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Axcan Scandipharm Inc. v. Ethex Corp. et al. US District Court : CIVIL PROCEEDURE | PHARMACEUTICALS - motion to dismiss; word count; FDA-equivalent vs. advertising-equivalent ; jursidiction

UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
Axcan Scandipharm Inc.,
Plaintiff,
Civ. No. 07-2556 (RHK/JSM)
MEMORANDUM OPINION
AND ORDER
v.
Ethex Corporation, KV Pharmaceutical
Company, Global Pharmaceuticals, and
Impax Laboratories, Inc.,
Defendants.
Ronn B. Kreps, Andre T. Hanson, Fulbright & Jaworski LLP, Minneapolis, Minnesota, Saul
H. Perloff, Fulbright & Jaworski LLP, San Antonio, Texas, Marc B. Collier, Fulbright &
Jaworski LLP, Austin, Texas, for Plaintiff.
William Z. Pentelovitch, Martin S. Fallon, Haley N. Schaffer, Maslon Edelman Borman &
Brand LLP, Minneapolis, Minnesota, Thomas C. Morrison, Robert W. Lehrburger, John C.
Knapp, Patterson Belknap Webb & Tyler LLP, New York, New York, for Defendants Ethex
Corporation and KV Pharmaceutical Company.
John B. Lunseth, Briggs and Morgan, P.A., Minneapolis, Minnesota, Claude M. Stern, Scott
B. Kidman, Quinn Emanuel Urquhart Oliver & Hedges, LLP, Los Angeles, California, for
Defendants Impax Laboratories, Inc. and Global Pharmaceuticals.
INTRODUCTION
The Plaintiff in this Lanham-Act action, Axcan Scandipharm, Inc. (Axcan),
manufactures and markets the Ultrase line of pancreatic-enzyme-supplement drugs.
Defendants Ethex Corporation (Ethex) and KV Pharmaceutical Company (KV)
manufacture and sell a generic line of Ultrase called Pangestyme. Similarly,
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Defendants Impax Laboratories, Inc. (Impax) and Global Pharmaceuticals (Global)
manufacture and sell a different generic line of Ultrase called Lipram. In this action,
Axcan alleges that Ethex, KV, Impax, and Global have engaged in false advertising and
unfair competition under the Lanham Act, 15 U.S.C. 1051 et seq., and Minnesota law
because neither Pangestyme nor Lipram is truly a generic equivalent version of Ultrase.
Ethex and KV now move for judgment on the pleadings, while Impax and Global move to
dismiss. For the reasons set forth below, the Motions will be granted in part and denied in
part.
BACKGROUND
Since the early 1990s, Axcan has manufactured and marketed its Ultrase line of
pancreatic-enzyme drugs. (Compl. 1.) These drugs help patients with pancreatic
insufficiencies such as those suffering from cystic fibrosis or chronic pancreatitis who
are unable to produce the enzymes necessary to break down and digest fats, proteins, and
carbohydrates in the foods they eat. (Id. 18-26.) Ultrase contains those needed
enzymes and comes in three formulations Ultrase MT12, Ultrase MT18, and Ultrase
MT20 which correspond to the amount of a certain pancreatic enzyme (lipase) contained
in each. (Id. 27.)
In addition to Ultrase, there are two other major brand-name lines of pancreaticenzyme
supplements: Creon, which is sold by Solvay Pharmaceuticals (Solvay), and
Pancrease, which is sold by Ortho-McNeil. Creon and Pancrease also come in different
1 Although Ultrase, Creon, and Pancrease all come in formulations containing the same amount
of lipase, they differ in that they contain unique amounts of other pancreatic enzymes (amylase and
protease). (Compl. 30 & n.3.)
2 According to the Complaint, Ethex is a wholly-owned subsidiary of KV and is responsible for
marketing KVs generic drugs. (Compl. 9.) Similarly, Global is Impaxs generic marketing
division and Impax controls and directs Globals operations. (Id. 11.)
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formulations, based on the amount of lipase they contain.1
In August 2000, KV began to manufacture, and Ethex began to sell, Pangestyme, an
allegedly generic equivalent version of Ultrase, in three formulations: Pangestyme-
UL12, Pangestyme-UL18, and Pangestyme-UL20. (Id. 35.) Likewise, in April 1999,
Global and Impax began to manufacture and sell their own generic equivalent version of
Ultrase Lipram in three similar formulations. (Id. 44.)2 Axcan alleges that the
Defendants advertise their pancreatic-enzyme drugs as being identical in formulation to
Ultrase even though they contain different amounts of lipase and other pancreatic enzymes
from Ultrase. (Id. 32, 46.) Axcan further alleges that the Defendants invite pharmacists
and others to compare the labeled ingredients in their drugs with Ultrase, and thereby imply
that those drugs are generic equivalent substitute[s] for Ultrase, when in fact they contain
different formulations. (Id. 38, 47.) Accordingly, Axcan alleges that Ethex, KV, Impax,
and Global have engaged in false advertising and unfair competition, leading pharmacists in
Minnesota and across the country . . . into believing that Lipram-UL and Pangestyme-UL
are generic equivalents to Ultrase and [to] substitute[] Pangestyme-UL and Lipram-UL for
Ultrase as a result. (Id. 61.)
This is not the first time that such allegations have been levied against the
3 It is unclear why this case and the Solvay cases were commenced in Minnesota. Axcan is
headquartered in Alabama, Solvay is headquartered in Georgia, KV and Ethex are headquartered in
Missouri, Impax is headquartered in California, and Global is headquartered in Pennsylvania. Because
the alleged false advertising and unfair competition occurred nationwide, the Defendants are subject to
personal jurisdiction and venue in any of the 50 states. Accordingly, one would expect Axcan and
Solvay to file their lawsuits in their home forums and not Minnesota, which has no obvious connection
to the parties or the claims.
4 Solvays lead counsel, Saul Perloff of the law firm Fulbright & Jaworski LLP, represents
Axcan in this case.
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Defendants. In 2003, Solvay filed lawsuits in this Court against Ethex and KV (Civil No.
03-2836 (Tunheim, J.) (Solvay I)) and Impax and Global (Civil No. 03-2854 (Frank, J.)
