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Shire ViroPharma Inc. v. CSL Behring LLC

United States District Court, D. Delaware

January 18, 2019

SHIRE VIROPHARMA INCORPORATED Plaintiff,
v.
CSL BEHRING LLC and CSL BEHRING GMBH Defendants.

          MEMORANDUM OPINION

          Goldberg, J.

         Before me is a patent infringement case wherein Plaintiff Shire ViroPharma Incorporated (“Plaintiff”) alleges that Defendants CSL Behring LLC and CSL Behring GMBH (collectively, “Defendant”) has infringed Plaintiff's U.S. Patent No. 9, 616, 111 through the development and marketing of Defendant's drug Haegarda®.[1] The parties currently seek construction of two of the patent's disputed terms pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996) (“Markman”). The disputed claim terms are construed as indicated in this Memorandum and accompanying Order.

         I. FACTUAL BACKGROUND

         A. Hereditary Angioedema

         Hereditary angioedema (“HAE”) is a rare genetic disorder causing insufficient natural production of functional or adequate amounts of a protein called C1 esterase inhibitor (“C1-INH”). This protein helps to regulate several complex processes involved in immune system function and fibrinolytic system function. HAE exists in two forms. Type I occurs where the individual produces either no or low C1-INH. Type II is present where the individual has the normal amount of C1-INH, but it does not properly function.

         Patients suffering from HAE experience symptoms including unpredictable, recurrent attacks of swelling commonly affecting the hands, feet, arms, legs, face, abdomen, tongue, genitals, and larynx. Currently, only approximately 6, 500 people in the United States suffer from this condition.

         HAE may be treated by administration of a drug containing a C1 esterase inhibitor in order to restore the levels of C1-INH to levels sufficient to prevent or reduce the frequency or severity of HAE attacks. HAE can be treated either acutely-meaning immediate treatment of an HAE attack in order to slow it down or stop it altogether-or prophylactically-meaning administration of a medication on a regular basis to prevent attacks.

         B. The ‘111 Patent

         On April 11, 2017, the United States Patent and Trademark Office (“PTO”) issued U.S. Patent No. 9, 616, 111 (the “‘111 patent”), entitled “C1-INH Compositions and Methods for the Prevention and Treatment of Disorders Associated with C1 Esterase Inhibitor Deficiency.” The ‘111 patent is directed to methods of treating hereditary angioedema (“HAE”).

         Claim 1 recites:

A method for treating hereditary angioedema (HAE) said method comprising subcutaneously administering to a subject in need thereof a composition comprising a C1 esterase inhibitor, a buffer selected from citrate or phosphate, and having a pH ranging from 6.5-8.0, wherein the C1 esterase inhibitor is administered at a concentration of at least about 400 U/mL and a dose of at least about 1000 U and wherein the administration of the composition comprising the C1 esterase inhibitor increases the level of C1 esterase inhibitor in the blood of the subject to at least about 0.4 U/mL, and wherein the C1 esterase inhibitor comprises an amino acid sequence at least 95% identical to residues 23 of 500 of SEQ ID NO:1.

(‘111 Patent, col. 13, lines 13-25 (emphasis added).)

         The remaining asserted claims depend from claim 1. Several of these dependent claims are also at issue here. Claim 3 recites: “[t]he method of claim 1, wherein the composition is administered daily, every other day, or every three days.” (Id., col. 13, lines 29-30.) Claim 4 recites: “[t]he method of claim 1, wherein the composition is administered one, two, or three times a week.” (Id., col. 13, lines 31-32.) Claims 7, 8, and 9 state:

7. The method of claim 1, wherein the administration of the composition comprising a C1 esterase inhibitor results in HAE prophylactic treatment.
8. The method of claim 1, wherein the administration of the composition comprising a C1 esterase inhibitor results in treatment of an HAE attack.
9. The method of claim 1, wherein the administration of the composition results in at least a reduction in the severity and/or number of HAE attacks.

