Baxter Healthcare Corp. v. Mylan Labs. Ltd.
| Decision Date | 05 April 2016 |
| Docket Number | 15-1684 (JBS/JS),Civil Action Nos. 14-7094 (JBS/JS) |
| Citation | 346 F.Supp.3d 643 |
| Parties | BAXTER HEALTHCARE CORPORATION, Baxter International Inc., and Baxter Healthcare S.A., Plaintiffs, v. MYLAN LABORATORIES LTD. and Mylan Pharmaceuticals Inc., Defendants. Baxter Healthcare Corporation, Baxter International Inc., and Baxter Healthcare S.A., Plaintiffs, v. Sagent Pharmaceuticals Inc., Defendant. |
| Court | U.S. District Court — District of New Jersey |
Robert D. Rhoad, Esq., Brian M. Goldberg, Esq., DECHERT LLP, 902 Carnegie Center, Suite 500, Princeton, NJ 08540, Martin J. Black, Esq., Kevin M. Flannery, Esq., Teri-Lynn A. Evans, Esq., DECHERT LLP, Circa Centre, 2929 Arch Street, Philadelphia, PA 19104, Counsel to the Baxter Plaintiffs
Amy Luria, Esq., CRITCHLEY, KINUM, & DENOIA, LLC, 75 Livingston Avenue, Roseland NJ 07068, Tung-On Kong, Esq., Sami Sedghani, Esq., WILSON SONSINI GOODRICH & ROSATI, P.C., One Market Street, Spear Tower, Suite 3300, San Francisco, CA 94105, Wendy L. Devine, Esq., WILSON SONSINI GOODRICH & ROSATI, P.C., 12235 El Camino Real, Suite 200, San Diego, CA 92130, Lisa D. Zang, Esq. WILSON SONSINI GOODRICH & ROSATI, P.C., 633 West Fifth Street, Suite 1550, Los Angeles, CA 90071, Counsel to the Mylan Defendants
George H. Parsells, III, Esq., Michael Rato, Esq., Riadh Quadir, Esq., McELROY, DEUTSCH, MULVANEY & CARPENTER, LLP, 1300 Mount Kemble Avenue, Morristown, NJ 07962, Ronald M. Daignault, Esq., POLSINELLI PC, 900 Third Avenue, 21st Floor, New York, NY 10022, Richard Juang, Esq., POLSINELLI PC, 100 S. Fourth Street, Suite 1000, St. Louis, MO 63102, Counsel to Defendant Sagent Pharmaceuticals Inc.
MARKMAN OPINION
Table of Contents
A. Claim Construction, Generally...651
B. Standards for Finding Lexicography and/or Disavowal...652
A. Defendants' No Construction Approach...653
B. "Sterile"...654
C. "Aqueous" pharmaceutical composition...659
D. Injectable, aqueous pharmaceutical composition...663
I. INTRODUCTION
These related patent infringement actions under the Hatch-Waxman Act, 35 U.S.C. §§ 271, 282, generally concern the assertions of Plaintiffs Baxter Healthcare Corporation, Baxter International Inc., and Baxter Healthcare S.A. (collectively, "Baxter ") that the proposed generic esmolol
hydrochloride products of Defendants Mylan Laboratories Ltd., Mylan Pharmaceuticals Inc. (hereinafter, "Mylan "), and Sagent Pharmaceuticals Inc. (hereinafter, "Sagent " and collectively, "Defendants ")1 infringe the various patents covering Baxter's esmolol hydrochloride product, U.S. Patent Nos. 6,310,094 (hereinafter, "'094 Patent") and 6,528,540 (hereinafter, " '540 Patent" and collectively, the "patents-in-suit" or "Patents"), a "continuation-in-part" of the '094 Patent.2
Following factual and claims construction discovery, the parties now request that the Court construe the following three claim terms:3
In seeking construction, Baxter takes the position, on essentially each disputed claim term, that the intrinsic record discloses a specific definition, and/or reflects the patentee's intention that the term be defined by reference to the "ordinary" meaning advanced in its extrinsic sources (namely, expert testimony and dictionary definitions). (See, e.g., Baxter's Opening Br. at 8-23; Baxter's Responsive Br. at 2-20.) More specifically, though, Baxter claims (1) that the inventors acted as their own lexicographer in reciting the term "sterile," (2) intended to incorporate their view on the "ordinary mean" of the term "aqueous," and (3) limited the scope of the phrase "injectable, aqueous pharmaceutical composition" through reference, in the specification, to the characteristics that form the "heart" of Baxter's claimed invention (namely, a stable, ready-to-use composition, capable of being autoclaved). (Baxter's Opening Br. at 8-23; Baxter's Responsive Br. at 2-20.)
