Hill Dermaceuticals, Inc. v. Amneal Pharmaceuticals, LLC et al
Filing
37
ORDER denying 5 Motion for Preliminary Injunction; denying 28 Motion to Compel; finding as moot 24 Motion to allow electronic equipment; and finding as moot 30 Motion for Leave to File. Signed by Judge John Antoon II on 12/13/2011. (EK)
UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
ORLANDO DIVISION
HILL DERMACEUTICALS, INC.,
Plaintiff,
-vs-
Case No. 6:11-cv-1827-Orl-28DAB
AMNEAL PHARMACEUTICALS, LLC,
AND IDENTI PHARMACEUTICALS, LLC
Defendants.
_____________________________________
ORDER
Plaintiff manufactures three brand-name topical drugs that treat certain skin diseases
(“Plaintiff’s drugs”). Defendant Identi Pharmaceuticals, LLC (“Identi”) developed generic
versions of Plaintiff’s drugs, and Defendant Amneal Pharmaceuticals, LLC (“Amneal”)
manufactures and distributes those generic drugs. This cause is before the Court on
Plaintiff’s Motion for Preliminary Injunction (Doc. 5), in which Plaintiff asks this Court to enjoin
Defendants from producing and distributing their generic drugs while this suit is pending.1
Defendants have filed Responses (Docs. 18 & 22), and oral argument was heard on
December 12, 2011. For the reasons set forth below, Plaintiff’s motion shall be denied.
1
Plaintiff also filed a Motion to Compel (Doc. 28), requesting the Court to compel
Defendants to provide exemplars of each of the three generic drugs to Plaintiff for testing to
support Plaintiff’s Motion for Preliminary Injunction. As discussed below, however, even if
Plaintiff demonstrated that Defendants’ drugs are not bioequivalent to Plaintiff’s drugs,
Plaintiff has not shown that it has a likelihood of success on the merits. Additionally, in its
previous Order (Doc. 9), this Court denied Plaintiff’s request for an evidentiary hearing.
Accordingly, Plaintiff’s Motion to Compel (Doc. 28) shall be denied.
In order to obtain a preliminary injunction, a plaintiff must show that “(1) it has a
substantial likelihood of success on the merits; (2) irreparable injury will be suffered unless
the injunction issues; (3) the threatened injury to the movant outweighs whatever damage
the proposed injunction may cause the opposing party; and (4) if issued, the injunction would
not be adverse to the public interest.” Siegel v. LePore, 234 F.3d 1163, 1176 (11th Cir.
2000). The Court need not address all of these factors because Plaintiff has failed to show
a likelihood of success on the merits.
Plaintiff’s drugs contain peanut oil, and Plaintiff developed a test to ensure that the
oil was made up of 0.5 ppm or less of peanut protein so that it would not cause an allergic
reaction in patients with a peanut allergy. In 2004, Plaintiff submitted a citizen petition to the
Food and Drug Administration (“FDA”) requesting that the FDA deny approval of any
Abbreviated New Drug Application (“ANDA”) for a generic version of Plaintiff’s drugs unless
the applicants undertook clinical trials and safety testing.2 The FDA denied Plaintiff’s Citizen
Petition.
Thereafter, Identi submitted ANDAs for its generic versions of Plaintiff’s drugs, and
in 2011 the FDA approved all three of Identi’s generic drugs. In response, Plaintiff filed suit
in the U.S. District Court for the District of Columbia against the FDA and other related
government officials (“the D.C. Action”), seeking “to enjoin the FDA to withdraw or suspend
its approval of the three [ANDAs] submitted by Identi on the basis that the approval
2
Generally, ANDA applicants need not submit new clinical evidence on drug safety
because the proposed generic drug must be bioequivalent to an approved drug, and
therefore, the applicant is able to rely on the FDA’s findings for the brand name drug. See
generally 21 U.S.C. § 355(j).
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contravenes the sameness requirements, the misbranding restrictions, and the
bioequivalence requirements of the Food, Drug, and Cosmetic Act and its implementing
regulations.” Hill Dermaceuticals, Inc. v. U.S. Food & Drug Admin., No. 11-1950 (RCL),
2011 WL 6005195, at *1 (D.D.C. Dec. 2, 2011). On December 11, 2011, the D.C. Court
denied Plaintiff’s motion for preliminary injunction. Id. at 10.
The crux of Plaintiff’s claims in this case is that Defendants’ generic drugs are not
biologically equivalent to Plaintiff’s drugs and therefore “are illegal in the State of Florida”
pursuant to section 465.025, Florida Statutes. (Mot.Prelim. Inj., Doc. 5, at 3). Plaintiff
asserts that under section 465.025 the State of Florida undertakes its own, distinct inquiry
into whether or not a generic drug is the bioequivalent of the brand name drug; therefore,
Plaintiff argues this suit is not duplicative of the D.C. action.
Section 465.025 provides in relevant part that “[a] pharmacist who receives a
prescription for a brand name drug shall, unless requested otherwise by the purchaser,
substitute a less expensive, generically equivalent drug product that is . . . [l]isted in the
formulary of generic and brand name drug products . . . for the brand name drug prescribed”
unless the prescriber provides otherwise. § 465.025(2), Fla Stat. Section 465.025(5) then
requires “[e]ach community pharmacy” to establish its own “formulary of generic and brand
name drug products which, if selected as the drug product of choice, would not pose a threat
to the health and safety of patients receiving prescription medication” based on “drug
product research, testing, information, and formularies compiled by other pharmacies, by
states, by the United States Department of Health, Education, and Welfare, by the United
States Department of Health and Human Services, or by any other source which the
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pharmacist deems reliable.” Furthermore, the drugs on the formulary must be “obtained
from manufacturers or distributors holding an approved new drug application or abbreviated
new drug application issued by the [FDA] permitting that manufacturer or distributor to
market those medicinal drugs or when the former is non-applicable, those manufacturers or
distributors supplying those medicinal drugs must show compliance with other applicable
[FDA] marketing requirements.” Fla. Admin. Code R. 64B16-27.520.
Contrary to Plaintiff’s contention, section 465.025 does not provide for a separate
state determination as to whether a generic drug is bioequivalent to the name brand, nor
does it provide for a private right of action. Rather, section 465.025 contemplates a state
administrative scheme, under which the state uses FDA determinations to further its policy
of providing more affordable drugs to its citizens. See Abbott Labs. v. Mylan Pharms., Inc.,
15 So. 3d 642, 646 (Fla. 1st DCA 2009) (noting that “[u]ntil the mid-1970s, nearly all states
required pharmacists to dispense the exact drug specified by the prescribing physician, even
if equivalent generic products were available” but that “with the advent of strict federal drug
laws, most states more freely allow substitution in order to contain the high cost of drugs”).
As such, it is unlikely that Plaintiff will prevail on the merits of this case.3
In accordance with the foregoing, Plaintiff’s Motion for Preliminary Injunction (Doc. 5)
and Plaintiff’s Motion to Compel (Doc. 28) are DENIED. Plaintiff’s Motion for Use of
3
In its Complaint, Plaintiff also asserts violations of the Uniform Trade Secrets Act,
section 688.001, et. seq., Fla. Stat. and the Sherman Antitrust Act, 15 U.S.C. § 1, but
Plaintiff did not assert that either of these claims constituted a basis for this Court to enter
a preliminary injunction.
-4-
Electronic Equipment at Hearing (Doc. 24) and Plaintiff’s Motion to File Reply Memorandum
(Doc. 30) are moot.
DONE and ORDERED in Chambers, Orlando, Florida this 13th day of December,
2011.
Copies furnished to:
Counsel of Record
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