[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FILED
FOR THE ELEVENTH CIRCUIT U.S. COURT OF APPEALS
________________________ ELEVENTH CIRCUIT
AUGUST 29, 2005
No. 03-13605 THOMAS K. KAHN
________________________ CLERK
D. C. Docket No. 00-03481-CV-AJ
ANDRX PHARMACEUTICALS, INC.,
Plaintiff-Appellant,
versus
ELAN CORPORATION, PLC,
Defendant-Appellee,
SKYEPHARMA, INC.,
Defendant.
________________________
Appeal from the United States District Court
for the Southern District of Florida
_________________________
(August 29, 2005)
Before BIRCH and WILSON, Circuit Judges, and DOWD *, District Judge.
*
Honorable David D. Dowd, Jr., United States District Judge for the Northern District of
Ohio, sitting by designation.
BIRCH, Circuit Judge:
In this appeal, we address whether the district court properly granted a
patentholder’s motion for judgment on the pleadings in a competitor’s antitrust
suit. The district court granted the motion because it found that the Noerr-
Pennington doctrine immunized Defendant-appellee Elan Corporation, PLC
(“Elan”) from the maintenance of an antitrust suit based on the allegations of
Plaintiff-appellant Andrx Pharmaceuticals, Inc. (“Andrx”) that Elan engaged in
patent infringement proceedings to improperly protect its monopoly on the market
for a controlled release naproxen medication. In addition, the district court found
that Andrx’s allegations regarding a licensing agreement entered into by Elan and
another competitor to settle a separate infringement suit were insufficient to
support an antitrust action under the Sherman Anti-Trust Act, 15 U.S.C. §§ 1 and
2. Finally, the district court denied Andrx’s motion for leave to amend its
complaint. For the reasons discussed more fully in this opinion, we conclude the
district court properly construed the Noerr-Pennington doctrine to immunize Elan
from liability for its infrigement suits, and did not abuse its discretion in denying
leave to amend. The district court erred, however, in dismissing Andrx’s claims
regarding its settlement agreement with one of Andrx’s competitors. Accordingly,
the district court’s order is AFFIRMED in part, REVERSED in part, and
2
REMANDED for further proceedings.
I. BACKGROUND 1
At its core, this litigation concerns the right to manufacture and sell the drug
naproxen, an analgesic medication prescribed to treat pain and other disorders.
Because the complex statutory regulations which govern the manufacture and sale
of drugs in the United States provide context for the facts in this case, we will
begin by briefly summarizing the relevant statutory provisions, after which we will
recount the relevant facts specific to the parties.
The Food and Drug Administration (“FDA”) must give its approval before
any new drug can be marketed or sold in the United States. 21 U.S.C. § 355(a).
Under § 355, different FDA approval standards apply depending on the drug the
applicant is attempting to market. See Valley Drug Co. v. Geneva Pharms., 344
F.3d 1294, 1296 (11th Cir. 2003), cert. denied __ U.S. __, 125 S. Ct. 308 (2004).
To gain approval for a drug that has not been introduced previously to the market,
an applicant must file a new drug application (“NDA”) and must meet the
1
Because this appeal arises from the district court’s grant of Elan’s motion for judgment
on the pleadings, the facts are derived from the allegations in Andrx’s complaint, which we must
accept as true, and are presented in the light most favorable to Andrx. See Ortega v. Christian,
85 F.3d 1521, 1524 (11th Cir. 1996). We need not accept as true, however, conclusory legal
allegations made in the complaint. See Green Leaf Nursery v. E.I. DuPont de Nemours & Co.,
341 F.3d 1292, 1304 n.12 (11th Cir. 2003), cert. denied 541 U.S. 1037, 124 S. Ct. 2094 (2004).
Because the district court denied Andrx leave to file a second amended complaint, see R2-73 at
11, our inquiry is limited to the allegations in the first amended complaint.
