Case 2:17-cv-09105-SRC-CLW Document 319 Filed 05/09/19 Page 1 of 25 PagelD: 8304
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`SANOFI-AVENTIS U.S. LLC et al.,
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`Plaintiffs,
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`Civil Action No. 17-9105 (SRC)
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`V.
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`MYLAN GMBH et al.,
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`OPINION & ORDER
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`Defendants.
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`CHESLER, U.S.D.J.
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`This matter comes before the Court on the application for claim construction by Plaintiffs
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`Sanofi Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop Industrie
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`("Sanofi") and Defendants Mylan GmbH, Biocon Research Ltd., Biocon S.A., and Biocon Sdn.
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`Bhd. (collectively, "Mylan"). In this patent infringement action, the parties seek construction of
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`claim terms in six U.S. Patents. For the reasons that follow, this Court finds that, with the
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`exception of "thread," where Defendants' proposed construction is unopposed, neither party has
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`overcome the presumption that the claim terms carry their ordinary meaning.
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`BACKGROUND
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`This case arises from a patent infringement dispute involving a set of pharmaceutical
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`patents related to a diabetes treatment. Plaintiffs own U.S. Patent Nos. 7,476,652 and 7,713,930
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`(the "formulation patents") and U.S. Patent Nos. 8,603,044; 8,679,069; 8,992,486; and 9,526,844
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`(the "device patents"). The formulation patents, generally, are directed to insulin formulations;
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`Sanofi markets such formulations under the Lantus® brand name. The device patents, generally,
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`1
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`Sanofi Exhibit 2165.001
`Mylan v. Sanofi
`IPR2018-01675
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`are directed to prefilled delivery pen devices that are used to inject medication into the body;
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`Sanofi markets such devices under the Lantus SoloSTAR® brand name. Defendants have
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`submitted a 505(b )(2) New Drug Application seeking FDA approval to market products which,
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`Plaintiffs contend, infringe these patents.
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`The parties' briefs refer to claim construction decisions in two cases before Judge
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`Andrews in the District of Delaware, Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., 14-cv-113
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`(RGA) (D. Del.) ("the Lilly case") and Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme
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`Corp., 16-cv-812 (RGA) (D. Del.) ("the Merck case"). In these cases, Sanofi asserted some of
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`the formulation and device patents at issue against other defendants.
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`I.
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`The law of claim construction
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`ANALYSIS
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`A court's determination "of patent infringement requires a two-step process: first, the
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`court determines the meaning of the disputed claim terms, then the accused device is compared
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`to the claims as construed to determine infringement." Acumed LLC v. Stryker Corp., 483 F.3d
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`800, 804 (Fed. Cir. 2007). "[W]hen the district court reviews only evidence intrinsic to the
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`patent (the patent claims and specifications, along with the patent's prosecution history), the
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`judge's determination will amount solely to a determination of law." Teva Pharms. USA, Inc. v.
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`Sandoz, Inc., 135 S. Ct. 831, 841 (2015).
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`The focus of claim construction is the claim language itself:
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`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. Attending this
`principle, a claim construction analysis must begin and remain centered on the
`claim language itself, for that is the language the patentee has chosen to
`'particularly point[] out and distinctly claim[] the subject matter which the
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`2
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`Sanofi Exhibit 2165.002
`Mylan v. Sanofi
`IPR2018-01675
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`patentee regards as his invention.'
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`Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir.
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`2004) (citations omitted).
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`The Federal Circuit has established this framework for the construction of claim
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`language:
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`We have frequently stated that the words of a claim 'are generally given their
`ordinary and customary meaning.' We have made clear, moreover, that the
`ordinary and customary meaning of a claim term 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.
`The inquiry into how a person of ordinary skill in the art understands a claim term
`provides an objective baseline from which to begin claim interpretation ...
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`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. In such circumstances,
`general purpose dictionaries may be helpful. In many cases that give rise to
`litigation, however, determining the ordinary and customary meaning of the claim
`requires examination of terms that have a particular meaning in a field of art.
