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Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC

United States District Court, D. New Jersey

November 6, 2017

AMNEAL PHARMACEUTICALS, LLC, et al., Defendants. Jazz Defendants The Court Phrase Jazz Defendants The Court Defendants The Court


          Esther Salas, U.S.D.J.

         Before the Court is the parties' request for claim construction. The Court held a Markman hearing on April 27, 2017. (D.E. No. 350). This Opinion sets forth the Court's constructions of the disputed terms.


         Plaintiffs Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (together, “Jazz”) market the drug product Xyrem®, which is used to treat patients with two of the most prevalent symptoms of narcolepsy: excessive daytime sleepiness and cataplexy. Defendants[2] filed Abbreviated New Drug Applications with the FDA seeking approval to market generic versions of Xyrem®. Jazz sued Defendants for patent infringement under 35 U.S.C. § 100 et seq., alleging, among other things, that Defendants' proposed generic versions of Xyrem® will infringe Jazz's patents.

         Xyrem® is sold as a concentrated oral solution that is diluted by the patient with water prior to its use at bedtime. The active ingredient in Xyrem® is sodium oxybate (also known as gamma-hydroxybutyrate, or GHB). Under certain conditions, GHB may become chemically unstable and break down. GHB solutions may also become prone to microbial contamination.

         This Markman decision involves eleven patents stemming from two patent families: the ‘431 patent family and the ‘306 patent family.[3] The ‘431 patent family covers pharmaceutical compositions of GHB-and methods of making and using such pharmaceutical compositions- that are chemically stable and microbial resistant, without the need for a preservative.

         The ‘306 patent family (comprising what are known as “DDI”-or “drug-drug-interaction”-patents) covers specific methods of treating sleep disorders in patients receiving both GHB and valproate. Valproate (also known as divalproex sodium) is used as an anticonvulsant and mood-stabilizing drug, primarily for treating epilepsy and bipolar disorder. Significantly, valproate is involved in processes that can both raise and lower the levels of GHB in a patient. So, the DDI patents claim methods for safely co-administering GHB and valproate to treat patients with sleep disorders.

         The parties submitted a Joint Claim Construction and Prehearing Statement identifying seven disputed terms. (D.E. No. 315 (“Joint Stmt.”)). Following Markman briefing, [4] the parties submitted an Amended Joint Claim Construction and Prehearing Statement reducing the number of disputed terms to five. (D.E. No. 348 (“Am. Joint Stmt.”)).

         II. Legal Standard

         A. Basics of Claim Construction

         A patent claim is that “portion of the patent document that defines the scope of the patentee's rights.” Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 835 (2015).[5] When the parties in a patent infringement action “present a fundamental dispute regarding the scope of a claim term, it is the court's duty to resolve it.” O2 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008).

         The words of a claim are generally given their ordinary and customary meaning, which is “the meaning that the term would have to a person of ordinary skill in the art [(a “POSA”)] in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). To determine the ordinary and customary meaning of a disputed term, the court must look to “those sources available to the public that show what a [POSA] would have understood [the] disputed claim language to mean.” Id. at 1314.

         B. Intrinsic and Extrinsic Evidence

         “In determining the proper construction of a claim, the court has numerous sources that it may properly utilize for guidance. These sources . . . include both intrinsic evidence (e.g., the patent specification and file history) and extrinsic evidence (e.g., expert testimony).” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

         With respect to intrinsic evidence, “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” Phillips, 415 F.3d at 1314. Indeed, “the context in which a term is used in the asserted claim can be highly instructive.” Id. Similarly, “[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment as to the meaning of a claim term.” Id.

         Importantly, the specification “is always highly relevant to the claim construction analysis” and “is the single best guide to the meaning of a disputed term.” Id. at 1315 (quoting Vitronics, 90 F.3d at 1582). “[T]he specification may reveal a special definition given to a claim term by the patentee” or “may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor.” Id. at 1316. Thus, “the specification necessarily informs the proper construction of the claims, ” and it is “entirely appropriate for a court, when conducting claim construction, to rely heavily on the written description for guidance as to the meaning of the claims.” Id. at 1316-17. Notably, however, the court may “not read limitations from the specification into claims.” Thorner v. Sony Computer Entm't Am. LLC, 669 F.3d 1362, 1366 (Fed. Cir. 2012). In particular, the Federal Circuit has “repeatedly warned against confining the claims to . . . embodiments” described in the specification. Phillips, 415 F.3d at 1323.

         The court must also consider the patent's prosecution history, i.e., “the complete record of the proceedings before the PTO . . . includ[ing] the prior art cited during the examination of the patent.” Id. at 1317. Although the prosecution history “often lacks the clarity of the specification and thus is less useful for claim construction purposes, ” it can nevertheless “inform the meaning of the claim language by demonstrating how the inventor understood the invention and whether the inventor limited the invention in the course of prosecution, making the claim scope narrower than it would otherwise be.” Id.

         The court may also rely on extrinsic evidence, i.e., “all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.” Id. But, extrinsic evidence “is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence.” Id. at 1319.