(Id., col. 13, line 38-col. 14, line 18.) Finally, claim 15 teaches “[t]he method of claim 1, wherein the administration of the composition comprising the C1 esterase inhibitor increases the level of C1 esterase inhibitor in the blood of the subject up to about 1 U/mL.” (Id. col. 14, lines 30-33.)

         C. Procedural Background

         According to the Second Amended Complaint, on July 25, 2017, Defendants began U.S. sales of a prophylactic C1 esterase inhibitor treatment for subcutaneous administration. Defendants marketed the new C1 esterase inhibitor product as “HAEGARDA, ” which received FDA approval on June 22, 2017. Defendants immediately issued a press release announcing the availability of HAEGARDA in the United States. (Sec. Am. Compl. ¶¶ 20-21.) The HAEGARDA product label instructs, in part, that the drug is a “plasma-derived concentrate of C1 Esterase Inhibitor (Human)” to be used for “routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.” (Id. ¶ 24.) The label further directs HAEGARDA's self-administration by subcutaneous injection. (Id. ¶¶ 20-21, 24, 25.)

         Plaintiff initiated this action on April 11, 2017, the same day that the ‘111 patent issued. It filed its Second Amended Complaint on August 24, 2017, alleging direct infringement, inducement of infringement, contributory infringement, and willful infringement.

         On June 18, 2018, the parties submitted opening claim construction briefs setting forth their positions on two disputed terms in the ‘111 patent. I held a Markman hearing regarding these terms on September 12, 2018. Having fully reviewed the parties' briefing and evidentiary submissions, I now set forth the legal construction of the disputed claim terms.

         II. STANDARD OF REVIEW

         The first step in a patent infringement analysis is to define the meaning and scope of the claims of the patent. Markman, 52 F.3d at 976. Claim construction, which serves this purpose, is a matter of law exclusively for the court. Id. at 979. “‘[T]here is no magic formula or catechism for conducting claim construction.' Instead, the court is free to attach the appropriate weight to appropriate sources ‘in light of the statutes and policies that inform patent law.'” SoftView LLC v. Apple Inc., No. 10-389, 2013 WL 4758195, at *1 (D. Del. Sept. 4, 2013) (quoting Phillips v. AWH Corp., 415 F.3d 1303, 1324 (Fed. Cir. 2005)).

         “It 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 omitted). The focus of a court's analysis must therefore begin and remain on the language of the claims, “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). The terms used in the claims bear a “heavy presumption” that they mean what they say and have their ordinary and customary meaning. Texas Digital Sys., Inc. v. Telegenix, Inc., 308 F.3d 1193, 1202 (Fed. Cir. 2002). That ordinary 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.

         Generally, a person of ordinary skill in the art would not understand the ordinary and customary meaning of a claim term in isolation. As such, the ordinary meaning may be derived from a variety of sources including intrinsic evidence, such as the claim language, the written description, drawings, and the prosecution history; as well as extrinsic evidence, such as dictionaries, treatises, or expert testimony. Dow Chem. Co. v. Sumitomo Chem. Co., Ltd., 257 F.3d 1364, 1373 (Fed. Cir. 2001).

         The “most significant source” of authority is “the intrinsic evidence of record, i.e., the patent itself, including the claims, the patent specification[2] and, if in evidence, the prosecution history.” Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996); see also Phillips, 415 F.3d at 1313 (holding that a person of ordinary skill in the art is deemed to read the claim terms in the context of the entire patent, including the specification). The specification “is the single best guide to the meaning of a disputed term” and is usually dispositive as to the meaning of words. Vitronics, 90 F.3d at 1582. Although it is improper to import limitations from the specification into the claims, “one may look to the written description to define a term already in a claim limitation, for a claim must be read in view of the specification of which it is a part.” Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998). On occasion, “the specification may reveal a special definition given to a claim term . . . that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs.” Phillips, 415 F.3d at 1316. The specification may also “reveal an intentional disclaimer, or disavowal, of claim scope by the inventor . . . [, which] is regarded as dispositive.” Id. “The 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, 158 F.3d at 1250.

