Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 1 of 23 PageID #: 4726
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELA WARE
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`SANOFI-AVENTIS U.S. LLC, et al.,
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`Plaintiffs,
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`V.
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`MERCK SHARP & DOHME CORP.,
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`Defendant.
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`Civil Action No. 16-812-RGA
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`MEMORANDUM OPINION
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`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.
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`Attorneys for Plaintiffs
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`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.
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`Attorneys for Defendant
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`January 11, 2018
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 1 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 2 of 23 PageID #: 4727
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`AN~.~is~E:
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`Presently before the Court is the issue of claim construction of multiple terms in U.S.
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`Patent Nos. 8,603,044 (the "'044 patent"), 8,679,069 (the '"069 patent"), 8,992,486 (the "'486
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`patent"), 9,526,844 (the "'844 patent"), 9,533,105 (the "'105 patent"), 9,457,152 (the '"152
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`patent"), 9,592,348 (the "'348 patent"), 7,476,652 (the "'652 patent"), 7,713,930 (the "'930
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`patent"), and 9,604,008 (the "'008 patent"). 1 The Court has considered the parties' joint claim
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`construction brief. (D.I. 127). The Court heard oral argument on November 6, 2017. (D.I. 164)
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`("Tr.").
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`I.
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`BACKGROUND
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`On September 16, 2016, Plaintiffs filed this action against Defendant Merck Sharp &
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`Dohme Corp. alleging infringement often patents. (D.I. 1). With the Court's permission,
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`Plaintiffs filed First Amended (D.I. 58) and Second Amended (D.I. 93) complaints on April 5,
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`2017 and June 28, 2017, respectively, in which they asserted additional patents. The patents-in-
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`suit generally relate to a diabetes pharmaceutical, or to pen-type injectors used to administer the
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`pharmaceutical.
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`II.
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`LEGALSTANDARD
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`"It is a bedrock principle of patent law that the claims of a patent define the invention to
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`which the patentee is entitled the right to exclude." Phillips v. AWHCorp., 415 F.3d 1303, 1312
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`(Fed. Cir. 2005) (en bane). "' [T]here is no magic formula or catechism for conducting claim
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`construction.' Instead, the court is free to attach the appropriate weight to appropriate sources
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`'in light of the statutes and policies that inform patent law."' Soft View LLC v. Apple Inc., 2013
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`!
`i
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`1 Plaintiffs no longer assert U.S. Patent No. 9,486,587. Plaintiffs have also reduced the number of
`asserted claims substantially since the Markman hearing. (D.I. 169). The opinion refers to the '587
`patent and now unasserted claims.
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 2 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 3 of 23 PageID #: 4728
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`WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips, 415 F.3d at 1324) (alteration in
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`original). When construing patent claims, a court considers the literal language of the claim, the
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`patent specification, and the prosecution history. Markman v. Westview Instruments, Inc., 52
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`F.3d 967, 977-80 (Fed. Cir. 1995) (en bane), aff'd, 517 U.S. 370 (1996). Of these sources, "the
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`specification is always highly relevant to the claim construction analysis. Usually, it is
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`dispositive; it is the single best guide to the meaning of a disputed term." Phillips, 415 F.3d at
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`1315.
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`"[T]he words of a claim are generally given their ordinary and customary meaning ....
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`[Which is] the meaning that the term would have to a person of ordinary skill in the art in
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`question at the time of the invention, i.e., as of the effective filing date of the patent application."
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`Id. at 1312-13. "[T]he ordinary meaning of a claim term is its meaning to [an] ordinary artisan
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`after reading the entire patent." Id. at 132. "In some cases, the ordinary meaning of claim
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`language as understood by a person of skill in the art may be readily apparent even to lay judges,
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`and claim construction in such cases involves little more than the application of the widely
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`accepted meaning of commonly understood words." Id. at 1314.
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`When a court relies solely upon the intrinsic evidence-the patent claims, the
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`specification, and the prosecution history-the court's construction is a determination oflaw.
