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Shire ViroPharma Inc. v. CSL Behring LLC

United States District Court, D. Delaware

August 5, 2019

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

          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 infringed four of Plaintiff's patents on drugs used for the treatment and prevention of a condition known as hereditary angioedema. Before me is a partial Motion to Dismiss seeking dismissal of allegations of infringement regarding any of the dependent claims of the four patents at issue. For the following reasons, I will deny the Motion in its entirety.

         I. FACTS ALLEGED IN THE SECOND AMENDED COMPLAINT

         The Second Amended Complaint alleges the following:[1]

         A. Background

         Hereditary angioedema (“HAE”) is a rare genetic disorder causing insufficient natural production of functional or adequate amounts of a protein called C1 esterase inhibitor. This protein is needed to help regulate several complex processes involved in immune system function and fibrinolytic system 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. HAE may be treated by administration of a drug containing a C1 esterase inhibitor in order to restore the levels of C1 esterase inhibitor to levels sufficient to prevent or reduce the frequency or severity of HAE attacks. (Second Am. Compl. (“SAC”) ¶¶ 13-14.)

         Plaintiff, through its corporate affiliates, makes and sells products for the treatment of HAE, including CINRYZE, FIRAZYR, KALBITOR, and TAKHZYRO. CINRYZE has been approved by the United States Food and Drug Administration (“FDA”) for routine prophylactic treatment of angioedema attacks in adolescent and adult patients with HAE, and is indicated for intravenous treatment. Both FIRAZYR and KALBITOR are approved for subcutaneous administration for treatment of acute attacks of HAE. TAKHZYRO is a subcutaneously administered monoclonal antibody indicated for prophylactic treatment of HAE that the FDA approved for commercial marketing on August 23, 2018. (Id. ¶¶ 14-19.)

         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 “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 '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 ...


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