`Because the meaning of a claim term as understood by persons of skill in the art is
`often not immediately apparent, and because patentees frequently use terms
`idiosyncratically, the court looks to those sources available to the public that show
`what a person of skill in the art would have understood disputed claim language to
`mean. Those sources include the words of the claims themselves, the remainder
`of the specification, the prosecution hi story, and extrinsic evidence concerning
`relevant scientific principles, the meaning of technical terms, and the state of the
`art.
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`Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314 (Fed. Cir. 2005) (citations omitted).
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`II.
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`Claim construction of the disputed terms
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`A The formulation patents
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`The parties dispute the interpretation of four claim terms in the formulation patents:
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`"chemical entity," "esters and ethers of polyhydric alcohol," "at least one chemical
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`3
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`Sanofi Exhibit 2165.003
`Mylan v. Sanofi
`IPR2018-01675
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`entity chosen from," and "effective amount to avoid turbidity."
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`1. "chemical entity"
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`The parties dispute the meaning of the phrase, "chemical entity," which appears in claims
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`1, 2, 7, 17, 18, 19, 23, and 24 of the '652 Patent, as well as claims 1, 14, 15, and 16 of the '930
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`Patent. Plaintiffs contend that the term has its ordinary meaning, which a skilled artisan would
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`understand to be "chemical compound." Defendants contend that the term should be construed
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`to mean, "surfactant that reduces turbidity." Defendants here attempt to import limitations from
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`the embodiments without any demonstration that the patentees used "expressions of manifest
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`exclusion or restriction." Defendants ignore this requirement, and cite VirnetX, Inc. v. Cisco
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`m, 767 F.3d 1308, 1318 (Fed. Cir. 2014) for this statement: "The fact that anonymity is
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`'repeatedly and consistently' used to characterize the invention strongly suggests that it should
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`be read as part of the claim." 1 As Plaintiffs note in response, Defendants have taken this out of
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`context. Crucially, in VirnetX, the Federal Circuit began the analysis of the construction of
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`"secure communication link" with this foundation: "As an initial matter, we note that there is no
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`dispute that the word 'secure' does not have a plain and ordinary meaning in this context, and so
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`must be defined by reference to the specification." Id. at 1317. Defendants have not established
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`that premise here. A typical use of this phrase appears in claim 1 of the '652 patent: "at least one
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`1 Defendants also point to a statement made during prosecution, in a March 19, 2008 Request for
`Continued Examination. It is sufficient to note that Defendants have not here pointed to any use
`of the claim term, "chemical entity," nor explained how the identified statement relates to the
`meaning of this claim term. In the absence of any argument that this prosecution statement
`meets the requirements for prosecution disclaimer, see Omega Eng'g, Inc. v. Raytek Corp., 334
`F.3d 1314, 1324 (Fed. Cir. 2003), this Court does not discern how this impacts the present claim
`construction inquiry.
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`4
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`Sanofi Exhibit 2165.004
`Mylan v. Sanofi
`IPR2018-01675
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`chemical entity chosen from polysorbate 20 and polysorbate 80."2 The meaning of "chemical
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`entity" in this example is clear on its face; Defendants point to no ambiguity. Unlike Virnetx,
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`the term here, in the context of the claim, has a plain meaning.
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`In the absence of expressions of manifest exclusion, the Court declines to narrow the
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`meaning of a claim term that is, on its face, unambiguous, and used in claim phrases which are
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`precise. Defendants have not overcome the presumption that "chemical entity" carries its
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`ordinary meaning which, as Plaintiffs state, is "chemical compound."
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`2. "chosen from"
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`The parties dispute the meaning of "chosen from," as used in the phrase, "at least one
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`chemical entity chosen from." Plaintiffs propose that the term has its plain and ordinary
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`meaning. Defendants propose that "chosen from" means "selected to be included in the
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`pharmaceutical formulation from." Defendants seek to insert into the claim language a scienter
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`requirement. Defendants point to nothing in any of these patents that indicates that the inventors
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`patented a formulation process requiring a particular mental state when deciding between
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`polysorbate 20 and polysorbate 80. Consider, again, claim I of the '652 patent, which begins as
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`follows: "A pharmaceutical formulation comprising ... " The claim on its face covers a
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`formulation, not a method for formulating. As Plaintiffs argue, the patentees drafted these
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`claims using a Markush group. Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1372
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`(Fed. Cir. 2005) ("A Markush group lists specified alternatives in a patent claim, typically in the
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`form: a member selected from the group consisting of A, B, and C.") "Chosen from" has its
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`2 If there is more than one reasonable interpretation of this claim phrase, Defendants have not
`pointed to it.
