Wyeth v. Sandoz, Inc.

• Decision Date: 03 July 2008
• Docket Number: No. 5:07-CV-234-D.,5:07-CV-234-D.
• Citation: 570 F.Supp.2d 815
• Court: U.S. District Court — Eastern District of North Carolina
• Parties: WYETH, Plaintiff, v. SANDOZ, INC., Defendant.

570 F.Supp.2d 815

WYETH, Plaintiff, v. SANDOZ, INC., Defendant.

No. 5:07-CV-234-D.

United States District Court, E.D. North Carolina, Western Division.

July 3, 2008.

COPYRIGHT MATERIAL OMITTED

COPYRIGHT MATERIAL OMITTED

Paul K. Sun, Jr., Richard W. Ellis, Ellis & Winters, Raleigh, NC, for Plaintiff.

F. Hill Allen, IV, Tharrington Smith, Denise Walker, U.S. Attorney's Office, Raleigh, NC, for Defendant.

ORDER

JAMES C. DEVER III, District Judge.

In this patent infringement action, plaintiff Wyeth alleges that defendant Sandoz, Inc.'s ("Sandoz") generic extended release venlafaxine product infringes U.S. Patent Nos. 6,274,171 B1 ("the '171 patent"), 6,419,958 B2 ("the '958 patent"), and 6,403,120 B1 ("the '120 patent") (collectively "the Wyeth patents"). The parties seek construction of five disputed claim terms and phrases from the patents-in-suit. The parties briefed their respective positions on claim construction, and the court conducted a Markman hearing on May-29, 2008. The court enters this order to explain its construction of the disputed claim terms and phrases.

I.

Wyeth markets extended release venlafaxine hydrochloride, an antidepressant medication, under the brand name Effexor ® XR. Sandoz filed an Abbreviated New Drug Application seeking to market a generic extended release venlafaxine product at its Wilson, North Carolina facility. The key difference between Effexor® XR and Sandoz's generic formulation is that Sandoz's formulation uses a different inactive ingredient (i.e., an Eudragit® polymer) to coat the encapsulated spheroids which contain the active pharmaceutical ingredient ("API").

The Wyeth patents issued from related patent applications and share an essentially identical specification. Thus, the court construes the disputed terms similarly in each patent. See, e.g., NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1293 (Fed.Cir.2005).¹ Wyeth has asserted against Sandoz the following claims from the patents-in-suit: claims 20-25 of the `171 patent, claims 1-6 of the '958 patent, and claims 1, 2, 13, and 14 of the '120 patent. Generally, the asserted claims concern methods for treating patients with depression or other disorders responsive to venlafaxine by administering an extended release formulation of venlafaxine hydrochloride that provides a therapeutic concentration of the drug over a twenty-four hour period. The asserted claims are all method claims, which require either peak blood plasma levels of venlafaxine within a specified time period or peak blood plasma levels of venlafaxine within specified concentrations. Some claims also provide that the claimed method results in "diminished incidences of nausea and emesis," as compared to the immediate release formulation of venlafaxine hydrochloride. See, e.g., '171 patent, col. 12:63-13:3 (claim 20). Other claims provide that the claimed method "eliminat[es] the troughs and peaks of drug concentration in a patient[']s blood plasma attending the therapeutic metabolism of plural daily doses of venlafaxine hydrochloride." See, e.g., id. at col. 13:4-17 (claim 21).

From these method claims, the parties have identified five disputed claim terms and phrases: (1) "extended release formulation," (2) "diminished incidence(s) of nausea and emesis," (3) "a method for eliminating the troughs and peaks of drug concentration in a patient's blood plasma," (4) "about," as used in the claim phrase "peak blood plasma levels of venlafaxine of no more than about 150 ng/ml," and (5) "about," as used in the claim phrase "a peak blood plasma level of venlafaxine in about 6 hours [or in from about 4 [or 5] to about 8 hours]." See generally Joint Claim Construction Statement [hereinafter "Joint Statement"].

II.

The purpose of patent claim construction is to "to ascertain the meaning of a claim to one of ordinary skill in the art at the time of the invention." SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1338 (Fed.Cir.2005); see Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 372, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). When the parties raise an actual dispute regarding the proper scope of patent claims, the court must resolve that dispute. See Markman, 52 F.3d at 979 (holding that claim construction is a matter of law).

