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Novartis Pharmaceuticals Corp. v. Actavis, Inc.

United States District Court, Third Circuit

November 21, 2013

NO VARUS PHARMACEUTICALS CORPORATION, NOVARTIS CORPORATION, NOVARTIS AG, and NOVARTIS PHARMA AG, Plaintiffs,
v.
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[1] (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.

I. BACKGROUND

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)[2]

1. The '504 Patent[3]

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).

III. DISCUSSION

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 formula (II) wherein ... or a pharmaceutically acceptable salt thereof.

(750 Patent, col. 27:63-28:55)

8. A method of treating iron overload comprising administering a subject in need of such treatment a therapeutically effective amount of a compound of claim 3, or a pharmaceutically acceptable salt thereof.

(Id., col. 30:36-39) In addition to their disputes regarding the three claim terms set out above, the parties further dispute whether claims 8 and 16 are independent or dependent claims. (D.I. 65; D.I. 70 at 2; D.I. 76 at 16) The Court perceives these disputes to be live, (D.I. 83 at 2-4; Tr. at 39-40), and to require resolution.

A. "diseases"

The first dispute concerns the term "diseases, " which appears in or relates to claims 1-13 and 15-18 of the 750 Patent. (750 Patent) Plaintiffs argue that the term can be understood by its plain and ordinary meaning, which they assert is "generally understood to include" their proposed construction: "disorders." (D.I. 70 at 8 (internal quotation marks omitted); see also Tr. at 13-14) In the parties' Joint Claim Construction Chart, Defendants proposed that this term be construed to mean "disorders of body function, system, or organ[.]" (D.I. 65 at 2) However, in response to extrinsic evidence cited by Plaintiffs, Defendants subsequently modified their proposal for the term. They now argue that the term's plain and ordinary meaning is "disorders of body function, system, or organ occasioned by environmental factors, specific infective agents, or genetic defects[.]" (D.I. 76 at 7-8 & n.6; D.I. 83 at 4 (emphasis added)) For the following reasons, the Court recommends that Defendants' original proposed construction—"disorders of body function, system, or organ"—should be adopted.

In construing this term, the Court looks first to the claim language itself. Claim 3, which is representative of the term's use in other claims, describes 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 ...." (750 Patent, col. 27:63-65 (emphasis added)) In determining the proper construction of a claim term, the context of the surrounding words of the claim is important. ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1088 (Fed. Cir. 2003) (citing cases); see also IGT v. Bally Gaming Int'l, Inc., 659 F.3d 1109, 1117 (Fed. Cir. 2011) ("We caution that claim language must be construed in the context of the claim in which it appears."); Phillips, 415 F.3d at 1314. Here, the surrounding claim language provides certain additional detail about the claimed "diseases." That is, the claim speaks of treating a certain subset of diseases—those that either (1) cause an excess of metal in the body, or (2) are caused by an excess of metal in the body.

This information reveals the problem with the newly added portion of Defendants' proposed construction (i.e., "disorders ... occasioned by environmental factors, specific infective agents, or genetic defects"). The relevant claims of the 750 Patent, in part, explicitly describe a subset of diseases that are "caused by an excess of metal" in the body. Yet as Plaintiffs note, (Tr. at 26-27), the second portion of Defendants' proposal attempts to do the very same thing—it too defines "diseases" by reference to what they are "occasioned" (or caused) by. Indeed, as to Defendants' proposal, if one simply replaces "occasioned" with its synonym "caused, " then claim 3 would, in essence, describe "treating disorders ... [caused] by environmental factors, specific infective agents, or genetic defects ... [such disorders being] caused by an excess of metal in a human or animal body . .." In this way, then, the language of the claims strongly suggests that the term "diseases" should not itself be defined by the factors that cause such "diseases." To do otherwise and adopt this portion of Defendants' proposal would render other portions of the claim redundant and inject confusion, rather than clarity, into the understanding of this term's meaning. See, e.g., Chalumeau Power Sys. LLC v. Alcatel-Lucent, Civil Action No. 11-1175-RGA, 2013 WL 5913849, at *4 (D. Del. Oct. 30, 2013) (rejecting proposed construction of claim term "type of device" where the proposal rendered language in a later portion of the relevant claim "redundant"); AVM Techs., LLC v. Intel Corp., Civil Action No. 10-610-RGA, 2012 WL 1134484, at *6 (D. Del. Mar. 30, 2012) (same, as to term "a delay"); Life Techs. Corp. v. Illumina, Inc., Civil Action No. 09-706-RK, 2010 WL 5343177, at *8-9 (D. Del. Dec. 15, 2010) (same, as to term "thin layer").[4]