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`5
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`Sanofi Exhibit 2165.005
`Mylan v. Sanofi
`IPR2018-01675
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`ordinary meaning.
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`3. "the polysorbate 20 is present in an effective amount to avoid turbidity"
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`The parties agree that this phrase, which appears only in claim 8 of the '652 patent, has
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`its ordinary meaning, but they dispute what that ordinary meaning is. Plaintiffs propose that the
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`ordinary meaning is "the polysorbate 20 is present in an effective amount to prevent cloudiness."
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`Defendants propose that the ordinary meaning is "the amount of polysorbate chosen prevents
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`cloudiness." Defendants explain that the only meaningful difference between the two
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`constructions involves the question of whether the claim language requires the polysorbate 20 to
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`be chosen, as previously discussed. For the reasons already stated, the Court will not insert a
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`sci enter requirement into these formulation claims. The ordinary meaning of this phrase does
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`not require any particular mental state.
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`4. "esters and ethers of polyhydric alcohols"
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`Although this term involves chemistry, the parties appear to agree on the meaning within
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`chemistry. Neither party identifies any remaining ambiguity in the claim language. The parties'
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`briefs, which give very short treatment to this dispute, identify no actual question about the
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`meaning of this term. Instead, the briefs debate the question of whether Plaintiffs' proposed
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`construction is redundant. Since the parties agree about how a chemist would understand this
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`phrase, the Court concludes that the parties do not have any substantive dispute over the meaning
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`of this term.
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`B. The device patents
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`The parties dispute the construction of thirteen terms in the device patents. These four
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`patents descend from one application, No. 10/790,225, through chains of continuation
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`6
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`Sanofi Exhibit 2165.006
`Mylan v. Sanofi
`IPR2018-01675
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`applications. The parties agree that the device patents share a common specification.
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`With the exception of "thread," where Defendants' proposed construction is unopposed,
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`this Court resolves all of the claim construction disputes before it by application of one
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`fundamental principle of Federal Circuit law: "There is a heavy presumption that claim terms are
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`to be given their ordinary and customary meaning." Aventis Pharm., Inc. v. Amino Chems. Ltd.,
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`715 F.3d 1363, 1373 (Fed. Cir. 2013). "Properly viewed, the 'ordinary meaning' of a claim term
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`is its meaning to the ordinary artisan after reading the entire patent." Phillips, 415 F.3d at 1321.
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`"An accused infringer may overcome this 'heavy presumption' and narrow a claim term's
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`ordinary meaning, but he cannot do so simply by pointing to the preferred embodiment or other
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`structures or steps disclosed in the specification or prosecution history." CCS Fitness, Inc. v.
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`Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). In short, this Court finds that neither
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`party, for any claim term in dispute, has overcome the presumption that each term has its
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`ordinary meaning.
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`1. "piston rod"
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`Plaintiffs propose this construction: "A rod that engages with the drive
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`sleeve/driver/driving member to advance the piston during dose dispensing." Defendants
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`propose this construction: "a rod that moves axially to advance the piston." Neither party
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`contends that the term has its ordinary meaning.