         The court “should also consider the patent's prosecution history, if it is in evidence.” Markman, 52 F.3d at 980. This consists of “the complete record of proceedings before the Patent Office and includes the prior art cited during examination.” Phillips, 415 F.3d at 1317. “Like the specification, the prosecution history provides evidence of how the [Patent and Trademark Office] and the inventor understood the patent.” Id. at 1317. Nonetheless, it is the least probative form of intrinsic evidence because it “represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation.” Id.

         If ambiguity still exists after considering all the intrinsic evidence, the court may rely on extrinsic evidence, which is “all evidence external to the patent and prosecution history, including expert and inventor testimony, dictionaries, and learned treatises.” Markman, 52 F.3d at 980. “[D]ictionaries, and especially technical dictionaries, . . . have been properly recognized as among the many tools that can assist the court in determining the meaning of particular terminology.” Phillips, 415 F.3d at 1318. Additionally, expert testimony can provide background on the technology at issue, explain how it works, speak to what a person of ordinary skill in the art would understand, and establish that a particular term has a particular meaning in the pertinent field. Id. Notably, however, extrinsic evidence is “less significant than the intrinsic record in determining ‘the legally operative meaning of claim language.'” C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862 (Fed. Cir. 2004) (quoting Vanderlande Indus. Nederland BV v. Int=l Trade Comm=n, 366 F.3d 1311, 1318 (Fed. Cir. 2004)).

         Ultimately, during claim construction, “[t]he sequence of steps used by the judge in consulting various sources is not important; what matters is for the court to attach the appropriate weight to be assigned to those sources in light of the statutes and policies that inform patent law.” Phillips, 415 F.3d at 303.

         III. DISCUSSION

         Two claim terms of the ‘111 patent are in dispute. Specifically, the parties disagree on the correct construction of (1) the phrase “treating hereditary angioedema” and (2) the phrase “increases the level of C1 esterase inhibitor in the blood of the subject up to about 1 U/mL.”[3] I address each claim term below.

         A. “Treating Hereditary Angioedema”

          The first disputed claim term is the phrase “treating hereditary angioedema, ” which appears in claim 1 of the ‘111 patent. (‘111 patent, col. 13, line 13.) Plaintiff proposes the following construction:

[A]ny type of treatment that imparts a benefit to a patient afflicted with HAE, including improvement in the condition of the patient (e.g., in one or more symptoms), delay in the progression of the condition, etc. In a particular embodiment, the treatment of HAE results in at least a reduction in the severity and/or number of HAE attacks.

(Pl.'s Opening Claim Constr. Br. 4.) Defendant offers a different proposed construction:

[I]mparting a benefit to a patient experiencing HAE symptoms, including improvement in one or more of the symptoms associated with HAE or delaying the progression of the severity of HAE symptoms, wherein such treatment does not include inhibiting or preventing HAE symptoms.

(Def.'s Opening Claim Constr. Br. 7.)

         The distinction between these two proposals lies in the precise definition of the word “treating.” Plaintiff posits that “treating” encompasses both acute and prophylactic care, whereas Defendant urges that “treating” is limited to purely acute care. Considering the various sources identified by the parties and for the following reasons, I will adopt Plaintiff's proposed definition.

         1. The Definitions Section

         “The specification is the single best guide to the meaning of a disputed term.” Pressure Prods. Med. Supplies, Inc. v. Greatbatch Ltd., 599 F.3d 1308, 1314-15 (Fed. Cir. 2010) (quotations omitted). “When a patentee explicitly defines a claim term in the patent specification, the patentee's definition controls.” Martek Biosicences Corp. v. Nutrinova, Inc., 579 F.3d 1364, 1380 (Fed. Cir. 2009); see also 3M Innovative Props. Co. v. Avery Dennison Corp., 350 F.3d 1365, 1374 (Fed. Cir. 2003) (“Because 3M expressly acted as its own lexicographer by providing a definition of embossed in the specification, the definition in the specification controls the meaning of embossed, regardless of any potential conflict with the term's ordinary meaning as reflected in technical dictionaries.”); Jack Guttman, Inc. v. Kopykake Enters., Inc., 302 F.3d 1352, 1360 (Fed. Cir. 2002) (“Where . . . the patentee has clearly defined a claim term, that definition ‘[u]sually . . . is dispositive;' it is the single best guide to the meaning of a disputed term.”) (quotations omitted).

