The opinion of the court was delivered by: Goldberg, J.
Before the Court is a patent claim construction pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370, 388-91 (1996). The invention at issue is a pharmaceutical composition comprising modafinil in the form of particles of defined size.
This case is one of many separate lawsuits currently before the Court and consolidated under the caption In re Modafinil. The lawsuit commenced on June 26, 2006, with the filing of the original complaint, which raised patent claims regarding Cephalon's RE'516 patent for Provigil(r)*fn1 and antitrust claims against Cephalon and four generic drug defendants. Since that time, the original complaint has been consolidated with a separate complaint filed by Apotex regarding a second Cephalon patent - '346, also relating to Provigil(r). Thereafter, Apotex filed an amended complaint and a second amended complaint, the latter of which raises the patent claim construction issues before the Court. Apotex has moved for a declaratory judgment, alleging that its drug, Abbreviated New Drug Application 77-667, a generic form of Provigil(r), does not infringe on Cephalon's RE'516 patent or the '346 patent.
On July 16, 2010, the parties submitted their proposed claim constructions and respective briefs. The parties agreed on the claim construction for the '346 patent and also agreed to all but three constructions, which affect seven different claims, on the RE'516 patent. A Markman hearing was held on September 14, 2010, wherein no witnesses were called and counsel set forth their respective positions.
The RE'516 patent covers a pharmaceutical composition of modafinil in the form of particles, of which 95% have a diameter less than 200 microns (um). Modafinil was known for decades before Cephalon sought the RE'516 patent and consequently, the RE'516 patent could only be designed to cover a new, unique form or usage of the previously known drug. Hence, the RE'516 patent was designed to cover modafinil of a certain particle size, which produced a predictable bioavailability and potency in humans. The claims at issue are set forth verbatim below:
1. A pharmaceutical composition comprising a substantial homogeneous mixture of modafinil particles, wherein at least about 95% of the cumulative total of modafinil particles in said composition have a diameter of less than about 200 microns (um).
2. The composition of claim 1 wherein said particles have a median diameter range of between 2 um and about 60 um.
7. A pharmaceutical composition in an oral unit dose form comprising: an amount of modafinil effective to alter a somnolent state of a mammal upon oral administration, said amount of modafinil being in the form of solid modafinil particles, said particles having a size distribution wherein at least about 95% of the cumulative total of said particles have a diameter of less than about 200 microns (um).
8. The composition in unit dose form of claim 7 wherein said effective amount comprises particles have a median diameter range between about 2 um and about 60 um.
13. A pharmaceutical composition according to claim 7, further comprising additional modafinil particles in excess of said effective amount.
14. A pharmaceutical composition according to claim 13 wherein said additional modafinil particles represent about 10-15% of said effective amount of modafinil.
16. A method of treating a mammal diagnosed with a modafinil-responsive disease or condition selected from the group consisting of narcolepsy, Parkinson's disease, urinary incontinence, or Alzheimer's disorder, said method comprising administering an amount of modafinil, as one or more oral unit doses, to said mammal, said oral unit dose comprising: an amount of modafinil effective to treat said modafinil-response disease or condition of said mammal upon oral administration, said amount of modafinil being in the form of solid modafinil particles, said particles have a size distribution wherein at least about 95% of the cumulative total of said particles have a diameter of less than about 200 microns (um).
From these seven claims, the parties dispute three discrete issues: what "95% of the cumulative total of modafinil/said particles" encompasses; how diameter and size distribution of the particles is measured; and whether agglomerates fall within the definition of a particle.
III. Applicable Precedent
Patent infringement cases typically involve a two-part analysis. The first step, known as the "claim construction" involves a determination of the meaning and the scope of any disputed claims. Because a patent is a written instrument, judges, not juries, must interpret the words of the patent's claims. Markman, 517 U.S. at 388-89. In short, claim construction is a matter of law to be determined by the court. Four main sources should be considered in analyzing a claim: (1) the words of the claims themselves, (2) the specification,*fn2 (3) the prosecution history, and, if necessary, (4) "extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art." Phillips v. AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005), cert. denied, 546 U.S. 1170 (2006) (citations omitted).
The claims analysis begins and remains focused on the language of the claims themselves because that is what the inventor used to describe his invention. Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (citing 35 U.S.C. § 112, ¶ 2); Sipco LLC v. Toro Co., No. 08-505, 2009 WL 330969, at *1 (E.D.Pa. Feb.11, 2009). As the Federal Circuit has explained:
Ultimately, the interpretation to be given a term can only be determined and confirmed with a full understanding of what the inventors actually invented and intended to envelopwith the claim. The construction that stays true to the claim language and most naturally aligns with the patent's ...