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`In their opening brief, Plaintiffs present only one argument to support their proposed
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`construction: "it aligns with the intrinsic record ... " (Pls.' Br. 28.) Under Federal Circuit law,
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`this is not sufficient to overcome the presumption of ordinary meaning. In particular, as to the
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`proposed subphrase, "that engages with the drive sleeve/driver/driving member," Plaintiffs point
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`7
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`Sanofi Exhibit 2165.007
`Mylan v. Sanofi
`IPR2018-01675
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`Case 2:17-cv-09105-SRC-CLW Document 319 Filed 05/09/19 Page 8 of 25 PagelD: 8311
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`to three claims, from three of the device patents, which require such engagement. These do not
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`support their position. Two of the three examples point to characteristics of other components:
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`I) claim I of the '069 patent ("internal threading [ of drive sleeve] adapted to engage an external
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`thread of said piston rod") (Pls.' Br. 29); and 2) claim I of the '486 patent ("internal threading
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`[of driver] adapted to engage an external thread of said piston rod") (id.) Note that, in both of
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`these examples, the language states characteristics of the threading of the drive sleeve and driver,
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`as well as characteristics of the interaction between the "external thread of said piston rod" and
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`the internal thread of the other component. Plaintiffs do not explain why these expressly stated
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`characteristics should be incorporated into the construction of "piston rod." In these two
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`examples, the claim expressly discloses that the piston rod has an external thread with a
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`particular interaction with other components. Since this is expressly stated, why should it be
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`made implicit in the construction of "piston rod?" Given that there is no dispute that the drive
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`sleeve and driver are separate and different components from the piston rod, why would this
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`Court expand the concept3 of the piston rod to incorporate aspects of other components, or of the
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`interaction between the piston rod and another component?
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`Plaintiffs' third example is claim 21 of the '844 patent, quoting as follows: "piston rod ..
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`. that is engaged with the third thread [of the driving member]" (Pls.' Br. 29.) Plaintiffs do not
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`recognize that their proposed construction, if accepted, would introduce redundancy into this
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`claim language, which would become: "rod that engages with the driving member to advance the
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`3 While the Court here describes this as expanding the concept, the effect is to narrow the scope
`of coverage of the claim term: "piston rod" necessarily has a broader scope than a "rod that
`engages with the drive sleeve/driver/driving member to advance the piston during dose
`dispensing." Ultimately, both parties propose narrowing constructions of many terms.
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`8
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`Sanofi Exhibit 2165.008
`Mylan v. Sanofi
`IPR2018-01675
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`Case 2:17-cv-09105-SRC-CLW Document 319 Filed 05/09/19 Page 9 of 25 PagelD: 8312
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`piston during dose dispensing . .. that is engaged with the third thread [of the driving member.]"
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`This unwieldy and redundant interpretation demonstrates that the meaning of "piston rod" should
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`not be expanded to incorporate other components.
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`Overall, the parties' claim construction briefs repeatedly run into this problem. 4 Both
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`sides propose a number of constructions and arguments that ask the Court to narrow the scope of
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`claim terms by incorporating characteristics of other components or of the interaction between
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`components. "It is settled law that when a patent claim does not contain a certain limitation and
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`another claim does, that limitation cannot be read into the former claim in determining either
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`validity or infringement." SRI Int'l v. Matsushita Elec. Corp., 775 F.2d 1107, 1122 (Fed. Cir.
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`1985). Constructions that create redundancy are also likely to render the incorporated claim
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`language superfluous, in whole or in part. "A claim construction that gives meaning to all the
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`terms of the claim is preferred over one that does not do so." Vederi, LLC v. Google, Inc., 744
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`F.3d 1376, 1383 (Fed. Cir. 2014) (quoting Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d
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`1364, 1372 (Fed. Cir. 2005). If this Court incorporates into the meaning of "piston rod" the
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`express claim language that describes the interaction between the piston rod and the drive sleeve,
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`this renders that claim language superfluous.
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`4 A similar recurring problem in both parties' briefing of these claim construction disputes is the
`failure to distinguish the meaning of a claim term from the characteristics of embodiments of the
`invention. One might have a patent for an insulated coffee mug, for example, and every
`embodiment might have a Styrofoam insulation layer, but that fact alone does not prove that the
`meaning of the claim term "insulated" means "insulated by a Styrofoam layer." "Generally, a
`claim is not limited to the embodiments described in the specification unless the patentee has
`demonstrated a clear intention to limit the claim's scope with words or expressions of manifest
`exclusion or restriction." i4i Ltd. P'ship v. Microsoft Corp., 598 F.3d 831, 843 (Fed. Cir. 2010).
