Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Shire Development LLC v. Teva Pharmaceuticals USA, Inc.

United States District Court, D. Delaware

February 28, 2019

SHIRE DEVELOPMENT LLC, SHIRE LLC, and SHIRE U.S. INC., Plaintiffs,
v.
TEVA PHARMACEUTICALS USA, INC., et al., Defendants.

          Derek Fahnestock, MORRIS, NICHOLS, ARSHT & TUNNELL LLP, Wilmington, DE; Edgar H. Haug, Nicholas Giove (argued), Anna N. Lukacher, Andrew S. Roper, and Laura A. Chubb, HAUG PARTNERS LLP, New York, NY. Attorneys for Plaintiffs.

          Karen E. Keller, SHAW KELLER LLP, Wilmington, DE; Daryl L. Wiesen (argued), Emily L. Rapalino (argued), Brian T. Drummond, and Andrew McDonough, GOODWIN PROCTOR, Boston, MA. Attorneys for Defendants Teva Pharmaceuticals USA, Inc and Actavis Laboratories FL, Inc.

          David A. Bilson, PHILLIPS, GOLDMAN, McLAUGHLIN & HALL, P.A., Wilmington, DE; C. Kyle Musgrove and Scott A. Cunning II, HAYNES & BOONE, LLP, Washington, D.C. Attorneys for Defendant Impax Laboratories, LLC.

          Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE; Gary E. Hood, Mark T. Deming, John P. Snow, Enes Ovcina, Helena Berezowskyj, and Randal S. Alexander, POLSINELLI P.C., Chicago, IL. Attorneys for Defendant SpecGx LLC.

          MEMORANDUM OPINION

          ANDREWS, U.S. DISTRICT JUDGE

         Presently before me is the issue of claim construction of multiple terms in U.S. Patent Nos. 6, 913, 768 ('"768 Patent"), 8, 846, 100 ('"100 Patent"), and 9, 173, 857 ('"857 Patent). (D.I. 89).

         I have read and considered the Parties' Joint Claim Construction Brief and letters. (D.I. 89, 105, 106, 107, 108). I heard oral argument on January 23, 2019. (D.I. 104 ("Tr.")).

         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. AWHCorp., 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 ["POSA"] 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.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).

         I. BACKGROUND

         The patents-in-suit relate generally to pharmaceutical compositions capable of sustained release of amphetamines or amphetamine salts. (D.I. 89).

         The Parties dispute a term in claims 1, 7, 9, 11, 12, 13, 14, 15, and 35 of the '768 Patent. This patent relates to "compositions for providing an orally administrable sustained release (SR) form of one or more amphetamines and/or amphetamine salts." ('768 Patent at 1:6-8). The following claims of the '768 Patent are representative:

1. A pharmaceutical composition comprising a mixture of dextro- and levo-amphetamine and/or salt(s) thereof and a sustained release coating or matrix which comprises an amount of poly vinyl acetate, cellulose acetate, cellulose acetate butyrate, cellulose acetate propionate, ethyl cellulose, a fatty acid, a fatty acid ester, an alkyl alcohol, a wax, zein (prolamine from corn), a poly(meth)acrylate, microcrystalline cellulose or poly(ethylene oxide) effective to achieve continuous sustained release of said amphetamines and/or salt(s) to provide a mean plasma concentration profile in human ADHD patients which is substantially the same as the dextroamphetamine XR profile and/or the levoamphetamine XR profile of FIG. 1 over the course of the first twelve hours after administration, for a 20 mg total dose, or to provide a profile directly proportional to said XR profile(s) for a total dose other than 20 mg.
14. A pharmaceutical composition comprising a mixture of dextro- and levoamphetamine and/or salt(s) thereof and a sustained release coating or matrix which comprises an amount of polyvinyl acetate, cellulose acetate, cellulose acetate butyrate, cellulose acetate propionate, ethyl cellulose, a fatty acid, a fatty acid ester, an alkyl alcohol, a wax, zein (prolamine from corn), a poly(meth)acrylate, microcrystalline cellulose or polyethylene oxide) [sic] effective to achieve about a first order sustained dissolution release of said amphetamines and/or salt(s), which has [a recited plasma concentration profile], for a 20 mg total dose, or respective AUC and Cmax values directly proportional thereto for a total dose other than 20 mg.

