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Horizon Pharma AG v. Watson Laboratories, Inc.— Florida

United States District Court, D. New Jersey

November 10, 2014

HORIZON PHARMA AG and JAGOTEC AG, Plaintiffs,
v.
WATSON LABORATORIES, INC. — FLORIDA, Defendant.

PEPPER HAMILTON, LLP, Melissa A. Chuderewicz, Esq., Princeton, New Jersey, Counsel for Plaintiffs.

LEYDIG, VOIT, & MAYER, LTD., Caryn Borg-Breen, Esq., Chicago, Illinois, Counsel for Plaintiffs, Pro hac vice.

MINTZ, LEVIN, COHN, FENIS, GLOVSKY, AND POPEO, PC, John Bauer, Esq., New York, New York, Counsel for Plaintiffs.

CONNELL FOLEY LLP, Rukhsanah Singh, Esq., Roseland NJ, Counsel for Defendant. Pro hac vice.

MERCHANT & GOULD PC, B. Jefferson Boggs, Esq., Christopher Sorenson, Esq., Alexandria, Virginia, Counsel for Defendant. Pro hac vice.

CLAIM CONSTRUCTION OPINION

JOSEPH E. IRENAS, Senior District Judge.

The parties in this pharmaceutical patent infringement case have asked this Court to construe two disputed claim terms. The Court held a claim construction hearing pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) on October 16, 2014, and now adopts Plaintiffs' construction of both of these terms for the reasons set forth below.

I. Relevant Facts

Plaintiffs Horizon Pharma AG ("Horizon") and Jagotec AG ("Jagotec") have brought claims of patent infringement against Defendant Watson Laboratories, Inc. ("Watson") for filing an Abbreviated New Drug Application ("ANDA") to market a generic version of Horizon's pharmaceutical product RAYOS®, in alleged infringement of three patents held by Plaintiffs. The claim construction dispute before the Court today concerns only two of those patents: U.S. Patent No. 8, 394, 407 (the "'407 patent") and U.S. Patent No. 8, 309, 124 (the "'124 patent"). Inventors Guy Vergnault of Kembs, France; Pascal Grenler of Kappelen, France; and Christophe Dragan of Geispitzen, France, filed the '124 patent on March 19, 2012 (issued November 13, 2012) and the '407 patent on March 23, 2012 (issued March 12, 2013). By recorded assignment, both patents now belong to Plaintiff Jagotec.

Both patents concern the "Delayed Release Tablet with Defined Core Geometry, " which is designed to release an active agent "rapidly after a lag time during which time no active agent is released." (Abstract, '124 Patent at 2 and Abstract, '407 patent at 2) The patents suggest that the invention may prove particularly useful to patients suffering from rheumatoid arthritis, who require a dose of the drug prednisone in the middle of the night to maximize effectiveness of the treatment and prevent morning stiffness and pain. ('124 Patent at 5, col. 1, ll. 40-56 and '407 patent at 6, col. 1, ll. 31-47) Rather than waking up in the middle of the night to take a pill, a patient can take the patents' delayed-release tablet prior to bedtime and have the tablet release its active agent a few hours later, while the patient is sleeping. (Id.)

The prior art had delayed release by surrounding the active agent with a coating that is gelled or of a heavier weight in order to slow diffusion. ('124 Patent at 5, col. 2, ll. 16-36 and '407 patent at 6, col. 2, ll. 6-26) However, diffusion releases the drug too gradually and thicker pills are both more expensive to make and more difficult for patients to swallow, among other problems. (Id.)

The patentees address these problems by encasing the active agent core inside an oval-shaped coating that varies in thickness and material along its shorter (A-B) and longer (X-Y) axes. ( See Fig. 1, '124 Patent at 3 and '407 patent at 4) While the coating around the A-B axis is relatively dense to prevent the release of the active agent in the core, the coating around the X-Y axis of the tablet is "relatively porous and permissive towards the ingress of aqueous media, " allowing such media to enter the tablet through the X-Y axis, cause the core to swell on contact, and thereby break open the tablet like "an opened clam shell." ('124 Patent at 6, col. 4, ll. 4-23 and '407 patent at 7, col. 3, l. 59-col. 4, l. 11). The timing of release is therefore managed not only through the thickness of the coating around the active agent core but also the density and porosity of its material. A key aspect of the patents is that the active agent is released through a rupturing of the tablet rather than diffusion through the coating.

