NOSTRUM PHARMACEUTICALS, LLC. v. UNITED STATES FOOD AND DRUG ADMINISTRATION
Filing
32
OPINION filed. Signed by Judge Joel A. Pisano on 7/5/2011. (eaj)
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
____________________________________
:
NOSTRUM PHARMACEUTICALS, LLC, :
:
Plaintiff,
:
:
v.
:
:
UNITED STATES FOOD AND DRUG
:
ADMINISTRATION,
:
:
:
Defendants.
:
____________________________________:
Civil Action No. 11-3111 (JAP)
OPINION
PISANO, District Judge.
Plaintiff Nostrum Pharmaceuticals, LLC (“Nostrum” or “Plaintiff”) brings this
action challenging certain decisions of the United States Food and Drug Administration
(“FDA” or “Defendant”) relating to Nostrum’s Abbreviated New Drug Application
(“ANDA”) for carbamazepine 300 mg extended-release capsules. Nostrum alleges that the
FDA incorrectly determined that Nostrum’s statutory exclusivity period for marketing its
generic carbamazepine product has expired as to U.S. Patent No. 5,912,013 (“the ‘013
patent”) and may be shortened as to U.S. Patent 5,326,570 (“the ‘570 patent”) by reason of
pending expiration of that patent. Apotex Inc. (“Apotex”), a subsequent ANDA filer for
carbamazepine extended-release capsules, has intervened in the matter as a defendant.
Presently before the Court is a motion by Nostrum for a preliminary injunction enjoining
the FDA from approving any competing carbamazepine ANDAs until after November 16,
2011, on which date Nostrum will have had the full statutory 180 days of marketing
exclusivity. Alternatively, Nostrum seeks an order enjoining the FDA from approving
competing ANDAs without advance notice to both Nostrum and the Court sufficient to
permit Nostrum to move the court for relief to protect its exclusivity. The FDA and
Apotex have filed opposition the motion. The Court heard oral argument on the motion
June 27, 2011, and Plaintiff has requested the Court issue an expedited decision in light of
the time-sensitive nature of the issues in order to allow it to take a prompt appeal. For the
reasons below, Nostrum’s motion is denied.
I.
Background
A. Generic Drug Approval Process
Under the Federal Food, Drug, and Cosmetic Act (“FDCA”), the FDA is authorized
to regulate the manufacture, distribution, and sale of drugs in the United States. In
accordance with the FDCA, pharmaceutical companies seeking to market new drugs (often
referred to as “pioneer” or “branded” drugs) must first obtain FDA approval by filing a
new drug application (“NDA”) containing extensive scientific data demonstrating the
safety and effectiveness of the drug. U.S.C. §§ 355(a), (b). An NDA applicant must also
submit information on any patent that claims the drug, or a method of using the drug, and
for which a claim of patent infringement could reasonably be asserted against an
unauthorized party. 21 U.S.C. §§ 355(b)(1), (c)(2). The FDA publishes this patent
information in the “Approved Drug Products with Therapeutic Equivalence Evaluations”
list, commonly known as the “Orange Book.” Id.; see also 21 C.F.R. § 314.53(e).
The approval of generic drugs is governed by the FDCA as modified by the Drug
Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman
Amendments”), codified at 21 U.S.C. § 355 and 35 U.S.C. §§ 156, 271, and 282. These
2
amendments were designed to balance the interests of encouraging innovation in the
development of new drugs and accelerating the availability of lower-cost generic
alternatives to branded drugs.
Under the Hatch-Waxman Amendments, a manufacturer submits an abbreviated
new drug application (“ANDA”) requesting approval of a generic version of an approved
drug product. 21 U.S.C. § 355(j). The ANDA must include, among other things, data
showing that the generic drug product is the bioequivalent to the branded drug product. 21
U.S.C. § § 355(j)(2)(A)(iv); (j)(4)(F). With respect to Orange Book listed patents for the
branded drug, an ANDA must contain one of four certifications:
(I)
that such patent information has not been filed,
(II)
that such patent has expired,
(III) …the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by the
manufacture, use, or sale of the new drug for which the application is
submitted.