`In resolving these claim construction disputes, this Court will frequently rely on this principle,
`when the parties have overlooked it.
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`9
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`Sanofi Exhibit 2165.009
`Mylan v. Sanofi
`IPR2018-01675
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`Defendants' proposed construction of "piston rod" runs into the same problems.
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`Defendants present examples from the claims and embodiments in the specification that manifest
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`the narrowing characteristics they wish to import into their construction. For the reasons already
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`stated, this Court rejects this approach to claim construction.
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`This Court finds that neither party has overcome the presumption that "piston rod" carries
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`its ordinary meaning. The Court derives the ordinary meaning of "piston rod" from the attributes
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`that the parties agree on. The intersection of the proposed constructions is: "a rod that advances
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`the piston." The Court modifies this slightly to reflect that, while the piston rod advances the
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`piston5 only during dose delivery, it remains a piston rod even at rest. Thus, the ordinary
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`meaning of "piston rod" is "a rod that can advance the piston."
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`2. "clutch"
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`Plaintiffs propose this construction: "a structure that couples and decouples a moveable
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`component from another component." Defendants propose that clutch is a means-plus-function
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`term or, in the alternative, that it has this construction: "a component that, during dose setting,
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`operates to reversibly lock two components in rotation."
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`Plaintiffs' sole argument in support of their proposed construction is that it was adopted
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`by the Lilly court, 2015 U.S. Dist. LEXIS 5946 at *14. This Court has great respect for its sister
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`court, but this is not a valid claim construction argument under Federal Circuit law. No one
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`contends that any preclusion doctrine applies here. The Lilly court had before it a different set of
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`5 The Court notes that, while some claims in the device patents disclose a "plunger" instead of a
`"piston," the parties have not argued that the construction of "piston rod" must take this into
`account.
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`10
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`Sanofi Exhibit 2165.010
`Mylan v. Sanofi
`IPR2018-01675
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`patents, a different defendant, and different constructions proposed by the parties. Id. The Lilly
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`court resolved the particular claim construction disputes that those parties presented to it. As to
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`"clutch," the Lilly opinion clearly states what that dispute was: "The only point of contention is
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`'whether the claims require that the 'clutch' be a separate component of the claimed devices ... or
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`merely a 'structure' that could reside on another, separately claimed component."' Id. at *15.
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`The present parties have not presented that point of contention to this Court. 6 The present parties
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`have presented to this Court different proposed constructions and a different dispute: the word
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`"clutch" may be the same, but the dispute is not. The Lilly court's resolution of a different
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`dispute over "clutch" does not help this Court resolve the present one. Plaintiffs' argument does
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`not begin to rebut the presumption of ordinary meaning.
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`Defendants argue primarily that "clutch" is a means-plus-function term, pursuant to 35
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`U.S.C. § 112(6). Under§ 112(6), a claim limitation "may be expressed as a means or step for
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`performing a specified function without the recital of structure ... , and such claim shall be
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`construed to cover the corresponding structure ... " 35 U.S.C. § 112(6). When a claim
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`limitation does not include the word "means," as is the case here, there is a presumption that it is
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`not a means-plus-function limitation, and§ 112(6) does not apply. Williamson v. Citrix Online,
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`LLC, 792 F.3d 1339, 1349 (Fed. Cir. 2015). To overcome that presumption, Defendants have
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`the burden to demonstrate by a preponderance of the evidence that the "claim term fails to recite
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`sufficiently definite structure or else recites function without reciting sufficient structure for
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`6 Moreover, as Defendants note, the Lilly claim construction decision preceded the Federal
`Circuit's decision in Williamson, which substantially revised the law applicable to the
`construction of means-plus-function terms.
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`11
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`Sanofi Exhibit 2165.011
`Mylan v. Sanofi
`IPR2018-01675
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`performing that function." Zeroclick LLC v. Apple, Inc., 891 F.3d 1003, 1007 (Fed. Cir. 2018)
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`( citations omitted).