The parties have identified two claim terms, both related to the substance of the tablet's coating, that now require construction: (1) "insoluble or poorly water soluble hydrophobic material" and (2) "wherein the coating comprises calcium phosphate salt, glyceryl behenate, and polyvinyl pyrollidone, or mixtures thereof." The Court addresses each of these terms in turn.

II. Legal Standard

Claim construction is a matter of law for the Court to decide. Markman, 517 U.S. at 391. The purpose of claim construction is to "determin[e] the meaning and scope of the patent claims asserted to be infringed, " Markman v. Westview Instruments, Inc., 52 F.3d 967, 979-80 (Fed. Cir. 1995), aff'd 517 U.S. 370 (1996), and "[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, '" Phillips v. AWH Corp., 415 F.3d 1303, 1319 (Fed. Cir. 2005) (en banc) (quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)).

The Court begins a claim construction analysis by examining the intrinsic evidence, which includes the claims, the specification, and the prosecution history of each patent.[1] Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). "A claim construction analysis must begin and remain centered on the claim language itself, " Innova, 381 F.3d at 1116, and every word should be assumed to have meaning and given effect, Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir 2006).

The claims themselves and the context in which a term is used within the claims can "provide substantial guidance as to the meaning of particular claim terms, " and other claims of the patent may be useful in construing a term, as "claim terms are normally used consistently throughout the patent." Phillips, 415 F.3d at 1314. Similarly, claims that differ from each other may provide insight into how a term should be read. Laitram Corp. v. Rexnord, Inc., 939 F.2d 1533, 1538 (Fed. Cir. 1991).

There is a heavy presumption that a claim term conveys its ordinary and customary meaning, which "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." Phillips, 415 F.3d at 1312-13. But a patentee may overcome this presumption and choose "to be his or her own lexicographer by clearly setting forth an explicit definition for a claim term." Johnson Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 990 (Fed. Cir. 1999); see also Schering Corp. v. Amgen Inc., 222 F.3d 1347, 1353 (Fed. Cir. 2000); Markman, 52 F.3d at 979-80.

After examining the claims, "it is always necessary to review the specification to determine whether the inventor has used any terms in a manner inconsistent with their ordinary meaning." Vitronics, 90 F.3d at 1582. "For claim construction purposes, the description [contained within a specification] may act as a sort of dictionary, which explains the invention and may define terms used in the claims." Markman, 52 F.3d at 979. For this reason, "the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Vitronics, 90 F.3d at 1582.

Finally, the Court should also examine the prosecution history, if it is in evidence: "The prosecution history can often inform the meaning of the claim language by demonstrating 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.

"[I]deally there should be no ambiguity' in claim language to one of ordinary skill in the art that would require resort to evidence outside the specification and prosecution history." Markman, 52 F.3d at 986. But if the term remains unclear or ambiguous after examining the intrinsic evidence, the Court may turn to extrinsic evidence. Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211, 1216 (Fed. Cir. 1995). "Extrinsic evidence consists of all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises." Markman, 52 F.3d at 980. Although extrinsic evidence is useful in determining how a person of ordinary skill in the art would understand the term, it is less reliable for the purposes of claim construction than the patent and its prosecution history. Phillips, 415 F.3d at 1318-19. Therefore, extrinsic evidence must be viewed within the context of intrinsic evidence. Id. at 1319.

III. Discussion

In the course of briefing, the parties identified two disputed claim terms in the '407 and '124 patents: (1) "insoluble or poorly water soluble hydrophobic material" explicitly appearing in claims 1 and 8 of the '124 patent and claims 1 and 3 of the '407 patent, and (2) "wherein the coating comprises calcium phosphate salt, glyceryl behenate, and polyvinyl pyrollidone, or mixtures thereof" appearing in claim 4 of the '407 patent. The ...


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