The Court next turns to the specification, which provides some additional guidance regarding the proper construction of the term. Plaintiffs rely heavily on the specification in arguing for a broad construction—that "diseases" be construed simply to mean "disorders." In doing so, Plaintiffs assert that the specification uses the terms "diseases" and "disorders" interchangeably. (D.I. 81 at 3; Tr. at 25-26, 56) The Court will address this line of argument first.

Although the term "disorders" is not used in any of the claims, both it and the term "diseases" are separately found in the specification. Ordinarily, when different words are used in a patent, it is presumed that they carry different meanings. See, e.g., Helmsderfer v. Bobrick Washroom Equip., Inc., 527 F.3d 1379, 1382 (Fed. Cir. 2008); Va. Innovation Scis., Inc. v. Samsung Elecs. Co., Ltd., No. 2:12cv548, 2013 WL 5410013, at *15 (E.D. Va. Sept. 25, 2013); comScore, Inc. v. Moat, Inc., Civil Action No. 2:12cv351, 2013 WL 3874548, at *4 (E.D. Va. July 25, 2013). Yet courts have also noted that, particularly where the terms at issue lack discernibly different meanings, "different words [may] be used to express similar concepts, even though it may be poor drafting practice[.]" Bancorp Servs., L.L.C. v. Hartford Life Ins. Co., 359 F.3d 1367, 1373 (Fed. Cir. 2004); see also Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d 1111, 1120 (Fed. Cir. 2004); Va. Innovation Scis., 2013 WL 5410013, at *15.

Here, the Court finds that the patent's usage of the terms "disorders" and "diseases" do not signal that they mean the same thing; instead their use suggests that while there is a relationship between the terms, the former carries a broader meaning than the latter. By way of example, the specification begins by explaining that: "[v]arious disorders of warm-blooded animals are linked with an excess of metals ... in the body tissues. For example, aluminum in .. . Alzheimer's disease is representative." (750 Patent, col. 1:11-15 (emphasis added)) The manner of usage of the terms "disorders" and "disease" here is the first suggestion that the patentees did not intend them to mean exactly the same thing. Instead, as Defendants note, the patentees "particularly refer to Alzheimer's as a disease" in a manner suggesting that "disorders is a broad category" while "disease" is a term that is "more particular and more precise." (Tr. at 46-47 (Defendants' counsel noting that "[t]here would be no need to say Alzheimer's is a disease if people already knew it because the introductory phrase sa[ys] in various disorders ... "))

The specification again utilizes the term "disorders" at the beginning of column 2 of the patent, when introducing the general concept that it "has now been found that certain [compounds] have valuable pharmacological properties when used in the treatment of disorders which cause an excess of metal in the human or animal body or are caused by it[.]" (750 Patent, col. 2:4-18 (emphasis added)) Thereafter, the specification goes on to focus more particularly on the present invention, explaining in two other places that the invention "relates to the use of [deferasirox] ... for the treatment of diseases which cause an excess of iron in the human or animal body or are caused by it[.]" (Id., col. 4:53-56 (emphasis added); see also id., col. 2:19-57 (noting that the present invention "relates to the use of [deferasirox] ... in the treatment of diseases which cause an excess of metal in the human or animal body or are caused by it") (emphasis added)) Plaintiffs seize on the similarity of these references to "disorders" and "diseases" in arguing that the patent uses the terms interchangeably.