21 U.S.C. § 355(j)(2)(A)(vii). This certification is typically referred to as a “paragraph I,”
“paragraph II,” “paragraph III,” or “paragraph IV” certification.
An applicant wishing to challenge the validity of a patent or to claim that the patent
would not be infringed by the product covered by the ANDA submits a paragraph IV
certification. The filing of a paragraph IV is an act of infringement, 35 U.S.C. §
271(e)(2)(A), and if a suit is brought within 45 days of receipt of notice of the certification
by the patent owner or NDA applicant, the FDA must stay approval of the ANDA for up to
30 months. 21 U.S.C. § 355(J)(5)(B)(iii). If no action is brought within the requisite
period, the FDA may approve the ANDA immediately. 21 U.S.C. § 355(J)(5)(B)(iii).
3
To encourage generic drug companies to bear the costs and potential risks
associated with submitting a paragraph IV certification, the Hatch-Waxman Amendments
provide a “180-day exclusivity period” to the applicant who is the first to file an ANDA
containing a paragraph IV certification. 21 U.S.C. § 355(j)(5)(B)(iv). During this period,
the applicant who is the first to file may market its product while FDA approval of all other
ANDAs covering the same product are delayed. Under the statutory provisions relevant to
this action, 1 the 180 period begins to run the earlier of (1) the first commercial marketing
of the generic drug by the first ANDA filer; or (2) “the date of a decision of a court …
holding the patent which is the subject of the certification to be invalid or not infringed.”
21 U.S.C. § 355(j)(5)(B)(iv) (2002).
B. Nostrum’s ANDA
The relevant facts in this matter are undisputed. Shire Development Inc. (“Shire”)
is the reference listed drug manufacturer for carbamazepine extended-release capsules,
marketed under the brand name Carbatrol. Two patents are listed in the Orange Book for
Carbatrol: the ‘013 patent and the ‘570 patent.
On March 26, 2003, Nostrum was the first to file an ANDA for the 300 mg strength
of carbamazepine containing paragraph IV certifications as to the ‘013 and ‘570 patents.
On September 18, 2003, Shire commenced patent infringement litigation against Nostrum.
Shire Labs. v. Nostrum Pharms. Inc., Civil Action No. 03-4436-MLC (D.N.J.). In 2006,
the matter was stayed and, thereafter, the stay was extended a number of times. On March
1
Congress amended 21 U.S.C. § 355(j) in 2003. See The Access to Affordable
Pharmaceuticals provisions of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (Dec. 8, 2003) (the
“MMA”). Because Nostrum’s application was submitted before the December 8, 2003
enactment date of the amendments, pre-MMA exclusivity provisions apply in this case.
4
22, 2010, the parties ultimately settled. This settlement included a license giving Nostrum
the right to sell carbamazepine extended release capsules on or after October 1, 2010.
According to Nostrum, it was prepared to market its generic product as of that date;
however, its release was subject to FDA approval, which had not yet been granted.
Nostrum’s ANDA received final FDA approval on May 20, 2011. In its approval
letter, the FDA recognized that Nostrum was the first to file an ANDA for carbamazepine
containing a paragraph IV certification as to the ‘013 and ‘570 patents and, therefore, was
eligible for the 180-day exclusivity period. Mulye Decl. Ex. A at 2. However, the FDA
determined that such exclusivity would be based only upon the ‘570 patent because, as the
FDA advised Nostrum, it concluded that the exclusivity period for the ‘013 patent had
been triggered by a 2009 judgment in the matter Shire Labs, Inc. v. CorePharma, LLC,
Civil Action 06-2266 (D.N.J.). Id. Shire was a patent infringement action in which the
court had granted a motion for summary judgment and entered final judgment in favor of
defendant CorePharma LLC on July 14, 2009. Thus, according to the FDA, upon approval
of Nostrum’s ANDA, the exclusivity period for the ‘013 patent had long since expired.