3
requirements outlined in § 355(b). Id. Section 355(b) requires the submission of
“exhaustive information about the drug,” including reports about the safety and
efficacy of the drug. Id. To gain approval for a generic, bioequivalent version of a
drug which has already gained approval under § 355(b), however, an applicant may
file an abbreviated new drug application (“ANDA”), in which the applicant must
satisfy the less exhaustive requirements outlined in § 355(j). See id. While §
355(j) allows an ANDA applicant to satisfy its burden by demonstrating a certain
bioequivalency between its drug and a drug approved under § 355(b), § 355(j) does
require the ANDA applicant to certify that the manufacture and sale of its drug
would not violate any patents held on the drug approved under § 355(b). See §
355(j)(2)(A)(vii). If an ANDA applicant certifies that its generic drug would not
violate an existing patent, or would only violate a patent on a § 355(b)-approved
drug which is invalid, see § 355(j)(2)(A)(vii)(IV),2 the ANDA applicant must
notify the patentholder, which is then given forty-five days to initiate patent
infringement proceedings against the ANDA applicant, see § 355(j)(5)(B)(iii). If
the patentholder timely initiates such litigation, FDA approval for the generic drug
2
As an incentive for drug manufacturers to submit ANDA applications for the production
of generic drugs, § 355 grants the first manufacturer to file an ANDA application for a generic
drug using the type of certification outlined in § 355(j)(2)(A)(vii)(IV) an exclusive 180-day
period to market the generic drug before another ANDA application is approved for a similar
generic drug. § 355(j)(5)(B)(iv)(I). This 180-day exclusivity period begins to run “after the date
of the first commercial marketing of the drug.” Id.
4
will be stayed for up to thirty months, unless the patent being litigated expires or a
final determination on the patent’s validity is reached at an earlier date. Id.
Against this background of information on drug approval procedures, we
proceed to the facts relevant to the parties on appeal. Elan was the owner of U.S.
Patent No. 5,637,320 (“the ‘320 patent”), which granted it the exclusive right to
manufacture and sell in the United States a controlled release naproxen medication.
In 1998, SkyePharma, Inc. (“SkyePharma”)3 filed an ANDA application pursuant
to § 355(j) to manufacture and sell a generic version of Elan’s controlled release
naproxen medication. In making its application, SkyePharma certified pursuant to
§ 355(j)(2)(A)(vii)(IV) that its activity would not constitute patent infringement.
Consequently, pursuant to § 355(j)(5)(B)(iii), Elan initiated patent infringement
proceedings against SkyePharma. According to Andrx’s complaint, Elan and
SkyePharma settled the litigation by entering into an agreement in which
SkyePharma admitted to infringing the ‘320 patent in exchange for a license from
Elan to manufacture a generic controlled release naproxen medication. Because
SkyePharma was the first filing ANDA applicant, pursuant to § 355(j)(5)(B)(iv)(I),
the license agreement effectively would have given SkyePharma an exclusive 180-
day period to market a generic naproxen medication. According to Andrx’s
3
Although SkyePharma was also a named defendant in Andrx’s first amended complaint,
Andrx settled and voluntarily dismissed its claims against SkyePharma. See R2-73 at 1.
5
complaint, however, SkyePharma had no intention of marketing its generic drug
and therefore would never trigger the running of the 180-day exclusivity period.
Accordingly, the settlement agreement had the effect of preventing any generic
competition in the controlled release naproxen market and constituted a conspiracy
to restrain trade.
In addition to SkyePharma’s alleged attempt to seek FDA approval for a
generic controlled release naproxen medication, Andrx contends that it also sought
to introduce a generic naproxen to the market. After Andrx filed notice of non-
infringement as required by § 355(j)(2)(B)(ii), however, Elan filed patent
infringement proceedings against Andrx. According to Andrx’s complaint, Elan
initiated this litigation “despite the absence of any reasonable belief that the claim
might fairly be held to be valid upon adjudication.” R1-3 ¶ 29, at 5. Andrx alleged
that Elan could not maintain its suit because the ‘320 patent had not been “validly
issued because of inter alia, the SCRIP publication of June 22, 1988 which
advertised its controlled release naproxen in the United States more than one year
prior to the filing of the application which resulted in the ‘320 patent.” Id. ¶ 27.4
4
Patent law provides that a patent shall not be granted if the invention was “described in
a printed publication in this or a foreign country or in public use or on sale in this country, more
than one year prior to the date of the application for patent in the United States.” 35 U.S.C. §
