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Sanofi-Aventis U.S. LLC v. Mylan GmbH

United States District Court, D. New Jersey

May 9, 2019

SANOFI-AVENTIS U.S. LLC et al., Plaintiffs,
v.
MYLAN GMBH et al., Defendants.

          OPINION & ORDER

          STANLEY R. CHESTER, U.S.D.J.

         This matter comes before the Court on the application for claim construction by Plaintiffs Sanofi Aventis U.S. LLC, Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop Industrie ("Sanofi") and Defendants Mylan GmbH, Biocon Research Ltd., Biocon S.A., and Biocon Sdn. Bhd. (collectively, "Mylan"). In this patent infringement action, the parties seek construction of claim terms in six U.S. Patents. For the reasons that follow, this Court finds that, with the exception of "thread," where Defendants' proposed construction is unopposed, neither party has overcome the presumption that the claim terms carry their ordinary meaning.

         BACKGROUND

         This case arises from a patent infringement dispute involving a set of pharmaceutical patents related to a diabetes treatment. Plaintiffs own U.S. Patent Nos. 7, 476, 652 and 7, 713, 930 (the "formulation patents") and U.S. Patent Nos. 8, 603, 044; 8, 679, 069; 8, 992, 486; and 9, 526, 844 (the "device patents"). The formulation patents, generally, are directed to insulin formulations; Sanofi markets such formulations under the Lantus® brand name. The device patents, generally, are directed to prefilled delivery pen devices that are used to inject medication into the body; Sanofi markets such devices under the Lantus SoloSTAR® brand name. Defendants have submitted a 505(b)(2) New Drug Application seeking FDA approval to market products which, Plaintiffs contend, infringe these patents.

         The parties' briefs refer to claim construction decisions in two cases before Judge Andrews in the District of Delaware, Sanofi-Aventis U.S. LLC v. Eli Lilly & Co., 14-cv-l 13 (RGA) (D. Del.) ("the Lilly case") and Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., 16-cv-812 (RGA) (D. Del.) ("the Merck case"). In these cases, Sanofi asserted some of the formulation and device patents at issue against other defendants.

         ANALYSIS

         I. The law of claim construction

         A court's determination "of patent infringement requires a two-step process: first, the court determines the meaning of the disputed claim terms, then the accused device is compared to the claims as construed to determine infringement." Acumed LLC v. Stryker Corp., 483 F.3d 800, 804 (Fed. Cir. 2007). "[W]hen the district court reviews only evidence intrinsic to the patent (the patent claims and specifications, along with the patent's prosecution history), the judge's determination will amount solely to a determination of law." Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 841 (2015).

         The focus of claim construction is the claim language itself:

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 patentee regards as his invention.'

Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir. 2004) (citations omitted).

         The Federal Circuit has established this framework for the construction of claim language:

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. . .
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 history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.

Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314 (Fed. Cir. 2005) (citations omitted).

         II. Claim construction of the disputed terms

          A. The formulation patents

         The parties dispute the interpretation of four claim terms in the formulation patents: "chemical entity," "esters and ethers of polyhydric alcohol," "at least one chemical entity chosen from," and "effective amount to avoid turbidity."

         1. "chemical entity"

         The parties dispute the meaning of the phrase, "chemical entity," which appears in claims 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 Patent. Plaintiffs contend that the term has its ordinary meaning, which a skilled artisan would understand to be "chemical compound." Defendants contend that the term should be construed to mean, "surfactant that reduces turbidity." Defendants here attempt to import limitations from the embodiments without any demonstration that the patentees used "expressions of manifest exclusion or restriction." Defendants ignore this requirement, and cite VirnetX, Inc. v. Cisco Sys., 767 F.3d 1308, 1318 (Fed. Cir. 2014) for this statement: "The fact that anonymity is 'repeatedly and consistently' used to characterize the invention strongly suggests that it should be read as part of the claim."[1] As Plaintiffs note in response, Defendants have taken this out of context. Crucially, in VirnetX, the Federal Circuit began the analysis of the construction of "secure communication link" with this foundation: "As an initial matter, we note that there is no dispute that the word 'secure' does not have a plain and ordinary meaning in this context, and so must be defined by reference to the specification." Id. at 1317. Defendants have not established that premise here. A typical use of this phrase appears in claim 1 of the '652 patent: "at least one chemical entity chosen from polysorbate 20 and polysorbate 80."[2] The meaning of "chemical entity" in this example is clear on its face; Defendants point to no ambiguity. Unlike Virnetx, the term here, in the context of the claim, has a plain meaning.

         In the absence of expressions of manifest exclusion, the Court declines to narrow the meaning of a claim term that is, on its face, unambiguous, and used in claim phrases which are precise. Defendants have not overcome the presumption that "chemical entity" carries its ordinary meaning which, as Plaintiffs state, is "chemical compound."

