, and 29 of the '587 Patent. This patent relates to "a method of treating inflammatory lesions of papulopustular rosacea." ('587 Patent at 2:38-40). The following claim of the '587 Patent is representative:

1. A method of treating papulopustular rosacea or inflammatory lesions of rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea or the inflammatory lesions of rosacea a therapeutically effective amount of a pharmaceutical composition comprising about 0.1% to about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain an onset of a significant reduction in inflammatory lesion count in the subject 2 weeks after the initial administration of the pharmaceutical composition without co-administration of another active ingredient, wherein the subject has moderate to severe papulopustular rosacea or 10 or more of the inflammatory lesions before the treatment.

('587 Patent, claim 1) (disputed terms italicized).

         The parties dispute terms in claims 1, 5, and 6 of the '118 Patent. This patent relates to "a method of treating inflammatory lesions of papulopustular rosacea." ('118 Patent at 2:38-40). The following claim of the '118 Patent is representative:

1. A method of treating papulopustular rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea a therapeutically effective amount of a pharmaceutical composition comprising about 1% by weight ivermectin and a pharmaceutically acceptable carrier to thereby obtain a significant reduction in inflammatory lesion count in the subject.

('118 Patent, claim 1) (disputed terms italicized).

         The parties dispute terms in claims 1, 2, 3, 4, 9, 10, 11, 13, and 17 of the '425 Patent. The '425 Patents relates to "a method of treating inflammatory lesions of papulopustular rosacea." ('425 Patent at 2:50-52). The following claim of the '425 Patent is representative:

1. A method of treating papulopustular rosacea in a subject in need thereof, comprising topically administering, once daily, to a skin area affected by the papulopustular rosacea a therapeutically effective amount of a pharmaceutical composition comprising ivermectin and a pharmaceutically acceptable carrier without co-administration of another active pharmaceutical ingredient, wherein the pharmaceutical composition comprises 0.5% to 1.5% by weight ivermectin.

('425 Patent, claim 1) (disputed terms italicized).

         The parties agree on a construction for five additional terms. (D.I. 110 at 7-8).

         III. CONSTRUCTION OF DISPUTED TERMS

         1."oily solvent"

         a. Plaintiffs' proposed construction:

Plain and ordinary meaning, "an oil or oil-like compound that can dissolve ivermectin"

         b. Defendant's proposed construction:

"an organic solvent not miscible with water and excluding alcohols or glycols"

         c. Court's construction:

"organic solvent not miscible with water that can dissolve ivermectin excluding alcohols or glycols except octyl dodecanol"

         This term appears in claims 1 and 7 of the '069 Patent. The parties agree that "the '069 Patent's 'oily solvent' is a solvent for the avermectin compound that is part of an oily or fatty phase of the composition." (D.I. 110 at 11, 15). The parties further agree that a POSA would understand an "oily solvent" to be "organic" and "not miscible with water." (Tr. at 15-16, 28). However, the parties disagree on (1) the proper characteristics of an "oily solvent" to include in a construction and (2) whether alcohols and glycols were disclaimed during prosecution.

         Focusing on the first point of disagreement, Defendant argues that its definition including "organic" and "not miscible with water" is consistent with the '069 Patent's specification's description of an oily solvent. (D.I. 110 at 11-12). Defendant asserts that "the '069 Patent uses [the concept of miscibility] when describing the two phases of an oil-in-water emulsion" and "the POSA would have understood 'oily solvent' to refer to a 'solvent not miscible with water.'" (Id. at 12). Defendant also notes that "miscibility (or immiscibility) with water is readily discernable based on chemical structure." (Id. at 19). Plaintiffs broadly reject Defendant's characterization of "oily solvents," saying, "Teva's two qualifiers are unnecessary . . . ." (Id. at 16). Considering "organic," Plaintiffs argue that this "connotes any carbon-based solvent, not just oils or oil-like compounds" and "is so broad . . . that it does nothing to clarify the term's scope." (Id. at 9, 15-16). Plaintiffs further argue that "not miscible with water" creates ambiguity. (Id. at 16).

         With respect to Plaintiffs' proposed construction, Defendant argues that the term "oil-like" is not contained in the specification and is inconsistent with the '069 Patent's preferred solvent. (Id. at 12). Plaintiffs respond that "oil-like" encompasses "fatty alcohols and esters preferred by the inventors." (Id. at 15). At oral argument, Plaintiffs suggested that "oil-like" might mean "[f]atty, oily, lipophilic, or just . . . that it's going to be part of the oily phase of this emulsion." (Tr. at 14).

         On the characterization of an "oily solvent," I largely agree with Defendant. As agreed by the parties, Defendant's construction accurately characterizes an "oily solvent." Plaintiffs do not provide a persuasive reason the agreed accurate construction is unhelpful. Furthermore, adopting Plaintiffs' suggested "oil-like" construction, a term Plaintiffs admit is synonymous with "oily," does not clarify the term.

         Regarding the second point of disagreement, Defendant argues that the patentees disavowed alcohols and glycols to overcome an obviousness rejection based on the Manetta prior art reference. (D.I. 110 at 13 (citing '069 Patent File History: Amendment (May 4, 2012) at 9-14 (D.I. 112 at App. 77-82)); see also U.S. Pat. Pub. No. 2006/0100165 ("Manetta")). Defendant argues the disclaimer is evidenced by Applicants "attribut[ing] the 'surprisingly good physical and chemical stability properties' of the claimed emulsions to a lack of alcohol or glycol." (D.I. 110 at 13 (citing '069 Patent File History: Amendment (May 4, 2012) at 12-13 (D.I. 112 at App. 78-79))).

         Plaintiffs argue that the inclusion of an alcohol as a solvent in the claims of the '069 Patent precludes a finding of disclaimer. (Id. at 10). Defendant admits that "octyl dodecanol, a fatty alcohol" is identified "as a solvent for avermectin" in the claims and specification of the '069 Patent. (Id. at 14). To overcome this apparent inconsistency, Defendant states that the inclusion of octyl dodecanol "merely suggests that the patentees did not intend 'alcohol-type solvent' to include the particular fatty alcohol octyl dodecanol." (Id.). Defendant argues that I should find disclaimer of alcohols, except for octyl dodecanol, because the '069 Patent characterizes certain alcohols as inferior and because a fatty alcohol, oleyl alcohol, "is one of the alcohols used by the Manetta prior art." (Id.).

         Additionally, Plaintiffs assert that "Manetta . . . describe[s] formulations using certain alcohols or glycols to solubilize ivermectin as part of the aqueous phase of an emulsion, whereas all claims of the '069 Patent (proposed and issued) used oily solvents that dissolved the active within the oily phase." (Id. at 17-18 (emphasis in original)). In response, Defendant points to the argument made by the Applicants during prosecution that focuses on the solvent and makes no mention of the aqueous/oily phase distinction. (See Id. at 18-19). For example, when directly addressing Manetta, Applicants argued, "Marietta repeatedly defines emulsions wherein an avermectin compound (ivermectin) is required to be solubilized in [an] alcohol or glycol solvent or the like." ('069 Patent File History: Amendment (May 4, ...


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