(Solvay II)) alleging nearly identical claims to those asserted by Axcan here.3 Impax and
Global settled Solvay II; after almost four years of litigation, Solvay I resulted in a defense
verdict following a six-week jury trial.4
Ethex and KV now move for judgment on the pleadings, while Impax and Global
move to dismiss. In their Motion, Ethex and KV argue that (1) the Food and Drug
Administration (FDA) has primary jurisdiction over Axcans claims; (2) Axcans claims
are beyond the applicable statutes of limitations; (3) Axcans claims are barred by res
judicata; and (4) Axcans claims are barred by laches. Impax and Global make similar
arguments in their Motion, and also assert that (1) marketing one drug as an alternative to
another, or asking consumers to compare two drugs, cannot be false advertising as a
matter of law, and (2) Axcans claims are not pleaded with sufficient particularity under
Federal Rule of Civil Procedure 9(b). In addition, Ethex and KV have adopted as their own
5 Pursuant to Local Rule 7.1(c), a party filing a dispositive motion is limited to a total of 12,000
words between its opening memorandum and its reply memorandum. By adopting the arguments made
by the other Defendants in their moving papers, all of the Defendants have violated the spirit, if not the
letter, of this Local Rule.
6 The Court pauses to note that Ethex and KV previously moved for judgment on the pleadings
and, in support of that Motion, submitted a plethora of documents outside the pleadings. Ethex and
KV then moved to withdraw their Motion. The Court granted the Motion to Withdraw and, at that
time, advised Ethex and KV that matters outside the pleadings are not appropriately considered by the
Court when resolving such a motion. (See July 27, 2007 Order (Doc. No. 32) at 2 n.1.)
In their re-filed Motion for Judgment on the Pleadings, Ethex and KV apparently ignored the
Courts warning; they have once again submitted a large number of documents beyond the pleadings in
support of their Motion. The Court declines to consider those documents. See Fed. R. Civ. P. 12(c).
Regardless, most of the issues raised in Ethexs and KVs Motion are purely legal matters, which are
unaffected by the documents Ethex and KV have submitted.
Taking a slightly different tack, Impax and Global have asked the Court to take judicial notice
of the Complaints filed in Solvay I and Solvay II, the docket sheet in Solvay II, and a webpage from
the Food and Drug Administration. (Doc. No. 43.) Insofar as these are all matters appropriate for
judicial notice, that request is GRANTED. See Great Plains Trust Co. v. Union Pac. R.R. Co., 492
F.3d 986, 995-96 (8th Cir. 2007) (court may take judicial notice of proceedings in other cases, as well
as agency documents). Nevertheless, these matters are of limited assistance to the Court in connection
with the instant Motions.
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the arguments raised by Impax and Global, and vice versa.5
STANDARD OF REVIEW
Ethexs and KVs Motion for Judgment on the Pleadings is reviewed under the same
standard as Impaxs and Globals Motion to Dismiss. Westcott v. City of Omaha, 901 F.2d
1486, 1488 (8th Cir. 1990). In Bell Atlantic Corp. v. Twombly, __ U.S. __, 127 S. Ct.
1955 (2007), however, the Supreme Court recently altered the legal landscape for
evaluating a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6).6
To avoid dismissal under Rule 12(b)(6), a complaint must include enough facts to
state a claim to relief that is plausible on its face. Id. at 1974. While Rule 8 of the
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Federal Rules of Civil Procedure does not require the pleading of detailed factual
allegations, a plaintiff nevertheless must plead sufficient facts to provide the grounds of
his entitle[ment] to relief, [which] requires more than labels and conclusions, and [for
which] a formulaic recitation of the elements of a cause of action will not do. Id. at 1964-
65 (citation omitted). Thus, a complaint cannot simply le[ave] open the possibility that a
plaintiff might later establish some set of undisclosed facts to support recovery. Id. at
1968 (citation omitted). Rather, the facts set forth in the complaint must be sufficient to
nudge the[] claims across the line from conceivable to plausible. Id. at 1974.
When reviewing a motion to dismiss, the complaint must be liberally construed,
assuming the facts alleged therein as true and drawing all reasonable inferences from those
facts in the plaintiffs favor. Id. at 1964-65. A complaint should not be dismissed simply
because the court is doubtful that the plaintiff will be able to prove all of the factual
allegations contained therein. Id. Accordingly, a well-pleaded complaint will survive a
motion to dismiss even if it appears that a recovery is very remote and unlikely. Id. at
1965 (citation omitted).
ANALYSIS
I. The Court enjoys subject-matter jurisdiction over Axcans claims.
The Court begins its analysis with the Defendants arguments concerning subjectmatter
jurisdiction. See Bell v. Hood, 327 U.S. 678, 682 (1946) (Whether the complaint
states a cause of action on which relief could be granted is a question of law [that] must be
decided after and not before the court has assumed jurisdiction over the controversy.);
7 The Defendants label this argument differently, with Ethex and KV asserting that Axcans
claims fall within the FDAs exclusive jurisdiction (Ethex & KV Mem. at 31-44), while Impax and
Global assert that the claims are precluded by the Food, Drug, and Cosmetic Act, 21 U.S.C. 301
et seq. (Impax & Global Mem. at 5-18). Despite the semantic differences, it is clear that these
arguments are one-and-the-same. (Compare Ethex & KV Mem. at 34 (If Ethex is unlawfully
marketing Pangestyme as a generic, that is a matter for the FDA, not a private litigant.) with Impax &
Global Mem. at 7-8 (Axcans complaint is that Impax may not lawfully market or sell Lipram as a
generic version of . . . Ultrase . . . . That, however, is a matter that falls squarely within the primary
jurisdiction of the FDA and, as a matter of law, cannot be the subject of a private right of action.).)
8 Two drugs are considered pharmaceutically equivalent if they have the same active
ingredients, strength, and dosage, while two drugs are considered bioequivalent if they do not have
significantly different rates and extent of absorption in the body. See 21 C.F.R. 320.1(c), (e);
Preface to the Twenty-Second Edition, Approved Drug Products with Therapeutic Equivalence
Evaluations, available at http://www.fda.gov/cder/orange/adppreface.htm.