Nostrum began marketing its product immediately upon approval and, as such,
there is no dispute that the start of the exclusivity period as to the ‘570 was triggered on
that date. The ‘570 patent expires on July 23, 2011. 2 See Notice at D.I. 30. It is the
FDA’s position that, for reasons described more fully below, upon expiration of the ‘570
patent any later-filed carbamazepine ANDA that is otherwise eligible for approval may be
approved after that date.
2
The parties originally believed and had advised the Court that the patent expired on July
5, 2011. A recent filing with the FDA by the patent holder provided the corrected date.
5
II.
Analysis
Nostrum’s challenge to the FDA’s action is two-fold. First, Nostrum argues that
the FDA’s determination that the ‘013 patent exclusivity period was triggered by the 2009
CorePharma decision reflects an incorrect application of the relevant standard. Second,
Nostrum argues that the FDA’s determination that it may approve competing ANDAs
upon expiration of the ‘570 patent and thereby cut short Nostrum’s exclusivity period is
contrary to the governing law. In its complaint, Nostrum seeks declaratory and injunctive
relief. By way of this motion, Nostrum seeks a preliminary injunction barring the FDA
from approving competing ANDAs for 300 mg carbamazepine until at least November 16,
2011. In the alternative, Nostrum seeks an order enjoining the FDA from approving
subsequently filed ANDAs without first providing notice to Nostrum and the Court
sufficient to permit Nostrum to move this Court for relief “to protect Nostrum’s exclusivity
period.” Pl. Br. at 36.
When evaluating a motion for preliminary injunctive relief, a district court must
consider: “(1) whether the movant has shown a reasonable probability of success on the
merits; (2) whether the movant will be irreparably injured by denial of the relief; (3)
whether granting preliminary relief will result in even greater harm to the nonmoving
party; and (4) whether granting the preliminary relief will be in the public interest.”
McTernan v. City of York, 577 F.3d 521, 526 (3rd Cir. 2009). A preliminary injunction
“should not be granted unless the movant, by a clear showing, carries the burden of
persuasion.” Masurekv. Armstrong, 520 U.S. 968, 972, 117 S.Ct. 1865, 138 L.Ed.2d 162
(1997). Preliminary injunctive relief is an “extraordinary and drastic remedy”, id., which
“should issue only if the plaintiff produces evidence sufficient to convince the district court
6
that all four factors favor preliminary relief.” American Tel. and Tel. Co. v. Winback and
Conserve Program, Inc., 42 F.3d 1421, 1427 (3d Cir. 1994). “The burden lies with the
plaintiff to establish every element in its favor, or the grant of a preliminary injunction is
inappropriate.” P.C. Yonkers, Inc. v. Celebrations the Party and Seasonal Superstore,
LLC, 428 F.3d 504, 508 (3d Cir. 2005). Because, as set forth below, the court finds that
Nostrum has failed to establish its likelihood of success on the merits, the court addresses
only that element in its analysis. 3
A. Standard of Review Under the APA
This Court reviews the FDA’s administrative decisions under the Administrative
Procedure Act (“APA”). The Court must uphold such decisions unless they are “arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. §
706(2)(A). This is a very narrow and highly deferential standard under which an agency’s
action is presumed valid. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 415,
91 S.Ct. 814, 28 L.Ed.2d 136 (1971); Clean Ocean Action v. York, 861 F.Supp. 1203, 1219
(D.N.J. 1994). A reviewing “court is not empowered to substitute its judgment for the
agency’s.” Citizens to Preserve Overton Park, 401 U.S. at 416, 91 S.Ct. 814. Instead, the
court’s inquiry is limited to determining whether the agency “considered the relevant
factors and articulated a rational connection between the facts found and the choice made,”
Baltimore Gas & Elec. Co. v. Natural Res. Def. Council, Inc., 462 U.S. 87, 105, 103 S.Ct.
3
However, were the Court to reach the irreparable harm prong of the analysis, it appears
that Plaintiff would be unable to establish that element as well. As the FDA notes,
Nostrum’s claim of harm is based on a loss of exclusivity and can only occur if and when
the FDA approves a subsequent carbamazepine ANDA. The FDA has advised that, at
least as of the date of oral argument, there are no pending carbamazepine ANDAs that
have been even tentatively approved. Thus, it is speculative whether Nostrum would face
competition between July and November 2011.