102. This statutory provision is termed the “on-sale bar” to patent validity. See Ferag AG v.
Quipp Inc., 45 F.3d 1562, 1566 (Fed. Cir. 1995). Because Elan purportedly advertised its
controlled release naproxen for sale in the publication SCRIP World Pharmaceutical News,
Andrx argued that the on-sale bar was triggered, thereby invalidating the ‘320 patent. Andrx’s
6
Moreover, Andrx alleged that “Elan’s goal and intention in bringing [the
infringement proceedings] was solely to . . . cause Andrx damage from the
automatic administrative delay in the approval process” pursuant to §
355(j)(5)(B)(iii). Id. ¶ 29, at 5-6. In addition to these allegations, Andrx alleged
that “Elan has engaged in a pattern and practice of baseless and sham litigation”
against companies seeking to complete ANDAs for generic controlled release
naproxen medications. Id. ¶ 26, at 5. According to Andrx, Elan sought through
this behavior to preserve its monopoly over the controlled release naproxen market
in the United States. Id. ¶ 39, at 7.
Based on these allegations, Andrx filed suit against Elan and SkyePharma
and alleged violations of the Sherman Anti-Trust Act, 15 U.S.C. §§ 1 and 2, and
the Florida antitrust laws, F LA. S TAT. ch. 542.18 and ch. 542.19. Citing the Noerr-
Pennington doctrine and precedent which allowed for the licensing settlement
reached by Elan and SkyePharma, the district court granted Elan’s motion for
judgment on the pleadings. In addition, the district court denied Andrx’s motion to
amend its complaint on account of Andrx’s undue delay. On appeal, Andrx argues
arguments notwithstanding, the district court found that the SCRIP publication did not trigger
the on-sale bar. See Elan Corp., PLC v. Andrx Pharms., Inc., 272 F. Supp. 2d 1325, 1340 (S.D.
Fla. 2002). The district court did find, however, that a letter written by Elan to Lederle
Laboratories in 1987 triggered the on-sale bar and invalidated the ‘320 patent. Id. at 1349. This
latter finding was reversed by the Federal Circuit, which remanded Elan’s patent infringement
suit for further proceedings. See Elan Corp., PLC v. Andrx Pharms., Inc., 366 F.3d 1336, 1342
(Fed. Cir. 2004).
7
that the district court erred in dismissing with prejudice its suit against Elan
because the district court misconstrued the Noerr-Pennington doctrine and its sham
litigation exception. In addition, Andrx argues that the district court erred by
denying its motion for leave to amend its complaint.
II. DISCUSSION
A. Judgment on the Pleadings
“We review de novo the district court’s ruling on a motion for judgment on
the pleadings pursuant to Federal Rule of Civil Procedure 12(c).” Horsley v.
Rivera, 292 F.3d 695, 700 (11th Cir. 2002). The application of the Noerr-
Pennington doctrine is a question of law, and therefore also reviewed de novo. See
Tec Cogeneration Inc. v. Fla. Power & Light Co., 76 F.3d 1560, 1567 (11th Cir.
1996), modified in part on other grounds, 86 F.3d 1028 (11th Cir. 1996) (per
curiam). Judgment on the pleadings is proper when no issues of material fact exist,
and the moving party is entitled to judgment as a matter of law based on the
substance of the pleadings and any judicially noticed facts. See Horsley, 292 F.3d
at 700.
The Sherman Anti-Trust Act provides that “[e]very contract . . . in restraint
of trade or commerce among the several States, or with foreign nations, is . . .
illegal.” 15 U.S.C. § 1. The Act also proscribes acts which seek “to monopolize
8
any part of the trade or commerce among the several States, or with foreign
nations.” 15 U.S.C. § 2.5 Citing the Sherman Act and the Florida antitrust statutes,
Andrx alleges that Elan improperly sought to monopolize the controlled release
naproxen market and prevent competition by: (1) initiating sham patent
infringement litigation against Andrx; and (2) entering into a settlement agreement
with SkyePharma which granted SkyePharma exclusive licensing rights to
manufacture and sell a generic controlled release naproxen medication. We will
examine each set of allegations in turn.
