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Shire ViroPharma Inc. v. CSL Behring LLC

United States District Court, D. Delaware

November 18, 2019

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

          MEMORANDUM OPINION

          GOLDBERG, J.

         In this patent infringement case, Plaintiff Shire ViroPharma Incorporated (“Plaintiff”) alleges that Defendants CSL Behring LLC and CSL Behring GMBH (collectively, “Defendants”) have, through the development and marketing of their drug HAEGARDA®, infringed multiple patents owned by Plaintiff. Plaintiff originally alleged infringement of U.S. Patent No. 9, 616, 111 (the “'111 patent”), the claims of which I have already construed. Plaintiff subsequently alleged infringement of four additional patents-U.S. Patent Nos. 10, 080, 788 (the “'788 patent”), 10, 105, 423 (the “'423 patent”), 10, 130690 (the “'690 patent”), and 10, 201, 595 (the “'595” patent)-which share the same specification as the '111 patent and which are collectively known as the “Continuation Patents.” The parties now seek construction of three of the Continuation Patents' disputed terms pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995), aff'd, 517 U.S. 370 (1996). The disputed claim terms are construed as indicated in this Memorandum and accompanying Order.[1]

         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. (Sec. Am. Compl. ¶ 12.)

         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, there are approximately 6, 500 people in the United States who suffer from this condition. (Id.)

         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. (Id. ¶ 13.)

         B. The Patents-in Suit

         1. The '788 patent

         On September 25, 2018, the United States Patent and Trademark Office (“PTO”) issued the '788 patent, entitled “C1-INH Compositions and Methods for the Prevention and Treatment of Disorders Associated With C1 Esterase Inhibitor Deficiency.” The claims of the '788 patent are directed generally to

[A] method for prophylactic treatment of hereditary angioedema (HAE) comprising subcutaneously administering . . . a pharmaceutical composition comprising C1 esterase inhibitor, sodium citrate, and having a pH ranging from 6.5-8.0, wherein the C1 esterase inhibitor has a concentration of about 500 U/mL . . . [The administration of the composition] increases the level of the C1 esterase inhibitor in the blood of the subject to at least about 0.4 U/mL, [and the] ¶ 1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1, [which amino acid sequence is identified in the '788 patent.]

         Plaintiff is the assignee and owner of all rights, title, and interest in the '788 patent. (Id. ¶¶ 20- 22.)

         2. The '423 Patent

         On October 23, 2018, the PTO issued the '423 patent, entitled “C1-INH Compositions and Methods for the Prevention and Treatment of Disorders Associated With C2 Esterase Inhibitor Deficiency.” The claims of the '423 patent are directed generally to

[A] pharmaceutical composition comprising C1 esterase inhibitor, sodium citrate, and having a pH ranging from 6.5-8.0, wherein the C1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1, [which amino acid sequence is identified in the '423 patent.]

         Plaintiff is the assignee and owner of all rights, title, and interest in the '423 patent. (Id. ¶¶ 23-25.)

         3. The '690 Patent

         On November 20, 2018, the PTO issued the '690 patent, entitled “C1-INH Compositions and Methods for the Prevention and Treatment of Disorders Associated With C1 Esterase Inhibitor Deficiency.” The claims of the '690 patent are directed generally to

[A] pharmaceutical composition comprising C1 esterase inhibitor, sodium citrate, and having a pH ranging from 6.5-8.0, wherein the C1 esterase inhibitor has a concentration of about 400-600 U/mL, and wherein the C1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1, [which amino acid sequence is identified in the '690 patent.]

         Plaintiff is the assignee and owner of all rights, title and interest in the '690 patent. (Id. ¶¶ 26-28.)

         4. The '595 Patent

         On February 12, 2019, the PTO issued the '595 patent, entitled “C1-INH Compositions and Methods for the Prevention and Treatment of Disorders Associated With C1 Esterase Inhibitor Deficiency.” The claims of the '595 patent are directed generally to

[A] method for prophylactic treatment of hereditary angioedema (HAE) comprising subcutaneously administering . . . a pharmaceutical composition comprising C1 esterase inhibitor, sodium citrate, and having a pH ranging from 6.5-8.0, wherein the C1 esterase inhibitor has a concentration of about 400-600 U/mL . . . . [The administration of the composition] increases the level of the C1 esterase inhibitor in the blood of the subject to at least about 0.4 U/mL, [and the] ¶ 1 esterase inhibitor comprises the amino acid sequence of residues 23 to 500 of SEQ ID NO: 1, [which amino acid sequence is identified in the '595 patent.]

         Plaintiff is the assignee and owner of all rights, title, and interest in the '595 patent. (Id. ¶¶ 29- 31.)

         C. Defendants' Alleged Infringement

         On or about July 25, 2017, Defendants began U.S. sales of HAEGARDA®, a prophylactic C1 esterase inhibitor treatment for subcutaneous administration, which received FDA approval on June 22, 2017. Plaintiff alleges that Defendants' manufacture, importation, use, sale, and/or offer to sell HAEGARDA in the United States directly infringes, induces others to infringe, and/or contributorily infringes, either directly or under the doctrine of equivalents, one or more claims of the Continuation Patents. (Id. ¶¶ 32-100.)

         D. Procedural History

         On April 11, 2017, Plaintiff filed a patent infringement action against Defendants-under Civil Action No. 17-414. In connection with that action, and by way of Memorandum and Order dated January 18, 2019, I construed two terms: (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.”

         Subsequently, on September 25, 2018, the PTO issued the '788 patent to Plaintiff, which is a continuation of the '111 patent. Plaintiff filed a new complaint in this matter on the same day-under Civil Action No. 18-1476-alleging that Defendants' HAEGARDA product also infringed at least claim 1 of the '788 patent. The PTO then issued two other continuation applications: the '423 patent (October 23, 2018) and the '690 patent (November 20, 2018). Following a status conference, I directed that Plaintiff file an amended complaint in Civil Action No. 18-1476.

         Plaintiff filed its First Amended Complaint on January 7, 2019, alleging infringement of at least claim 1 of the '788 patent, the '423 patent, and the '690 patent. The PTO then indicated that a fourth continuation patent-the ‘595 patent-would issue on February 12, 2019. The parties agreed that Plaintiff would file a second amended complaint to include the '595 patent. As noted above, the Second Amended Complaint sets forth four counts of infringement, one for each of the four Continuation Patents ('788, '423, '690, and '595).

         On January 24, 2019, I administratively closed Civil Action No. 18-1476 and consolidated it with the original action under Civil Action No. 17-414.

         Currently pending are claim construction issues with respect to the Continuation Patents. There are three terms in dispute.[2]

         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[3] 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 ...


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