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`Defendants therefore bear the burden of rebutting the presumption that "clutch" is not a
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`means-plus-function term under the Zeroclick standard just quoted. Despite the fact that
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`Williamson sets forth exactly the same standard as Zeroclick, Defendants ignore those standards
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`and offer a different one, snipped from Williamson: "A test for determining whether a claim
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`element conveys sufficiently definite structure is asking whether it 'sets forth the same black box
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`recitation of structure for providing the same specified function as if the term 'means' had been
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`used."' (Defs.' Br. 21.) Defendants have indeed snipped a piece of Williamson here, but the
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`Federal Circuit did not state any alternate test. Here is what Williamson states: "Here, the word
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`'module' does not provide any indication of structure because it sets forth the same black box
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`recitation of structure for providing the same specified function as if the term 'means' had been
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`used." Williamson, 792 F.3d at 1350. Defendants have not applied the correct standard for
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`determining whether a claim term is a means-plus-function term. Defendants have not
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`demonstrated, by a preponderance of the evidence, that "clutch" fails to recite sufficiently
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`definite structure or else recites function without reciting sufficient structure for performing that
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`function.7 The presumption that "clutch" is not a means-plus-function term has not been
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`rebutted.
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`This leaves the Court to consider Defendants' alternate construction: "a component that,
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`7 Moreover, Defendants' expert, Dr. Ochoa, begins a paragraph about the construction of
`"clutch" with this statement: "The specification further defines the structure," followed by a
`detailed summary of the structural information given. (Ochoa Dec. ,i 68.) This alone negates
`Defendants' position.
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`12
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`Sanofi Exhibit 2165.012
`Mylan v. Sanofi
`IPR2018-01675
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`Case 2:17-cv-09105-SRC-CLW Document 319 Filed 05/09/19 Page 13 of 25 PagelD: 8316
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`during dose setting, operates to reversibly lock two components in rotation." This appears to be
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`close to the ordinary meaning of clutch, except that the qualifying phrase, "during dose setting,"
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`cannot be part of the ordinary meaning because, for example, a driver of a car with a manual
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`transmission engages and disengages the clutch without ever setting a dose. The Court
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`concludes that neither party has overcome the presumption that "clutch" has its ordinary
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`meaning, which is: "a component that can operate to reversibly lock two components in
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`rotation." 8
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`3. "drive sleeve," "drive," "driving member"
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`The device patents at issue each use one or more of these claim terms. "Drive sleeve"
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`appears in claims in the '844, '069, and '044 patents. "Driving member" appears in claims in the
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`'844 patent. "Driver" appears in claims in the '486 patent. Thus, some claims in the '844 patent
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`specify a "drive sleeve," and other claims in that patent specify a "driver."
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`Defendants propose this construction for all three terms: "an essentially tubular
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`component that moves axially to drive the piston rod." Plaintiffs propose this construction for
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`"drive sleeve:" "an essentially tubular component of essentially circular cross-section releasably
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`connected to the dose dial sleeve that imparts motion during dose dispensing." For "driver" and
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`"driving member," Plaintiffs propose this construction: "a component releasably connected to
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`the dose dial sleeve that imparts motion during dose dispensing."
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`As to the construction of "drive sleeve," Plaintiffs argue that their proposed construction
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`8 The parties agree that the claim term "tubular clutch" should be construed in conformity with
`this construction.
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`13
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`Sanofi Exhibit 2165.013
`Mylan v. Sanofi
`IPR2018-01675
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`Case 2:17-cv-09105-SRC-CLW Document 319 Filed 05/09/19 Page 14 of 25 PagelD: 8317
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`is derived from 9 a "lexicographical definition" stated in the '008 patent, and that this
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`construction overcomes the presumption of ordinary meaning based on the lexicography
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`exception. At the time of briefing, the '008 patent was at issue in this case. Subsequently, the
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`parties resolved the dispute over the '008 patent and dropped it from this case. At the Markman
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`hearing, however, Plaintiffs again asserted this lexicography argument.
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`There is no dispute that the four device patents presently at issue do not share a common
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`specification with the '008 patent, nor that the '008 patent has no parent application in common
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`with the device patents in the U.S. patent system. It is undisputed that the sole link between the
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`'008 patent and the four device patents rests on the fact that all five patents assert a priority date
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`from one British patent application, GB 0304822.0. At the Markman hearing, the Court Ordered
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`the parties to submit supplemental briefing on the issue of the relationship between the '008
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`patent and the four device patents.