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Ramming v. United States, 281 F.3d 158, 161 (5th Cir. 2001) (a district court should
consider [a] jurisdictional attack before addressing any attack on the merits). The
Defendants argue that the Court lacks jurisdiction over Axcans claims because the FDA
has primary responsibility for regulating pancreatic-enzyme-drug marketing.7 This
argument was rejected in both Solvay I and Solvay II. Rather than painting on a blank
palette, the Court will quote extensively from Judge Tunheims succinct recitation of the
controlling legal framework in Solvay I:
A. The FDCA and FDA
The primary regulatory system covering prescription drugs was created by the
Food, Drug and Cosmetic Act (FDCA). 21 U.S.C. 301-92. The FDCA
requires FDA approval, through a new drug application (NDA), before a new
drug may be put on the market. Id. at 331(d), 355(a). A product similar to
an NDA approved drug may be approved and marketed based on an abbreviated
new drug application (ANDA). Id. at 355(j). An ANDA requires the
manufacturer of the similar drug to demonstrate that the two drugs are
therapeutically equivalent, that is pharmaceutically equivalent and bioequivalent.
Id. at 355(j)(2)(A)(i)-(viii).8 Each year the FDA publishes Approved Drug
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Products with Therapeutic Equivalence Evaluations, commonly known as the
Orange Book, listing all NDA approved drugs along with therapeutic
equivalence determinations. Enforcement of the FDCA is permitted exclusively
by and in the name of the United States or, in certain circumstances, by a state.
21 U.S.C. 337; see Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d
222, 231 (3rd Cir. 1990) (FDA and FTC share exclusive jurisdiction over
regulation of drug marketing requiring original interpretation of FDA or FTC
acts or regulations).
Prescription pancreatic enzyme supplements are, like any other drug, subject to
FDA regulation. In 1995 the FDA declared that all pancreatic enzyme drugs
would require NDA or ANDA approval, but permitted such drugs to remain on
the market while the FDA fleshed out the approval process. Thus, neither Creon
[Solvays brand-name pancreatic-enzyme drug] nor Pangestyme [Ethexs and
KVs generic] has been tested, approved, compared or otherwise passed on by
the FDA, and neither is listed in the Orange Book.
B. The Lanham Act
The Lanham Act provides a private remedy to a plaintiff who has been harmed
by commercial advertising or promotion that misrepresents the nature,
characteristics, qualities, or geographic origin of his or her or another persons
goods, services, or commercial activities. 15 U.S.C. 1125(a)(1)(B). The Act
primarily protects commercial interests of individuals. Sandoz, 902 F.2d at
230. In contrast to the FDCA, the Lanham Act expressly establishes a private
right of action. See 15 U.S.C. 1125(a). Ethex markets Pangestyme to
doctors, pharmacists, drug wholesalers, and drug retailers.
C. Overlap
The FDCA and the Lanham Act overlap to the extent that both regulate drug
products in the marketplace. Courts have recognized the potential conflict
between the two Acts and have struggled to define the proper scope of each law.
Courts have come to the general conclusion that the FDAs enforcement of the
FDCA is primarily concerned with the safety and efficacy of new drugs, while
the Lanham Act is focused on the truth or falsity of advertising claims. See, e.g.,
Sandoz, 902 F.2d at 230. More specifically, where a claim requires
interpretation of a matter that is exclusively within the jurisdiction and expertise
of the FDA and FDCA, plaintiffs cannot use the Lanham Act as a backdoor to
private enforcement. Id. at 231; Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1139
(4th Cir. 1993). However, false statements are actionable under the Lanham
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Act, even if their truth may be generally within the purview of the FDA.
Solvay I, 2004 WL 742033, at *2-3 (D. Minn. Mar. 30, 2004) (footnote 8 added by this
Court) (citations and footnotes omitted); see also Solvay II, 298 F. Supp. 2d 880, 883-85
(D. Minn. 2004).
Here, as in Solvay, the Defendants argue that, by challenging their marketing of
Pangestyme and Lipram as generic equivalents to or substitutes for Ultrase, Axcan has
necessarily asserted that the Defendants are improperly representing their drugs as
equivalent to Ultrase in the FDAs sense of that term in other words, the Defendants
understand Axcans claims to mean that the Defendants are improperly suggesting that
Pangestyme and Lipram are pharmaceutically equivalent and bioequivalent to Ultrase. (See
Impax & Global Mem. at 8; Ethex & KV Mem. at 33-34.) According to the Defendants,
whether their drugs are equivalent to Ultrase in such fashions can only be determined by
the FDA.
The Defendants, however, misapprehend the nature of Axcans claims. Axcan does
not allege that the Defendants have falsely implied that their drugs are equivalent in the
FDA sense that is, bioequivalent and pharmaceutically equivalent to Ultrase. Rather,
Axcan asserts that, by advertising their drugs as generic equivalents to or substitutes for
Ultrase, the Defendants have engaged in false advertising based on the proper market
definition[s] of these terms. (Mem. in Oppn at 18.) Stated differently, Axcan seeks to
proffer evidence of the generally understood meanings of the terms generic
equivalence and substitute, and not the FDAs definition of equivalence, in order to
9 This is not to say that Axcan cannot use the FDAs definitions of bioequivalence or
pharmaceutical equivalence when seeking to prove its claims. The FDAs primary jurisdiction does
not prohibit a plaintiff from relying on the FDAs definitions merely to establish the standard [that the]
defendants allegedly failed to meet. Solvay I, 2004 WL 742033, at *4 (quoting Grove Fresh
Distribs., Inc. v. Flavor Fresh Foods, Inc., 720 F. Supp. 714, 716 (N.D. Ill. 1989)); accord Alpharma,
Inc. v. Pennfield Oil Co., 411 F.3d 934, 939 (8th Cir. 2005) (Lanham-Act claim may proceed even
when it turns on the meaning of [FDA] publications in the Federal Register and Code of Federal
Regulations).
The Defendants argue that, in Solvay I, Solvay sought to prove its claims not by pointing to
Ethexs and KVs advertising, but rather by arguing that Pangestyme could not be marketed as a
generic version of Creon without a determination that Pangestyme meets the FDAs definition of
generic. (Ethex & KV Mem. at 31.) Assuming arguendo that the Defendants description of
Solvays arguments is correct and that those arguments somehow infringed on the FDAs primary
jurisdiction, that would pose no hurdle to Axcans claims here. Just because Solvay may have
attempted to prove its claims in a certain fashion does not mean that Axcan will seek to replicate
Solvays methods of proof in this case, notwithstanding that Axcan is represented by the same counsel
as Solvay.
