United States District Court, D. Delaware
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.
FACTS ALLEGED IN THE SECOND AMENDED COMPLAINT
Second Amended Complaint alleges the following:
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.)
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.)
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. ¶¶
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.)
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.
STANDARD OF REVIEW
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.
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.
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).