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`See TevaPharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841 (2015). The court may also
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`make factual findings based upon consideration of extrinsic evidence, which "consists of all
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`evidence external to the patent and prosecution history, including expert and inventor testimony,
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`dictionaries, and learned treatises." Phillips, 415 F.3d at 1317-19. Extrinsic evidence may assist
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`the court in understanding the underlying technology, the meaning of terms to one skilled in the
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`2
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 3 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 4 of 23 PageID #: 4729
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`art, and how the invention works. Id Extrinsic evidence, however, is less reliable and less
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`useful in claim construction than the patent and its prosecution history. Id.
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`"A claim construction is persuasive, not because it follows a certain rule, but because it
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`defines terms in the context of the whole patent." Renishaw PLC v. Marposs Societa 'per
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`Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would
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`exclude the inventor's device is rarely the correct interpretation." Osram GMBH v. Int 'l Trade
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`Comm 'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007).
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`III. CONSTRUCTION OF DISPUTED TERMS
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`1. "chemical entity" ('652 patent, claims 1, 2, 7, 17, 18, 19, 23,
`24; '930 patent, claims 1, 14, 15, 16)
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`a. Plaintiffs' proposed construction: no construction necessary; plain and
`ordinary meaning
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`b. Defendant's proposed construction: "surfactant that stabilizes the formulation,
`in a concentration of 5-200 µg/mL"
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`c. Court's construction: no construction necessary; plain and ordinary meaning
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`Plaintiffs argue the Court need not construe the term "chemical entity" because its plain
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`and ordinary meaning is apparent to a person of ordinary skill in the art. (D.I. 127 at 14). They
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`fault Defendant for "attempt[ing] to re-write the claim entirely." (Id at 15). Defendant's
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`proposed construction, according to Plaintiffs, improperly imports into the claims a function and
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`a limitation from the specification. (Id). Plaintiffs also assert that Defendant's proposed
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`construction runs afoul of the claim differentiation doctrine. (Id at 16).
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`Defendant responds by arguing that the scope of the claims is limited in two principal
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`ways. First, Defendant argues the scope is limited by the "present invention" description in the
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`specification, which according to Defendant, makes clear the invention requires that the
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`"chemical entity" be present in an amount sufficient to stabilize the formulation, that is, in a
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`3
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 4 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 5 of 23 PageID #: 4730
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`concentration of 5-200 µg/ml. (Id. at 19). Defendant primarily relies upon the following
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`sentence from the "detailed description of the invention" in the '652 patent: "The surfactants are
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`present in the pharmaceutical composition in a concentration of 5-200 µg/ml, preferably 5-120
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`µg/mlandparticularlypreferablyof20-75 µg/ml." (See id. at 18; Tr. at 18:10-14). Second,
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`Defendant argues the scope of the '652 patent is limited by disavowal. Specifically, Defendant
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`argues that because the "patent specification distinguished two prior art references on the basis
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`that they did not describe surfactants that provided 'stabilization in an acidic solution,'" the term
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`should "be construed to require an amount sufficient to stabilize the preparation." (D.I. 127 at
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`20). Finally, Defendant asserts that Plaintiffs' statements during patent prosecution provide
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`another basis upon which to find disavowal of claim scope. (Id.).
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`I am not persuaded by Defendant's argument that Plaintiffs have limited the scope of the
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`claims by disavowal such that the surfactant in the claims must "stabilize[] the formulation, in a
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`concentration of 5-200 µg/mL." A patentee may disavow claim scope through a description in
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`the specification of the "present invention." E.g., Luminara Worldwide, LLC v. Liown Elecs. Co.
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`Ltd., 814 F.3d 1343, 1353 (Fed. Cir. 2016). To do so, however, the patentee must make "clear
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`and unmistakable statements ... that limit the claims, such as 'the present invention includes ..
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`. ' or 'the present invention is ... ' or 'all embodiments of the present invention are .... "' Id.
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`"When a patentee 'describes the features of the present invention as a whole,' he implicitly alerts
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`the reader that 'this description limits the scope of the invention.'" Id.