('768 Patent, claims 1, 14).

         The Parties dispute two terms which appear in claim 1 of the '100 Patent and claim 1 of the '857 Patent. The Patents relate to "a long-acting amphetamine pharmaceutical composition, which includes an immediate release component, a delayed pulsed release component and a sustained release component, to meet the therapeutic needs for ADHD patients with longer-day demands." ('100 Patent at 3:53-57). Claim 1 of the '100 Patent is representative:

1. A pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a. first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt;
wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and
wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

('100 Patent, claim 1 (emphasis added). The parties agree on constructions for ten additional terms. (D.I. 89 at 1).

         III. CONSTRUCTION OF DISPUTED TERMS 1.

         '768 Patent Antecedent Basis Issue

          a. Plaintiffs' position:

         The pharmaceutical composition as a whole must provide the claimed plasma profile.

         b. Defendants' position:

         A sustained-release coating or matrix must provide [control][1] the claimed plasma profile.

         Alternatively, indefinite.

         c. Court's construction:

         The pharmaceutical composition as a whole must provide the claimed plasma profile.

         Although the Parties agree on the meanings of the individual words in the '768 Patent's claims, they disagree on the proper way to read those words in context.

         Defendants' argue that the grammatical structure of the claims requires that the sustained-release coating or matrix provide the claimed plasma profile. Their argument stems from an application of the "last antecedent" doctrine. (D.I. 89 at 14-17). The last antecedent doctrine is a doctrine of statutory construction which advises that, absent clear contextual clues, "qualifying words, phrases and clauses must be applied to the words or phrases immediately preceding them and are not to be construed as extending to and including others more remote." Wilshire Westwood Assocs. v. Ail. Richfield Corp., 881 F.2d 801, 804 (9th Cir. 1989). The doctrine is inapplicable, however, if it creates an absurd result. See Demko v. United States, 216 F.3d 1049, 1053 (Fed. Cir. 2000).

         The Federal Circuit has not directly addressed the last antecedent doctrine's application to the claim construction analysis. It has, however, discussed the doctrine in the patent law context on a few occasions. See, e.g., Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1335-36 (Fed. Cir. 2008) (applying doctrine to a prior art reference and noting that English grammar and statutory construction "are not entirely coterminous because the meaning of a prior art reference requires analysis of the understanding of an artisan of ordinary skill"); Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 2018 WL 1583031, at *3 (Fed. Cir. Jan. 16, 2018) (discussing the doctrine's application to the statutory interpretation of post-AIA Section 101). District courts have only rarely invoked the last antecedent doctrine during claim construction. Defendant points to just one district court case where the court applied the doctrine to resolve a claim construction dispute: Iridescent Networks, Inc. v. AT&T Mobility, LLC, 2017 WL 3033400 at *8 (E.D. Tex. July 18, 2017) (describing the last-antecedent doctrine as "dictating" an understanding of the claim). Other courts, however, have taken a more tentative approach to applying the doctrine to claim construction. See CA, Inc. v. Simple.com, Inc., 780 F.Supp.2d 196, 233 (E.D.N.Y. 2009) (applying the last antecedent doctrine, but noting the lack of contrary intent in the intrinsic record); Gamesa Eolica, S.A. v. Gen. Elec. Co., 359 F.Supp.2d 790, 801 (W.D. Wis. 2005) (finding that the claim language and the specification negated a strict application of the last antecedent rule). I have similarly found the last antecedent doctrine unpersuasive when faced with intrinsic evidence that a POSA would not understand the claim to have the meaning which grammar might normally command. St. Jude Med. v. Volcano Corp., 2013 WL 2372190, at *1 (D. Del. May 30, 2013).

         This is all to say, the claim construction inquiry, as described in Markman and Philips, is not hamstrung by the rigidities of English grammar. A court is to consider the claims, the specification, and the prosecution history to give the claims meaning. Thus, although the last antecedent ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.