7
2246, 76 L.Ed.2d 437 (1983), and “whether there has been a clear error of judgment.”
Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mutual Auto. Ins. Co., 463 U.S. 29,
43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983). An agency’s conclusions will be upheld “if
they are supported by such relevant evidence as a reasonable mind might accept as
adequate to support a conclusion.” Passaic Valley Sewerage Comm'ns v. U.S. Dept. of
Labor, 992 F.2d 474, 480 (3d Cir.1993); see also Friends of the Earth v. Hintz, 800 F.2d
822, 831 (9th Cir.1986) (“The court may not set aside agency action as arbitrary or
capricious unless there is no rational basis for the action.”).
Where the review involves an agency’s interpretation of a statute, a court applies
the deferential two-part framework of Chevron U.S.A. Inc. v. Natural Res. Def. Council,
Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). Under Chevron, a court must
first determine “whether Congress has directly spoken to the precise question at issue.”
Chevron, 467 U.S. at 842, 104 S.Ct. 2778. If the intent of Congress is clear, the
unambiguously expressed intent of Congress must be given effect. Id. at 843, 104 S.Ct.
2778. However, “[i]f the statute is silent or ambiguous with respect to the specific issue,
the question for the court is whether the agency’s answer is based on a permissible
construction of the statute.” Id.
B. ‘013 Patent – Court Decision Trigger
As noted above, the pre-MMA version of the FDCA that governs this case
contains two potential “triggers” for the commencement of the 180-day exclusivity period:
the first commercial marketing of the product, or an applicable court decision. The socalled “court decision trigger” provides that exclusivity begins to run on “the date of a
decision of a court in an action described in clause (iii) [i.e., a patent infringement case
8
triggered by the notice of a paragraph IV certification] holding the patent which is the
subject of the certification to be invalid or not infringed.” 21 U.S.C. § 355(j)(5)(B)(iv)(II)
(2002). Following the decision in Teva Pharmaceuticals USA, Inc. v. FDA, 441 F.3d 1
(D.C. Cir. 2006), the FDA has interpreted the court decision trigger to require “a decision
of a court that on its face evidences a holding on the merits that a patent is invalid, not
infringed, or unenforceable” (referred to herein as the “holding-on-the-merits” standard).
See Letter from G. Buehler to Apotex Corp. (April 11, 2006), FDA Ex. B. Purportedly
applying this standard, the FDA determined that the 2009 final judgment in Shire Labs,
Inc. v. CorePharma, LLC, triggered exclusivity as to the ‘013 patent. See 2008 WL
4822186, Civil Action 06-2266 (D.N.J. November 3, 2008). Consequently, by the time
Nostrum’s ANDA received final approval, the FDA determined its 180-day exclusivity on
the ‘013 patent had expired. Nostrum challenges the FDA’s determination, arguing that
the CorePharma decision was not a court decision under 21 U.S.C. § 355(j)(5)(B)(iv)(II)
(2002) for purposes of triggering 180-day exclusivity with respect to the ‘013 patent.
The CorePharma case was a Hatch-Waxman infringement suit involving the ‘570
and ‘013 patents. The original complaint in the action included claims for infringement of
both the ‘570 and ‘013 patents, but an amended complaint filed one day after service of the
original complaint omitted the claims as to the ‘013 patent. In answering the amended
complaint, CorePharma included a counterclaim for declaratory judgment of
noninfringement of the ‘013 patent.
CorePharma moved for judgment on the pleadings of noninfringement of the ‘013
patent, and Shire cross-moved to dismiss the counterclaim, arguing that there was no
justiciable case or controversy over the ’013 patent and that the court thus lacked subject
9
matter jurisdiction. The court in the Corepharma decision described the basis of Shire’s
jurisdictional argument:
In its reply brief, Shire stated:
Shire further assured Corepharma [] that infringement of the
’013 patent was no longer at issue – Shire repeated its
statements of noninfringement in its Reply, Brief in support
of this Motion, Plaintiff’s Brief in Opposition to Defendant’s
Motion for Judgment on the Pleadings, and in
communications between counsel. These facts must not be
ignored.