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`In the supplementary briefing, Defendants argued that the Court need not determine the
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`precise relationship between the '008 patent and the four device patents because, in any event,
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`the specification of the '008 patent is not the specification of the device patents at issue. This is
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`correct. Under Federal Circuit law:
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`To act as its own lexicographer, a patentee must clearly set forth a definition of
`the disputed claim term other than its plain and ordinary meaning. It is not
`enough for a patentee to simply disclose a single embodiment or use a word in the
`same manner in all embodiments, the patentee must clearly express an intent to
`redefine the term.
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`9 The '008 patent states: "The term 'drive sleeve' according to instant invention shall mean any
`essentially tubular component of essentially circular cross-section and which is further releasibly
`connected to the dose dial sleeve." '008 patent, col.4 11.1-4. Plaintiffs' proposed construction
`adds "that imparts motion during dose dispensing" to the end of this definition.
`
`14
`
`Sanofi Exhibit 2165.014
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 319 Filed 05/09/19 Page 15 of 25 PagelD: 8318
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`Thomer v. Sony Comput. Entm't Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012) (citation
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`omitted). It is worth noting that, in this quoted passage, the Federal Circuit said not once, but
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`twice, that, to act as lexicographer, the patentee must do so clearly. A definition in some other
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`patent specification cannot meet the requirement of clearly expressing an intent to redefine the
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`term. To the contrary, the most reasonable inference from the present facts is that the patentees
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`did not clearly intend that a definition present in the specification of the '008 patent, but absent
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`from the specification of the four device patents at issue, redefined the term "drive sleeve" in the
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`four device patents. Plaintiffs have not demonstrated that the requirements of Thomer have been
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`met here.
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`Plaintiffs further propose that the phrase "that imparts motion during dose dispensing"
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`should be added to the definition of "drive sleeve" found in the '008 patent specification.
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`Plaintiffs now appear to have forgotten about their lexicography argument and are proposing a
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`melange construction. Plaintiffs offer some extrinsic evidence of ordinary meaning in support,
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`but the evidence does not support the proposition that the ordinary meaning of "drive" involves
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`dose dispensing.
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`Defendants propose one construction for all three drive terms. Defendants argue:
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`Notably, aside from the abstracts and claims of the '486 and '844 patents, the
`Device Patents never refer to a "driver" or "driving member." Ochoa, ,i 56. Thus,
`the POSA would not understand the terms "driver" and "driving member" to refer
`to anything other than the "drive sleeve."
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`(Defs.' Br. 18.) The intrinsic evidence does not support this view. Defendants cannot dispute
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`that some claims in the '486 and '844 patents refer not to a "drive sleeve," but to a "driver" or
`
`15
`
`Sanofi Exhibit 2165.015
`Mylan v. Sanofi
`IPR2018-01675
`
`

`

`Case 2:17-cv-09105-SRC-CLW Document 319 Filed 05/09/19 Page 16 of 25 PagelD: 8319
`
`"driving member." 10 Defendants' position appears to be that the three different terms are just all
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`the same thing, for no reason. This is not only unpersuasive, but the inference of sameness is not
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`supported by the clear language of the claims of the '844 patent. Claim 1 of the '844 patent
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`refers to a "drive sleeve." Contrast that with claim 21 in that patent (emphasis added):
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`21. A drug delivery device comprising:
`a housing comprising a dose dispensing end and a first thread;
`a dose indicator comprising a second thread that engages with the first thread;
`a driving member comprising a third thread;
`a sleeve that is (i) disposed between the dose indicator and the driving member
`and (ii) releasably connected to the dose indicator; a piston rod comprising either
`an internal or an external fourth thread that is engaged with the third thread;
`a piston rod holder that is rotatably fixed relative to the housing and configured to
`(i) prevent the piston rod from rotating during dose setting and (ii) permit the
`piston rod to traverse axially towards the distal end during dose dispensing;
`wher