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establish the falsity of the Defendants advertisements. Such claims in no way infringe on
the FDAs right to determine whether two drugs are equivalent to one another based on its
definition of equivalence. See Solvay I, 2004 WL 742033, at *4 (an FDA determination
is not necessarily required in order for two drugs to be properly considered equivalent);
Solvay II, 298 F. Supp. 2d at 884-85.9 Simply put, Axcans claims do not require the Court
to determine anything within the particular jurisdiction of the FDA; the claims do not
concern the safety and efficacy of the Defendants drugs, but rather the truth or falsity of
[their] advertising claims. Solvay I, 2004 WL 742033, at *3-4; accord Midlothian Labs.,
L.L.C. v. Pamlab, L.L.C., No. 2:04cv836, 2007 WL 2458409, at *14 (M.D. Ala. Aug. 28,
2007) (assertion that generic equivalence is false advertising is not preempted by the
FDA to the extent that [the counter-plaintiff] seeks to prove its claim with evidence that
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pharmacists understand generic equivalence to imply therapeutic equivalence (or some
other standard of equivalence), rather than with evidence that FDA regulations require
therapeutic equivalence); Pediamed Pharms., Inc. v. Breckenridge Pharms., Inc., 419 F.
Supp. 2d 715, 725-26 (D. Md. 2006).
Recognizing that they face an uphill battle due to Solvay I and Solvay II, the
Defendants argue that those decisions are no longer good law in light of two subsequent
cases: Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934 (8th Cir. 2005), and Credit Suisse
Securities (USA) LLC v. Billing, __ U.S. __, 127 S. Ct. 2383 (2007). Neither Alpharma
nor Credit Suisse, however, aids the Defendants cause.
In Alpharma, the plaintiff alleged that the defendant had violated the Lanham Act by
advertising its antibiotic as approved for certain uses by the FDA, even though it had not
been so approved. The district court dismissed the action based on the FDAs primary
jurisdiction, but the Eighth Circuit reversed. The court held that the plaintiffs claim that
the defendant was improperly advertising that its product has been approved as safe and
effective turned simply on the truth or falsity of that assertion, and was much different
from determining whether the defendants product should be approved as safe and
effective, which was within the exclusive province of the FDA. 411 F.3d at 939
(emphases added). Since the plaintiffs claim turned only on the veracity of the defendants
advertising i.e., had the drug actually been proved safe and effective? the court held that
the claim was not barred. Id. Similarly, the issue here is not whether the FDA should deem
the Defendants products to be generic versions of Ultrase; rather, the issue is whether,
10 The Courts research has failed to unearth any cases applying Credit Suisse to Lanham-Act
claims.
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by advertising and marketing those products as generic equivalents to or substitutes for
Ultrase when they do not contain the same ingredients, the Defendants advertising is
literally or implicitly false, based on commonly understood meanings of equivalent and
substitute. Nothing in Alpharma bars such a claim.
In Credit Suisse, the Supreme Court held that federal antitrust law must yield to
federal securities law in particular, regulations issued by the Securities and Exchange
Commission (SEC) where the two are clearly incompatible. 127 S. Ct. at 2392. The
Court identified several factors used to determine whether the SECs regulatory scheme
precluded application of the antitrust laws, one of which is whether there exists a serious
conflict between the antitrust and regulatory schemes. Id. at 2397. According to the
Defendants, Credit Suisse teaches that Axcans Lanham-Act claims must yield to the FDAs
regulatory scheme concerning generic drugs, but this Court does not agree.
Credit Suisse does not break any new ground, at least in the Lanham-Act context10
indeed, Solvay I and Solvay II each noted that federal courts have long struggled to resolve
the interplay between the FDAs and the Lanham Acts regulation of drug marketing.
Moreover, even if Credit Suisse somehow heralds sweeping changes to existing
precedent (Mem. in Oppn at 24), its holding would still be inapposite because there is no
serious conflict between the FDAs regulations and Axcans claims here. 127 S. Ct. at
2397. As discussed above, the claims in this case focus on the truth or falsity of the
11 Axcan also alleges a claim that was not alleged in Solvay: that the Defendants advertise their
drugs as meeting the quality standards promulgated by the United States Pharmacopeia (USP) when in
fact they do not. (Compl. 40, 49, 64-65.) Clearly, a claim alleging that such advertising is false
does not turn on the safety or efficacy of the Defendants drugs, but rather turns on whether the
Defendants drugs do, in fact, meet USP standards. As with Axcans other Lanham-Act claims,
therefore, the claims based on such advertising are not preempted by the FDAs primary jurisdiction.
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Defendants advertising that their pancreatic-enzyme drugs are, among other things,
generic equivalents to or substitutes for Ultrase, based on commonly understood
meanings of those terms. Such claims can be maintained in this Court without infringing on
the FDAs right to determine whether the Defendants drugs are generic versions of
Ultrase under its own definition of equivalence. Simply put, there is no conflict here.11
Accordingly, Axcans claims are not barred by the FDAs primary jurisdiction.
II. The statute of limitations bars claims for conduct occurring prior to June 1,
2001.
The Lanham Act does not contain a statute of limitations. When a Lanham-Act
defendant asserts that the plaintiffs claims are barred by the statute of limitations, a court
must look to the local statute which bears the closest resemblance to the [Lanham Act] and
then apply the limitation period applicable to it. Fox Chem. Co. v. Amsoil, Inc., 445 F.
Supp. 1355, 1358-59 (D. Minn. 1978) (Devitt, J.) (citations omitted); accord Island Insteel
Sys., Inc. v. Waters, 296 F.3d 200, 206 (3rd Cir. 2002). For Lanham-Act claims,
Minnesota federal courts borrow the six-year statute of limitations in Minnesota Statutes
Section 541.05(2). See LensCrafters, Inc. v. Vision World, Inc., 943 F. Supp. 1481, 1491
12 Claims under the Lanham Act whether for damages or for injunctive relief are subject
to the principles of equity. 15 U.S.C. 1116(a), 1117(a). As a result, some courts and
commentators have questioned whether Lanham-Act claims are subject to a laches defense, and not a
statute-of-limitations defense, since the Lanham Act contains no limitations period and [l]aches [is] an
equitable defense [while] the statute of limitations [is] a creature of law. Jarrow Formulas, Inc. v.
