Legal Opinions - U.S. District Court, Maryland: October 20, 2008

Daily Record, The (Baltimore), Oct 20, 2008

Lupin applied for an Abbreviated new Drug Application (ANDA) with the United States Food and Drug Administration (FDA). FDA approval would authorize Lupin to produce and sell a generic version of Effexor(R) XR.

In March 2007, Wyeth sued Lupin for a declaratory judgment that the commercial manufacture, use, sale, or importation of Lupin's extended release venlafaxine hydrochloride product would infringe the patents-in-suit, and an injunction prohibiting FDA approval of Lupin's ANDA until the expiration of the patents-in-suit. In April 2007, Lupin answered Wyeth's complaint and filed counterclaims seeking a declaration that its ANDA product did not, and would not, infringe any claims of the patents-in-suit.

In September 2007, the court denied Lupin Pharmaceutical's motion to dismiss. In June 2008, Wyeth filed a motion for partial summary judgment. In July 2008, Lupin filed its motion for summary judgment.

The district court denied both motions for summary judgment.

LAW: Patents are composed of two parts. The specification describes the invention and the manner and process of using it. See 35 U.S.C. [section]112. The claims define the scope of the invention and state which parts of the invention the patentee is entitled the right to exclude. See 35 U.S.C. [section]112; Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc).

Infringement analysis entails two steps. The first step requires "claim construction," a determination of the "meaning and scope" of the patent claims alleged to be infringed. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc). Claim construction is a question of law. Id. at 978. The second step requires comparing the "properly construed claims to the device accused of infringing." Id. That step involves a question of fact.

To find infringement, every element of the patent must be infringed, either literally or under the doctrine of equivalents. See Leggett & Platt, Inc. v. Hickory Springs Mfg. Co., 285 F.3d 1353, 1358 (Fed. Cir. 2002). A claim element is equivalently present in an accused devices if only insubstantial differences distinguish the missing claim element from the corresponding aspects of the accused device. Id. at 1359.

When construing claims, the court gives terms "the ordinary and customary 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 1313. A person of ordinary skill in the art is presumed to read the claim terms in light of the entire patent, including the specification. Id. Thus, "the court starts the decision making process by reviewing the...patent specification and the prosecution history." Id.

The claim text and other claims in the patent also provide "substantial guidance" to the meaning of the terms, although the Federal Circuit cautions that the specification is the "best source for understanding a particular term." Id at 1314-15. To aid its claim construction, a court may look to publicly available sources that explain what a person skilled in the art would understand the term to mean. Id. These sources include "extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art." Id. Extrinsic evidence may include dictionaries, treatises, and expert testimony. Id. at 1317. Intrinsic evidence is favored over extrinsic evidence in claim construction. Id. at 1318.