Words of a claim are generally given their ordinary and customary meaning, Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996), which is the meaning a term would have to a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed.Cir.2005) (en banc). The person of ordinary skill in the art is deemed to read the claim term in the context of the particular claim in which the disputed term appears and in the context of the entire patent, including the specification and prosecution history. Id. at 1313. "In some cases, the ordinary meaning of claim language ... 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." Id. at 1314. "In such circumstances, general purpose dictionaries may be helpful." Id. However, in many cases, the meaning of a claim term as understood by persons of skill in the art is not readily apparent. Id. In those cases, the court must look to "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. (quotation omitted).

The claims "provide substantial guidance as to the meaning of particular claim terms." Id. The context in which a term is used in an asserted claim, the usage of the term in other claims of the patent, and differences among claims are useful guides in ascertaining the meaning of a particular claim term. Id. at 1314-15. For example, under the doctrine of claim differentiation, when a patent contains dependant claims that add a particular limitation, the court must initially apply a presumption that the limitation in question is not present in the independent claim. See id. The absence of a limitation in the independent claim is "strong evidence" that the independent claim is not bound by the limitations listed in the narrower, dependent claims. See Saunders Group, Inc. v. Comfortrac, Inc., 492 F.3d 1326, 1331 (Fed.Cir.2007); Honeywell Int'l Inc. v. Universal Avionics Sys. Corp., 488 F.3d 982, 994 (Fed.Cir.2007).

However, claims must be read in light of the specification. Phillips, 415 F.3d at 1315. "[T]he specification is always highly relevant ... [and] is the single best guide to the meaning of a disputed term." Id. (quotation omitted). The specification "may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess," or the specification "may reveal an intentional disclaimer, or disavowal, of claim scope by the inventor." Id. at 1316. Where a patentee chooses to act as its own lexicographer, the patentee "must clearly express that intent in the written description." Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1381 (Fed.Cir.2008); see Phillips, 415 F.3d at 1316; Bell Atl. Network Servs. v. Covad Commc'ns Group, Inc., 262 F.3d 1258, 1268 (Fed.Cir.2001). Likewise, an inventor's disavowal of scope should be "clear and unmistakable." See Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1120 (Fed.Cir.2004).

The prosecution history is "created by the patentee in attempting to explain and obtain the patent," and provides "evidence of how the [Patent and Trademark Office ("PTO") ] and the inventor understood the patent." Phillips, 415 F.3d at 1317. However, the prosecution history is "less useful" because "it often lacks the clarity of the specification." Id. Finally, courts may consider extrinsic evidence, which includes expert and inventor testimony, dictionaries, and treatises. Id. Extrinsic evidence is generally "less reliable than the patent and its prosecution history," id. at, 1318-19, and must be "considered in the context of the intrinsic evidence." Id. at 1319. With this framework in mind, the court turns to the disputed claim terms and phrases.²

III.

A.

"Extended Release Formulation"

The central issue involves construction of the claim term "extended release formulation." Wyeth argues that "extended release formulation" should be construed according to its ordinary meaning as "[a] formulation, other than a hydrogel tablet, which releases the active ingredient at a slower rate than the immediate release formulation of the active ingredient such that the dosing frequency is once-aday rather than the plural daily dosing for the immediate release formulation." Joint Statement, Tab 1. In contrast, Sandoz contends that Wyeth acted as its own lexicographer and, therefore, construes the term as restricted to the specific ingredients set forth in the patents.³ Thus, Sandoz asserts that "extended release formulation" means

a formulation that comprises from about 6% to about 40% venlafaxine HCI by weight, from about 50% to about 94% microcrystalline cellulose ("MCC") by weight, and optionally, from about 0.25% to about 1% hydroxypropyl-methylcelluose ("HPMC") by weight, coated with a mixture of ethyl cellulose and HPMC in an amount needed to provide a specific unit dosage administered once-a-day to provide a therapeutic blood plasma level of venlafaxine over an entire 24-hour period of administration.

Id. at Tab 2.

1.

Initially, the court rejects Sandoz's argument that "extended release formulation" embodies a means-plus-function claim limitation that invokes 35 U.S.C. § 112, paragraph 6.⁴ See Def.'s Opening Br. 23-24. Where, as here, the asserted claims do not contain the term "means," there is a strong presumption that the claims are not...