Nutrition Now, Inc., 304 F.3d 829, 835 (9th Cir. 2002); see also id. at 836-37 (collecting cases).
Because all parties here agree that Axcans Lanham-Act claims are subject to a statute of limitations
(see Impax & Global Mem. at 21; Ethex & KV Mem. at 18-19; Axcan Opp. at 32), the Court need
not opine on this issue.
13 While the Complaint is dated May 31, 2001, it was filed on June 1, 2001.
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n.6 (D. Minn. 1996); Fox Chem., 445 F. Supp. at 1358.12 Similarly, Axcans state-law
claims also are subject to a six-year statute of limitations. See, e.g., Klehr v. A.O. Smith
Corp., 875 F. Supp. 1342, 1352-53 (D. Minn. 1995).
There is no dispute that some of the conduct challenged by Axcan occurred prior to
June 1, 2001 (six years prior to the date the Complaint was filed). (See Mem. in Oppn at
34.)13 Nevertheless, Axcan argues that it can seek relief based on that conduct, relying on
the continuing-violation doctrine. There are two types of continuing violations: those in
which a defendants plan, practice, or procedure causes unlawful acts to occur both outside
and inside the limitations period (in which case the earlier violations are not time barred),
and those in which an independent and distinct violation occurring outside the limitations
period is repeated within the period (in which case the earlier violation is time barred).
See, e.g., Mandy v. Minn. Mining & Mfg., 940 F. Supp. 1463, 1468 (D. Minn. 1996).
Axcan attempts to shoehorn the Defendants conduct into the first type of continuing
violation and, hence, argues that Defendants allegedly false advertising before June 1,
14 Axcan also argues that the Court need not decide at this early date which type of
continuing-violation theory applies to the Defendants conduct. (Mem. in Oppn at 32-34 (describing
the issue as academically interesting but premature because it relates only to Axcans potential
damages).) Demarcating which advertisements are actionable, however, will narrow the issues for
discovery and ultimately help to streamline the trial in this case. As evidenced by the Solvay cases,
discovery in this case is likely to be both time-consuming and expensive. Paring down the scope of
discovery, therefore, will be beneficial.
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2001 is actionable. The Court does not agree.14
The term continuing violation . . . implies that there is but one incessant violation
and that the plaintiff[] should be able to recover for the entire duration of the violation,
without regard to the fact that it began outside the statute of limitations window. Knight v.
Columbus, Ga., 19 F.3d 579, 582 (11th Cir. 1994). Here, however, the challenged conduct
was not the result of one incessant violation, but rather was a series of repeated
violations of an identical nature, namely, the Defendants repeated (false) advertising of
their drugs as generic equivalents to and substitutes for Ultrase. Id. (continuingviolation
doctrine not applicable to repeated failure to pay overtime to employees, since
each failure constituted a new violation); see also Natl R.R. Passenger Corp. v. Morgan,
536 U.S. 101, 112 (2002) (discrete acts that fall within the statutory time period do not
make timely acts that fall outside the time period); Pioneer Co. v. Talon, Inc., 462 F.2d
1106, 1108 (8th Cir. 1972) (each time a plaintiff is injured by an act of the defendants a
cause of action accrues to him to recover the damages caused by that act and . . . the statute
of limitations runs from the commission of the act).
Moreover, the first type of continuing violation typically concerns an unlawful
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practice or procedure Knights so-called incessant violation that spawns specific
unlawful acts, such as a hostile work environment. See, e.g., Morgan, 536 U.S. at 120-21;
Derrick Mfg. Corp. v. Sw. Wire Cloth, Inc., 934 F. Supp. 796, 808 (S.D. Tex. 1996) (These
claims are such that later violations are inseparable from the earlier ones and thus are all
deemed a single wrong.). In such a situation, it is the policy that is unlawful, but neither
the policy nor its unlawfulness becomes evident until specific unlawful acts caused by the
policy have been repeated several times. See Morgan, 536 U.S. at 120 & n.12. Here,
however, with each (allegedly) false advertisement, the Defendants illegal conduct was
manifest and Axcan could have sued; where each [instance of wrongful conduct] is
separate, distinct, and could have been challenged by a plaintiff, the continuing [violation]
doctrine does not apply. Hope v. Klabal, 457 F.3d 784, 793 (8th Cir. 2006). Axcan has
cited no Lanham-Act cases applying the first type of continuing violation, and the Court has
found none.
Accordingly, the Court concludes that Axcans claims are time barred insofar as
they challenge conduct occurring prior to June 1, 2001.
III. It is too early to decide whether res judicata applies.
The Defendants next argue that Axcans claims are barred by res judicata due to the
defense verdict in Solvay I. Under the doctrine of res judicata, a judgment on the merits
in a prior suit bars a second suit involving the same parties or their privies based on the
same cause of action. Daley v. Marriott Intl, Inc., 415 F.3d 889, 895-96 (8th Cir. 2005).
Although the claims here parallel the claims in Solvay I, Axcan was not a party to that
-17-
action. Res judicata, therefore, bars Axcans claims only if it is in privity with Solvay.
The Defendants rely on the virtual-representation doctrine to argue that Axcan is
in privity with Solvay. Under that doctrine, privity with a party to a prior lawsuit may exist
if the latter partys interests were adequately represented by the litigant in the earlier case
that is, if the latter partys interests are so closely aligned with the prior partys
interests that the prior party was, in essence, the latter partys virtual representative. Tyus
v. Schoemehl, 93 F.3d 449, 454 (8th Cir. 1996) (quoting Aerojet-Gen. Corp. v. Askew, 511
F.2d 710, 719 (5th Cir. 1975)). There is no bright-line rule to decide when to apply the
virtual-representation doctrine; it is a fact-intensive inquiry aimed at determining whether
the relationship between the party to the prior litigation and the party to the subsequent
litigation is close enough. Id. at 455 (quoting Gerrard v. Larsen, 517 F.2d 1127, 1134
(8th Cir. 1975)). This fact alone suggests that it would be inappropriate to dismiss Axcans
claims, at this early stage of the litigation and on an undeveloped factual record, based on
Solvays purported virtual representation of Axcan. See, e.g., EEOC v. Pemco Aeroplex,
Inc., 383 F.3d 1280, 1287 (11th Cir. 2004) (Whether or not a party is a virtual
representative of another is a question of fact.).