However, a closer look at the context of these references counsels against that conclusion. Column 2's opening sentence (that which uses "disorders") is a broad, general sentence, one not directly tied to the present invention, and refers to a group of "disorders" which cause or are caused by an excess of "metal." In contrast, the other two sentences at issue are couched in more narrow terms—in that they summarize the present invention—and they refer to certain "iron" or "metal'-related "diseases, " not "disorders."[5] This juxtaposition provides some indication that even when the terms "disorders" and "diseases" were being used in sentences with similar phraseology, the term "diseases" was used in a more precise context, suggesting that it carries a narrower meaning than does "disorders."

In the end, it is clear that the patentees knew how to use the term "disorders, " and did so at various points in the specification. However, in summarizing the invention, and in setting out the patent's claims, they chose to use a distinctly different word—"diseases." It is well-settled that "a patent applicant defines his invention in the claims, not in the specification[, ]" for it is the "claims, not the specification, [that] provide the measure of the patentee's right to exclude." Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., Inc., 285 F.3d 1046, 1052 (Fed. Cir. 2002) (citing cases).[6] Taken together, all of the above indicates that "disorders" is a broader term than "diseases, " and that the patentees were claiming something narrower in referencing the treatment of the latter, not the former.

Before leaving the specification, it is worth noting that it uses the term "diseases" in one other notable instance—in a manner that does not conflict with the Defendants' original proposed construction. In explaining the need for the present invention, the specification describes the problematic treatment for iron overload that preceded deferasirox, known as desferoxamine B. (750 Patent, col. 1:43-65) It explains that certain difficulties with administration of this therapy severely hampered the ability to use it to comprehensively treat "thalassaemias ... malaria ... and sickle-cell anemia[, ]" which are thereafter described as "widespread diseases[.]" (Id., col. 1:45-61 (emphasis added)) This use of "diseases" signals that the proper construction of the term must account for and include these three maladies.[7] And it is not disputed that each of these three listed diseases would be recognized by a person of ordinary skill in the art to fall within the remaining portion of Defendants' proposed construction: "disorders of body function, system, or organ." (D.I. 76 at 8; D.I. 81 at 3)

The Court lastly turns to extrinsic evidence presented by the parties. Here, both parties provided citations to dictionary definitions, though Plaintiffs cite to no dictionary that defines "diseases" as being referred to interchangeably with "disorders." (Tr. at 48) Defendants put forward multiple dictionary definitions, but the one the Court finds most persuasive is Defendants' citation to Stedman 's Medical Dictionary ("Stedman's"). (D.I. 76 at 10 & n.7) It is the only one of Defendants' referenced dictionaries that is not outside the relevant field of art, and the only one that Plaintiffs do not take issue with. (D.I. 81 at 5) In fact, Plaintiffs affirmatively cite to this very source in support of their construction for another disputed term, "iron overload." (Id. at 8) Stedman's defines "disease" as "an interruption, cessation, or disorder of body function, system, or organ"—tracking the substance of Defendants' original proposed construction (but not the second, newly-added portion relating to causation). (D.I. 84, ex. 14 at JA000284) This definition supports Defendants' position that the plain and ordinary meaning of "diseases" is that they are a subgroup of "disorders, " and affect particular portions or aspects of the body. (Tr. at 47-48)

For the foregoing reasons, the Court recommends that "diseases" be construed to mean "disorders of body function, system, or organ."

B. "iron overload"

The parties next dispute the construction of the term "iron overload." The term appears in or relates to claims 8, 16, and 17 of the patent. Defendants propose that the term be construed to mean "an excess of iron in various tissues of a subject." (D.I. 76 at 13; D.I. 83 at 8) Plaintiffs argue that the term should be construed to mean "an excess of iron." (D.I. 70 at 15; D.I. 81 at 7) For the following reasons, the Court concludes that Defendants' proposal for "iron overload" should be adopted.

