NO VARUS PHARMACEUTICALS CORPORATION, NOVARTIS CORPORATION, NOVARTIS AG, and NOVARTIS PHARMA AG, Plaintiffs,
ACTAVIS, INC. and ACTA VIS ELIZABETH LLC, Defendants.
REPORT AND RECOMMENDATION
Christopher J. Burke, UNITED STATES MAGISTRATE JUDGE
In this Hatch-Waxman action filed by Plaintiffs Novartis Pharmaceuticals Corporation ("NPC"), Novartis Corporation, Novartis AG, and Novartis Pharma AG (collectively, "Novartis" or "Plaintiffs") against Defendants Actavis, Inc. and Actavis Elizabeth LLC (collectively, "Actavis" or "Defendants"), Plaintiffs allege infringement of U.S. Patent Nos. 6, 465, 504 (the "'504 Patent") and 6, 596, 750 (the "750 Patent") (collectively, the "patents-in-suit"). Presently before the Court is the matter of claim construction. The Court recommends that the District Court adopt the constructions as set forth below.
A. The Parties
Novartis manufactures and sells the drug deferasirox under the trade name EXJADE®. (D.I. 1 at 11) Novartis is the owner, by assignment, of the patents-in-suit. (Id. At ¶¶ 25-26) Actavis, Inc., and its wholly owned subsidiary Actavis Elizabeth LLC, are engaged in the business of developing, manufacturing, and distributing generic versions of branded drug products throughout the United States. (D.I. 86 at ¶¶ 11, 13)
B. The Patents-in-Suit
The '504 Patent and 750 Patent share the same title, "Substituted 3, 5-Diphenyl-l, 2, 4-Triazoles and Their Use as Pharmaceutical Metal Chelatorsf, ]" as well as the same abstract. (D.I. 84, ex. 1-2)
1. The '504 Patent
The '504 Patent was issued on October 15, 2002. ('504 Patent) Certain claims of the '504 Patent recite the chemical entity known as deferasirox. (Id.; D.I. 70 at 1) Deferasirox is an iron chelator, which is a compound that causes iron to be removed from the body. ('504 Patent, col. 1:28-30; D.I. 70 at 5)
2. The '750 Patent
The '750 Patent was issued on July 22, 2003. (750 Patent) The patent is directed to methods of using certain compounds, including deferasirox, to treat diseases which cause an excess of metal in the human body or are caused by such an excess of metal. (Id; D.I. 70 at 1) The patent's specification explains that certain disorders (such as Alzheimer's disease) are linked with an excess of metals in the body tissues, and that in other illnesses, an excess of iron occurs in the various tissues (for instance, after repeated blood transfusions or after increased uptake of iron from the gastrointestinal tract). (750 Patent, col. 1:11-20) When left untreated, such iron overload can cause severe organ damage and can lead to death. (Id., col. 1:29-31) Iron chelators such as deferasirox help to prevent these problems, as they "are able to mobilize and excrete the iron deposited in the organs and thus lower the iron-related morbidity and mortality." (Id., col. 1:31-33) Deferasirox is administered orally in tablet form. (Id., col. 5:31-43)
The 750 Patent contains eighteen claims. (Id., col. 27:19-34:42) Claims 1, 3, 6, 9, and 18 are independent claims and describe "[a] method of treating diseases which cause an excess of metal in a human or animal body or are caused by an excess of metal in a human or animal body comprising administering ... a therapeutically effective amount" of certain compounds, including deferasirox. (Id.) Among the other claims of the 750 Patent are Claims 8 and 16, which recite "[a] method of treating iron overload ...." and refer back to claims 3 and 9, respectively. (Id., col. 30:36-39, 32:57-61)
C. Procedural History
This case arises out of Defendants' submission of Abbreviated New Drug Application ("ANDA") No. 203560 to the United States Food and Drug Administration ("FDA"), which seeks approval to market a generic version of EXJADE®. (D.I. 1 at ¶1) NPC is the holder of approved New Drag Application No. 21-882, which covers EXJADE®. (Id. At ¶ 27) EXJADE® is deferasirox in tablet form for oral suspension. (Id. at ¶ 1)
Plaintiffs filed suit against Defendants on March 21, 2012, (D.I. 1), alleging that Defendants' submission of ANDA No. 203560 infringes at least one claim of each of the patents-in-suit under 35 U.S.C. § 271(e)(2)(A). (Id. at ¶¶ 33, 38) Further, Plaintiffs allege that upon FDA approval of Defendants' AND A, Defendants will infringe the patents-in-suit in violation of 35 U.S.C. § 271(a)-(c) by making, using, offering to sell, and selling its generic deferasirox product and by actively inducing and contributing to infringement by others. (Id. at ¶¶ 34, 39)
On June 6, 2012, this case was referred to the Court by Judge Richard G. Andrews to hear and resolve all pretrial matters, up to and including case-dispositive motions. The parties completed initial briefing on claim construction on February 27, 2013. (D.I. 83) The Court held a Markman hearing on March 19, 2013. (D.I. 149, hereinafter "Tr.") During the hearing, the Court ordered the parties to submit supplemental letter briefs to address newly disclosed extrinsic evidence and caselaw, (Tr. at 111-12, 136), which the parties filed on March 26, 2013, (D.I. 92, 93).