***
In addition to Shire’s representations of noninfringement
made before this Court, Shire has provided Corepharma with
an unconditional covenant not to sue. Such a covenant is, on
its own, sufficient to moot a patent-based declaratory
judgment action.
Shire stated that it provided Corepharma with the following covenant:
[Shire] unconditionally represents, stipulates, agrees and
covenants that it will not sue Corepharma [] for
infringement, or otherwise assert, enforce, or hold
Corepharma liable for infringement of Shire’s U.S. Patent
No. 5,912,013 based on the importation, use, sale, or offer
for sale of the extended-release carbamazepine capsules that
are the subject of and described in Corepharma’s ANDA 78159 as disclosed to Shire as of September 1, 2006. This
disclosure is limited to the materials sent by Corepharma to
Shire under a cover letter dated April 25, 2006, as well as
Corepharma’s Notice of Patent Certification with
attachment, dated March 30, 2006.
Shire Labs, Inc., 2008 WL 4822186 at *1-2. The CorePharma court granted Shire’s
motion and dismissed the counterclaim for lack of subject matter jurisdiction. Id. at *2.
Subsequently, the Federal Circuit issued its decision in Caraco Pharm. Labs., Ltd.
v. Forest Labs., Ltd., 527 F.3d 1278 (Fed. Cir. 2008), in which the court found that a
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unilateral covenant not to sue provided to an ANDA applicant from a patent holder did not
render moot a declaratory judgment action over a patent. In light of Caraco, the
CorePharma court vacated its order dismissing the counterclaim. CorePharma then filed a
motion for summary judgment of noninfringement of the ‘013 patent.
In support of its summary judgment motion, CorePharma argued that “Shire has no
evidence of infringement and cannot prove it.” Shire Labs, Inc., 2008 WL 4822186 at *4.
CorePharma relied primarily on the argument that judicial estoppel precluded Shire from
defeating the motion. Id. As the court noted, Shire took several inconsistent positions
with respect to the motion:
1) the previous position that Corepharma’s ANDA products do not infringe
the ’013 patent is inconsistent with the present position that Corepharma’s
ANDA products do infringe the ’013 patent; 2) the previous statement to
the Court that Shire has unconditionally promised not to assert that
Corepharma’s ANDA products infringe the ’013 patent is inconsistent with
the present arguments that Corepharma’s ANDA products infringe the ’013
patent; and 3) the previous statement to the Court that Shire’s unconditional
promise encompassed the product samples Corepharma gave Shire in April
of 2006 is inconsistent with Shire’s present use of evidence derived from
those samples.
Id. Ultimately, the court found that judicial estoppel precluded Shire from contesting
infringement of the ‘013 patent. Id. at *10. The court held as follows:
Because Shire has been judicially estopped from contesting infringement of
the ’013 patent, Corepharma’s motion for summary judgment is unopposed.
This Court finds that Shire has no evidence and cannot prove that
Corepharma has infringed the ’013 patent. Corepharma is entitled to
judgment of noninfringement of the ’013 patent as a matter of law. The
motion for summary judgment will be granted.
Id. (emphasis added). Final judgment based upon this decision was entered on July 14,
2009, and the FDA determined that exclusivity was triggered as of that date.
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Nostrum does not challenge the FDA’s interpretation of the court decision trigger;
that is, it does not challenge the correctness of the “holding-on-the-merits” standard
applied by the FDA. Indeed, courts addressing the issue have upheld the FDA’s “holdingon-the-merits” standard. See, e.g., Apotex, Inc. v. FDA, 449 F.3d 1249 (D.C. Cir. 2006).