Defendants, by contrast, largely eschew the need for formal claim construction and submit, in each instance, that the claim terms involve little more than the application of widely accepted meanings to commonly understood words. (See, e.g., Defs' Opening Br. at 5-7, 11, 15-16; Defs.' Responsive Br. at 1, 4, 10, 13.) In other words, Defendants claim that the disputed terms have "self-evident" or "readily apparent" meanings, and argue that Baxter's narrow definitions result from a litigation-driven effort to avoid relevant prior art. (See, e.g., id. ) In the event this Court deems construction necessary (as it does), Defendants alternatively advance specific constructions consonant with their view of the intrinsic record of the patents-in-suit. (See, e.g., Defs.' Opening Br. at 7-10, 12-14, 16.)
Despite any nuances in the disclosures of the patents-in-suit, the claim terms at issue here constitute obviously commonplace terms. The primary issue relative to the construction of "sterile" and "injectable, aqueous pharmaceutical composition" concerns whether the patentees ascribed a specific scope to these claim terms, or whether the more general ordinary meaning should prevail. Resolution of the term "aqueous," by contrast, turns, more simply, upon how to characterize the plain and ordinary meaning.
In considering the claim terms, the Court has benefited from extensive briefing and attorney argument at a Markman hearing.6 For the reasons that follow, the Court construes the disputed claim terms as follows:7
Term Court's Construction
"sterile" and "state of a composition that has been
sterility" brought to a state of sterility
and has not been subsequently
exposed to microbiological
contamination (i.e. the
container holding the sterile
composition has not been
compromised)
-and-
sterility is freedom from live
bacteria or other
microorganisms
"aqueous" pharmaceutical an "aqueous" pharmaceutical
composition composition is a solution in
which water is the solvent
"Injectable, aqueous a stable, ready-to-use aqueous
pharmaceutical composition" parenteral solution
II. BACKGROUND
A. Factual and Procedural Background
hydrochloride constitutes one type of "beta-blocker," a class of drugs that block the "beta" receptor of heart muscles, arteries, and certain other tissue. ( '094 Patent at 1:13-23.) Within this large class of drugs, however, esmolol proves unique because of its "short-acting" nature, making it "often desirable in the critical care setting to quickly reduce heart work or improve rhythmicity during a cardiac crisis." ( Id. )
Baxter, a trailblazer in the esmolol industry, has " ‘successfully commercialized various esmolol products under its BREVIBLOC® trademark’ " for over thirty years. Baxter Healthcare Corp v. HQ Specialty Pharma Corp., 157 F.Supp.3d 407, 413–14, No. 13–6228, 2016 WL 344888, at *3 (D.N.J. Jan. 26, 2016) (citations omitted). Early esmolol
formulations, however, suffered from "extreme susceptibility to hydrolytic degradation," limited (if any) resilience to sterilization by autoclaving,8 and dilution errors by the ultimate users (often resulting in patients receiving an excess dosage of the formulation). ( '540 Patent at 1:30-40.) In other words, the prior art esmolol compositions readily broke down in the presence of water, and proved incapable of effective terminal sterilization (requiring that the formulations instead be sterilized aseptically in a "clean" environment). ( '094 Patent at 1:40-49; '540 Patent at 2:1-41.)
Hydrochloride Product, BREVIBLOC®
Through the patents-in-suit, Baxter claims to have solved these problems, and developed a ready-to-use, stable aqueous esmolol
formulation capable of sterilization by autoclaving. ( '094 Patent at 2:1-14; '540 Patent at 2:1-14.) Indeed, in contrast to the prior art, the claimed formulations prove "stable against hydrolytic degradation and other adverse chemical reactions," and possess "a pharmaceutically-acceptable shelf-life." ( '094 Patent at 2:3-5.)
Taken together, Baxter's Patents purport to provide a stable, ready-to-use parenteral solution containing esmolol
hydrochloride, a buffering agent, an osmotic-adjusting agent, and methods for preparing the solution in a premixed and injectable form. More specifically, though, the '094 Patent, titled "READY-TO-USE ESMOLOL SOLUTION ," discloses a ready-to-use injectable, aqueous form of Baxter's esmolol formulation, in a flexible plastic container or intravenous bag (generally identified in the '094 Patent as an IntraVia™ flexible plastic container). ( '094 Patent at Title Page, 1:4-10, 62-65.)...
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