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`In my opinion, the patentee has not done so here. The sentence upon which Defendant
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`primarily relies is far from a "clear and unmistakable" statement limiting the claims. See id. The
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`sentence begins, "The surfactants are present in the pharmaceutical composition .... " ('652
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`patent, 3:55-56). It does not purport to describe "features of the present invention as a whole,"
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`4
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 5 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 6 of 23 PageID #: 4731
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`Luminara, 814 F.3d at 1353, and, in fact, it never refers to the "present invention" at all. Rather,
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`when read in context, the sentence cannot properly be understood to limit the claims. The entire
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`paragraph generally relates to the types of surfactants that "can be used" or are "preferred." (See
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`'652 patent, 3:50-56). Nor do any of the other portions of the specification upon which
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`Defendant relies constitute "clear and unmistakable" statements limiting the claims. Luminara,
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`814 F.3d at 1353. Those portions generally refer to the object or goals of the invention, and,
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`accordingly, cannot be characterized as unambiguous statements of disavowal. (See D.I. 127 at
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`18 (quoting '652 patent, 3:32-36)).
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`Further, I am not persuaded that Plaintiffs have disavowed claim scope by
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`"distinguish[ing] or disparag[ing] prior art based on the absence of [a particular] feature." Poly-
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`Am., L.P. v. AP! Indus., Inc., 839 F.3d 1131, 1136 (Fed. Cir. 2016). The standard for finding
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`disavowal is "exacting." GE Lighting Sols., LLC v. AgiLight, Inc., 750 F.3d 1304, 1309 (Fed.
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`Cir. 2015). "To find disavowal, [the court] must find that the specification is 'both so clear as to
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`show reasonable clarity and deliberateness, and so unmistakable as to be unambiguous evidence
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`of disclaimer.'" Openwave Sys., Inc. v. Apple Inc., 808 F.3d 509, 513 (Fed. Cir. 2015).
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`In my opinion, it is not clear that Plaintiffs distinguished prior art references WO
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`00/23098 and WO 02/076495 on the basis that they do not describe "stabilization by the
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`surfactant." (See D.I. 127 at 19-20). The prosecution history indicates that Plaintiffs
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`distinguished those references on the basis that they "do[] not describe the stabilization in an
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`acidic solution." (Id. at 26). Plaintiffs argue, therefore, that the present invention was
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`distinguished from the prior art by "pH and insulin type, not stabilization." (Id.). I do not think
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`the prosecution history is entirely clear on this point. In any event, where the reason for
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`distinguishing the prior art is ambiguous, there can be no basis for concluding that Plaintiffs
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`5
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 6 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 7 of 23 PageID #: 4732
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`clearly and deliberately disavowed claim scope. See Openwave, 808 F.3d at 513. Similarly, it is
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`not clear that Plaintiffs distinguished prior art references before the patent examiner on the basis
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`that they did not disclose a formulation that would be stable. For the same reasons, therefore, I
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`find Plaintiffs have not disavowed claim scope through their statements during patent
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`prosecution.
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`Finally, I agree with Plaintiffs that Defendant's proposed construction runs afoul of the
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`claim differentiation doctrine. Under the doctrine, there is "a presumption that distinct claims,
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`particularly an independent claim and its dependent claim, have different scopes." World Class
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`Tech. Corp. v. Ormco Corp., 769 F.3d 1120, 1125 (Fed. Cir. 2014); see also Am. Med. Sys., Inc.
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`v. Biolitec, Inc., 618 F.3d 1354, 1360 (Fed. Cir. 2010) ("Under the doctrine of claim
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`differentiation, []dependent claims give rise to a presumption that the broader independent
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`claims are not confined to that range." (citation omitted)).
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`Here, the asserted independent claims do not include concentration limitations, while
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`dependent claims in the '652 and '930 patents recite several specific ranges. These ranges
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`include 5-200 µg/ml, required by Defendant's proposed construction, as well as 5-120 µg/ml and
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`20-75 µg/ml. ('652 patent, 12:13-18; '930 patent, 12:36-41). Defendant's proposed
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`construction would render meaningless the difference in scope between these claims. Contrary
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`to Defendant's contentions, this is not a case where claim differentiation is "overcome by a
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`contrary construction dictated by the written description or prosecution history." Seachange
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`Int'!, Inc. v. C-COR, Inc., 413 F.3d 1361, 1369 (Fed. Cir. 2005).