Rather, Nostrum contends that FDA applied that standard incorrectly here. As noted
above, this standard requires “a decision of a court that on its face evidences a holding on
the merits that a patent is invalid, not infringed, or unenforceable.” Nostrum argues that
because the CorePharma court judicially estopped Shire from arguing that CorePharma’s
product infringed the ‘013 patent after Shire had previously conceded non-infringement,
the court’s grant of summary judgment in favor of CorePharma was more akin to a
dismissal for lack of jurisdiction than a decision on the merits of infringement. According
to Nostrum, a holding on the merits of infringement requires a court to compare the
accused product to the asserted claims and conclude, based upon the comparison, that the
ANDA product does not infringe.
The Court is unconvinced by Nostrum’s argument. As an initial matter, the FDA
has never interpreted the court decision trigger provision to require a court to compare the
claims of the asserted patents to the accused generic product. Rather, the FDA has
interpreted the statute’s express requirement of a court decision “holding the patent which
is the subject of the certification to be invalid or not infringed” as resolution of the issues
of validity, infringement and enforceability “on the merits.” Letter from G. Buehler to
Apotex Corp. (April 11, 2006), FDA Ex. B at 7. Nothing suggests that the only way a
court can reach a decision “on the merits” of an infringement claims is in the manner
suggested by Nostrum. Indeed, in the context of a motion for summary judgment a court is
12
called upon to examine evidence, weigh substantive arguments and perform legal analysis.
The court must determine whether there exists a genuine dispute of material fact and
whether the undisputed facts entitle a party to judgment as a matter of law. Addressing
such a motion, the CorePharma court concluded that there were no facts from which
infringement could be found and entered judgment of noninfringement of the ‘013 patent
as a matter of law. The FDA need not look any further than that.
Nostrum’s approach would have required the agency to look beyond the face of the
decision itself and is contrary to the FDA’s interpretation of the court decision trigger
provision, which sought to have exclusivity triggering determinations “governed by a legal
regime that is clear and easily administered.” Id. at 14. The holding-on-the-merits
standard “provide[s] a bright line that is more easily administrable by FDA and …
enable[s] industry to make appropriate business planning decisions. Id. at 2. A goal of
the FDA’s holding-on-the-merits approach is to “enable the agency to rely on the face of
the court’s decision to determine whether there has been a holding that a patent is invalid,
not infringed, or unenforceable.” Id. at 9. This is what the FDA did here. The
CorePharma court granted CorePharma’s motion for summary judgment, ruling that Shire
“has no evidence and cannot prove that Corepharma has infringed the ‘013 patent.” 2008
WL 4822186 at *10. It further ruled that CorePharma was therefore “entitled to judgment
of noninfringement of the ‘013 patent as a matter of law.” Id. Relying on the face of the
decision, the FDA concluded that the decision constituted a holding on the merits that the
‘013 patent was not infringed.
The Court finds the CorePharma decision at issue in this case to be similar to the
grant of partial summary judgment recognized as the triggering decision by the FDA in
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Granutec, Inc. v. Shalala, 139 F.3d 889, 1998 WL 153410 (4th Cir. Apr. 3, 1998). See
Letter from G. Buehler to Apotex Corp. (April 11, 2006) at 12, FDA Ex. B (“The
underlying decision in Granutec was a memorandum decision granting a motion for partial
summary judgment of noninfringement based on the patentee’s concession that the
defendant’s product did not infringe.”); Memorandum Decision, Glaxo, Inc. v. Boehringer
Ingelheim Corp., No. 95-01342 (D. Conn Oct 7, 1996), Wettre Decl. Ex. B. As noted by
the court in Apotex, Inc. v. FDA, 2006 WL 1030151 (D.D.C. April 19, 2006):
The Granutec court granted partial summary judgment, through a
memorandum opinion, in one party’s favor on the basis of representations
that had estoppel effect. By its very nature, summary judgment requires the
weighing of substantive arguments and necessitates legal analysis -- the
court is required to determine that there is no genuine dispute of material
fact, and the moving party is entitled to prevail as a matter of law. …In
Granutec, the court was called upon to make a factual and legal finding
with respect to the substantive arguments presented on the issue of patent
invalidity, infringement, or unenforceability. … [T]he parties in Granutec
could never have obtained the outcome in that case -- partial summary
judgment -- without a court decision addressing the merits.
