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ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED v. TORRENT PHARMACEUTICALS LIMITED OPINION and TORRENT PHARMA INC

November 30, 2010

ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED PLAINTIFFS,
v.
HANDA PHARMACEUTICALS, LLC AND JOHN DOE ENTITY DEFENDANTS.
ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED PLAINTIFFS,
v.
ACCORD HEALTHCARE, INC., AND INTAS PHARMACEUTICAL LTD., DEFENDANTS.
ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED PLAINTIFFS,
v.
BIOVAIL LABORATORIES INTERNATIONAL SRL, BIOVAIL CORPORATION AND BTA PHARMACEUTICALS, INC., DEFENDANTS.
ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED PLAINTIFFS,
v.
ANCHEN PHARMACEUTICALS, INC. DEFENDANT.
ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED PLAINTIFFS,
v.
OSMOTICA PHARMACEUTICAL CORPORATION, DEFENDANT.
ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA UK LIMITED PLAINTIFFS,
v.
TORRENT PHARMACEUTICALS LIMITED OPINION AND TORRENT PHARMA INC., DEFENDANTS.



The opinion of the court was delivered by: Pisano, District Judge.

NOT FOR PUBLICATION

Plaintiffs AstraZeneca Pharmaceuticals LP and AstraZeneca UK Limited (collectively, "Astra") bring these patent infringement actions against Handa Pharmaceuticals, LLC and John Doe Entity (collectively, "Handa"); Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd. (collectively, "Accord"); Biovail Laboratories International SRL, Biovail Corporation, and BTA Pharmaceuticals, Inc. (collectively, "Biovail"); Anchen Pharmaceuticals, Inc. ("Anchen"); Osmotica Pharmaceutical Corporation ("Osmotica"); and Torrent Pharmaceuticals Limited and Torrent Pharma Inc. (collectively, "Torrent"). The patent at issue in this case is Astra's patent, United States Patent No. 5,948,437 (the "'437 Patent"), titled "Pharmaceutical Compositions Using Thiazepine." This patent relates to particular sustained release formulations, the process for preparing the formulations, and methods for treating psychotic states and hyperactivity using the formulations.

Presently before the Court is the parties' request for claim construction. The Court held a Markman hearing on November 22, 2010. This Opinion addresses the proper construction of the disputed claim terms.

I. Standards for Claim Construction

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). 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 (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).

In Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005), the Federal Circuit emphasized that "[i]t 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." 415 F.3d at 1312 (internal quotations omitted) (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) ("[W]e look to the words of the claims themselves . . . to define the scope of the patented invention"); Markman, 52 F.3d at 980 ("The written description part of the specification itself does not delimit the right to exclude. That is the function and purpose of claims."). 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.3dat 1312-13 (citations omitted). In this regard, the Federal Circuit has noted:

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 the process of determining 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 "the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art." Id. at 1314. While a court is permitted to turn to extrinsic evidence, such evidence is generally of less significance and less value in the claim construction process. Id. at 1317. Extrinsic evidence would include 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 in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence."

II. The Disputed Claim Terms

The parties have identified a number of disputed claim terms in the patent. The Court will address each of these in turn.

1. "A sustained release formulation"

This disputed phrase appears in the preamble of Claim 1 of the '437 Patent. All parties agree that "sustained release" means the release of the active pharmaceutical ingredient over an extended period of time. The parties also agree that because the remaining claims depend on Claim 1, the construction of this preamble language applies to all claims of the patent. The dispute is whether the preamble is a claim limitation. Astra contends that the preamble should be construed as a claim limitation meaning: "A solid oral dosage form that releases its active pharmaceutical ingredient over an extended period of time." Torrent argues that the preamble should be read to shed light on the meaning of the remaining terms, and terms such as "gelling agent" should be construed in the context of the preamble language. Handa, Biovail, Anchen, and Osmotica ask that the Court address the question of whether the preamble is a claim limitation at a later time. Accord takes no position on the disputed term.

The Court adopts Astra's position on the construction of "A sustained release formulation." It is well settled that a "preamble limits the [claimed] invention if it recites essential structure or steps, or if it is 'necessary to give life, meaning, and vitality' to the claim." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999). The entire specification of the '437 Patent and all examples are directed to sustained release formulations. The sustained release aspect of the formulations is a fundamental feature of the claimed invention, and thus is an element of the claims. See Glaxo Wellcome v. Impax Labs. Inc., 356 F.3d 1348, 1353 (Fed. Cir. 2004) ("The 'sustained release ...


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