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`Accordingly, I will not adopt Defendant's proposed construction. I conclude that no
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`construction is needed for the term "chemical entity." It will be construed according to its plain
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`and ordinary meaning.
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`6
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 7 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 8 of 23 PageID #: 4733
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`2. "housing" ('844 patent, claim 21; '105 patent, claims 1, 4; '008 patent, claims 1,
`3, 6, 11)
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`The parties included the term "housing" in their joint claim construction brief. However,
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`Defendant has agreed to Plaintiffs' proposed construction. (D.1. 127 at 36 n. 10). Thus, there is
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`no need for the Court to construe this term.
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`3. "main housing" I "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)
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`a. Plaintiffs' proposed construction: "an exterior unitary or multi part component
`configured to house, fix, protect, guide and/or engage with one or more inner
`components"
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`b. Defendant's proposed construction: "single, indivisible component that is an
`external case or enclosure"
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`c. Court's construction: "an exterior unitary or multi part component configured
`to house, fix, protect, guide and/or engage with one or more inner
`components"
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`Plaintiffs argue their proposed construction, which adds the word "exterior"2 to the
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`agreed-upon construction for the term "housing," is supported by the patentee's lexicography
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`and is consistent with the plain meaning of the term. (Id. at 35). Plaintiffs argue that
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`Defendant's proposed construction "violates the principle that all terms in a claim have
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`meaning," by construing "external housing" the same way as "housing." (Id.). In contrast to
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`their proposed construction, Plaintiffs assert, Defendant's construction is "divorce[ d] [] entirely
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`from the agreed definition of 'housing."' (Id. at 45).
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`Citing several dictionary definitions, Defendant argues the plain meaning of "main
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`housing" dictates that the component be a single part. (Id. at 37). Defendant further asserts that
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`2 At the Markman hearing, Plaintiffs represented their proposed construction as including the word
`"external," rather than "exterior." (Tr. at 32:3-5). In the parties' joint claim construction brief, however,
`Plaintiffs' proposed construction includes the word "exterior." (D.I. 127 at 35). In any event, I do not see
`any meaningful difference between "external" and "exterior."
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`7
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 8 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 9 of 23 PageID #: 4734
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`Plaintiffs' proposed construction would render the word "main" meaningless. (Id.). Defendant
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`points to the specifications of the '069, '044, and '486 patents, which distinguish between
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`"housing" and the "main housing part." (Id.). Further, Defendant contends that the prosecution
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`history and the patent specifications indicate that "main housing" refers to a single component.
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`(Id at 37-40). Similarly, with respect to the term "external housing," Defendant argues that
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`Plaintiffs' proposed construction eliminates the distinction between the "external housing" and
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`the other components of the claims. (Id. at 43).
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`I disagree with Defendant's assertion that the patent specifications and the plain meaning
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`of the terms "main housing" and "external housing" require single, indivisible components. The
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`embodiments upon which Defendant relies do not make clear that the "main housing" and
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`"external housing" are single, indivisible components, and, in any event, it is generally improper
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`to import limitations from the specification into the claims. E.g., Hill-Rom Servs., Inc. v. Stryker
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`Corp., 755 F.3d 1367, 1371 (Fed. Cir. 2014). Further, nothing in the plain language of the terms
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`suggests the "main housing" and "external housing" cannot be made of multiple parts. The
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`definitions upon which Defendant relies address the meaning of the word "main," defining it as,
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`for example, "chief or principal in rank, importance, [or] size." (D.I. 127 at 37 (quoting Collins
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`English Dictionary)). That a component is "chief or principal in rank," however, does not mean
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`it cannot be a multipart component.
