The opinion of the court was delivered by: Hon. Dennis M. Cavanaugh
DENNIS M. CAVANAUGH, U.S.D.J.
This matter comes before the Court by request of Pfizer Inc. ("Plaintiffs") and Impax Laboratories, Inc. ("Impax"), Mylan Inc. and Mylan Pharmaceuticals, Inc. ("Mylan"), and Sandoz Inc. ("Sandoz") (collectively "Defendants") for a claim construction hearing, pursuant to Local Patent Rule 4.5. The parties sought the Court's interpretation of disputed terms in U.S. Patent No. 6,630,162 (the "'162 patent") and U.S. Patent No. 6,770,295 (the "'295 patent") (collectively the "patents-in-suit").*fn1 A Markman hearing was held on February 14, 2012, at which all parties ably presented sophisticated and intelligent arguments. Having considered the parties' written and oral arguments, the Court has set forth its construction of the disputed terms.
The patents-in-suit claim controlled release formulations and methods of administering the previously known pharmaceutical compound tolterodine. Tolterodine provides a treatment for overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Tolderodine had previously been administered twice daily in the formulation entitled "Detrol." The patents-in-suit relate to a new, controlled release formulation entitled "Detrol LA."
Defendants each filed Abbreviated New Drug Application ("ANDA") forms with the U.S. Food and Drug Administration seeking to market generic versions of Detrol LA. Pfizer subsequently filed suit against Defendants for infringement of claims 1 through 18 and 20 through 23 of the '162 patent, and claims 5, 13, 16, and 17 of the '295 patent. The parties now seek construction of certain claim terms. While there are eighteen different claim terms in dispute, many of these claim terms present the same or similar issues. Thus, there are only four primary issues for the Court to consider.These issues are: (1) how to construe terms related to pharmacokinetic properties; (2) whether "Tolterodine-Related Compound(s)" and "Active Moiety or Moieties" should include the term "prodrugs;" (3) how to construe "About;" and (4) how to construe "Reduced Undesirable Side Effects."
Claim construction is a matter of law to be determined solely by the court. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005), cert. denied, 546 U.S. 1170 (2006). Analysis of a patent infringement claim is a two-step process. Tate Access Floors, Inc. v. Interface Architectural Resources, Inc., 279 F.3d 1357, 1365 (Fed. Cir. 2002). A court must first construe the meaning and scope of the patent claims, Markman v. Westview Instruments, Inc., 52 F.3d 967, 978 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996), and then compare the claims as construed to the alleged infringing product. Tate, 279 F.3d at 1365. At this stage, the Court will only engage in the first step.
To construe the terms of a patent, a court should look first to the language of the claim itself. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Terms within a claim "are generally given their ordinary and customary meaning." Id. "[T]he ordinary and customary meaning of a claim term 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." Phillips, 415 F.3d at 1313.
To determine how a person of skill in the art would understand a patent's claim language, a court must first examine the intrinsic record--the patent itself, including the claims, the specification and the prosecution history. Vitronics, 90 F.3d at 1582 (citing Markman, 52 F.3d at 979). The specification "acts as a dictionary when it expressly defines terms used in the claims or when it defines terms by implication." Id. Indeed, the Federal Circuit has explained that the specification is "usually . . . dispositive . . . [and is the] best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582) (internal quotations omitted). It is proper for a court to "rely heavily on the written description for guidance as to the meaning of the claims." Id. at 1317.
A patent's prosecution history is also a critical source of guidance, as it "provides evidence of how the [Patent Trademark Office] and the inventor understood the patent." Id. The prosecution history is the complete record of the proceedings before the PTO, and "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. The Federal Circuit has repeatedly emphasized the need to consult the prosecution history to "exclude any interpretation that was disclaimed during prosecution." See Rhodia Chimie v. PPG Indus., 402 F.3d 1371, 1384 (Fed. Cir. 2005) (recognizing that, in exchanges with the PTO, a patent applicant may disavow or disclaim certain claim coverage, thereby precluding any claim interpretation that would encompass the disavowed or disclaimed subject matter).
After consulting intrinsic evidence, a district court may also examine extrinsic evidence-i.e., "all evidence external to the patent and prosecution history." Markman, 52 F.3d at 980; Phillips, 415 F.3d at 1317-18 (stating that the Federal Circuit "ha[s] authorized district courts to rely on extrinsic evidence"). Such evidence consists of testimony by the inventor or by experts, dictionaries, and treatises. Markman, 52 F.3d at 980. However, extrinsic evidence is generally "less significant than the intrinsic record in determining the legally operative meaning of claim language." C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (quotations omitted). Extrinsic evidence, when relied upon, must be considered in view of the specification and prosecution history. Phillips, 415 F.3d at 1320. ("[E]xtrinsic evidence may be useful to the court, but it is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of intrinsic evidence.").
A. Pharmacokinetic Claim Terms
i. Substantially Constant Serum Level Each party argues that their respective definition of "substantially constant serum level" is derived directly from the definition provided in the specifications of the patents-in-suit.
Pfizer advances the following definition as it appears in the patents-in-suit*fn2
The term "substantially constant" with respect to the serum level of active moiety or moieties means that the serum profile after administration of the controlled release formulation does essentially not exhibit any substantial peak values. This may, more sophistically, also be expressed by reference to the "flucuation [sic] index" (emphasis added)
See '162 patent, col. 3 ll.20-25. Pfizer further explains that the "peak values" referred to within the definition are those that result from the administration of an immediate release formulation to which the instant invention is compared. Such "peak values" are claimed to be eliminated with the administration of the constant release formulation of the present invention, which accordingly achieves a "substantially constant serum concentration."*fn3 The "fluctuation index" referred to is explained to be a mathematical expression of the relative "flatness" of a given serum profile that sufficiently "eliminates" the peaks exhibited by the immediate release formulation.*fn4 The patent further specifies that the fluctuation index of the claimed invention should be no higher than 2.0.*fn5
(See e.g. '162 Patent, col. 3 ll.36-40).
Defendants suggest that the definition of "substantially constant serum level" should be limited to the language that immediately follows the word "means," without accounting for the fluctuation index or the repeated comparison to the immediate release formulation found throughout the remainder of the patent. Accordingly, Defendants provide that "substantially constant serum level" should be construed to mean "the serum profile essentially does not exhibit any peak values." Defendants Mylan and Sandoz further require that the term translates to "approximately or close to flat." While Impax acknowledges that a completely flat profile is not possible as there will always be some "peak" value, Pfizer proffers that Pfizer's definition is approximately the same as that provided by Mylan and Sandoz.
The Court concludes that the construction advanced by Pfizer is supported by the claims, examples, and prosecution history of the patents-in-suit. The Court ...