In any event, courts look at several factors when deciding whether to apply the
virtual-representation doctrine, including (1) identity of interests between the parties,
(2) the closeness of the parties relationship, (3) participation in the prior litigation,
(4) acquiescence in the prior litigation, (5) whether the present party deliberately
maneuvered to avoid the effects of the first action, (6) adequacy of representation, that
15 By way of example here, Solvay may have been litigating against the Defendants in an
attempt to strengthen its share of the pancreatic-enzyme market, to Axcans potential detriment. See
Kourtis v. Cameron, 419 F.3d 989, 997 (9th Cir. 2005) (a conflict of interest between a non-party
and his purported representative forecloses the possibility of privity).
-18-
is, whether the prior litigant had a strong incentive to protect the interests of the second
party, and (7) whether a public-law issue or a private-law issue is raised. Id. at 455-56
(citations omitted). Despite the Defendants best efforts to convince the Court otherwise,
and although at least some of these factors appear to weigh in the Defendants favor, at the
present juncture the Court is not persuaded that these factors mandate the dismissal of
Axcans claims.
First, there is no basis for the Court to conclude that Solvay had a strong incentive
or any incentive at all to adequately represent Axcans interests in its prior litigation
against the Defendants. Axcan and Solvay are competitors in the pancreatic-enzyme-drug
market and, hence, their interests are not necessarily aligned. See Nordhorn v. Ladish Co.,
9 F.3d 1402, 1405-06 (9th Cir. 1993) (holding that one company did not virtually represent
another company in prior litigation, even though their interests were aligned, when there
was no indication that [the first company] had any interest in [the second companys]
affairs or well-being during or after [its] lawsuit).15 By the same token, it is difficult to
conceive that Axcan and Solvay have a close relationship when they compete in the same
market. Cf. Tyus, 93 F.3d at 457 (close relationship existed when second action involved
some of the same plaintiffs as earlier action and all plaintiffs were St. Louis alderman suing
16 The Defendants point out that Axcan and Solvay have engaged the same counsel, but use of
the same counsel in itself is hardly dispositive of whether a close relationship exists. Taylor v. Blakey,
490 F.3d 965, 974 (D.C. Cir. 2007) (citing S. Cent. Bell Tel. Co. v. Alabama, 526 U.S. 160, 167-68
(1999)).
17 The Defendants argue that Axcan could have sought to intervene in Solvay (Ethex & KV
Mem. at 30), and that this fact militates in favor of applying the virtual-representation doctrine. In fact,
just the opposite is true. As the court noted in People Who Care v. Rockford Board of Education:
Res judicata cannot bar [a partys] claim . . . unless [his] legal interests are so closely
aligned with one or more of the parties that they are at least his virtual representatives.
However, if he is so closely aligned with one or more of the parties that they are his virtual
representatives, then his concerns have certainly received adequate representation. And,
if his interests are represented, he need not intervene; in fact, he cannot intervene unless
he lacks adequate representation by the existing parties. Thus if [the party] may
intervene because he lacks sufficient representation, then there is no privity and res
judicata will not bar his claim.
68 F.3d 172, 177 (7th Cir. 1995) (second emphasis added) (citations omitted). In any event, it is well-
-19-
to challenge aldermanic re-districting).16 At this early stage of the proceedings, the Court
simply does not have an adequate record upon which to determine whether Solvays and
Axcans interests are aligned.
Second, even if it can be said that Solvay and Axcan share an identity of interests,
that alone is not sufficient. Id. at 455. Rather, it is necessary to show not just that [Solvay
and Axcan] wanted the same results but also that [Solvay] had substantially the same
incentive to achieve it. Taylor v. Blakey, 490 F.3d 965, 972 (D.C. Cir. 2007). At this
motion-to-dismiss stage, there is no evidence before the Court upon which it could make
such a determination. Cf. id. (at summary judgment, concluding that evidence demonstrated
identity of interests and incentive to protect those interests).
Third, there is no evidence that Axcan participated in Solvay17 or that it waited to
settled that [t]he law does not impose upon any person . . . the burden of voluntary intervention in a
suit to which he is a stranger. Richards v. Jefferson County, 517 U.S. 793, 800 n.5 (1996).
18 Taylor noted that filing a lawsuit immediately after a prior plaintiffs case was resolved in
favor of the same defendant (as here) could be evidence of deliberate maneuvering to obtain multiple
bites of the litigatory apple. 490 F.3d at 975-76. Yet, such timing is not automatically susceptible to a
nefarious inference; the timing of the later suit could have occurred by happenstance or for other
perfectly legitimate reasons. See id. Accordingly, the Taylor court did not consider this factor as
weighing in favor of, or against, applying the virtual-representation doctrine. Here, at the motion-todismiss
stage, Axcan is entitled to the benefit of the doubt on this issue.
-20-
bring this lawsuit out of a concern that Solvay would lose its litigation and, hence,
deliberately maneuvered to avoid the effects of Solvay I. See Pemco, 383 F.3d at 1288
(deliberate maneuvering means maneuvering to avoid preclusion).18 Nor is there any
evidence indicating that Axcan acquiesced in Solvays litigation against the Defendants or
agreed to be bound by the judgment obtained in Solvay I. See Restatement (Second) of
Judgments 40 cmt. b (1982 & Supp. 2007) (no agreement to be bound by judgment
should be inferred except upon the plainest circumstances).
Finally, the claims in this case do not, as the Defendants argue, raise public-law
issues. The Defendants assert that the purported false advertising of their drugs raises a
public interest because it calls into question the safety and efficacy of pancreatic
enzymes. (Ethex & KV Reply at 4-5.) However, what Axcan asserts in this case is simply
a damages claim for false advertising, a mere private right shared not in common with the
public. Tyus, 93 F.3d at 457. Stated differently, an endless number of possible plaintiffs
alleging the same claims as Axcan (and Solvay) do not exist. Rather, only a finite and
limited number of entities may claim Lanham-Act damages as a result of the Defendants
-21-
allegedly false advertising. The claims, therefore, are private. Id.
For these reasons, the Court concludes that application of the virtual-representation
doctrine is unwarranted at this time. Accordingly, the Motions must be denied on this
ground.