         C. Indefiniteness at the Markman Stage

         Patent claims must “inform those skilled in the art about the scope of the invention with reasonable certainty, ” when read in light of the specification and prosecution history. Nautilus, Inc. v. Biosig Instruments, Inc., 134 S.Ct. 2120, 2129 (2014). A patent claim that fails to so inform a POSA is indefinite. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1340-41 (Fed. Cir. 2015). “A party challenging the validity of a patent must establish invalidity by clear and convincing evidence.” Summit 6, LLC v. Samsung Elecs. Co., 802 F.3d 1283, 1294 (Fed. Cir. 2015) (citing Microsoft Corp. v. i4i Ltd. P'ship, 131 S.Ct. 2238, 2242 (2011)). “Of course, claims are not indefinite merely because they present a difficult task of claim construction.” Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1249-50 (Fed. Cir. 2008). Rather, “if the meaning of the claim is discernible, even though the task may be formidable and the conclusion may be one over which reasonable persons will disagree, ” the claim is sufficiently clear to avoid invalidity on indefiniteness grounds. See id.

         Claim indefiniteness presents a question of law, and district courts may find claims indefinite at the Markman stage. See, e.g., Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1368-74 (Fed. Cir. 2014) (affirming the district court's indefiniteness ruling at claim construction post-Nautilus); Mycone Dental Supply Co. v. Creative Nail Design, Inc., No. 11-4380, 2014 WL 3362364, at *4 (D.N.J. July 9, 2014) (“[I]ndefiniteness is a significant issue to be adjudicated at claim construction . . . .”).[6]

         III. Construction of Disputed Claim Terms

         A. The ‘431 Patent Family

         1. “Third Container Means”

         Claim 17 of the ‘650 patent:

         “The set of claim 15, comprising a third container means capable of retaining a first container means, a second container means, and one or more delivery vehicles capable of administering the pharmaceutical composition to the patient.”[7]

The Court

“a container distinct from a first and second container”

This is a means-plus-function term under 35 U.S.C. § 112 ¶ 6; and it is indefinite.

This is a means-plus-function term under 35 U.S.C. § 112 ¶ 6; and it is indefinite.

         i.Third Container Means” is a Means-Plus-Function Limitation

         As a threshold matter, the parties dispute whether “third container means” is a means-plus-function limitation. “A means-plus-function limitation recites a function to be performed rather than definite structure or materials for performing that function.” Lockheed Martin Corp. v. Space Systems/Loral, Inc., 324 F.3d 1308, 1318 (Fed. Cir. 2003). The relevant statutory language provides that

[a]n element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, materials, or acts described in the specification and equivalents thereof.

35 U.S.C. § 112, ¶ 6.[8]

         Use of the word “means” in claim language creates a presumption that § 112, ¶ 6 applies. TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259 (Fed. Cir. 2008). This presumption, however, can be rebutted in two ways. Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1427 (Fed. Cir. 1997). First, “where a claim uses the word ‘means, ' but specifies no function for the ‘means, ' it does not implicate section 112.” Id. Second, “where a claim recites a function, but then goes on to elaborate sufficient structure, material, or acts within the claim itself to perform entirely the recited function, the claim is not in means-plus-function format.” Id. at 1427-28. The second scenario applies here.

         The Federal Circuit has explained that “[s]ufficient structure exists when the claim language specifies the exact structure that performs the functions in question without need to resort to other portions of the specification or extrinsic evidence for an adequate understanding of the structure.” TriMed, Inc., 514 F.3d at 1259-60. Courts “decide on an element-by-element basis, based upon the patent and its prosecution history, whether § 112, ¶ 6 applies.” Cole v. Kimberly-Clark Corp., 102 F.3d 524, 531 (Fed. Cir. 1996).

         Jazz argues that “third container means” is not a means-plus-function limitation because the claims containing that term recite sufficient structure. (Jazz Open. Br. at 5-8; Jazz Resp. Br. at 6-9). Specifically, Jazz contends that the claims “describe[] a structure-a container-that is used to hold other structures such as a first and second container and delivery vehicles.” (Jazz Open. Br. at 8). According to Jazz, “Defendants recognize that the terms ‘first container means' and ‘second container means' recite sufficient structure because Defendants do not contend that these terms fall under § 112, ¶ 6.” (Id.). And Jazz asserts that the claims' functional description for “third container means”-i.e., that the “third container means” is “capable of” performing a function-does not convert the term into a means-plus-function limitation. (Id.).

         Defendants counter that, as an initial matter, “third container means” is presumed to be a means-plus-function limitation because the claim contains the word “means.” (Def. Open. Br. at 13; Def. Resp. Br. at 8). Defendants then argue that there is no evidence to rebut this presumption, as the “claims plainly recite three functions for the ‘third container means' and do not describe any contemplated structure to perform those functions.” (Def. Open. Br. at 13). In fact, according to Defendants, “there is no explicit structure at all recited for the ‘third container means.'” (Id. at 14) (emphasis in original). Rather, Defendants argue that “the word ‘container' conveys the general function of containing, not a specific structure.” (Id. at 15). Defendants further argue that “even if ‘container' could reasonably refer to some endless category of structures, it is far from sufficient to rebut ...

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