While the claim language itself does not shed light on whether "iron overload" must occur "in various tissues" of a subject, Defendants argue that the specification "expressly defines" the term. (D.I. 76 at 13; D.I. 83 at 8; Tr. at 79-80) The relevant portion of the specification states:

In other illnesses, in particular of man, an excess of iron occurs in the various tissues. This is designated as iron overload (formerly haemosiderosis). It occurs, e.g., after parenteral administration of iron (especially repeated blood transfusions) or after increased uptake of iron from the gastrointestinal tract.

(750 Patent, col. 1:15-20 (emphasis added))

The Court agrees with Defendants that the highlighted language above conveys the patentees' definition of "iron overload" to the person of ordinary skill in the art (and indeed, as will be discussed further below, a definition that is consistent with the term's plain and ordinary meaning). It is well-settled that "[t]he specification acts as a dictionary when it expressly defines terms used in the claims[.]" Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir.1996). And when the specification does so, "without ambiguity or incompleteness, there is no need to search further for the meaning of the term." Multiform Desiccants, Inc. v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). The highlighted language is the first reference to "iron overload" made after the patent's Abstract, and sets out the meaning of that term in a very precise, specific way. The Court is thus persuaded that the phrase "[t]his is designated as" is being used as definitional language here, and that it provides clear indication that the preceding language—"an excess of iron occurring] in the various tissues"—is meant to define what "iron overload" is. See, e.g., Mars, Inc. v. JCMAm. Corp., Civil No. 05-3165 (RBK), 2008 WL 2684118, at *12 (D.N.J. July 2, 2008) (finding that patent provided a definition of term "document" where the specification stated that "[t]hroughout the following, the term document will designate a rectangular sheet of paper or other material of suitable dimensions ....") (emphasis added).[8] Thus, this portion of the specification indicates that the patentees defined "iron overload" to mean an excess of iron in various tissues.[9]

Indeed, additional intrinsic evidence further supports Defendants' proposed construction. For instance, in the next paragraph, the specification recites that "[i]ron chelators are able to mobilize and excrete the iron deposited in the organs[.]" (750 Patent, col. 1:31-32) Additionally, the Kontoghiorges reference, cited in the 750 Patent specification and acknowledged to be intrinsic evidence by both parties, (D.I. 76 at 14; Tr. at 87), states that "[t]he presence of excess iron in tissues leads to the saturation of the metabolic, antioxidant and other controls, usually protecting the body from such toxicity and as a result molecular and tissue damage could occur which, in the case of transfusional iron overload, may be irreversible." (D.I. 84, ex. 9 at JA000074 (emphasis added)) And the Prescribing Information for EXJADE® explains that in two clinical studies involving patients undergoing transfusion, iron overload was measured by liver biopsies. (Id., ex. 11 at JA000132-33)

Indeed, in this case, the specification's definition of "iron overload" actually comports with the ordinary meaning of the term as understood by a person of skill in the art—further underscoring that Defendants' proposal should be adopted. (D.I. 76 at 15; Tr. at 77, 88) For example, a food and nutrition encyclopedia cited by Defendants describes iron overload as "[a]n increase in nontoxic tissue storage of iron [] called hemosiderosis [iron overload.]" (D.I. 84, ex. 17 at JA000310) And a New Scientist and Science Journal article, also cited by Defendants, explains that "iron overload can be of several types. Excess tissue iron may be acquired orally, by high environmental levels of iron or through high alcohol intake, or by repeated blood transfusions. The term used to describe the high level of tissue iron in these circumstances is haemosiderosis [iron overload]." (Id., ex. 18 at JA000315) Plaintiffs failed to address these extrinsic sources, instead simply asserting in conclusory fashion that "[t]he plain meaning of iron overload, i.e., excess of iron, does not so limit the term [to iron deposited in tissues]." (D.I. 81 at 7)

Tellingly, even Plaintiffs "agree[] that iron overload includes iron deposited in the tissues." (Id.) Plaintiffs' briefing and argument at the Markman hearing reveals that their primary disagreement is not so much with the substance of Defendants' proposed construction, but instead with any argument by Defendants that "an excess of iron in various tissues of a subject" cannot refer to an excess of iron found in blood plasma. (See, e.g., D.I. 70 at 15-17; D.I. 81 at 7) Indeed, the section of Plaintiffs' reply claim construction brief regarding "iron overload" is almost entirely devoted to arguing that blood plasma is a tissue. (D.I. 81 at 7-8)[10]

Thus, the Court recommends that "iron overload" be construed to mean "an excess of iron in various tissues of a subject."

