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Horatio Washington Depot Technologies LLC v. Tolmar, Inc.

United States District Court, D. Delaware

December 26, 2018


          Kelly E. Farnan, RICHARDS, LAYTON & FINGER, Wilmington, DE A. Neal Seth, Lawrence M. Sung, Teresa Summers, and Alexander B. Owczarczak, WILEY REIN LLP, Washington, DC Attorneys for Plaintiff

          Adam W. Poff, YOUNG, CONWAY, STARGATT & TAYLOR, Wilmington, DE Jeffrey R. Gargano, Kevin P. Shortsle, and Zachary D. Miller, MORGAN, LEWIS & BOCKIUS LLP, Chicago, IL Attorneys for Defendants



         Plaintiff Horatio Washington Depot Technologies, LLC ("Horatio") sued Defendants TOLMAR, Inc., TOLMAR Pharmaceuticals, Inc., and TOLMAR Therapeutics, Inc. (together, "Tolmar"), alleging that Tolmar infringes Horatio's U.S. Patent Nos. 5, 932, 547 ("the '547 patent"), 6, 124, 261 ("the '261 patent"), and 6, 235, 712 ("the '712 patent"). (D.I. 1) The patents-in-suit describe stable non-aqueous formulations that include a peptide and a polar aprotic solvent.[1] (See '547 patent, Abstract) These formulations may be used, for example, to treat prostatic cancer. ('547 patent, 2:29-46)

         Presently before the Court are the parties' disputes over the meaning of certain terms in the asserted claims. The parties submitted technology tutorials (D.I. 67, 68) and claim construction briefs (D.I. 62, 66, 70, 72). Tolmar also filed objections to Horatio's technology tutorial. (D.I. 69) The Court held a claim construction hearing on October 22, 2018. (D.I. 79 ("Tr."))


         The ultimate question of the proper construction of a patent presents an issue of law. See Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 837 (2015) (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996)). "It is a bedrock principle of patent law that the claims of a patent define the invention to which the patentee is entitled the right to exclude." Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (citation and internal quotation marks omitted). "[T]here is no magic formula or catechism for conducting claim construction." Id. at 1324. Instead, the court is free to attach the appropriate weight to appropriate sources "in light of the statutes and policies that inform patent law." Id.

         "[T]he words of a claim are generally given their ordinary and customary meaning ... [which is] the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Id. at 1312-13 (internal citations and quotation marks omitted). "[T]he ordinary meaning of a claim term is its meaning to the ordinary artisan after reading the entire patent." Id. at 1321 (internal quotation marks omitted). The patent "specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).

         While "the claims themselves provide substantial guidance as to the meaning of particular claim terms," the context of the surrounding words of the claim also must be considered. Phillips, 415 F.3d at 1314. Furthermore, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable sources of enlightenment... [b]ecause claim terms are normally used consistently throughout the patent." Id. (internal citation omitted).

         It is likewise true that "[differences among claims can also be a useful guide .... For example, the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15 (internal citation omitted). This "presumption is especially strong when the limitation in dispute is the only meaningful difference between an independent and dependent claim, and one party is urging that the limitation in the dependent claim should be read into the independent claim." SunRace Roots Enter. Co., Ltd. v. SRAM Corp., 336 F.3d 1298, 1303 (Fed. Cir. 2003).

         It is also possible that "the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Phillips, 415 F.3d at 1316. It bears emphasis that "[e]ven when the specification describes only a single embodiment, the claims of the patent will not be read restrictively unless the patentee has demonstrated a clear intention to limit the claim scope using words or expressions of manifest exclusion or restriction." Hill-Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367, 1372 (Fed. Cir. 2014) (internal quotation marks omitted).

         In addition to the specification, a court "should also consider the patent's prosecution history, if it is in evidence." Markman v. Westview Instruments, Inc., 52 F.3d 967, 980 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The prosecution history, which is "intrinsic evidence," "consists of the complete record of the proceedings before the [Patent and Trademark Office] and includes the prior art cited during the examination of the patent." Phillips, 415 F.3d at 1317. "[T]he prosecution history can often 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.

         "In some cases, ... the district court will need to look beyond the patent's intrinsic evidence and to consult extrinsic evidence in order to understand, for example, the background science or the meaning of a term in the relevant art during the relevant time period." Teva, 135 S.Ct. at 841. "Extrinsic evidence consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. For instance, technical dictionaries can assist the court in determining the meaning of a term to those of skill in the relevant art because such dictionaries "endeavor to collect the accepted meanings of terms used in various fields of science and technology." Phillips, 415 F.3d at 1318. In addition, expert testimony can be useful "to ensure that the court's understanding of the technical aspects of the patent is consistent with that of a person of skill in the art, or to establish that a particular term in the patent or the prior art has a particular meaning in the pertinent field." Id. Nonetheless, courts must not lose sight of the fact that "expert reports and testimony [are] generated at the time of and for the purpose of litigation and thus can suffer from bias that is not present in intrinsic evidence." Id. Overall, while extrinsic evidence "may be useful to the court," it is "less reliable" than intrinsic evidence, and its consideration "is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." Id. at 1318-19. Where the intrinsic record unambiguously describes the scope of the patented invention, reliance on any extrinsic evidence is improper. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999).

         Finally, "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998). It follows that "a claim interpretation that would exclude the inventor's device is rarely the correct interpretation." Osram GmbH v. Int'l Trade Comm'n 505 F.3d 1351, 1358 (Fed. Cir. 2007) (internal quotation marks omitted).


         All three patents-in-suit are entitled "Non-Aqueous Polar Aprotic Peptide Formulations." The asserted claims relate to "stable non-aqueous formulation[s]" comprising a "peptide compound," such as luteinizing hormone-releasing hormone (LHRH), and a "polar aprotic solvent," methods for preparing these formulations, and methods for treating prostatic cancer using these formulations. ('547 patent, cl. 1; '261 patent, cl. 3, 4; '712 patent, cl. 1, 8) According to the specification, using non-aqueous polar aprotic solvents results in more physically and chemically stable peptide formulations than "standard" formulations, which "consist of dilute aqueous solutions." ('547 patent, 4:14-36) The specification states that this increased stability "mak[es] possible the delivery of peptides in long term implantable devices that would not otherwise be feasible." ('547 patent, 4:48-56)

         A. "[stable] non-aqueous formulation"[3]


plain and ordinary meaning


"solution having a non-water-based solvent system"


"solution having a non-water-based solvent system"

         The parties agree that "stable" is expressly defined in the specification (see '547 patent, 3:12-13, 5:4-7) and agree that the use of the term in the preamble is limiting, but they disagree as to the meaning of "non-aqueous formulation." (See D.I. 62 at 14; D.I. 66 at 3) The dispute centers on whether a "formulation" can be, as Horatio contends, a depot, suspension, or dispersion or whether, as Tolmar ...

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