Endo USA, Inc. and Endo Operations Limited v. Baxter Healthcare Corporation

CourtDistrict Court, D. Delaware
DecidedSeptember 6, 2024
Docket1:23-cv-00358
StatusUnknown

This text of Endo USA, Inc. and Endo Operations Limited v. Baxter Healthcare Corporation (Endo USA, Inc. and Endo Operations Limited v. Baxter Healthcare Corporation) is published on Counsel Stack Legal Research, covering District Court, D. Delaware primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Endo USA, Inc. and Endo Operations Limited v. Baxter Healthcare Corporation, (D. Del. 2024).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PAR PHARMACEUTICAL, INC.,PAR — ) STERILE PRODUCTS, LLC, and ENDO _ ) PAR INNOVATION COMPANY, LLC, — ) ) Plaintiffs, ) □ ) V. ) Civil Action No, 23-358-GBW-SRF ) BAXTER HEALTHCARE ) CORPORATION, ) ) Defendant. ) REPORT AND RECOMMENDATION Pending before the court is the parties’ claim construction dispute regarding two disputed terms in United States Patent Nos. 9,993,520 (“the ’520 patent”), 11,135,265 (“the ’265 patent”), and 11,207,372 (“the 372 patent;” collectively, the “Asserted Patents”).! The Asserted Patents are generally directed to ready-to-use (““RTU”) vasopressin formulations that can be stored for extended periods of time. Plaintiffs Par Pharmaceutical, Inc., Par Sterile Products, LLC, and Endo Par Innovation Company, LLC (collectively, “Plaintiffs”) brought this patent infringement action against defendant Baxter Healthcare Corporation (“Baxter”) on March 29, 2023, alleging that Baxter’s Vasopressin in 0.9% Sodium Chloride Injection product (“Baxter’s Product”) infringes the Asserted Patents, (D.I. 1) Following a review of the parties’ joint claim construction brief and associated materials (D.1. 105; D.I. 106), and after consideration of the arguments presented at the Marfonan hearing held on September 4, 2024, I recommend that the court adopt the following constructions for the disputed terms for the reasons set forth below:

' Consistent with the parties’ joint claim construction brief, the court cites the disclosures as found in the ’520 patent for ease of reference. (D.J. 105 at 1 n.1)

“providing ... storing... administering” | Construction necessary only because the parties (520 patent, claims 1, 4-9, & 13; °372 dispute the plain and ordinary meaning, which is patent, claims 1-3 & 6-13) that the steps must occur in this order: providing, then storing, then administering. “unit dosage form” No construction necessary. patent, claims 1, 4-9, & 13; °265 patent, claims 1-4, 7-14, & 16; °372 atent, claims 1-3 & 6-13) 1. BACKGROUND OF THE TECHNOLOGY Vasopressin is a peptide hormone that acts to regulate water retention in the body and increase blood volume. (7520 patent, col. 4:63-5:8) In higher concentrations, vasopressin raises blood pressure by constricting blood vessels throughout the body. (/d., col. 5:8-9) Vasopressin can be used clinically to treat sepsis, cardiac conditions, and low blood pressure, among other conditions. Ud, col. 7:12-29) Vasopressin formulations can be used clinically to treat patients suffering from dangerously low blood pressure. (/d., col. 8:24-26) Vasopressin formulated as an aqueous solution can be diluted or reconstituted prior to use. (/d., col. 8:59-61) In prior art formulations, once the vasopressin was diluted or reconstituted into unit dosage form, the solution could be refrigerated for stability for about one day, after which the solution would begin to degrade and become unsuitabie for use. (/d., col. 8:61-65; 67:28-32) The Asserted Patents are directed to premixed vasopressin formulations and methods of administering those formulations that include stabilizing polymer agents to prolong the shelf life of the diluted RTU formulations beyond one day and up to two years under refrigeration, (/d., Abstract; col. 52:56-58) Plaintiffs allege that Baxter’s Vasopressin in 0.9% Sodium Chloride Injection product (“Baxter’s Product”) infringes claims 1, 4-9, and 13 of the 7520 patent, claims 1-3 and 6-13 of the °372 patent, and claims 1-4, 7-14, and 16 of the ’265 patent (collectively, the “Asserted

Claims”). (D.I. 94 at A-1, A-3) The disputed claim terms are found in the Asserted Claims. Independent claim | of the ’520 patent is exemplary and recites: A method of increasing blood pressure in a human in need thereof, the method comprising: a) providing a unit dosage form for intravenous administration, wherein the unit dosage form comprises: i) from about 0.1 units/ml to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) from about 1 mM to about 10 mM acetate buffer; iii) O-2% vasopressin degradation products; iv) sodium chloride; and Vv) water; and b) storing the unit dosage form for at least about 24 hours at from about 0.1 units/ml to about | unit/m! of vasopressin or a pharmaceutically-acceptable salt thereof; and c) after storing, administering the unit dosage form to the human by intravenous administration, wherein the unit dosage form that is administered to the human comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; wherein: the unit dosage form has a pH of 3.4 to 3.8; the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically- acceptable salt thereof per minute to about 0,1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and the human is hypotensive, (520 patent, col, 175:32-58) H. LEGAL STANDARD The purpose of the claim construction process is to “determin[e] the meaning and scope of the patent claims asserted to be infringed.” Markman y, Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), aff'd, 517 U.S. 370, 388-90 (1996). Construing the claims of a patent presents a question of law, although subsidiary fact finding is sometimes necessary. Teva Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318, 326 (2015) (citing Markman, 52 F.3d at 977-

78). An actual dispute regarding the proper scope of a claim term must be resolved by a judge, as opposed to the jury. Adarkman, 52 F.3d at 979. “(There is no magic formula or catechism for conducting claim construction.” Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005). Instead, the court may attach the appropriate weight to appropriate sources “in light of the statutes and policies that inform patent law.” Jd. The words of the claims “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.” Jd. at 1312-13 Gnternal citations and quotation marks omitted). If the meaning of a claim term is not readily apparent, the court considers sources including “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.” Inmova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1116 (ed. Cir. 2004). “Tt 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, 415 F.3d at 1312 CGinternal quotation marks omitted). Accordingly, “the claims themselves provide substantial guidance as to the meaning of particular claim terms.” /d@. at 1314. Claim terms are typically used consistently throughout the patent, and “usage of a term in one claim can often illuminate the meaning of the same term in other claims.” fd. Also, “{dlifferences 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.” Jd. at 1314- 15 (internal citation omitted).

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Endo USA, Inc. and Endo Operations Limited v. Baxter Healthcare Corporation, Counsel Stack Legal Research, https://law.counselstack.com/opinion/endo-usa-inc-and-endo-operations-limited-v-baxter-healthcare-corporation-ded-2024.