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`Further, I agree with Plaintiffs' inclusion of the language from the lexicography of the
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`'105 and '008 patents, that is, "configured to house, fix, protect, guide and/or engage with one or
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`more inner components." Although this definition appears only in the '105 and '008 patents, I
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`believe it also makes sense to include it in the construction for the terms "main housing" and
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`"external housing" in the '069, '044, and '486 patents.
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`8
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 9 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 10 of 23 PageID #: 4735
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`Claim 1 of the '044 patent describes a "cartridge retaining part" being "coupled to said
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`main housing." ('044 patent, 7:13-14; see also '486 patent, 10:3-4 (reciting "a tubular barrel
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`retainer" being "operatively coupled to said external housing")). Claim 11 of the '044 patent and
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`claim 1 of the '069 patent recite a "dose dial sleeve comprising a helical groove configured to
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`engage a threading provided by said main housing." ('044 patent, 8:12-14; '069 patent, 6:41-
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`43). These examples demonstrate the "main housing" and "external housing" being configured
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`to fix or engage with inner components of the pen-type injector. Throughout the patent
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`specifications, these terms are repeatedly described in a way that is consistent with the
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`lexicography from the '105 and '008 patents. (See, e.g., '044 patent, 5 :9-11 ("The main housing
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`4 is further provided with a helical rib 46, adapted to be seated in the helical groove 74 on the
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`outer surface of the dose dial sleeve 70.")). A construction that includes Plaintiffs' proposed
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`language is therefore supported by the intrinsic record.
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`Accordingly, I will construe "main housing" and "external housing" to mean "an exterior
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`unitary or multipart component configured to house, fix, protect, guide and/or engage with one
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`or more inner components."
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`4. "thread/threading" ('044 patent, claims 1, 7, 10, 11, 17, 20; '069 patent, claim 1;
`'486 patent, claims 1, 24, 25, 31, 43; '844 patent, claim 21; '105 patent, claims 3
`and 4; '348 patent, claims 2 and 30; '152 patent, claim 14; '008 patent, claims 1,
`6, 7, 11, 16, and 18)
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`a. Plaintiffs' proposed construction: "a rib or groove on a first structure that
`engages a corresponding groove or rib on a second structure"
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`b. Defendant's proposed construction: "rib or groove on a first structure that
`engages a corresponding groove or rib on a second structure and that allows
`rotational and axial movement between the first and second structures"
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`c. Court's construction: "rib or groove on a first structure that engages a
`corresponding groove or rib on a second structure and that allows rotational
`and axial movement between the first and second structures"
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`9
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`I
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 10 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 11 of 23 PageID #: 4736
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`Plaintiffs argue that Defendant is attempting to include the meaning of the word "helical"
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`in its construction, which the Court rejected in Lilly when it construed the term "thread." (D.I.
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`127 at 50). Although Defendant's construction does not use the word "helical," Plaintiffs argue
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`that Defendant's proposed construction "would achieve the same result," because a "helical"
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`thread is "commonly understood as a thread that provides for both rotational and axial movement
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`between structures." (Id.). Plaintiffs further point to the specifications of the '105 and '348
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`patents, which, according to Plaintiffs, show that Defendant is incorrect that a "thread" must
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`"allow[] rotational and axial movement." (Id. at 51 ).
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`Defendant responds that Plaintiffs' proposed construction of "thread" would include a
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`"spline," which is inconsistent with the plain meaning of the terms and the patent specifications,
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`which distinguish between the two words. (Id. at 53). Contrary to Plaintiffs' assertions,
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`Defendant argues, Defendant's proposed construction includes both helical and non-helical
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`threads. (Id. at 54).
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`I agree with Defendant that Plaintiffs' proposed construction for "thread" would include a
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`"spline," which conflicts with the patent specifications. The specifications do not appear to use
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`the words "thread" and "spline" interchangeably. Nor do they suggest that a "spline" is a type of
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`"thread." Rather, the patents differentiate between the two. For example, the '044 and '105
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`patents describe a "nut 40" having an "internal thread matching the intermediate thread 36," and
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`the "nut 40" advancing along the intermediate thread "by the rotation of the drive sleeve." ('044
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`patent, 4:20-21, 6:4-6; '105 patent, 8:4-6, 9:58-60). They describe "splines," on the other hand,
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`as being used "to prevent relative rotation between the nut 40 and the main housing 4, while
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`allowing relative longitudinal movement there between." ('044 patent, 4:22-26; '105 patent,
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 11 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 12 of 23 PageID #: 4737
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`8:6-10). According to the '044 and '105 patents,3 therefore, a "thread" allows for rotational
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`movement, while a "spline" does not. There is no reason to conclude that the patents use the
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`word "spline" to refer to a type of "thread."
