Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Warner Chilcott Company, LLC v. Mylan Inc.

United States District Court, Third Circuit

July 1, 2013

WARNER CHILCOTT COMPANY, LLC, Plaintiff(s),
v.
MYLAN INC., et al. Defendant(s). WARNER CHILCOTT COMPANY, LLC, Plaintiff(s),
v.
LUPIN LTD., et al., Defendant(s).

OPINION

JOEL A. PISANO, District Judge.

This is a Hatch-Waxman patent infringement action in which Plaintiff Warner Chilcott Company LLC ("Plaintiff "or "Warner") alleges that Mylan, Inc., Mylan Pharmaceuticals Inc. and Famy Care Ltd. (collectively, "Mylan") and Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, "Lupin"; and with Mylan, "Defendants") have infringed U.S. Patent 6, 667, 050 (the "'050 patent"). Presently before the Court is the parties' request for claim construction. The Court held a Markman hearing on June 12, 2013. This Opinion addresses the proper construction of the disputed claim terms.

I. BACKGROUND

The 050 patent issued from U.S. Patent Application No. 09/879, 028, filed on June 21, 2001. It is entitled "Chewable Oral Contraceptive" and contains 60 claims, 36 of which are asserted in these actions. The asserted claims are directed to chewable, palatable oral contraceptive tablets and methods of female oral contraception. The drug product underlying the dispute is the oral contraceptive Generess FE, which Plaintiff alleges is covered by the 050 patent. Mylan and Lupin have filed abbreviated new drug applications ("ANDAs" seeking to market chewable oral contraceptive products that Plaintiff contends infringe the 050 patent.

The parties have identified certain terms in need of construction. They have agreed on the construction of three of those terms, and the agreed constructions are set forth in Exhibit B of the parties joint claim construction statement. See D.I. 53 in Civil Action No. 11-6844. The following three term remain in dispute: "tablet"; "at least one of a flavor agent, a sweetener, and a color agent"; and "has a hardness sufficient for blister packaging." The Court construes these below.

II. LEGAL STANDARDS

In order to prevail in a patent infringement suit, a plaintiff must establish that the patent claim "covers the alleged infringer's product or process." Markman v. Westview Instrs., Inc., 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). "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." Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (internal quotations omitted) (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) ("we look to the words of the claims themselves... to define the scope of the patented invention"). Consequently, the first step in an infringement analysis involves determining the meaning and the scope of the claims of the patent. Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 988 (Fed. Cir. 1995). Claim construction is a matter of law, Markman v. Westview Instrs., Inc., 52 F.3d 967, 979 (Fed. Cir. 1995) aff'd 517 U.S. 370 , 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996), therefore, it is "[t]he duty of the trial judge... to determine the meaning of the claims at issue, " Exxon Chem. Patents, Inc. v. Lubrizoil Corp., 64 F.3d 1553, 1555 (Fed. Cir. 1995).

Generally, the words of a claim are given their "ordinary and customary meaning, " which is defined as "the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention." Phillips, 415 F.3d at 1312-13 (citations omitted). In this regard, the Federal Circuit has noted that

It is the person of ordinary skill in the field of the invention through whose eyes the claims are construed. Such person is deemed to read the words used in the patent documents with an understanding of their meaning in the field, and to have knowledge of any special meaning and usage in the field. The inventor's words that are used to describe the invention-the inventor's lexicography-must be understood and interpreted by the court as they would be understood and interpreted by a person in that field of technology. Thus the court starts the decisionmaking process by reviewing the same resources as would that person, viz., the patent specification and the prosecution history.

Id. (quoting Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998)).

In order to determine the meaning of a claim as understood by a person skilled in the art, a court may look to various sources from which the proper meaning may be discerned. These sources include intrinsic evidence, which consists of "the words of the claims themselves, the remainder of the specification, [and] the prosecution history, " id. at 1314, and extrinsic evidence "concerning relevant scientific principles, the meaning of technical terms, and the state of the art, " id.

When considering the intrinsic evidence, the court's focus must begin and remain on the language of the claims, "for it is that language that the patentee chose to particularly point[ ] out and distinctly claim[ ] the subject matter which the patentee regards as his invention.'" Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331 (Fed.Cir.2001) (quoting 35 U.S.C. § 112, ¶ 2). The specification is often the best guide to the meaning of a disputed term. Honeywell Int'l v. ITT Indus., 452 F.3d 1312, 1318 (Fed.Cir.2006). It is improper, however, to import limitations from the specification into the claims. Seachange Int'l v. C-COR Inc., 413 F.3d 1361, 1377 (Fed. Cir. 2005). The court may also consider as intrinsic evidence a patent's prosecution history, which is evidence of "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." Phillips, 415 F.3d at 1317.

While a court is permitted to consider extrinsic evidence, such evidence is generally of less significance and less value in the claim construction process. Id. at 1317. Extrinsic evidence is evidence that is outside the patent and prosecution history, and may include expert testimony, dictionaries, and treatises. Id. The Federal Circuit has noted that caution must be exercised in the use of extrinsic evidence, as this type of evidence may suffer from inherent flaws affecting its reliability in the claim construction analysis. Id. at 1319 ("We have viewed extrinsic evidence in general as less reliable than the patent and its prosecution history in determining how to read claim terms."). While "extrinsic evidence may be useful to the court, ... it is unlikely to result ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.