1. Patent Infringement Proceedings
While the Sherman Anti-Trust Act does proscribe activity in restraint of
trade, its reach has been tempered when its invocation would impair the exercise of
constitutional rights. Recognizing that the First Amendment guarantees the right
to “petition the Government for a redress of grievances,” U.S. C ONST. amend I, and
that this guarantee overrides the effect of a contrary federal statute, see Marbury v.
Madison, 5 U.S. 137, 177-78 (1803), and not wanting to “impute to Congress an
intent to invade the First Amendment right to petition,” Prof’l Real Estate Investors
5
As the district court noted, the Florida antitrust statutes, FLA . STAT . ch. 542.18 and ch.
542.19, closely track the language of the Sherman Act and are analyzed under the same rules and
case law. See All Care Nursing Serv. v. High Tech Staffing Servs., Inc., 135 F.3d 740, 745 n.11
(11th Cir. 1998). Accordingly, our discussion of federal antitrust law applies with equal force to
the Florida statutory provisions.
9
v. Columbia Pictures Indus., Inc., 508 U.S. 49, 56, 113 S. Ct. 1920, 1926 (1993)
(internal quotations omitted), the Supreme Court has held that a defendant is
immune from Sherman Act liability for concerted efforts to petition government to
pass legislation which has the effect of restraining or monopolizing trade in favor
of the defendant. See E. R.R. Presidents Conf. v. Noerr Motor Freight, Inc., 365
U.S. 127, 136, 81 S. Ct. 523, 529 (1961) (granting antitrust immunity for publicity
campaign designed to spur the adoption of monopoly-facilitating legislation);
United Mine Workers v. Pennington, 381 U.S. 657, 670, 85 S. Ct. 1585, 1593
(1965) (noting that Noerr shielded a defendant from antitrust liability for “efforts
to influence public officials . . . even though intended to eliminate competition”).
Subsequent precedent has extended Noerr-Pennington immunity to defendants who
exercise their right to petition government by resorting to administrative and/or
judicial proceedings. See Cal. Motor Transp. Co. v. Trucking Unlimited, 404 U.S.
508, 510, 92 S. Ct. 609, 611-12 (1972). Noerr-Pennington immunity thus shields a
defendant from antitrust liability for resorting to litigation to obtain from a court an
anticompetitive outcome.
An exception to the Noerr-Pennington doctrine exists, however, where the
defendant engages in “sham litigation.” Prof’l Real Estate Investors, 508 U.S. at
56, 113 S. Ct. at 1926; see Noerr, 365 U.S. at 144, 81 S. Ct. at 533 (finding
10
Sherman Act immunity inappropriate where the exercise of the right to petition
was “a mere sham to cover what is actually nothing more than an attempt to
interfere directly with the business relationships of a competitor”). To prevail on
the argument that Noerr-Pennington immunity should be abrogated based on the
sham litigation exception, a litigant must establish that: (1) “the lawsuit [is]
objectively baseless in the sense that no reasonable litigant could realistically
expect success on the merits”; and (2) the party bringing the allegedly baseless suit
did so with a “subjective motivation . . . to interfere directly with the business
relationships of a competitor.” Prof’l Real Estate Investors, 508 U.S. at 60-61, 113
S. Ct. at 1928. Construing the first prong of the sham litigation exception test, the
Court noted that the existence of probable cause to bring a lawsuit is sufficient to
thwart a claim that litigation was objectively baseless. See Prof’l Real Estate
Investors, 508 U.S. at 62, 113 S. Ct. at 1929. Moreover, the Court noted that “[a]
winning lawsuit is by definition a reasonable effort at petitioning for redress and
therefore not a sham.” Prof’l Real Estate Investors, 508 U.S. at 60 n.5, 113 S. Ct.
at 1928 n.5.