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`Further, I am not persuaded that a person of ordinary skill in the art, at the time of the
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`invention, would have understood a "spline" to be a type of "thread." Plaintiffs point to a
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`definition from 1917 in The Mechanical Engineer. (D.I. 127 at 58). Plaintiffs omit, however,
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`that the definition is "supplementary" and "open to discussion." (Id). It seems unlikely
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`therefore that the definition reflects the general understanding of one of ordinary skill in the art at
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`the time of the invention with respect to the meaning of the word "spline." Although Plaintiffs
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`also cite to a 2013 publication, nowhere does the text upon which Plaintiffs rely refer to a
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`"spline." (See id (citing Matrix Methods in the Design Analysis of Mechanism and Multibody
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`Systems (2013))). Rather, the text describes what happens to "threads" when "the pitch of a
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`helical joint is made infinite." (Id).
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`Finally, Plaintiffs point to a definition of "helical thread" in the '105 patent, which states:
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`"The term 'helical thread' according to the instant invention shall preferably mean a full or part
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`thread ... designed to allow continuous free rotational and/or axial movement between
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`components." (Id at 58 (quoting '105 patent, 3:27-36)). Plaintiffs argue this lexicography
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`contradicts Defendant's proposed construction, which requires "rotational and axial movement."
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`(Id.). Although this definition seems to suggest that a "helical thread" could be construed in such
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`a way so as to allow axial movement without "continuous free rotational movement," such axial
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`movement can occur without splines but still not include "continuous free rotational movement."
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`3 The parties do not argue this term should be construed differently for the other patents in which it
`appears.
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`11
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`l
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`1
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 13 of 23 PageID #: 4738
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`Therefore, in the context of these patents, "thread" does not suggest a "spline."
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`Accordingly, it will not be construed to mean "spline." I will construe "thread" as "rib or groove
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`on a first structure that engages a corresponding groove or rib on a second structure and that
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`allows rotational and axial movement between the first and second structures."
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`5. "the piston rod and the driving member are configured to rotate relative to one
`another during dose dispensing" ('844 patent, claim 21)
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`a. Plaintiffs' proposed construction: no construction necessary, plain and
`ordinary meaning
`
`b. Defendant's proposed construction: "both piston rod and driving member are
`configured to rotate, each at a different rate and/or direction, during dose
`dispensing"
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`c. Court's construction: "both piston rod and driving member are configured to
`rotate, each at a different rate and/or direction during dose dispensing"
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`Plaintiffs argue, "The claim language is clear and further construction is unnecessary:
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`during dose dispensing, the piston rod and the driving member are configured for relative
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`rotation." (Id. at 61). According to Plaintiffs, Defendant's proposed construction would "violate
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`core claim construction principles" by importing limitations unsupported by the intrinsic record
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`and by excluding a preferred embodiment. (Id. at 62). Specifically, Plaintiffs point to Figure 11,
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`which depicts an embodiment in which the piston rod, not the driving member, rotates relative to
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`the housing. (Id.). They also point to column 6, lines 48 to 58, which they argue show that the
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`specification "includes the possibility that one component rotates while the other does not." (Id.
`
`at 61).
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`Defendant counters that the plain language of the term "requires that each of the piston
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`rod and the driving member be configured to rotate, albeit in different directions or to a different
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`extent." (Id. at 62--63). If Plaintiffs sought to claim a device in which the piston rod did not
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`rotate, Defendant contends, they could have done so. (Id. at 63). In fact, the claim limitations
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`12
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`(
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 13 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 14 of 23 PageID #: 4739
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`show "the patentee knew how to draft claim limitations, where one or the other driving member
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`and piston rod are configured to rotate." (Tr. at 76:24-77:2). In response to Plaintiffs' argument
`
`that Defendant's proposed construction would exclude a preferred embodiment, Defendant
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`asserts that a claim in a patent, which is not asserted in this case, covers that preferred
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`embodiment. (D.I. 127 at 63).
