FAITH S. HOCHBERG, District Judge.
This case comes before the Court on requests for claim construction from Plaintiff Prometheus Laboratories Inc., ("Prometheus" or "Plaintiff") together with Defendants Roxane Laboratories, Inc. and Cipla Ltd. (collectively "Defendants"). The parties submitted their Joint Claim Construction and Prehearing Statement on October 21, 2011. On December 9, 2011, the parties filed their opening claim construction briefs, and on February 10, 2012, they filed their responsive briefs. The parties filed a second Joint Claim Construction and Prehearing Statement on February 21, 2012. On March 9, 2012, the parties filed a second set of opening claim construction briefs, and on April 9, 2012, they filed their responsive briefs. On October 11, 2012, the parties amended their Joint Claim Construction and Prehearing Statement. A Markman hearing took place on October 17, 2012. The parties again amended their Joint Claim Construction and Prehearing Statement on August 7, 2013.
These cases arise out of actions for patent infringement under the Federal Food, Drug, and Cosmetics Act ("FFDCA"), and, more specifically, the Hatch-Waxman Amendments to that law. Prometheus is the owner of U.S. Patent No. 6, 284, 770 (the "'770 patent") and U.S. Patent No. 6, 175, 014 (the "'014 patent").
On September 4, 2001, the United States Patent and Trademark Office ("USPTO") issued the '770 patent, "Medicaments for the treatment of non-constipated female irritable bowel syndrome." The '770 patent was thereafter subject to reexamination proceedings before the USPTO which resulted in the cancellation or amendment of all of the original claims of that patent. On October 19, 2010, the USPTO issued a reexamination certificate for the '770 patent.
Prometheus holds an approved New Drug Application ("NDA") under § 505(a) of the FFDCA, 21 U.S.C. § 355(a), for alosetron hydrochloride tablets (NDA No. 21-107), selling under the brand name LOTRONEX®. The reexamined claims of the '770 patent cover the methods of use and administration of alosetron or a pharmaceutically acceptable derivative thereof. After reexamination, the '770 patent was listed in the U.S. Food and Drug Administration ("FDA") publication, "Approved Drug Products with Therapeutic Equivalence Evaluations" (the "Orange Book"), with respect to LOTRONEX®.
Background of the '770 Patent
This case arises out of Roxane's filing of ANDA No. 200-652 with the FDA, which seeks approval to market a generic version of Prometheus' LOTRONEX® product. The active ingredient in LOTRONEX® is alosetron hydrochloride. Prometheus alleges, inter alia, that under 35 U.S.C. § 271(e)(2) Roxane's submission of ANDA No. 200-652 to the FDA constitutes infringement of the claims of reexamined '770 patent owned by Prometheus. Roxane alleges, inter alia, that the asserted claims are invalid and/or not infringed. The parties have identified six disputed claim terms.
LOTRONEX® was developed by Glaxo Wellcome, Inc. (currently d/b/a GlaxoSmithKline, hereinafter "GSK") and first approved by the FDA on February 9, 2000. Following its initial approval, some LOTRONEX® patients experienced severe adverse events, which in some cases were followed by hospitalization for fecal impaction, intestinal obstruction, ischemic ulceration of bowels, and gangrenous colitis. Due to safety concerns, it was withdrawn from the market in November 2000. LOTRONEX® was reintroduced to the market in late 2002 after safety features/protocols were implemented. It was decided that LOTRONEX® would have to be distributed under a Risk Evaluation and Mitigation Strategy (REMS) that incorporated the methods described in the '770 patent. The LOTRONEX® REMS is known today as the Prescribing Program for LOTRONEX®. In 2007, Prometheus acquired LOTRONEX® and the '770 patent.
Roxane claims that during reexamination, Prometheus and its patent attorneys, without the involvement of the inventors, proposed amendments to the original '770 patent claims adding words and phrases allegedly supported by the specification of the '770 patent. Roxane further argues that these added words and phrases bear little, if any, relationship to the subject matter described in the specification of the '770 patent. Roxane contends that, according to Prometheus, the limitations added to the amended claims corresponded to the changes GSK made to the LOTRONEX® label in conjunction with the reintroduction of LOTRONEX® in 2002- changes GSK made to the label long after the filing of the original '770 patent specification and after the issuance of the '770 patent.