IV. The Court cannot decide at this juncture whether laches bars Axcans claims.
The Defendants next argue that Axcans claims are barred by laches, because [n]ot
only did Axcan wait seven years to challenge [the Defendants] marketing [practices], it sat
on the sidelines for four years while its attorney prosecuted an identical lawsuit . . . on
behalf of an identically situated plaintiff. (Ethex & KV Mem. at 21.) At this stage of the
litigation, the Court cannot agree.
Laches is an equitable doctrine premised upon the same principal that underlies the
statute of limitations: the desire to avoid unfairness that can result from the prosecution of
stale claims. Midwestern Mach. Co. v. Nw. Airlines, Inc., 392 F.3d 265, 277 (8th Cir.
2004). In order for laches to apply, (1) a plaintiff must have unreasonably and inexcusably
delayed commencing his action and (2) the defendant must have suffered prejudice as a
result. Id. (quoting Goodman v. McDonnell Douglas Corp., 606 F.2d 800, 804 (8th Cir.
1979)). Because a court asked to apply laches must determine the reasonableness of and,
hence, the reasons and excuses for the plaintiffs delay in filing suit, as well as the
resulting prejudice suffered by the defendant, laches generally cannot be decided on a
motion for summary judgment, let alone a motion to dismiss. United States v. Portrait of
Wally, No. 99-Civ.-9940, 2002 WL 553532, at *22 (S.D.N.Y. Apr. 12, 2002); accord, e.g.,
19 The Defendants correctly note that some courts have applied laches at the motion-to-dismiss
stage. (See Ethex & KV Reply at 2 (citing cases).) The greater weight of authority, however, holds
that a laches defense can be resolved, if at all, only on a motion for summary judgment.
-22-
Kling v. Hallmark Cards, Inc., 225 F.3d 1030, 1041 (9th Cir. 2000) (because a claim of
laches depends on a close evaluation of all the particular facts in a case, it is seldom
susceptible of resolution by summary judgment) (internal quotation marks omitted);
Jeffries v. Chicago Transit Auth., 770 F.2d 676, 679 (7th Cir. 1985); Goldberg v. Cameron,
482 F. Supp. 2d 1136, 1152 (N.D. Cal. 2007); see also Azalea Fleet, Inc. v. Dreyfus Supply
& Mach. Corp., 782 F.2d 1455, 1458 n.2 (8th Cir. 1986) (noting the fact-bound nature of
the laches issue).19
Here, the Court concludes that it is not in a position, at this time, to opine on the
merits of the Defendants laches defense. Axcan makes several arguments concerning the
reasons for its delay such as its purported efforts to convince the Defendants to cease
their false advertising that go beyond the pleadings. Axcan must be afforded the
opportunity to develop and present evidence on these issues. Moreover, prejudice cannot
exist here unless the Defendants ha[ve] changed [their] position[s] in a way that would not
have occurred if [Axcan] had not delayed. Goodman, 606 F.2d at 809 n.17. In other
words, if the Defendants conduct would have been the same regardless of whether Axcan
sued earlier, then they cannot demonstrate any change in their position as a result of
Axcans delay and, hence, they cannot demonstrate prejudice. According to Axcan, that is
precisely the case, as evidenced by Defendants continuing their allegedly false advertising
20 The parties make several additional arguments concerning laches, such as whether it may bar
a Lanham-Act claim for damages (as opposed to injunctive relief) and whether, and in what
circumstances, a presumption of laches may apply. Because the Court concludes that the applicability
of laches cannot be addressed in the current procedural posture of this case, it need not wade into
these arguments at this time.
-23-
after having been sued by Solvay. (Mem. in Oppn at 39-40.) Once again, the Court is not
in a position to answer whether the Defendants would have changed their (allegedly)
improper advertising had Axcan commenced suit earlier; they are entitled to obtain
discovery on this issue. Finally, Axcan may be able to defeat the application of laches if it
is able to show that the Defendants conduct was willful or that they intended to engage in
false advertising. See, e.g., Danjaq LLC v. Sony Corp., 263 F.3d 942, 956-57 (9th Cir.
2001); Deere & Co. v. MTD Holdings, Inc., 70 U.S.P.Q.2d 1009, 1027 (S.D.N.Y. 2004).
As before, Axcan is entitled to discover facts that would support such an argument.
Accordingly, the Court will not dismiss Axcans claims on the ground of laches.20
V. To the extent that Axcans claims are based on compare to and alternative
to advertising, the claims may stand.
In addition to alleging that the Defendants have engaged in false advertising because
they market their drugs as identical in formulation to Ultrase, Axcan also alleges that the
Defendants have falsely suggested that their drugs are generic equivalent substitute[s] for
Ultrase by advertising their drugs as alternative[s] to Ultrase and by invit[ing]
pharmacists and others to compare the labeled ingredients in their drugs with Ultrase.
(Compl. 38, 47.) To the extent that Axcans claims are based on such comparative and
alternative advertising, the Defendants argue that the claims fail as a matter of law. The
-24-
Court does not agree.
The Defendants posit that comparative advertising is legal and, as a result, that the
Lanham Act cannot be used to prevent an advertiser from referring to its product as an
alternative to a competitors product or from inviting consumers to compare the two
products. (Impax & Global Mem. at 18.) Yet, several courts have held that advertisements
inviting consumers to compare one product to another can be misleading in context.
For example, in Nutrition & Fitness, Inc. v. Mark Nutritionals, Inc., the defendant
manufactured a dietary supplement called Body Solutions, and the plaintiff marketed a
competing supplement whose label stated Compare to Body Solutions. The defendant
brought a counterclaim against the plaintiff for false advertising under the Lanham Act, and
the plaintiff moved to dismiss, arguing that its label could not amount to false advertising as
a matter of law. The court rejected that argument, stating:
In order to form the base of a false advertising claim, the offending statement
must be either false on its face or, although literally true, likely to mislead and
to confuse consumers given the merchandising context. Accordingly, bald
assertions of superiority or general statements of opinion do not result in a
[Lanham Act] violation. Similarly, statements that are exaggerated advertising,
blustering and boasting upon which no reasonable buyer would rely are more
properly considered puffery and are not actionable under the Lanham Acts
false advertising provision. Other sources have described puffery as a general
claim of superiority over a comparative product that is so vague, it would be
understood as a mere expression of opinion.