Id. at 15 (emphasis added). Likewise, the CorePharma court here entered summary
judgment in favor of CorePharma, and ruled on the merits that the ‘013 patent was not
infringed.
Finally, the Court is not persuaded by Nostrum’s argument that, if the CorePharma
decision triggered the running of Nostrum’s exclusivity, the exclusivity has expired only as
to CorePharma and not any other later ANDA applicants. Although Nostrum argues that
there are “[s]everal strong policy reasons” that support such an outcome, Nostrum cites no
authority for its novel interpretation of the statute. The relevant statutory provision
prevents the FDA from approving “the application” of a subsequent ANDA filer until 180
days after “the date of a decision of a court in an action … holding the patent … to be …
14
not infringed.” 21 U.S.C. § 355(j)(5)(B)(iv) (2002) (emphasis added). Nowhere does the
provision suggest that it is applicable only to the ANDA applicant that was successful in
obtaining the triggering decision. Nostrum’s interpretation would, in essence, rewrite the
statute.
In light of the above, the Court concludes the FDA’s determination was an
appropriate application of its holding-on-the-merits standard and, therefore, Nostrum has
failed to establish that it has a likelihood of success on the merits of its claim. As such, the
Court finds preliminary injunctive relief is not appropriate and denies Plaintiff’s motion as
to the ‘013 patent.
C. Expiration of the ‘570 Patent
As noted earlier, the ‘570 patent expires on July 23, 2011. According to Nostrum,
it has been the FDA’s policy under the pre-MMA exclusivity provisions applicable to this
action that “when a patent that forms the basis … marketing exclusivity expires, so too
does a first-filer’s 180-day marketing exclusivity with respect to that patent.” Pl. Brf. at
23. More specifically, it is the FDA’s position that on July 24, 2011 (the day after
expiration of the ‘570 patent), any applicant with a pending carbamazepine ANDA that
contains a paragraph IV certification on the ‘570 patent will amend its certification to a
paragraph II to accurately reflect the status of the ‘570 patent. See 21 C.F.R. §
314.94(a)(12)(viii)(C) (“[A]n applicant shall amend a submitted certification if, at any time
before the effective date of the approval of the application, the applicant learns that the
submitted certification is no longer accurate.”) As such, the FDA asserts that there will no
longer be any basis to delay approval of otherwise approvable later-filed ANDAs, because
15
the statute only permits FDA to delay approval for those applications containing a
paragraph IV certification.
Nostrum contends such an interpretation of the relevant law is flawed because it
divests a first-filer of its full 180 days of marketing exclusivity. In support of its argument,
Nostrum relies upon the plain language of the exclusivity provision of the Hatch-Waxman
Amendments, which Nostrum argues does not limit exclusivity to patent terms. The
statute states in the relevant part as follows:
If the application contains a certification described in subclause (IV) of
paragraph (2)(A)(vii) [i.e., a paragraph IV certification] and is for a drug for
which a previous application has been submitted under this subsection
[containing] 4 such a certification, the application shall be made effective not
earlier than one hundred and eighty days after—
(I) the date the Secretary receives notice from the applicant under the
previous application of the first commercial marketing of the drug under the
previous application, or
(II) the date of a decision of a court in an action described in clause (iii)
holding the patent which is the subject of the certification to be invalid or
not infringed,
whichever is earlier.
21 U.S.C. § 355(j)(5)(B)(iv) (2002) (footnote added).
In making its “plain language” argument that exclusivity is not limited to the term
of the patent, Nostrum relies on the provision in the statute that that reads “the application
shall be made effective not earlier than one hundred and eighty days after ….” According
to Nostrum, this provision entitles it to a full 180 days of marketing exclusivity, regardless
4
The statute actually reads “continuing,” but this appears to be a typographical error.
Courts have noted that it probably should read “containing.” See Purepac Pharm. Co. v.
Friedman, 162 F.3d 1201, 1203 n.3 (D.C. Cir. 1998); Mova Pharmaceutical Corp., 140
F.3d at 1064 n. 3.