C. "treating"

The final term-at-issue is "treating." The term appears in or relates to claims 1-13 and 15-18 of the patent.[11] Defendants propose that "treating" be construed to mean "causing a therapeutic improvement in, " (D.I. 76 at 12-13; D.I. 83 at 7-8), a definition that they contend is the term's plain and ordinary meaning in the context of this patent, (Tr. at 109). For their part, Plaintiffs argue that no construction is necessary for this "well-understood" term. (D.I. 70 at 13-15; D.I. 81 at 5-7) Alternatively, Plaintiffs assert that the term could correctly be construed to mean "attempting to cause a therapeutic improvement[, ]" as such a construction would be consistent with the term's plain meaning. (D.I. 93 at 5; Tr. at 110) As is evident from these competing proposals, there is a real dispute here between the parties as to the term's ordinary meaning, one that is capable of resolution and should be resolved by the Court. See 02 Micro Int'l Ltd. v. Beyond Innovation Tech. Co., Ltd., 521 F.3d 1351, 1361 (Fed. Cir. 2008). The crux of that dispute is whether the patent requires that "treating" must cause a particular result—therapeutic improvement—or instead whether such an outcome "is possible, and even hoped for, but not required by the claim language." (D.I. 93 at 5; see also Tr. at 89) For the following reasons, the Court recommends that Plaintiffs' proposed construction of "attempting to cause a therapeutic improvement" be adopted.

In resolving this dispute, the Court turns first to the language of the claims. The use of the term "treating" in claim 3, set out above at the beginning of this Section, is representative. While the claim language does not explicitly define the term "treating[, ]" it is also true that nothing in that language imposes a requirement that "treating" bring about a particular result (i.e., the therapeutic improvement of diseases or iron overload). (See, e.g., 750 Patent, col. 27:63-67) The claims do not recite methods of "therapeutically treating" or "effectively treating" diseases or iron overload with the claimed compounds. (D.I. 70 at 14) As such, the Court agrees with Plaintiffs that Defendants' proposed construction improperly "injects a non-existent functional requirement into the claims, i.e., that the 'treatment' result in a 'therapeutic improvement.'" (Id. at 13; see also Tr. at 107-108)

In arguing to the contrary, Defendants rely heavily on the fact that the claims at issue state that "treating" diseases or iron overload involves administering a "therapeutically effective amount" of the relevant compound. (D.I. 76 at 12; D.I. 83 at 8; Tr. at 102-103, 109) In light of this, they argue that it is "abundantly clear that the 750 Patent claims 'causing a therapeutic improvement in' the disease." (D.I. 76 at 12)

The Court is not persuaded by this argument. Instead, the Court agrees with Plaintiffs that while the claims require administering a dose of the claimed compound that is a "therapeutically effective amount[, ]" such a requirement does not qualify the method of "treating" or otherwise require that "treating" cause a specific outcome. (D.I. 70 at 14; see also D.I. 81 at 6 ("[A] patient may be treated with a 'therapeutically effective amount' of a drug without that drug necessarily 'causing a therapeutic improvement' in the disease of the patient."); Tr. at 93 (Plaintiffs' counsel asserting that "what the doctor is doing in the course of [the treatment required by the claims] is giving that person that which has been found in others to be a therapeutically effective amount and hop[ing] that it will work in the course of this one person.")) It is obvious that the patentees knew how to use the word "therapeutically, " and their choice to not use the word (or a variation of it) to modify the term "treating" is meaningful. The patentees could have, but did not, claim "a method of therapeutically treating" diseases or iron overload. That choice must be given meaning here.

