United States District Court, D. Minnesota
T. Hanson, Esq., Katharyn Ann Grant, Esq., and Saul H.
Perloff, Esq., Norton Rose Fulbright U.S. LLP, counsel for
Edward Szymanski, Esq., Erin H. Chadwick, Esq., and Sarah M.
Stensland, Esq., Patterson Thuente Pederson, PA; and James
Thomas Wilcox, Esq., and Scott Lloyd Smith, Esq., Buchanan
Ingersoll & Rooney PC, counsel for Defendant.
MEMORANDUM OPINION AND ORDER
DONOVAN W. FRANK UNITED STATES DISTRICT JUDGE
matter is before the Court on a Motion to Dismiss brought by
Defendant ANI Pharmaceuticals, Inc. (Doc. No. 14.) For the
reasons set forth below, the Court grants the motion insofar
as Defendant seeks dismissal of Plaintiff's common law
unfair competition claim and denies the motion in all other
Arbor Pharmaceuticals, LLC, researches, develops, and
manufactures prescription drug products. In particular,
Plaintiff markets prescription erythromycin ethylsuccinate
for oral suspension under the brand names EryPed® and
E.E.S.® Granules, both of which are approved by the U.S.
Food and Drug Administration (“FDA”). (Doc. No.
1, Compl. ¶ 2.) EryPed® and E.E.S.® Granules are
prescription-only antibiotics. (Id. ¶ 11.)
According to the Complaint, these products are the only
FDA-approved products of their kind on the market.
(Id. ¶ 14.)
around September 2016, Defendant announced the launch of its
own Erythromycin Ethylsuccinate for Oral Suspension product
(the “Product” or “Defendant's
Product”), claiming it to be a generic version of
EryPed® and E.E.S.®. (Id. ¶¶
17-18.) Plaintiff alleges that Defendant promotes its Product
as FDA-approved and AB-rated pursuant to an approved
Abbreviated New Drug Application (“ANDA”).
(Id. ¶ 27.) Plaintiff further alleges that
these promotions are false and misleading because
Defendant's Product is not FDA-approved, does not have an
AB-rating, and that Defendant does not have a current,
approved ANDA for its Product. (Id. ¶¶ 29,
30.) Instead, Plaintiff alleges, on information and belief,
that Defendant acquired an ANDA from another pharmaceutical
company for a discontinued product that had been manufactured
using a process that differs from that used by Defendant.
(Id. ¶ 30.) Plaintiff further alleges that the
FDA considers this ANDA to be discontinued and that in
December 2016, notified Defendant that its application in
connection with its Product was not approvable. (Id.
acknowledges that it purchased the ANDA and took steps to
market its Product as a generic to EryPed® and
E.E.S.® Granules. Defendant submits that the relevant
ANDA was originally approved in 1978 for Barr
Pharmaceuticals, that Barr stopped marketing the approved
product in 2003, and that the ANDA was discontinued. (Doc.
No. 16 at 3.) Defendant also represents that on August 26,
2016, it filed a supplement to the ANDA with the FDA,
detailing changes it made to the manufacturing process of the
Product. Defendant indicated its intent to market the Product
if the FDA did not advise otherwise within 30 days. Having
not received an objection from the FDA within that period,
Defendant now contends that the FDA is aware that it is
distributing its Product and has not asked Defendant to stop.
(Doc. No. 16 at 5.)
action, Plaintiff asserts the following claims: False
Advertising in Violation of the Lanham Act (Count I); Unfair
Competition in Violation of the Lanham Act (Count II); Common
Law Unfair Competition (Count III); Violation of the
Minnesota Unfair Trade Practices Act (Count IV); Violation of
the Minnesota Uniform Deceptive Trade Practices Act (Count
V); and Violation of the Minnesota False Advertising Act
(Count VI). (Compl.) At the heart of all of Plaintiff's
claims is the assertion that Defendant is falsely advertising
its Product as an FDA-approved, AB-rated, generic substitute
for EryPed® and E.E.S.® Granules. Defendant moves to
dismiss all of Plaintiff's claims with prejudice.
deciding a motion to dismiss under Rule 12(b)(6), a court
assumes all facts in the complaint to be true and construes
all reasonable inferences from those facts in the light most
favorable to the complainant. Morton v. Becker, 793
F.2d 185, 187 (8th Cir. 1986). In doing so, however, a court
need not accept as true wholly conclusory allegations,
Hanten v. Sch. Dist. of Riverview Gardens, 183 F.3d
799, 805 (8th Cir. 1999), or legal conclusions drawn by the
pleader from the facts alleged, Westcott v. City of
Omaha, 901 F.2d 1486, 1488 (8th Cir. 1990). A court
deciding a motion to dismiss may consider the complaint,
matters of public record, orders, materials embraced by the
complaint, and exhibits attached to the complaint. See
Porous Media Corp. v. Pall Corp., 186 F.3d 1077, 1079
(8th Cir. 1999).
survive a motion to dismiss, a complaint must contain
“enough facts to state a claim to relief that is
plausible on its face.” Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 570 (2007). Although a complaint
need not contain “detailed factual allegations, ”
it must contain facts with enough specificity “to raise
a right to relief above the speculative level.”
Id. at 555. As the Supreme Court reiterated,
“[t]hreadbare recitals of the elements of a cause of
action, supported by mere conclusory statements, ” will
not pass muster under Twombly. Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009) (citing
Twombly, 550 U.S. at ...