16
of whether a subsequently-filed ANDA changes to a paragraph II certification. However,
as the FDA points out, Nostrum’s argument ignores opening phrase of the relevant
provision -- “[i]f the application contains [a paragraph IV certification].” Once a patent
has expired, an ANDA must be amended so that the paragraph IV certification to that
patent becomes a paragraph II certification. 21 C.F.R. § 314.94(a)(12)(viii)(C); see also
Dr. Reddy’s Laboratories, Inc. v. Thompson, 302 F. Supp. 2d 340, 354 (D.N.J. 2003)
(rejecting challenge to FDA’s regulatory requirement that ANDA applicants change
paragraph IV certifications to paragraph II certifications upon expiration of the relevant
patent); Mylan Labs., Inc. v. Thompson, 332 F. Supp. 2d 106, 122 (D.D.C. 2004) (upon
expiration of the relevant patent, an ANDA applicant must change paragraph IV
certification to paragraph II certification or the FDA could treat paragraph IV certification
as a paragraph II certification); Ranbaxy Labs. Ltd. v. FDA, 307 F. Supp. 2d 15 (D.D.C.
2004) (“[A]t that “magic moment,” midnight on [the patent expiration date], the Paragraph
IV certifications became invalid, and either converted as a matter of law to Paragraph II
certifications or became inaccurate, thereby creating both an obligation on [the ANDA
applicant’s] part to amend its ANDAs to reflect patent expiry and an inability on the part
of the FDA to approve the ANDAs in their inaccurate form.). Indeed, an application that
contains an untrue statement of material fact cannot be approved. 21 U.S.C. 355(j)(4)(K).
Thus, upon expiration of the ‘570 patent, later-filed carbamazepine ANDAs will no
longer “contain[]” paragraph IV certifications. By its plain terms, once this occurs, §
355(j)(5)(B)(iv) becomes inapplicable. There will no longer be any basis for the FDA to
delay approving any of the later-filed ANDAs that otherwise would be eligible for
approval. See Mylan Labs., Inc. v. Leavitt, 484 F. Supp. 2d 109, 122-23 (D.D.C. 2007)
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(rejecting the argument that “nothing in the text or legislative history of the Hatch–
Waxman Act indicates that generic exclusivity is forfeited upon patent expiration” in light
of the statutory scheme that provides that once “a patent has expired, those applications
with paragraph II certifications (including those converted from paragraph IV
certifications) are eligible for immediate drug approval”).
Prior courts addressing issues similar to the one raised here have ruled that the 180day exclusivity period expires along with the underlying patent. See generally S.
Upadhye, Generic Pharmaceutical Patent and FDA Law § 13:6. This Court agrees. The
statutory provision entitling Nostrum to exclusivity, by its terms, applies only to paragraph
IV certifications, “which cease to exist upon patent expiration.” Mylan, 484 F. Supp. 2d at
123. Applying step one of Chevron, the Court finds the FDCA unambiguously supports
the FDA’s determination that it is not prohibited by 21 U.S.C. § 355(j)(5)(B)(iv) (2002)
from approving later-filed ANDAs upon expiration of the ‘570 patent. As such, Nostrum
has failed to establish the likelihood of success on the merits of its claims as to the ‘570
patent.
D. Alternative Relief
As stated earlier, as an alternative for an injunction enjoining the FDA from
approving any competing carbamazepine ANDAs until after November 16, 2011, Nostrum
has asked the Court for an order enjoining the FDA from approving competing ANDAs
without first providing notice to Nostrum and the Court sufficient to permit Nostrum to
move this Court for relief “to protect Nostrum’s exclusivity period.” Pl. Br. at 36. The
Court denies that request for the reasons above and, further, because Nostrum has not
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established that the Court is empowered to fashion such relief given the existing
confidentiality concerns that relate to pending ANDA applications.
III. Conclusion
For the reasons above, Plaintiff’s motion for a preliminary injunction is denied. An
appropriate order accompanies this Opinion.
/s/ Joel A. Pisano
JOEL A. PISANO, U.S.D.J.
Dated: July 5, 2011
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