Alza Corp. v. Mylan Laboratories, Inc., CIV.A.1:03 CV 61.

Decision Date07 December 2004
Docket NumberNo. CIV.A.1:03 CV 61.,CIV.A.1:03 CV 61.
Citation349 F.Supp.2d 1002
PartiesALZA CORPORATION, Plaintiff, v. MYLAN LABORATORIES, INC. and Mylan Pharmaceuticals, Inc., Defendants.
CourtU.S. District Court — Northern District of West Virginia

Frank E. Simmerman, Jr., Esquire, Simmerman Law Office PLLC, Clarksburg, WV, Jeffrey I.D. Lewis, Esquire, Jeb Harben, Esquire, Richard J. McCormick, Esquire, Scott M. Brown, Esquire, Gregory Diskant, Esquire, Patterson, Belknap, Webb & Tyler LLP, New York, NY, for plaintiff and counter defendant Alza Corporation.

Gordon H. Copland, Esquire, Steptoe & Johnson, Clarksburg, WV, John B. Wyss, Esquire, Wiley, Rein & Fielding, James H. Wallace, Jr., Esquire, Wiley Rein & Fielding LLC, Washington, DC, Roberta R. Wilson, Esquire, DKW Law Group, Pittsburgh, PA, Kristin Yohannan, Esquire, Wiley, Rein & Fielding LLP, Washington, DC, for defendant Mylan Laboratories, Inc. Mylan Pharmaceuticals, Inc. and counter claimant Mylan Laboratories, Inc.

ORDER CONSTRUING CLAIMS AND DENYING SUMMARY JUDGMENT

KEELEY, Chief Judge.

This is a patent infringement suit involving a pharmaceutical invention disclosed by U.S. Patent No. 6,124,355 (issued Sept. 26, 2000) ("the '355 patent"). The plaintiff, Alza Corporation ("Alza"), holds title to the '355 patent. The defendants in this case are Mylan Laboratories, Inc. and Mylan Pharmaceuticals, Inc. (collectively "Mylan"). Before the Court are the parties' requests to construe the disputed claim language of the patent pursuant to Markman v. Westview Instruments, 52 F.3d 967 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). Five motions for summary judgment, filed by Mylan, are also pending. The parties have fully briefed and argued their respective positions on these matters. As elaborated below, the Court construes the claim terms according to their plain meanings and DENIES Mylan's motions for summary judgment.

I. BACKGROUND
A. Procedural History

Alza initiated this infringement action on May 2, 2003. Mylan filed its answer on May 27, 2003, asserting that the '355 patent was invalid or otherwise not infringed. On February 27, 2004, the parties submitted a Joint Claim Construction Report (or "JCCR"), which included numerous stipulated definitions of claim terms. Following the close of discovery, the parties completed three rounds of briefing on claim construction issues. Mylan also filed five motions for summary judgment, which were fully briefed by September 3, 2004. On October 12, 2004, the Court heard extensive oral argument with respect to claim construction and the motions for summary judgment.

B. The Disclosed Invention

Generally, the '355 patent discloses a sustained-release (or extended release) version of oxybutynin, a drug used for the treatment of urinary incontinence. Before the invention of its sustained-release formulation, oxybutynin was administered two to four times a day to patients. '355 patent, col. 1:63-65. In contrast, the sustained-release formulation can be administered once a day because it delivers oxybutynin at a controlled rate over a twenty-four hour period. See id. at figs. 1 & 2.

II. CLAIM CONSTRUCTION
A. Standard of Law

"Claim interpretation requires the court to ascertain the meaning of the claim to one of ordinary skill in the art at the time of invention." SmithKline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, 1313 (Fed.Cir.2004) (citations omitted). The analysis "must begin and remain centered on the claim language itself." Novartis Pharm. Corp. v. Abbott Labs., 375 F.3d 1328, 1334 (Fed.Cir.2004) (citation omitted). As such, there is a "`heavy presumption' that a claim term carries its ordinary and customary meaning. The ordinary meaning of a claim term may be determined by reviewing a variety of sources, including the claims themselves, other intrinsic evidence including the written description and the prosecution history, and dictionaries and treatises." Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed.Cir.2002) (citations omitted).

Patent claims "must be read in view of the specification, of which they are a part." Markman, 52 F.3d at 979 (citations omitted). It is improper, however, "to read a limitation from the specification into the claims." Microsoft Corp. v. Multi-Tech Systems, Inc., 357 F.3d 1340, 1347 (Fed.Cir.2004). Therefore, "[i]f the claim language is clear on its face,... consideration of the rest of the intrinsic evidence is restricted to determining if a deviation from the clear language of claims is specified." Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed.Cir.2001). "Absent evidence that a `patentee unequivocably imparted a novel meaning to [the] term[] or expressly relinquished claim scope during prosecution,' [a court must] give the limitation its full and ordinary meaning." Akamai Technologies, Inc. v. Cable & Wireless Internet Servs., Inc., 344 F.3d 1186, 1194 (Fed.Cir.2003) (quoting Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1323 (Fed.Cir.2003)) (emphasis added) (other citations omitted). Thus, the "heavy presumption" that a claim term carries its ordinary meaning "may be rebutted when: (1) the patentee has chosen to be his own lexicographer, or (2) a claim term lacks such clarity that there is `no means by which the scope of the claim may be ascertained from the language used.'" Novartis Pharm., 375 F.3d at 1334.