         Here, the ‘111 patent specification contains a separate “Definitions” section designed to ascribe precise meanings to certain terms within the claims. Although the specific term “treating” is not defined, the verb form “treat” is among the listed definitions. The definition states:

The term “treat” as used herein refers to any type of treatment that imparts a benefit to a patient afflicted with a disorder, including improvement in the condition of the patient (e.g., in one or more of the symptoms), delay in the progression of the condition, etc. In a particular embodiment, the treatment of HAE results in at least a reduction in the severity and/or number of HAE attacks.

(‘111 patent, col 6, lines 39-45.) As the definition specifically refers to “any type of treatment” imparting a benefit to a patient with HAE and explicitly states that “treatment” includes “at least a reduction in the severity and/or number of HAE attacks, ” it seemingly includes both acute and prophylactic treatment.

         In an effort to rebut this broad language, Defendant remarks that the “Definitions” section separately defines the word “prevent” to mean:

[T]he prophylactic treatment of a subject who is at risk of developing a condition (e.g., HAE or HAE attack) resulting in a decrease in the probability that the subject will develop the condition.

(‘111 patent, col 6, lines 35-38.) It posits that “[t]he Federal Circuit has consistently . . . [held] that when two terms are defined differently in the specification, one term cannot be construed to encompass the definition of the second term.” (Def.'s Answering Cl. Constr. Br. 4 (citing Speedtrack, Inc. v. Endeca Techs., Inc., 524 Fed.Appx. 651, 656 (Fed. Cir. 2013); Trintec Indust., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1296-97 (Fed. Cir. 2002).) Defendant goes on to argue that because these distinct definitions of “treat” and “prevent” do not overlap, they necessarily create a distinction between acute treatment and prophylactic therapy, the latter of which is not included in claim 1.

         Defendant's argument is not supported by the specification as a whole. As a general notion, there is a presumption that different terms in a claim have different meanings. Chicago Bd. Options Exchange, Inc. v. Int'l Secs. Exchange, LLC, 677 F.3d 1361, 1369 (Fed. Cir. 2012); accord Primos, Inc. v. Hunter's Specialities, Inc., 451 F.3d 841, 848 (Fed. Cir. 20016). “However, simply noting the difference in the use of claim language does not end the matter. Different terms or phrases in separate claims may be construed to cover the same subject matter where the written description and prosecution history indicate that such a reading of the terms or phrases is proper.” Nystrom v. TREX Co., 424 F.3d 1136, 1143 (Fed. Cir. 2005); see also Edwards Lifesciences LLC v. Cook Inc., 582 F.3d 1322, 1330 (Fed. Cir. 2009) (holding that the terms “graft, ” “graft structure, ” “bifurcated base structure, ” and “bifurcated base graft structure” have the same meaning where they were “used interchangeably in the specification and the claims[]”); Hyperphrase Techs., LLC v. Google, Inc., 260 F App'x 274, 278 (Fed. Cir. 2007) (noting that the terms “data reference, ” “record reference, ” “specifying reference, ” and “reference” were interchangeable); St. Clair Intellectual Prop Consultants, Inc. v. Acer, Inc., Nos. 09-354, 09-705, 10-282, 2012 WL 3536454, at *9 (D. Del. Aug. 7, 2012) (finding terms “mode” and “state” could be used interchangeably).

         Here, the express language used in the Definitions section overcomes any presumption that “treat” and “prevent” have mutually exclusive meanings. The definition of “treat” is “any form of treatment that imparts a benefit to a patient afflicted with a disorder, ” such as HAE.[4] This includes prophylactic treatment. Thereafter, “prevent” is defined as “the prophylactic treatment of a subject who is at risk of developing a condition, ” such as HAE or an HAE attack. Contrary to Defendant's argument, “prophylactic treatment” of a person who is at risk of having an HAE attack is a subset of “any type of treatment” for a person with HAE. In other words, the definitions are not mutually exclusive, but rather appear to ...


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