II. STANDARD OF REVIEW
It is well-understood that "[a] claim in a patent provides the metes and bounds of the right which the patent confers on the patentee to exclude others from making, using or selling the protected invention." Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989). The proper construction of claim terms is a question of law for the Court. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir. 1995), affd, 517 U.S. 370 (1996). The Court should generally give claim terms their "'ordinary and customary
meaning[, ]'" which is "the meaning that the term[s] 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 v. AWHCorp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (citations omitted). However, when determining the ordinary meaning of claim terms, the Court should not extract and isolate those terms from the context of the patent, but rather should endeavor to reflect their "meaning to the ordinary artisan after reading the entire patent." Id. at 1321.
To that end, the Court should look first and foremost to the language of the claims, because "[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, 415 F.3d at 1312 (internal quotation marks and citations omitted). For example, the context in which a term is used in a claim may be "highly instructive." Id. at 1314. In addition, "[o]ther claims of the patent in question, both asserted and unasserted, can also be valuable" in discerning the meaning of particular claim term. Id. This is "[b]ecause claim terms are normally used consistently throughout the patent, [and so] the usage of a term in one claim can often illuminate the meaning of the same term in other claims." Id. Moreover, "[differences among claims can also be a useful guide, " as when "the presence of a dependent claim that adds a particular limitation gives rise to a presumption that the limitation in question is not present in the independent claim." Id. at 1314-15.
In addition to the words of the claims, the Court should look to other intrinsic evidence. For example, the Court should analyze the patent specification, which "may reveal a special definition given to a claim term ... that differs from the meaning [that term] would otherwise possess." Id. at 1316. In that case, "the inventor's lexicography governs." Id. Even if the specification does not contain a special definition of the term-at-issue, it "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." Id. at 1315 (internal quotation marks and citation omitted). That said, however, the specification "is not a substitute for, nor can it be used to rewrite, the chosen claim language." SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). In addition to the specification, a court should also consider the patent's prosecution history, if it is in evidence, because it "can often inform the meaning of the claim language by demonstrating how the inventor understood the invention[.]" Phillips, 415 F.3d at 1317 (citations omitted).
Extrinsic evidence, "including expert and inventor testimony, dictionaries, and learned treatises[, ]" can also "shed useful light on the relevant art." Id. (internal quotation marks and citations omitted). Dictionaries (especially technical dictionaries) may be useful in this process because they typically provide "the accepted meanings of terms used in various fields of science and technology[.]" Id. at 1318. However, the United States Court of Appeals for the Federal Circuit has cautioned that "heavy reliance on [a] dictionary divorced from the intrinsic evidence risks transforming the meaning of the claim term to the artisan into the meaning of the term in the abstract, out of its particular context, which is the specification." Id. at 1321. Overall, while extrinsic evidence may be useful, it is "less significant than the intrinsic record in determining the legally operative meaning of claim language." Id. at 1317 (internal quotation marks and citations omitted); accord Markman, 52 F.3d at 981.
In utilizing these resources during claim construction, courts should keep in mind that "[t]he construction that stays true to the claim language and most naturally aligns with the patent's description of the invention will be, in the end, the correct construction." Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
The parties have identified three claim terms from the 750 Patent for construction: (1) "diseases"; (2) "iron overload"; and (3) "treating." (D.I. 65; D.I. 70 at 1-2; D.I. 76 at 7) Although Plaintiffs assert infringement of multiple claims of the 750 Patent, the use of the disputed terms in claims 3 and 8 is representative. Accordingly, these claims are reproduced below, with the disputed terms highlighted:
3. A method of treating diseases which cause an excess of metal in a human or animal body or are caused by an excess of metal in a human or animal body comprising administering to a subject in need of such treatment a therapeutically effective amount of a compound of ...