B. Claims 1 & 2

Claims 1 and 2 of the '355 patent read as follows:

1. A sustained-release oxybutynin formulation for oral administration to a patient comprising a therapeutic dose of an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that delivers from 0 to 20% of the oxybutynin in 0 to 4 hours, from 20 to 50% of the oxybutynin in 0 to 8 hours, from 50 to 85% of the oxybutynin in 0 to 14 hours, and greater than 75% of the oxybutynin in 0 to 24 hours for treating incontinence in the patient.

2. A sustained-release oxybutynin formulation for oral administration to a patient in need of treatment for urge incontinence comprising a therapeutic dose of an oxybutynin selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that delivers from 0 to 1 mg in 0 to 4 hours, from 1 mg to 2.5 mg in 0 to 8 hours, from 2.75 to 4.75 mg in 0 to 14 hours, and 3.75 mg to 5 mg in 0 to 24 hours for treating urge incontinence in the patient.

1. The Parties' Proposed Constructions

Both claims 1 and 2 recite "a sustained-release oxybutynin formulation for oral administration to a patient comprising a therapeutic dose of oxybutynin" that delivers a specified percentage or milligram amounts of oxybutynin at the end of certain time intervals. Pursuant to the stipulations in the parties' Joint Claim Construction Report, "formulation" means "something that is prepared according to a formula." (JCCR at 2.) Mylan contends that "sustained-release oxybutynin formulation" lacks any meaningful structure, and therefore must be construed as a means-plus-function limitation. See 35 U.S.C. § 112, ¶ 6. Mylan also maintains that, in the specification, the only described structure that administers the specified amounts of oxybutynin is the bilayer push/pull osmotic pump delivery system ("osmotic pump system" or "osmotic dosage form") disclosed in Examples 15-21. Accordingly, Mylan asserts that the "formulation" claims only cover the osmotic dosage form and its equivalents. See id. Alza, on the other hand, argues that "sustained-release oxybutynin formulation" recites sufficient structure and encompasses both osmotic and non-osmotic dosage forms.

2. The Court's Construction

According to 35 U.S.C. § 112 ¶ 6,

An element in a claim for 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, material, or acts described in the specification and equivalents thereof.

"Through use of means-plus-function limitations, patent applicants are allowed to claim an element of a combination functionally, without reciting structures for performing those functions." Apex, Inc. v. Raritan Computer, Inc., 325 F.3d 1364, 1371 (Fed.Cir.2003) (citation omitted). As § 112, ¶ 6 indicates, however, the scope of means-plus-function claims is limited "to the means specified in the written description and equivalents thereof." O.I. Corp. v. Tekmar Co., 115 F.3d 1576, 1583 (Fed.Cir.1997).

"[A] claim term that does not use `means' will trigger the rebuttable presumption that § 112, [paragraph] 6 does not apply. The term `means' is central to the analysis." Apex, 325 F.3d at 1371-72 (quoting Personalized Media Comm. v Int'l Trade Comm'n, 161 F.3d 696, 703 (Fed.Cir.1998)) (citation omitted). The challenger "can rebut this presumption if it demonstrates [by a preponderance of the evidence] that the claim term fails to `recite sufficiently definite structure' or else recites a `function without reciting sufficient structure for performing that function.'" Id. at 1372 (quotation and internal quotation omitted). "`To help determine whether a claim term recites sufficient structure, [a court should] examine whether it has an understood meaning in the art.'" Id. (quoting Watts v. XL Sys., Inc., 232 F.3d 877, 880 (Fed.Cir.2000)).

Here, claims 1 and 2 do not include the term "means." Therefore, Mylan bears the burden of showing that the disputed claim limitations, as understood by one of ordinary skill in the art, rely "on functional terms rather than structure or material to describe performance of the claimed function." Id. To determine whether the claim limitations recite sufficient structure, the Court may properly consider extrinsic evidence, including expert testimony. Personalized Media Comm., 161 F.3d at 704.

The disputed language, "sustained-release oxybutynin...

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2 cases
  • Alza Corp. v. Mylan Laboratories, Inc.
    • United States
    • U.S. District Court — Northern District of West Virginia
    • September 27, 2005
    ...plain meaning and the parties' stipulated definitions" and denied Mylan's motions for summary judgment. Alza Corp. v. Mylan Labs., 349 F.Supp.2d 1002, 1021 (N.D.W.Va.2004). The Court subsequently held a ten day bench trial, which concluded on April 18, 2005. Thereafter, the parties filed ex......
  • Alza Corp. v. Mylan Laboratories, Inc.
    • United States
    • U.S. Court of Appeals — Federal Circuit
    • September 6, 2006
    ...(emphasis added). The district court construed the '355 patent claims in its Markman Order, reported at Alza Corp. v. Mylan Labs., Inc., 349 F.Supp.2d 1002 (N.D.W.Va.2004) ("Alza I"). The court construed the word "deliver" to refer to the rate of in vivo release in the gastrointestinal ("GI......

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