The patent's specification does not counsel a different conclusion. In support of their argument, Defendants primarily point to two sections of the specification. The first section states that "[t]he present invention relates to the use of compounds . . . preferably in the form of pharmaceutically acceptable preparations, in particular in a method for the therapeutic treatment of the human body, and to a treatment method of this type." (750 Patent, col. 2:19-60 (emphasis added)) The second section similarly states that "[i]n particular, the invention relates to the use of a compound ... for the treatment of diseases ... preferably in the form of pharmaceutically acceptable preparations, in particular a method for the therapeutic treatment of the human body, and to a treatment method of this type." (Id., col. 4:53-59 (emphasis added))

However, as Plaintiffs note, (D.I. 93 at 4), given the use of the term "preferably" in these statements, this language appears to be "merely expressing a non-limiting preferred embodiment of a broader invention." See Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1357 (Fed. Cir. 2003) (explaining that "use of the term 'preferably' makes clear that the language describes a preferred embodiment, not the invention as a whole"); see also Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1250-51 (Fed. Cir. 2008). The Federal Circuit has repeatedly warned against confining the claims of a patent to specific embodiments described in the specification. Phillips, 415 F.3d at 1323. To the extent that "therapeutic treatment" as used in the specification suggests that "treating" must cause therapeutic improvement, it is significant that the patentees did not choose to modify "treating" in the claims themselves, and the Court will not here import such a limitation from the specification into the claim. Thus, the intrinsic evidence does not support construing "treating" to mean "causing a therapeutic improvement in."[12]

However, in ascertaining the plain and ordinary meaning of "treating" in the context of the 750 Patent, the Court agrees with Defendants that the term must connote something other than the physical act of "administering the claimed compounds." (D.I. 76 at 13; see also D.L 83 at 7-8; D.I. 92 at 1) The 750 Patent includes the step of "administering" the claimed compound as part of the claimed method for "treating" diseases or iron overload, and it is well-settled that claim terms must be construed "such that words in a claim are not rendered superfluous." Digital-Vending Servs. Int'l, LLC v. Univ. of Phx., Inc., 672 F.3d 1270, 1275 (Fed. Cir. 2012); Becton, Dickinson & Co. v. Tyco Healthcare Grp., LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010) (citation omitted).

Ultimately, though, the Court agrees with Plaintiffs that the plain and ordinary meaning of "treating" diseases or iron overload (as reflected by the term's use in the patent) is to attempt to cause a therapeutic improvement, without necessarily having assurance of what the outcome will be. This conclusion is in line with the decisions of other courts as to the plain and ordinary meaning of "treating, " in cases where the term was used alongside very similar claim language to that at issue here. Cf. Schering Corp. v. Mylan Pharms., Inc., Civil Action No. 09-6383 (JLL), 2011 WL 2446563, at *2, *5 (D.N.J. June 15, 2011) (in construing term "treating" that appeared in, inter alia, a claim requiring "[a] method of treating . . . atherosclerosis . . . comprising administering to a mammal... an effective amount" of the claimed compound, noting that "the plain meaning of 'treatment' does imply a goal of [stopping, slowing, or reversing the progression of a disease]" but "does not necessarily imply success"); Pfizer Inc. v. Teva Pharms. USA, Inc, 803 F.Supp.2d 397, 401, 406 (E.D. Va. 2011) (noting that construing "treating erectile dysfunction" to mean "keeping [erectile dysfunction] from returning, or preventing it" would not be in line with the ordinary or customary meaning of "treating, " and ultimately rejecting such a construction, where the method of "treating" in the claim was "comprising orally administering ... an effective amount of a compound"). None of these courts found that such a meaning was redundant to or rendered superfluous a claim's subsequent reference to "administering" the claimed compound at issue. Schering Corp., 2011 WL 2446563, at *5; Pfizer, 803 F.Supp.2d at 406. Nor does the Court here.

