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Unimed Pharmaceuticals, LLC v. Perrigo Co.

United States District Court, D. Delaware

March 11, 2015

UNIMED PHARMACEUTICALS, LLC, BESINS HEALTHCARE INC., and BESINS HEALTHCARE LUXEMBOURG SARL, Plaintiffs,
v.
PERRIGO COMPANY, and PERRIGO ISRAEL PHARMACEUTICALS LTD., Defendants.

Calvin Griffith (argued), Esq., Jones Day, Cleveland, OH; Kenneth Canfield, Esq., Jones Day, New York, NY; Jason Winchester, Esq., Jones Day, Chicago, IL; Mary Graham, Esq., Morris Nichols, Arsht & Tunnell LLP, Wilmington, DE; attorneys for Plaintiffs.

William Rakoczy (argued), Esq., Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL; Gregory Duff, Esq., Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL; Alice Riechers, Esq., Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL; Lauren Dunne, Esq., Rakoczy Molino Mazzochi Siwik LLP, Chicago, IL; Megan C. Haney, Esq., Phillips, Goldman & Spence, P.A., Wilmington, DE; attorneys for Defendants.

MEMORANDUM OPINION

RICHARD G. ANDREWS, District Judge.

Plaintiffs assert that Defendants' ANDAs infringe Plaintiffs' patents. Before this Court is the issue of claim construction of disputed terms found in nine patents: U.S. Patent No. 6, 503, 894 ("the '894 patent"); four patents collectively called the "Malladi Patents, " U.S. Patent Nos. 8, 466, 136 ("the '136 patent"), 8, 466, 137 ("the '13 7 patent"), 8, 466, 138 ("the '138 patent"), and 8, 486, 925 ("the 925 patent"); and four patents collectively called the "New Malladi Patents, " U.S. Patent Nos. 8, 729, 057 ("the '057 patent"), 8, 741, 881 ("the '881 patent"), 8, 754, 070 ("the '070 patent"), and 8, 759, 329 ("the '329 patent").

The Court has considered the parties' claim construction briefing (D.I. 227, 228, 229, 230, 231) and held a Markman hearing. (D.I. 238).

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. AWHCorp., 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.'" SoftView LLC v. Apple Inc., 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324). 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 bane), ajf'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 (internal quotation marks and citations 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." Phillips, 415 F.3d at 1312-13 (internal quotation marks and citations 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 (internal citations omitted).

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 (internal quotation marks and citations omitted). 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) (internal quotation marks and citation omitted).

II. AGREED UPON CONSTRUCTIONS

The parties have requested that the Court adopt several agreed upon constructions (D.I. 227 at p. 10), which it does:

A. The '894 patent

1. "about" (Claims 31, 35, and 38-41)

a. Construction: "approximately"

2. "pharmaceutical composition" (Claim 31)

a. Construction: "A composition intended for a pharmaceutical use"

B. Malladi Patents

1. "about"(' 137 patent, claims 4-5; '138 patent, claims 4-5)

a. Construction: "approximately"

2. "ethanol" ('136 patent, claim 1; '137 patent, claim 1; '138 patent, claim 1; '925 patent, claim 1)

a. Construction: "C2H5OH, such as dehydrated alcohol USP, alcohol USP, or any common form including in combination with various amounts of water"

C. New Malladi Patents

1. "about" ('881 patent, claims 13, 23, 26, 29; '329 patent, claim 18)

a. Construction: "approximately"

2. "absolute ethanol" ('057 patent, claims 3, 10-11; '881 patent, claims 3, 9-10, 15-16; '070 patent, claims 1, 6-7; '329 patent, claims 3, 9, 13, 16)

a. Construction: "C2H5OH"

3. "ethanol" ('057 patent, claims 1-3; '881 patent, claims 1-3; '329 patent, claims 1-3)[1]

a. Construction: "C2H5OH, such as dehydrated alcohol USP, alcohol USP, or any common form including in combination with various amounts of water"

III. CONSTRUCTION OF DISPUTED TERMS

A. The '894 Patent

Claim 31 of the '894 patent is representative:

A method for administering an active agent to a human subject in need thereof, the method comprising:
a. providing a pharmaceutical composition consisting essentially of :
(i) about 0.5% to about 5% testosterone;
(ii) about 0.1 % to about 5% isopropyl myristate;
(iii) about 30% to about 98% of an alcohol selected from the group consisting of ethanol and isopropanol; and
(iv) about 0.1 % to about 5% of a gelling agent; wherein the percentages are weight to weight of the composition; and
b. applying a daily dose of the composition to skin of the subject in an amount sufficient for the testosterone to reach the bloodstream of the subject wherein serum concentration is substantially maintained between about 400 ng testosterone per di serum to about 1050 ng testosterone per dl serum for at least 24 hours after the subject has applied the daily dose of the composition for at least 2 consecutive days.

(894 patent, claim 31) (disputed claim construction terms emphasized).

1. "consisting essentially of' (claim 31)

a. Plaintiffs' proposed construction: "The invention covers products containing the specified ingredients as well as products containing unspecified ingredients, provided that the unspecified ingredients do not materially ...


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