Based on this precedent, we agree with the district court that the Noerr-
Pennington doctrine shields Elan from antitrust liability for filing two patent
infringement suits against Andrx in relation to the manufacture and sale of
11
controlled release naproxen. The United States Constitution expressly permits the
government to grant exclusive monopolies in the form of patents, see U.S. C ONST.
art. I, § 8, cl. 8, and therefore the Sherman Act cannot be read to impede a litigant
from seeking to defend constitutionally-permitted patent rights. See Prof’l Real
Estate Investors, 508 U.S. at 56, 113 S. Ct. at 1926 (declining to impute an
unconstitutional purpose to Sherman Anti-Trust Act). Moreover, as the Supreme
Court has noted, engaging in litigation to seek an anticompetitive outcome from a
court is First Amendment activity that is immune from antitrust liability. See Cal.
Motor Transp. Co., 404 U.S. at 510, 92 S. Ct. at 611-12. Thus, we conclude Noerr-
Pennington immunity was triggered by Elan’s filing suit against Andrx. In
addition, we conclude that the sham litigation exception is inapplicable. Andrx’s
main contention in its complaint that the patent litigation was a sham hinged on its
claim that the on-sale bar found in 35 U.S.C. § 102 was triggered by Elan’s
naproxen advertisement in the publication SCRIP World Pharmaceutical News.
Two courts have subsequently rejected that argument. See Elan Corp., PLC, 272
F. Supp. 2d at 1340 (rejecting argument that the SCRIP advertisement triggered
on-sale bar); Elan Corp., PLC, 366 F.3d at 1342 (rejecting the argument that the
on-sale bar was triggered). Thus, while Elan may not have won its infringement
lawsuit at this point, it certainly has made a winning argument against Andrx’s
12
contentions of patent invalidity. Cf. Prof’l Real Estate Investors, 508 U.S. at 60
n.5, 113 S. Ct. at 1928 n.5. Thus, it is manifest that Elan’s patent infringement
proceedings were not objectively baseless, and therefore not a sham. Accordingly,
because the Noerr-Pennington doctrine applies, and the sham litigation exception is
inapplicable, the district court properly found that Elan was immunized from
antitrust liability for filing infringement proceedings against Andrx.
2. Elan-SkyePharma Settlement Agreement
In contrast, we conclude that the district court erred in finding that Andrx
had not sufficiently pled an antitrust violation in relation to the licensing agreement
which Elan signed with SkyePharma to terminate patent infringement litigation.
Under the Federal Rules of Civil Procedure, the plaintiff is required in the
complaint to make “a short and plain statement of the claim showing that the
[plaintiff] is entitled to relief.” F ED. R. C IV. P. 8(a)(2). While courts had
previously applied a heightened pleading requirement in antitrust cases, this view
has subsequently been rejected in favor of applying Rule 8(a)’s notice pleading
standard. Quality Foods de Centro America, S.A. v. Latin American Agribusiness
Dev. Corp., S.A., 711 F.2d 989, 995 (11th Cir. 1983); see Spanish Broad. Sys. of
Fla., Inc. v. Clear Channel Communications, Inc., 376 F.3d 1065, 1077 (11th Cir.
2004) (concluding that the “liberal pleading regime” outlined by Fed. R. Civ. P.
13
8(a)(2) applies to allegations of antitrust violations); Covad Communications Co.
v. BellSouth Corp., 299 F.3d 1272, 1279 (11th Cir. 2002) (describing the threshold
requirements for properly pleading an antitrust violation as “exceedingly low”),
vacated on other grounds by 540 U.S. 1147, 124 S. Ct. 1143 (2004). Accordingly,
absent some doctrine which immunizes the conduct alleged, such as the Noerr-
Pennington doctrine, “dismissals [on the pleadings] are particularly disfavored in
fact-intensive antitrust cases.” Covad Communications Co., 299 F.3d at 1279.
Against this background, we examine whether Andrx’s allegations sufficiently
state a claim under § 1 and/or § 2 of the Sherman Anti-Trust Act.
