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Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.

United States District Court, D. Delaware

January 12, 2018

SANOFI-AVENTIS U.S. LLC, et al., Plaintiffs,

          Douglas E. McCann, Martina Tyreus Hufnal, Ronald P. Golden III, FISH & RICHARDSON P.C., Wilmington, DE; John S. Goetz (argued), Brian D. Coggio, FISH & RICHARDSON P.C., New York, NY; Ahmed J. Davis, Min Woo Park, Sarah M. Cork, FISH & RICHARDSON P.C., Washington, DC; Matt Colvin, FISH & RICHARDSON P.C., Dallas, TX; D. Michael Underhill (argued), Jon R. Knight, BOIES SCHILLER & FLEXNER LLP, Washington, DC; William D. Marsillo, Alex Potter, BOIES SCHILLER & FLEXNER LLP, Armonk, NY; Bill Ward, Martin Ellison, BOIES SCHILLER & FLEXNER LLP, Santa Monica, CA. Attorneys for Plaintiffs

          Arthur G. Connolly III, Ryan P. Newell, Mary Akhimien, CONNOLLY GALLAGHER LLP, Wilmington, DE; Raymond N. Nimrod (argued), Brian P. Biddinger, Gregory D. Bonifield (argued), John P. Galanek, Amanda K. Antons, Matthew Traupman (argued), QUINN EMANUEL URQUHART & SULLIVAN, LLP, New York, NY. Attorneys for Defendant



         Presently before the Court is the issue of claim construction of multiple terms in U.S. Patent Nos. 8, 603, 044 (the '"044 patent"), 8, 679, 069 (the '"069 patent"), 8, 992, 486 (the '"486 patent"), 9, 526, 844 (the '"844 patent"), 9, 533, 105 (the '"105 patent"), 9, 457, 152 (the '"152 patent"), 9, 592, 348 (the '"348 patent"), 7, 476, 652 (the '"652 patent"), 7, 713, 930 (the '"930 patent"), and 9, 604, 008 (the '"008 patent").[1] The Court has considered the parties' joint claim construction brief. (D.I. 127). The Court heard oral argument on November 6, 2017. (D.I. 164) ("Tr.").

         I. BACKGROUND

         On September 16, 2016, Plaintiffs filed this action against Defendant Merck Sharp & Dohme Corp. alleging infringement often patents. (D.I. 1). With the Court's permission, Plaintiffs filed First Amended (D.I. 58) and Second Amended (D.I. 93) complaints on April 5, 2017 and June 28, 2017, respectively, in which they asserted additional patents. The patents-in-suit generally relate to a diabetes pharmaceutical, or to pen-type injectors used to administer the pharmaceutical.


         "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). '"[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. Marhnan v. Westview Instruments, Inc., 52 F.3d 967, 977-80 (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.... [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. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan after reading the entire patent." Id. at 132. "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 Pharms. 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 assis 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).


         1. "chemical entity" ('652 patent, claims 1, 2, 7, 17, 18, 19, 23, 24; '930 patent, claims 1, 14, 15, 16)

         a. Plaintiffs' proposed construction: no construction necessary; plain and ordinary meaning

         b. Defendant's proposed construction: "surfactant that stabilizes the formulation, in a concentration of 5-200 ng/rnL"

         c. Court's construction: no construction necessary; plain and ordinary meaning Plaintiffs argue the Court need not construe the term "chemical entity" because its plain and ordinary meaning is apparent to a person of ordinary skill in the art. (D.I. 127 at 14). They fault Defendant for "attempt[ing] to re-write the claim entirely." (Id. at 15). Defendant's proposed construction, according to Plaintiffs, improperly imports into the claims a function and a limitation from the specification. (Id). Plaintiffs also assert that Defendant's proposed construction runs afoul of the claim differentiation doctrine. (Id. at 16).

         Defendant responds by arguing that the scope of the claims is limited in two principal ways. First, Defendant argues the scope is limited by the "present invention" description in the specification, which according to Defendant, makes clear the invention requires that the "chemical entity" be present in an amount sufficient to stabilize the formulation, that is, in a concentration of 5-200 μg/ml. (Id. at 19). Defendant primarily relies upon the following sentence from the "detailed description of the invention" in the '652 patent: "The surfactants are present in the pharmaceutical composition in a concentration of 5-200 μg/ml, preferably 5-120 ug/ml and particularly preferably of 20-75 μg/ml." (See Id. at 18; Tr. at 18:10-14). Second, Defendant argues the scope of the '652 patent is limited by disavowal. Specifically, Defendant argues that because the "patent specification distinguished two prior art references on the basis that they did not describe surfactants that provided 'stabilization in an acidic solution, '" the term should "be construed to require an amount sufficient to stabilize the preparation." (D.I. 127 at 20). Finally, Defendant asserts that Plaintiffs' statements during patent prosecution provide another basis upon which to find disavowal of claim scope. (Id.).

         I am not persuaded by Defendant's argument that Plaintiffs have limited the scope of the claims by disavowal such that the surfactant in the claims must "stabilize [] the formulation, in a concentration of 5-200 μg/ml." A patentee may disavow claim scope through a description in the specification of the "present invention." E.g., Luminara Worldwide, LLC v. Liown Elecs. Co. Ltd., 814 F.3d 1343, 1353 (Fed. Cir. 2016). To do so, however, the patentee must make "clear and unmistakable statements .. . that limit the claims, such as 'the present invention includes . . .' or 'the present invention is . . .' or 'all embodiments of the present invention are. . ..'" Id. "When a patentee 'describes the features of the present invention as a whole, ' he implicitly alerts the reader that 'this description limits the scope of the invention.'" Id.