Background of the '014 Patent
This case arises out of Roxane's filing of ANDA No. 200-652 with the FDA, which seeks approval to market a generic version of Prometheus' LOTRONEX® product. Defendant Cipla Ltd. imports alosetron hydrochloride into the U.S. for use as the active pharmaceutical ingredient in Roxane's generic version of LOTRONEX®. On November 18, 2011, Prometheus filed its First Amended Complaint alleging, among other things, that Roxane will infringe the '014 patent under 35 U.S.C. § 271(g) by using, offering to sell, importing, and/or selling alosetron hydrochloride, and/or Roxane's ANDA products containing alosetron hydrochloride, manufactured by a process that infringes the '014 patent in the U.S. Roxane alleges, inter alia, that the asserted claims are not infringed.
A. Standard of Review
In a patent infringement analysis, the first step is to define the meaning and scope of the claims of the patent. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) ( en banc ), aff'd, 517 U.S. 370 (1996). The construction of patent claims is a matter of law reserved exclusively for the court. Markman, 52 F.3d at 977-79. There are two categories of evidence available to the Court when construing patent claims: (i) intrinsic evidence; and (ii) extrinsic evidence, such as expert testimony. "When construing a claim, a court principally consults the evidence intrinsic to the patent, including the claims, the written description, and any relevant prosecution history." Mantech Environmental Corp. v. Hudson Environmental Services, Inc., 152 F.3d 1368, 1371 (Fed. Cir. 1998); see also Markman, 52 F.3d at 979 ("To ascertain the meaning of claims, we consider three sources: The claims, the specifications, and the prosecution history.").
The court's analysis must begin with the language of the claims themselves, "for it is that language that the patentee chose to use to particularly point out and distinctly claim the subject matter which the patentee regards as his invention.'" Interactive Gift Express, Inc. v. Compuserve, Inc., 256 F.3d 1323, 1331 (Fed. Cir. 2001) (quoting 35 U.S.C. § 112, ¶ 2). Claims are "examined through the viewing glass of a person skilled in the art" as of the effective date of the patent, and claim terms are deemed to be read "not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification." Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) ( en banc ). When a patentee specifically defines a claim term in the specification, it is that definition that controls. Id. at 1316. When the patentee has not provided an explicit definition of a claim term, the words of a claim are given their plain and ordinary meaning to a person of ordinary skill in the art. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996).
To determine how a person of skill in the art would understand a patent's claim language, a court must first examine the intrinsic record, i.e., the patent itself, including the claims, the specification and the prosecution history. Id. (citing Markman, 52 F.3d at 979). The specification "acts as a dictionary when it expressly defines terms used in the claims or when it defines terms by implication." Id. The Federal Circuit has explained that the specification is "usually... dispositive... [and is the] best guide to the meaning of a disputed term." Phillips, 415 F.3d at 1315 (quoting Vitronics, 90 F.3d at 1582) (internal quotations omitted). Therefore, a court should "rely heavily on the written description for guidance as to the meaning of the claims." Id. at 1317.
A patent's prosecution history is another useful source of guidance, as it "provides evidence of how the PTO and the inventor understood the patent." Id. The prosecution history is the complete record of the proceedings before the USPTO, and "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." Id. The Federal Circuit has made clear the need to consult the prosecution history to "exclude any interpretation that was disclaimed during prosecution." See Rhodia Chimie v. PPG Indus., Inc., 402 F.3d 1371, 1384 (Fed. Cir. 2005) (the prosecution history limits the interpretation of claim terms so as to exclude any interpretation that was either disclaimed or disavowed during prosecution).
If the ambiguities of a disputed claim term have not been resolved after analysis of the intrinsic evidence, a court may also consider extrinsic evidence. Vitronics, 90 F.3d at 1582-83. While a court may rely on extrinsic evidence to construe a claim, "what matters is for the court to attach the appropriate weight to be assigned to those sources." Phillips, 415 F.3d at 1324. Extrinsic evidence ordinarily should not contradict intrinsic evidence. Id. at 1322-23.
1. Claim Construction Regarding U.S. Patent ...