Indeed, even the dictionary definition that Defendants introduced during the Markman hearing as "basically [their]" construction for "treating, " underscores that the plain meaning of the term does not absolutely require an improvement in the condition at issue. (Tr. at 98-99 (quoting Random House College Dictionary 1399 (rev. ed. 1984) ("to deal with (a disease, patient, etc.) in order to relieve or cure, as a physician does"))) As set out in that definition, "treating" a disease amounts to "deal[ing]" with the disease "in order to relieve or cure" it—wording that, to the Court, suggests intention that the disease be relieved or cured, but not certainty that success will be achieved.

Therefore, the Court recommends that "treating" be construed to mean "attempting to cause a therapeutic improvement in."

D. Claims 8 and 16

Finally, the parties dispute whether claims 8 and 16 of the 750 Patent are independent or dependent claims. Claim 8 is set out above in this Section (as is claim 3, referenced in claim 8). The language of claim 16 is similar to that of claim 8:

16. A method of treating iron overload comprising administering to a subject in need of such treatment a therapeutically effective amount of a compound of formula II, as claimed in claim 9, or a pharmaceutical^ acceptable salt thereof.

(750 Patent, col. 32:57-61).

And the language of claim 9, referenced in claim 16, is similar in nature to that of claim 3:

9. 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 formula (II) wherein ... or a pharmaceutically acceptable salt thereof.

(Id., col. 30:40-31:26)

While an independent claim stands on its own as described in a single claim, a dependent claim refers to and adds further limitations to an independent claim. 35 U.S.C. § 112(d) ("[A] claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers."); Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 1357 (Fed. Cir. 2007) ("To establish whether a claim is dependent upon another, this court examines if the new claim both refers to an earlier claim and further limits that referent."). "A claim's status as dependent or independent depends on the substance of the claim in light of the language of [Section 112(d)], and not the form alone." Monsanto, 503 F.3d at 1357-58 (citing Manual of Patent Examining Procedure ("MPEP") §§ 608.01(m), (n) (August 2006); 37 C.F.R. § 1.75 (2007) (setting forth proper drafts for independent and dependent claims)).

Defendants argue that the dependency of claims 8 and 16 is demonstrated by the plain language of the claims as well as by the prosecution history of the 750 Patent. (D.I. 76 at 16; D.I. 83 at 9) As to the language of the claims, Defendants point out that claims 8 and 16 refer to earlier claims (claims 3 and 9, respectively), and "further limit the scope of the claims from which they depend by specifying that the method at issue is narrower than treating the universe of diseases encompassed in the subject independent claim[s]." (D.I. 76 at 16-17) That is, according to Defendants, independent claims 3 and 9 sweep in two sets of diseases ((1) those "which cause an excess of metal" and (2) those which "are caused by an excess of metal"), while "[p]roperly construed, 'iron overload' [in claims 8 and 16] refers to only one of those two types of diseases"—the second type. (Id.; see also Tr. at 126) Thus, Defendants argue, the language of claims 8 and 16 follows the dictates of Section 112(d).

Beyond the claim language itself, Defendants note that during the prosecution history of the 750 Patent, the applicants made "two definitive statements" that issued claims 8 and 16 are narrower than those directed to methods of treating diseases which cause or are caused by an . excess of metal. (Tr. at 128; see also D.I. 76 at 17-20; Tr. at 135) After the filing of the relevant patent application, the United States Patent & Trademark Office ("PTO") required that the application be restricted to either claims reciting methods of treatment (Group I, then-claims 1-4) or claims reciting compounds (Group II, then-claims 10-16). (D.I. 84, ex. 12 at JA000200-205; Tr. at 117) Predecessor claim 11 contained language similar in nature to the language of claims 8 and 16, reciting "[a] method of treating iron overload comprising administering to a subject... a therapeutically effective amount of a compound of claim 12[, ]" with predecessor claim 12 reciting a compound. (D.I. 84, ex. 12 at JA000191) In response to the restriction requirement, Plaintiffs elected to prosecute the method-of-treatment claims. (Id. at JA000220) However, they also argued that the Examiner's inclusion of claim 11 among Group II (i.e., claims reciting compounds) was due to inadvertence; they noted that "[i]f not, [] Applicants traverse this portion of the restriction requirement because 'the method of treating iron overload' is not patentably distinct from 'the method of treating various diseases which cause an excess of metal or are caused by it' since the scope of the former is embraced by the latter." (Id. (emphasis added)) Defendants argue that with this statement, the Applicants made clear that '"treating iron overload' is merely a subset of the scope of the pertinent independent claims." (D.I. 76 at 17)