Plaintiff maintains that the Compare to Body Solutions statement on
its own product does not make a detailed or specific assertion of measurable
fact. As such, Plaintiff contends that the statement Defendants complain of is
merely nonactionable puffery. The court disagrees. This is not an instance
where the alleged false advertising claims are broad assertions of superiority in
the field. Instead, by referencing a particular competing product, that is, the
-25-
Body Solutions line, Plaintiffs invitation to compare does not qualify as a
vague claim of superiority. Unlike more subjective terms often used in
advertising, compare suggests that a products performance has in fact
been tested and verified. Although Compare to Body Solutions by itself
is not a false statement, Defendant alleges that the statement is misleading
in that it leads consumers to believe that Plaintiffs products have been
tested and are equivalent in efficacy or content with the Body Solutions line
when they in fact are not.
202 F. Supp. 2d 431, 435-36 (M.D.N.C. 2002) (emphasis added) (citations omitted); see
also Clorox Co. P.R. v. Procter & Gamble Commercial Co., 228 F.3d 24, 37 (1st Cir.
2000) (advertisement inviting consumers Compare to your detergent . . . Whiter is not
possible actionable as false advertising under Lanham Act); Cartier, Inc. v. Deziner
Wholesale, L.L.C., No. 98-Civ.-4947, 2000 WL 34171, at *4-5 (S.D.N.Y. Apr. 3, 2000)
(denying summary judgment on false-advertising claim where label on defendants product
invited consumers to compare prices, quality, and style with plaintiffs product). Similarly,
Axcan alleges in this case that by inviting pharmacists and others to compare the
Defendants pancreatic-enzyme drugs to Ultrase, they falsely suggest that the drugs are
equivalent in efficacy or ingredients. (Compl. 38, 47.)
Courts have also held that advertising one product as an alternative to another may
violate the Lanham Act. In Healthpoint, Ltd. v. Ethex Corp., Civil No. SA-01-CA-646,
2004 WL 2359420 (W.D. Tex. July 14, 2004), for example, the court held that Ethexs
advertising of its wound-debridement ointment as an alternative to the plaintiffs competing
ointment was actionable because it could suggest that the two products had the same active
ingredients in the same quantities. Id. at *16. Solvay I reached the same conclusion. See
-26-
2006 WL 738095, at *3 (D. Minn. Mar. 22, 2006). Following those rulings here, Axcan
can succeed on its alternative to claims if it can prove that the Defendants advertising
suggests that Pangestyme and Lipram contain the same ingredients, in the same quantities,
as Ultrase, when in fact they do not. (Compl. 37-38, 46-47.)
Accordingly, Axcan may proceed with its false-advertising claims based on the
Defendants compare to and alternative to advertising.
VI. Axcans claims are sufficiently pleaded.
Finally, the Defendants argue that Axcans claims are not pleaded with the requisite
specificity under Federal Rule of Civil Procedure 9(b). This argument lacks merit.
As an initial matter, it is not entirely clear that Rule 9(b)s strictures apply to
Lanham-Act claims. As Axcan points out in its response, there is a split of authority on this
issue. Compare, e.g., Conditional Ocular Enhancement, Inc. v. Bonaventura, 458 F. Supp.
2d 704, 709 (N.D. Ill. 2006) (Claims that allege . . . false advertising under the Lanham
Act are subject to the heightened pleading requirements of Fed. R. Civ. P. 9(b).) with John
P. Villano, Inc. v. CBS, Inc., 176 F.R.D. 130, 131 (S.D.N.Y. 1997) (a claim of false
advertising under [the Lanham Act] falls outside the ambit of Rule 9(b) and may not be
subject of any heightened pleading requirement); see also Nutrition & Fitness, Inc., 202 F.
Supp. 2d at 434 (recognizing that several district courts have applied heightened pleading
requirement but that no appellate court had opined on the propriety of doing so). Indeed,
the Villano court articulates several persuasive reasons why Lanham-Act claims should not
be subject to any pleading-with-particularity rule. See 176 F.R.D. at 131.
-27-
In any event, assuming arguendo that a heightened pleading requirement applies to
Axcans claims, the Court concludes that such requirement has been satisfied here. Rule
9(b) does not require that the exact particulars of every allegedly instance of false
advertising be specified in the Complaint. See 5A Charles A. Wright & Arthur R. Miller,
Federal Practice & Procedure: Civ. 2d 1297 (3rd ed. 2007). Rather, that Rule is satisfied
if the plaintiffs complaint sufficiently apprises the defendant of the nature of the claim
and the acts . . . relied upon by the plaintiff as constituting the unlawful conduct. Id.;
accord Commercial Prop. Inv., Inc. v. Quality Inns Intl, Inc., 61 F.3d 639, 644 (8th Cir.
1995). The Complaint here clearly apprises the Defendants of the acts relied upon by
Axcan in support of its claims. Stated differently, Axcan has pleaded the who [the
Defendants], what [false advertising], where [in ads targeted to drug databases, wholesalers,
and pharmacies], when [since the late 1990s], and how [falsely claiming their drugs are
generic equivalents or substitutes] of its claims. Great Plains Trust Co. v. Union Pac. R.
Co., 492 F.3d 986, 995 (8th Cir. 2007). The sheer length and breadth of the Defendants
Memoranda indicate that they have been fully apprised of the nature of Axcans claims and
can adequately prepare responses thereto. Solvay II involved claims pleaded in similar
fashion, see 298 F. Supp. 2d at 885-86, and the Court reached the same conclusion; this
Court perceives no reason to deviate from that ruling.
CONCLUSION
Based on the foregoing, and all the files, records, and proceedings herein, IT IS
ORDERED that Defendants Ethexs and KVs Motion for Judgment on the Pleadings (Doc.
-28-
No. 33) and Defendants Impaxs and Globals Motion to Dismiss (Doc. No. 41) are
GRANTED IN PART and DENIED IN PART as follows:
1. The Motions are GRANTED to the extent that they argue that claims for
conduct occurring before June 1, 2001, are barred by the statute of limitations, and claims
based on such conduct are DISMISSED WITH PREJUDICE; and
2. In all other respects, the Motions are DENIED.
Dated: October 19 , 2007 s/Richard H. Kyle
RICHARD H. KYLE
United States District Judge
 

 
 
 

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