As we noted previously, Section 1 of the Sherman Act provides that “[e]very
contract . . . in restraint of trade or commerce among the several States, or with
foreign nations, is . . . illegal.” 15 U.S.C. § 1. To prevail on a claim that a patent
infringement settlement agreement violates § 1 of the Sherman Act, a plaintiff
must prove “(1) the scope of the exclusionary potential of the patent; (2) the extent
to which the agreements exceed that scope; and (3) the resulting anticompetitive
effects” in the relevant market. Schering-Plough Corp. v. FTC, 402 F.3d 1056,
1066 (11th Cir. 2005) (citing Valley Drug Co., 344 F.3d at 1312). With regard to
the first element, the allegations in Andrx’s complaint demonstrated that the ‘320
patent was necessary to the manufacture and sale of a controlled release naproxen
14
medication, and that its owner could effectively exclude competitors from making
other controlled release naproxen medications. See R1-3 ¶¶ 22-23, 33-35. With
regard to the second element, Andrx alleged that the Elan-SkyePharma licensing
agreement, coupled with SkyePharma’s putative agreement to refrain from ever
marketing a generic controlled release naproxen medication, “effectively barr[ed]
any generic competitors from entering the market. Id. ¶¶ 22-23. If true, this
dynamic would exceed the scope of exclusion intended by the ‘320 patent. See 21
U.S.C. § 355(j) (outlining criteria for drug manufacturers to enter the market with a
generic version of previously-approved patented products). With regard to the
third element, Andrx described the relevant market as the “[c]ontrolled release
naproxen” market. See R1-3 ¶ 17. Andrx alleged that Elan had sufficient market
power to affect the controlled release naproxen market because it was the only
supplier of naproxen in the United States. See id. ¶ 16. Finally, demonstrating the
anticompetitive effects, Andrx alleged that Elan’s licensing agreement with
SkyePharma, and SkyePharma’s putative agreement to refrain from marketing its
generic drug, would “prevent competition in the market for controlled release
naproxen.” Id. ¶¶ 22-23; see also id. ¶ 44 (stating that the conduct of Elan and
SkyePharma “foreclosed” entry by competitors into the relevant market and
“precluded” competition). Additionally, Andrx alleged that the agreement had the
15
result of depriving the general public of a less expensive generic product. See id. ¶
43. Thus, Andrx sufficiently pled facts for a § 1 claim that the Elan-SkyePharma
settlement agreement constituted an antitrust violation.
Section 2 of the Sherman Act outlaws conduct which seeks “to monopolize
any part of the trade or commerce among the several States, or with foreign
nations.” 15 U.S.C. § 2. “To state a claim for attempted monopolization, plaintiff
must show specific intent on the part of the defendant to bring about a monopoly
and a dangerous probability of success.” Quality Foods de Centro America, S.A.,
711 F.2d at 996. In its complaint, Andrx alleged that Elan had the “specific intent
to monopolize and preserve a monopoly in the controlled release naproxen
market.” R1-3 ¶ 49. In addition, as we already noted, Andrx alleged that Elan was
the only supplier of naproxen in the United States, see id. ¶ 16, and therefore had
“achieved a probability of success,” id. ¶ 56. Accordingly, we conclude that Andrx
sufficiently pled a violation of § 2 of the Sherman Act.
In sum, then, while the allegations regarding Elan’s infringement suits
against Andrx were immunized under the Noerr-Pennington doctrine, Andrx did
sufficiently state a claim under both §1 and §2 of the Sherman Anti-Trust Act that
Elan’s settlement agreement with SkyePharma, coupled with SkyePharma’s
putative agreement not to market, violated antitrust law. Accordingly, we remand
16
this case for further proceedings as to those allegations. Our conclusion as to the
sufficiency of the complaint does not preclude, however, Andrx’s claims from
being challenged at the summary judgment stage. See Quality Foods de Centro
America, S.A., 711 F.2d at 999 (reversing a district court’s dismissal of antitrust
claims on the pleadings, but noting that the claims “may very well wash out on
summary judgment”). Our determination recognizes that antitrust cases are
“fact-intensive,” Covad Communications Co., 299 F.3d at 1279, and require
appropriate market analysis, see Schering-Plough Corp., 402 F.3d at 1065-66, and
therefore are typically inappropriate for a Rule 12 dismissal in the absence of an
applicable immunity doctrine. Accordingly, with regard to Andrx’s allegations
that the Elan-SkyePharma settlement agreement and SkyePharma’s alleged
agreement to refrain from marketing a generic controlled release naproxen
medication violated §§ 1 and 2 of the Sherman Anti-Trust Act, the case is
remanded for further proceedings.
