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Shire ViroPharma Inc. v. CSL Behring LLC

United States District Court, D. Delaware

January 8, 2018



          Goldberg, J.

         In the pending case, Plaintiff Shire ViroPharma Incorporated (“Plaintiff”) alleges that Defendants CSL Behring LLC and CSL Behring GMBH (collectively, “Defendants”) have infringed Plaintiff's U.S. Patent No. 9, 616, 111 through the development and marketing of Defendants' drug Haegarda®. Defendants move to dismiss Plaintiff's claim of willful infringement. For the following reasons, I will deny the Motion.


         The Second Amended Complaint alleges the following:[1]

         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”) ¶¶ 10-11.)

         Plaintiff, through its corporate affiliates, makes and sells products for the treatment of HAE, including CINRYZE, FIRAZYR, and KALBITOR products. Plaintiff also has other products in development, including those known as SHP616 and SHP643. 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. (Id. ¶¶ 12-16.)

         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 claims of the ‘111 patent are directed generally to methods “for treating hereditary angioedema (HAE) . . . comprising subcutaneously administering . . . 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. . . .” Plaintiff is the owner of all rights, title, and interest in the ‘111 patent. (Id. ¶¶ 17-18.)

         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. On July 25, 2017, Defendants issued a press release announcing the availability of HAEGARDA in the United States. (Id. ¶¶ 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. ¶ 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, setting forth allegations of direct infringement, inducement of infringement, contributory infringement, and willful infringement. On September 7, 2017, Defendants filed the instant Motion to Dismiss Plaintiff's willful infringement claim. Plaintiff responded on September 21, 2017, and Defendant submitted a reply brief on October 5, 2017.


         Under Federal Rule of Civil Procedure 12(b)(6), a defendant bears the burden of demonstrating that the plaintiff has not stated a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6); see also Hedges v. United States, 404 F.3d 744, 750 (3d Cir. 2005). The United States Supreme Court has recognized that “a plaintiff's obligation to provide the ‘grounds' of his ‘entitle[ment] to relief' requires more than labels and conclusions.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quotations omitted). “[T]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice” and “only a complaint that states a plausible claim for relief survives a motion to dismiss.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. A complaint does not show an entitlement to relief when the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct. Id.

         The United States Court of Appeals for the Third Circuit has detailed a three-step process to determine whether a complaint meets the pleadings standard. Bistrian v. Levi, 696 F.3d 352 (3d Cir. 2014). First, the court outlines the elements a plaintiff must plead to state a claim for relief. Id. at 365. Next, the court must “peel away those allegations that are no more than conclusions and thus not entitled to the assumption of truth.” Id. Finally, the court “look[s] for well-pled factual allegations, assume[s] their veracity, and then ‘determine[s] whether they plausibly give rise to an entitlement to relief.'” Id. (quoting Iqbal, 556 U.S. at 679). The last step is “a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.” Id. (quoting Iqbal, 556 U.S. at 679).

         Although claims of direct infringement were previously governed by Federal Rule of Civil Procedure 84 and the Appendix of Forms, those rules were abrogated effective December 1, 2015. Raindance Techs., Inc. v. 10x Genomics, Inc., No. 15-150, 2016 WL 927143, at *2 (D. Del. Mar. 4, 2016). It is now well established that both direct and indirect infringement claims are subject to the Twombly/Iqbal standard. IP Commc'n Solutions, LLC v. Viber Media (USA) Inc., No. 16-134, 2017 WL 1312942, at *2 (D. Del. Apr. 5, 2017); RAH Color Techs LLC v. Ricoh USA Inc., 194 F.Supp.3d 346, 350-51 (E.D. Pa. 2016).

         III. ...

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