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`"A claim construction that gives meaning to all the terms of the claim is preferred over
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`one that does not do so." Merck & Co., Inc. v. Teva Pharmas. USA, Inc., 395 F.3d 1364, 1372
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`(Fed. Cir. 2005). In my opinion, a construction, like Defendant's, which requires both the
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`"piston rod" and the "driving member" to be configured to rotate, appropriately gives meaning to
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`all the terms of the claim. Claim 21 twice refers to the "driving member" being "configured to
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`rotate relative" to another component of the pen-type injector. First, claim 21 recites, "the
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`driving member is configured to rotate relative to the piston rod." ('844 patent, 8:40-41).
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`Second, it recites the term at issue: "the piston rod and the driving member are configured to
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`rotate relative to one another during dose dispensing." (Id. at 8:45-46). Plaintiffs essentially ask
`
`the Court to ignore that these two claim limitations are worded differently. Plaintiffs assert that
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`the disputed term encompasses two configurations, one in which both the "piston rod" and the
`
`"driving member" are configured to rotate, and one in which only one or the other is configured
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`to rotate. (Tr. at 69:12-14). Such a construction, however, renders meaningless the difference in
`
`the way the two limitations are written. The patentee understood how to write a limitation in
`
`which either the "piston rod" or the "driving member" is configured to rotate. (See '844 patent,
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`8:40-41).
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`Further, I am not persuaded by Plaintiffs' argument that Defendant's proposed
`
`construction is improper because it excludes a preferred embodiment. A construction that
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`13
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1029, p. 14 of 23
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 15 of 23 PageID #: 4740
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`excludes a preferred embodiment is generally "disfavored." Pacing Techs., LLC v. Garmin Int'!,
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`Inc., 778 F.3d 1021, 1026 (Fed. Cir. 2015). However, "where the patent describes multiple
`
`embodiments, every claim does not need to cover every embodiment." Id "This is particularly
`
`true where the plain language of a limitation of the claim does not appear to cover that
`
`embodiment." Id Here, the plain language of the disputed limitation does not appear to cover
`
`the embodiments upon which Plaintiffs rely. Those embodiments describe or depict
`
`configurations in which the "driving member" rotates, while the "piston rod" does not.
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`Finally, I agree with Defendant's including "each at a different rate and/or direction" in
`
`its proposed construction. In my opinion, that language appropriately reflects what is meant by
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`the piston rod and driving member being configured to rotate "relative" to one another.
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`For the reasons stated above, I will construe this term to mean, "both piston rod and
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`driving member are configured to rotate, each at a different rate and/or direction during dose
`
`dispensing."
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`6. "abut" ('152 patent, claim 1)
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`Although the parties included "abut" in their joint claim construction brief, they have
`
`since agreed upon a construction. (D.I. 160 at 1). Thus, there is no need for the Court to
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`construe that term.
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`7. "drive member" ('152 patent, claims 1, 2, 6-11)
`
`a. Plaintiffs' proposed construction: "single component or multiple components
`configured to transfer force to the piston rod"
`
`b. Defendant's proposed construction: "single component, or multiple
`components moving as one, which transfers force or motion to the piston rod"
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`c. Court's construction: "single component or multiple components configured
`to transfer force to the piston rod"
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`14
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`Case 1:16-cv-00812-RGA-MPT Document 192 Filed 01/12/18 Page 16 of 23 PageID #: 4741
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`The parties dispute whether the "multiple components" of the "drive member" must
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`"move as one." Plaintiffs argue their proposed construction is correct because it is taken directly
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`from the patent specification. (D.I. 127 at 69). According to Plaintiffs, Defendant's proposed
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`construction is incorrect for three reasons. (Id.). First,