         In my opinion, the patentee has not done so here. The sentence upon which Defendant primarily relies is far from a "clear and unmistakable" statement limiting the claims. See Id. The sentence begins, "The surfactants are present in the pharmaceutical composition . . . ." ('652 patent, 3:55-56). It does not purport to describe "features of the present invention as a whole, " Luminara, 814 F.3d at 1353, and, in fact, it never refers to the "present invention" at all. Rather, when read in context, the sentence cannot properly be understood to limit the claims. The entire paragraph generally relates to the types of surfactants that "can be used" or are "preferred." (See '652 patent, 3:50-56). Nor do any of the other portions of the specification upon which Defendant relies constitute "clear and unmistakable" statements limiting the claims. Luminara, 814 F.3d at 1353. Those portions generally refer to the object or goals of the invention, and, accordingly, cannot be characterized as unambiguous statements of disavowal. (See D.I. 127 at 18 (quoting '652 patent, 3:32-36)).

         Further, I am not persuaded that Plaintiffs have disavowed claim scope by "distinguishing] or disparag[ing] prior art based on the absence of [a particular] feature." Poly-Am., L.P v. API Indus., Inc., 839 F.3d 1131, 1136 (Fed. Cir. 2016). The standard for finding disavowal is "exacting." GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1309 (Fed. Cir. 2015). "To find disavowal, [the court] must find that the specification is 'both so clear as to show reasonable clarity and deliberateness, and so unmistakable as to be unambiguous evidence of disclaimer.'" Openwave Sys., Inc. v. Apple Inc., 808 F.3d 509, 513 (Fed. Cir. 2015).

         In my opinion, it is not clear that Plaintiffs distinguished prior art references WO 00/23098 and WO 02/076495 on the basis that they do not describe "stabilization by the surfactant." (See D.I. 127 at 19-20). The prosecution history indicates that Plaintiffs distinguished those references on the basis that they "do[] not describe the stabilization in an acidic solution." (Id. at 26). Plaintiffs argue, therefore, that the present invention was distinguished from the prior art by "pH and insulin type, not stabilization." (Id.). I do not think the prosecution history is entirely clear on this point. In any event, where the reason for distinguishing the prior art is ambiguous, there can be no basis for concluding that Plaintiffs clearly and deliberately disavowed claim scope. See Openwave, 808 F.3d at 513. Similarly, it is not clear that Plaintiffs distinguished prior art references before the patent examiner on the basis that they did not disclose a formulation that would be stable. For the same reasons, therefore, I find Plaintiffs have not disavowed claim scope through their statements during patent prosecution.

         Finally, I agree with Plaintiffs that Defendant's proposed construction runs afoul of the claim differentiation doctrine. Under the doctrine, there is "a presumption that distinct claims, particularly an independent claim and its dependent claim, have different scopes." World Class Tech. Corp. v. Ormco Corp., 769 F.3d 1120, 1125 (Fed. Cir. 2014); see also Am. Med. Sys., Inc. v. Biolitec, Inc., 618 F.3d 1354, 1360 (Fed. Cir. 2010) ("Under the doctrine of claim differentiation, [] dependent claims give rise to a presumption that the broader independent claims are not confined to that range." (citation omitted)).

         Here, the asserted independent claims do not include concentration limitations, while dependent claims in the '652 and '930 patents recite several specific ranges. These ranges include 5-200 μg/ml, required by Defendant's proposed construction, as well as 5-120 |ag/ml and 20-75 μg/ml. ('652 patent, 12:13-18; '930 patent, 12:36-41). Defendant's proposed construction would render meaningless the difference in scope between these claims. Contrary to Defendant's contentions, this is not a case where claim differentiation is "overcome by a contrary construction dictated by the written description or prosecution history." Seachange Int'l, Inc. v. C-COR, Inc., 413 F.3d 1361, 1369 (Fed. Cir. 2005).

         Accordingly, I will not adopt Defendant's proposed construction. I conclude that no construction is needed for the term "chemical entity." It will be construed according to its plain and ordinary meaning.

         2. "housing" ('844 patent, claim 21; '105 patent, claims 1, 4; '008 patent, claims 1, 3, 6, 11)

         The parties included the term "housing" in their joint claim construction brief. However, Defendant has agreed to Plaintiffs' proposed construction. (D.I. 127 at 36 n. 10). Thus, there is no need for the Court to construe this term.

         3. "main housing" / "external housing" ('044 patent, claims 1, 2, 3, 8-11, 20; '069 patent, claims 1, 2; '486 patent, claims 1, 3, 4, 26-28, 31, 35, 38-39, 43-45, 48)

         a. Plaintiffs 'proposed construction: "an exterior unitary or multipart component configured to house, fix, protect, guide and/or engage with one or more inner components"

         b. Defendant's proposed construction: "single, indivisible component that is an external case or enclosure"

         c. Court's construction: "an exterior unitary or multipart component configured to house, fix, protect, guide and/or ...

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