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Warner Chilcott Labs. Ireland, et al v. Impax Laboratories

July 20, 2011


The opinion of the court was delivered by: Hon. William J. Martini



This matter comes before the Court on the parties‟ submissions seeking construction of five disputed claim terms found in the patent-in-suit. Having taken into consideration the parties‟ submissions and their arguments made during the Markman*fn1 hearing held on July 11, 2011, the Court construes the disputed claim terms as set out below.


Five Hatch-Waxman Act patent suits were consolidated for discovery purposes. These include: Warner Chilcott Labs. Ireland, et al. v. Impax Labs., Inc., et al., Civil Action No. 2:08-cv-06304-WJM-MF (consol.); Warner Chilcott Labs. Ireland, et al. v. Sandoz Inc., Civil Action No. 2:09-cv-00228-WJM-MF; Warner Chilcott Labs. Ireland, et al. v. Actavis Elizabeth LLC, et al., Civil Action No. 2:09-cv-00469-WJM-MF;*fn2 Warner Chilcott Labs. Ireland, et al. v. Impax Labs., Inc., Civil Action No. 2:09-cv-01233-WJMMF; and Warner Chilcott Labs. Ireland, et al. v. Mylan Pharms., Inc., et al., Civil Action No. 2:09-cv-02073-WJM-MF. The patent at issue in each case is: United States Patent No. 6,958,161 (October 25, 2005).

Patent No. 6,958,161 ('161 Patent). Plaintiffs‟ "161 Patent is titled "Modified Release Coated Drug Preparation." The drug product provides a "modified" or "delayed release" of an active ingredient, i.e., an antibiotic tetracycline. The drug product makes use of a "stabilizing coat" between the core element containing the active ingredient and the modified release coating. "As with all pharmaceutical preparations, an important aspect . . . is the stability over extended periods of time, which is often called "shelf life‟. Typically, a [pharmaceutical] preparation‟s shelf life is linked to two aspects; firstly, the stability of the ingredients themselves, namely the maintenance of their . . . properties over time; and secondly, the maintenance over time of the originally intended rate of drug release from the dosage form. This present invention is directed towards this second aspect of stability." Patent, col. 1, ll. 22-32. The claimed invention creates a preparation that is stable, i.e., the active ingredient‟s release profile is substantially the same even after the drug product has been stored for an extended period of time.

Defendants filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market generic versions of Plaintiffs‟ patented Doryx products. Plaintiffs assert infringement of the "161 Patent; Defendants assert the Patent is invalid, unenforceable, and/or not infringed.

Disputed terms include: (i) "a modified release preparation;" (ii) "modified release coating;" (iii) "delayed release coating;" (iv) "core element;" and (v) "stabilizing coat is provided between each core element and its modified release coating so that."


The objective of claim construction is to determine how a person of ordinary skill in the art would understand the claim terms. Phillips v. AWH Corp., 415 F.3d 1303, 1313, 1324 (Fed. Cir. 2005) (en banc). Generally, claim terms are given their ordinary and customary meaning. Id. at 1312-13 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). That meaning "is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." Phillips, 415 F.3d at 1313. In determining the ordinary meaning of a disputed claim term, the person of ordinary skill in the art is deemed to read the disputed claim terms in the context of the entire patent, including the particular claims in which the claim terms appear, the remaining claims, and the specification. Id. at 1313.

The claims "provide substantial guidance as to the meaning of particular claim terms." Id. at 1314. Oftentimes, the context in which a term is used in asserted and unasserted claims "can be highly instructive." Id. Further, differences among claims can provide useful insight into a term‟s meaning. Id.

But the claims cannot be looked at in isolation; rather, the claims must be considered in view of the specification. Id. at 1315. The specification is considered to be the "single best guide" for construing the claims. Id. The specification may reveal whether the patentee acted as his own lexicographer by giving a claim term a special definition. Id. Or, it may show that the patentee intentionally disclaimed claim scope. Id. In either case, the patentee‟s intent is dispositive. Id.

A court should also consider the prosecution history, if it is in evidence. Id. at 1317. The prosecution history "consists of the complete record of the proceedings before the [Patent and Trademark Office (PTO)] and includes the prior art cited during the examination of the patent." Id. (citing Autogiro Co. of Am. v. United States, 384 F.2d 391, 399 (Ct. Cl. 1967)). Although it "often lacks the clarity of the specification and thus is less useful for claim construction purposes," the prosecution history sheds light on the PTO and inventor‟s understanding of the patent. Phillips, 415 F.3d at 1317.

A court may, in its discretion, consult extrinsic evidence, i.e., dictionaries, treatises, and expert and inventor testimony, when construing claim terms. Id. "The purpose of expert testimony is to provide assistance to the court in understanding, when the claims are technologically complex or linguistically obscure, how a technician in the field, reading the patent, would understand the claims." Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 887 F.2d 1070, 1076 (Fed. Cir. 1989) (Newman, J., dissenting). Although extrinsic evidence may be used in claim construction, it may not be used to vary or contradict the intrinsic evidence. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1308 (Fed. Cir. 1999); Phillips, 415 F.3d at 1324. A court may consult extrinsic evidence to educate itself about the field of the invention and to aid its understanding of what one of ordinary skill in the art would understand a claim term to mean. Id. at 1319. But extrinsic evidence is "less significant" and "less reliable" than intrinsic evidence because it gives meaning to a claim term in the abstract, rather than in the particular context of the patent. Id. at 1317-18. Thus, extrinsic evidence may play only a supporting role in claim construction. See id. at 1324. The Federal Circuit reestablished the primacy of the intrinsic evidence -- the claims, specification and prosecution history -- and, as explained, classified dictionaries as part of the less significant extrinsic evidence. Id. at 1312.


A.A Modified Release Preparation*fn3

Contentions of the Parties. Plaintiffs‟ proposed construction of "a modified release preparation" is a preparation that provides a release profile for an active ingredient that is different from that of an immediate release preparation.Defendants argue that this preamble term is not limiting, and therefore, it should not be construed. However, Defendants do not otherwise dispute Plaintiffs‟ construction, and, for example, do not propose an alternative construction in the event that the Court should decide that this preamble phrase is limiting.

Claim Construction Analysis for Modified Release Preparation. "Generally speaking, there are three parts to every claim: the preamble, the transitional phrase, and the body. The transitional phrase, e.g., "comprising‟ or "consisting of,‟ connects the preamble to the body of the claim. The preamble is the portion of the claim that includes everything before the transitional phrase. The body is everything after the transitional phrase." IntellA-Check Corp. v. Autoscribe Corp., 346 F. Supp. 2d 698, 704 (D.N.J. 2004). If the preamble does not give "life, meaning and vitality to the claim," the preamble is considered to be "of no significance to claim construction because it cannot be said to constitute or explain a claim limitation." Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1371 (Fed. Cir. 2003). In order to determine whether the preamble should constitute a limitation, and therefore requires construction, the Court must look to the "overall form of the claim, and the invention as described in the specification and illuminated in the prosecution history." Id. When the preamble merely states a "purpose or intended use for the ...

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