The opinion of the court was delivered by: Chesler, U.S.D.J.
This matter comes before the Court on the applications by Plaintiffs Merck & Co., Inc. and Merck Sharp & Dohme Corp. (collectively, "Merck") and Defendant Sandoz Inc. ("Sandoz") for claim construction to resolve disputes over the construction of claim terms in U.S. Patent Nos. 5,378,804 (filed Mar. 16, 1993) (the "'804 patent") and 5,952,300 (filed Mar. 28, 1997) (the "'300 patent").
This matter involves two Hatch-Waxman actions for patent infringement. The cases have been consolidated for pretrial purposes and arise from the following facts. Briefly, Merck owns the '804 and '300 patents, which are directed to compounds and compositions associated with Merck's antifungal drug Cancidas®. Defendant is a generic pharmaceutical manufacturer who has filed an Abbreviated New Drug Application seeking FDA approval to engage in the manufacture and sale of generic versions of Cancidas® prior to the expiration of the Merck patents.
When the parties originally briefed this matter, briefs were filed by Defendant Teva Parenteral Medicines, Inc. ("Teva.") The action between Merck and Teva has since been settled.
I. The law of claim construction
A court's determination "of patent infringement requires a two-step process: first, the court determines the meaning of the disputed claim terms, then the accused device is compared to the claims as construed to determine infringement." Acumed LLC v. Stryker Corp., 483 F.3d 800, 804 (Fed. Cir. 2007). The Court decides claim construction as a matter of law: "the construction of a patent, including terms of art within its claim, is exclusively within the province of the court." Markman v. Westview Instruments, 517 U.S. 370, 372 (1996).
The focus of claim construction is the claim language itself: 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. Attending this principle, a claim construction analysis must begin and remain centered on the claim language itself, for that is the language the patentee has chosen to 'particularly point out and distinctly claim the subject matter which the patentee regards as his invention.'
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir. 2004) (citations omitted).
The Federal Circuit has established this framework for the construction of claim language:
We have frequently stated that the words of a claim 'are generally given their ordinary and customary meaning.' We have made clear, moreover, that the 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.
The inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to begin claim interpretation. . .
In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges, and claim construction in such cases involves little more than the application of the widely accepted meaning of commonly understood words. In such circumstances, general purpose dictionaries may be helpful. In many cases that give rise to litigation, however, determining the ordinary and customary meaning of the claim requires examination of terms that have a particular meaning in a field of art. Because the meaning of a claim term as understood by persons of skill in the art is often not immediately apparent, and because patentees frequently use terms idiosyncratically, the court looks to those sources available to the public that show what a person of skill in the art would have understood disputed claim language to mean. Those sources ...