         2. "chosen from"

         The parties dispute the meaning of "chosen from," as used in the phrase, "at least one chemical entity chosen from." Plaintiffs propose that the term has its plain and ordinary meaning. Defendants propose that "chosen from" means "selected to be included in the pharmaceutical formulation from." Defendants seek to insert into the claim language a scienter requirement. Defendants point to nothing in any of these patents that indicates that the inventors patented a formulation process requiring a particular mental state when deciding between polysorbate 20 and polysorbate 80. Consider, again, claim 1 of the '652 patent, which begins as follows: "A pharmaceutical formulation comprising . . ." The claim on its face covers a formulation, not a method for formulating. As Plaintiffs argue, the patentees drafted these claims using a Markush group. Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367, 1372 (Fed. Cir. 2005) ("A Markush group lists specified alternatives in a patent claim, typically in the form: a member selected from the group consisting of A, B, and C") "Chosen from" has its ordinary meaning.

         3. "the polysorbate 20 is present in an effective amount to avoid turbidity"

         The parties agree that this phrase, which appears only in claim 8 of the '652 patent, has its ordinary meaning, but they dispute what that ordinary meaning is. Plaintiffs propose that the ordinary meaning is "the polysorbate 20 is present in an effective amount to prevent cloudiness." Defendants propose that the ordinary meaning is "the amount of polysorbate chosen prevents cloudiness." Defendants explain that the only meaningful difference between the two constructions involves the question of whether the claim language requires the polysorbate 20 to be chosen, as previously discussed. For the reasons already stated, the Court will not insert a scienter requirement into these formulation claims. The ordinary meaning of this phrase does not require any particular mental state.

         4. "esters and ethers of polyhydric alcohols"

         Although this term involves chemistry, the parties appear to agree on the meaning within chemistry. Neither party identifies any remaining ambiguity in the claim language. The parties' briefs, which give very short treatment to this dispute, identify no actual question about the meaning of this term. Instead, the briefs debate the question of whether Plaintiffs' proposed construction is redundant. Since the parties agree about how a chemist would understand this phrase, the Court concludes that the parties do not have any substantive dispute over the meaning of this term.

         B. The device patents

         The parties dispute the construction of thirteen terms in the device patents. These four patents descend from one application, No. 10/790, 225, through chains of continuation applications. The parties agree that the device patents share a common specification.

         With the exception of "thread," where Defendants' proposed construction is unopposed, this Court resolves all of the claim construction disputes before it by application of one fundamental principle of Federal Circuit law: "There is a heavy presumption that claim terms are to be given their ordinary and customary meaning." Aventis Pharm, Inc. v. Amino Chems. Ltd., 715 F.3d 1363, 1373 (Fed. Cir. 2013). "Properly viewed, the 'ordinary meaning' of a claim term is its meaning to the ordinary artisan after reading the entire patent." Phillips, 415 F.3d at 1321. "An accused infringer may overcome this 'heavy presumption' and narrow a claim term's ordinary meaning, but he cannot do so simply by pointing to the preferred embodiment or other structures or steps disclosed in the specification or prosecution history." CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). In short, this Court finds that neither party, for any claim term in dispute, has overcome the presumption that each term has its ordinary meaning.

         1. "piston rod"

         Plaintiffs propose this construction: "A rod that engages with the drive sleeve/driver/driving member to advance the piston during dose dispensing." Defendants propose this construction: "a rod that moves axially to advance the piston." Neither party contends that the term has its ordinary meaning.

         In their opening brief, Plaintiffs present only one argument to support their proposed construction: "it aligns with the intrinsic record. . ." (Pis.' Br. 28.) Under Federal Circuit law, this is not sufficient to overcome the presumption of ordinary meaning. In particular, as to the proposed subphrase, "that engages with the drive sleeve/driver/driving member," Plaintiffs point to three claims, from three of the device patents, which require such engagement. These do not support their position. Two of the three examples point to characteristics of other components: 1) claim 1 of the '069 patent ("internal threading [of drive sleeve] adapted to engage an external thread of said piston rod") (Pis.' Br. 29); and 2) claim 1 of the '486 patent ("internal threading [of driver] adapted to engage an external thread of said piston rod") (id.) Note that, in both of these examples, the language states characteristics of the threading of the drive sleeve and driver, as well as characteristics of the interaction between the "external thread of said piston rod" and the internal thread of the other component. Plaintiffs do not explain why these expressly stated characteristics should be incorporated into the construction of "piston rod." In these two examples, the claim expressly discloses that the piston rod has an external thread with a particular interaction with other components. Since this is expressly stated, why should it be made implicit in the ...


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