B. Motion to Amend
We review the district court’s denial of a motion for leave to amend for clear
abuse of discretion. See Lowe’s Home Ctrs., Inc. v. Olin Corp., 313 F.3d 1307,
1315 (11th Cir. 2002). Under the Federal Rules of Civil Procedure, after a
responsive pleading has been filed, a litigant must obtain leave to amend the
17
complaint, which “shall be freely given when justice so requires.” F ED. R. C IV. P.
15(a). Leave may be denied because of “undue delay, bad faith or dilatory motive
on the part of the movant, repeated failure to cure deficiencies by amendments
previously allowed, undue prejudice to the opposing party by virtue of allowance
of the amendment, [or] futility of amendment.” Foman v. Davis, 371 U.S. 178,
182, 83 S. Ct. 227, 230 (1962).
Based on the foregoing precedent and the facts of this case, we discern no
abuse of discretion in the district court’s denial of Andrx’s motion for leave to
amend. As the district court noted, Andrx filed its first amended complaint in
March 2001, and was put on notice that its “sham litigation exception” theory was
insufficient at least by March 2002. However, Andrx did not move to amend until
it appeared in the district court in April 2003 to argue Elan’s motion for judgment
on the pleadings. See Smith v. Duff & Phelps, Inc., 5 F.3d 488, 493 (11th Cir.
1993) (finding no abuse of discretion where litigant waited more than a year to
seek leave to amend after it was put on notice that its claim was defective).
Moreover, we note that in its second amended complaint, Andrx purported to
advance a “sham litigation exception” theory based on Walker Process Equipment,
Inc. v. Food Machinery & Chemical Corp., 382 U.S. 172, 86 S. Ct. 347 (1965), a
theory not pled in the first amended complaint. See Burger King Corp. v. Weaver,
18
169 F.3d 1310, 1319 (11th Cir. 1999) (finding no abuse of discretion where
plaintiff attempted to introduce new theory of recovery in amended complaint).
Finally, we agree with the district court that Andrx’s explanations for its delay in
filing for leave to amend do not demonstrate that justice required the grant of the
motion to amend. See Carruthers v. BSA Adver., Inc., 357 F.3d 1213, 1218 (11th
Cir. 2004) (per curiam). Accordingly, even though Andrx was motivated to amend
its complaint to avoid the court’s grant of Elan’s motion for judgment on the
pleadings, Andrx’s undue delay in moving for leave to amend, its attempt to inject
a new theory of recovery, and its failure to show that justice required the grant of
its motion demonstrate that the district court did not clearly abuse its discretion in
denying Andrx’s motion for leave to amend. See Lowe’s Home Ctrs., Inc., 313
F.3d at 1315.
III. CONCLUSION
In this appeal, we were called upon to determine whether Andrx, a drug
manufacturer seeking to introduce to the market a generic controlled release
naproxen medication, could maintain suit against Elan, the owner of the patent for
controlled release naproxen, for its initiation of patent infringement proceedings
against Andrx and for its settlement agreement with SkyePharma which
purportedly shielded Elan from generic competition in the naproxen market.
19
Because the Noerr-Pennington doctrine immunized Elan from antitrust liability as
to the former allegations, the district court properly found that the allegations could
not state a claim for relief under antitrust law. But, because the latter allegations
sufficiently pled antitrust violations, the district court erred by granting Elan’s
motion for judgment on the pleadings, and therefore the case must be remanded for
further proceedings in relation to the alleged antitrust violations stemming from the
Elan-SkyePharma settlement agreement. On remand, because the district court did
not clearly abuse its discretion in denying Andrx’s motion for leave to amend, the
district court’s inquiry should be limited to the allegations of antitrust violations
contained in Andrx’s first amended complaint. Accordingly, the district court’s
grant of Elan’s motion for judgement on the pleadings is AFFIRMED in part and
REVERSED in part, and REMANDED for further proceedings.
20
Andrx Pharmaceuticals v. Elan Corporation
Court: Court of Appeals for the Eleventh Circuit
Date filed: 2005-08-29
Citations: 421 F.3d 1227
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