The applicants next cancelled certain claims and added new claims. (D.I. 84, ex. 12 at JA000211-221) Claims 17 and 23, like issued claims 3 and 9, recited a "method of treating diseases which cause an excess of metal... or are caused by it. ..." (Id. at JA000211-214) Claims 22 and 30 recited a "method of treating iron overload comprising administering ... a therapeutically effective amount of a compound of [claim 17 and 23, respectively], or a pharmaceutically acceptable salt thereof." (Id. at JA000214-217) The applicants told the Examiner that claim 22 (issued claim 8) is "directed to [a] preferred embodiment [] of claim 17 (issued, in essence, as claim 3), and that claim 30 (issued claim 16) is "directed to [a] preferred embodiment^ of claim 23 (issued, in essence, as claim 9). (Id. at JA000220)[13]

In view of the claim language—and particularly the prosecution history—the Court is persuaded that claims 8 and 16 are dependent claims. With the statements referenced above, Plaintiffs clearly presented claims 8 and 16 to the PTO as claims of dependency, strongly informing the Court's decision here. Monsanto, 503 F.3d at 1358 (in concluding that claim was dependent, considering prosecution history as it "provide[d] additional insight into the scope of [the] claim"); Maury Microwave, Inc. v. Focus Microwaves, Inc., No. CV 10-03902 MMM (JCGx), 2012 WL 9161988, at *31, *33 (CD. Cal. July 30, 2012) (same).

The Court's conclusion is strengthened by the fact that Plaintiffs have no real answer for how to square that prosecution history with their current position that the claims are independent. Their opening brief failed to address the prosecution history, despite the fact that Defendants cited to that history in the Joint Claim Construction Chart that preceded briefing. (D.I. 65 at 4-5) Plaintiffs' reply brief simply stated in conclusory fashion that the portions of the prosecution history that Defendants rely upon are not dispositive of the claims' status as independent or dependent (without explaining why that is so). (D.I. 81 at 9) And although Plaintiffs asserted at the Markman hearing that the file history does not support Defendants' arguments in this regard, they never really addressed the substance of that argument—that during the prosecution history, Plaintiffs stated that identical claim language to that at issue in claims 8 and 16 was language of dependency. (Tr. at 115-17)[14]

For these reasons, the Court recommends that claims 8 and 16 be construed as dependent claims.

IV. CONCLUSION

For the foregoing reasons, the Court recommends that the District Court adopt the following constructions:

1. "diseases" means "disorders of body function, system, or organ";
2. "iron overload" means "an excess of iron in various tissues of a subject";
3. "treating" means "attempting to cause a therapeutic improvement in"; and
4. Claims 8 and 16 are dependent claims.

This Report and Recommendation is filed pursuant to 28 U.S.C. § 636(b)(1)(B), Fed.R.Civ.P. 72(b)(1), and D. Del. LR 72.1. The parties may serve and file specific written objections within fourteen (14) days after being served with a copy of this Report and Recommendation. Fed.R.Civ.P. 72(b)(2). The failure of a party to object to legal conclusions may result in the loss of the right to de novo review in the district court. See Henderson v. Carlson, 812 F.2d 874, 878-79 (3d Cir. 1987); Sincavage v. Barnhart, 171 F.App'x 924, 925 n.l (3d Cir. 2006).

The parties are directed to the Court's Standing Order for Objections Filed Under Fed.R.Civ.P. 72, dated October 9, 2013, a copy of which is available on the District Court's website, located at http://www.ded.uscourts.gov.


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