Purdue Pharma L.P. et al v. IMPAX Laboratories, Inc.
Filing
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OPINION & ORDER. For the reasons set forth above, Purdue's actions for infringement and defendants' declaratory judgment counterclaims for non-infringement are moot. The Court presumes that defendants' declaratory judgment counterclaims for invalidity are not moot, but the Court nonetheless declines to exercise jurisdiction over those claims. These actions are hereby dismissed. (Signed by Judge Sidney H. Stein on 7/18/2013) (lmb)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
In re: OXYCONTIN ANTITRUST LITIGATION
04 Md. 1603 (SHS)
PURDUE PHARMA L.P., THE P.F.
LABORATORIES, INC., PURDUE
PHARMACEUTICALS L.P., and
RHODES TECHNOLOGIES,
OPINION & ORDER
This document relates to:
Plaintiffs,
10 Civ. 3734 (SHS)
‐against‐
RANBAXY INC., RANBAXY
PHARMACEUTICALS INC., RANBAXY
LABORATORIES LTD., ACTAVIS ELIZABETH
LLC, MYLAN PHARMACEUTICALS INC., and
MYLAN INC.,
Defendants.
PURDUE PHARMA L.P., THE P.F.
LABORATORIES, INC., PURDUE
PHARMACEUTICALS L.P., and
RHODES TECHNOLOGIES,
Plaintiffs,
13 Civ. 684 (SHS)
‐against‐
IMPAX LABORATORIES, INC.,
Defendant.
SIDNEY H. STEIN, U.S. District Judge.
Plaintiffs have sued defendants Mylan Pharmaceuticals Inc. and
Mylan Inc. (collectively “Mylan”) and Impax Laboratories, Inc. for patent
infringement as defined by the Hatch‐Waxman Act. Defendants have filed
counterclaims for declaratory judgment, asserting that defendants will not
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infringe plaintiffs’ patents and that those patents are invalid. An action by
the Food and Drug Administration during the pendency of these actions
has raised the issue of whether they are moot. For the reasons set forth
below, the Court holds that the claims of infringement and the
counterclaims asserting non‐infringement are moot. The Court also
declines to exercise jurisdiction over those of defendants’ counterclaims
that assert invalidity. As a result, these actions are dismissed.
I.
BACKGROUND
Plaintiffs (collectively “Purdue”) manufacture, market, and sell
OxyContin, a brand‐name controlled‐release oxycodone medication for the
treatment of moderate to severe pain. The original formulation of
OxyContin was the subject of New Drug Application (“NDA”) 20‐553,
which the Food and Drug Administration initially approved in December
1995. See Determination that the OXYCONTIN (Oxycodone
Hydrochloride) Drug Products Covered by New Drug Application 20‐553
Were Withdrawn from Sale for Reasons of Safety or Effectiveness, 78 Fed.
Reg. 23,273, 23,273 (Apr. 18, 2013) (hereinafter “FDA Determination”).
Purdue now manufactures and sells “Reformulated OxyContin,” which is
more resistant to abuse than original OxyContin. Reformulated
OxyContin is the subject of NDA 22‐272, initially approved by the FDA in
April 2010. As of August 2010, Purdue no longer sells original OxyContin
in the United States. See id.
The FDA Orange Book entries for original and Reformulated
OxyContin list several patents that cover these drugs. As relevant to this
order, three patents—the so‐called “Low‐ABUK Patents”—cover both
original and Reformulated OxyContin.1
Mylan and Impax each filed Abbreviated New Drug Applications
(“ANDAs”) with the FDA, seeking to make generic versions of original
OxyContin. See 21 U.S.C. § 355(j). Both ANDAs included a “Paragraph
IV” certification, which asserted that the patents claiming original
OxyContin—including the Low‐ABUK Patents—were “invalid or will not
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The Low‐ABUK Patents are U.S. Patent Nos. 7,674,799; 7,674,800; and 7,683,072.
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be infringed by the manufacture, use, or sale” of defendants’ proposed
generics. 21 U.S.C. § 355(j)(2)(A)(vii)(IV). After Purdue received notice of
defendants’ ANDAs, it brought these suits for patent infringement in the
U.S. District Court for the Southern District of New York. Defendants filed
counterclaims for declaratory judgment, asking the Court to rule that
Purdue’s patents would not be infringed or were invalid.
Mylan and Impax have also filed ANDAs seeking to make generic
versions of Reformulated OxyContin. In these ANDAs as well, defendants
certified to the FDA that the patents that claimed Reformulated
OxyContin—again, including the Low‐ABUK Patents—are invalid or
would not be infringed. Once more Purdue sued for infringement in the
Southern District of New York, and defendants asserted counterclaims for
declaratory judgment as to non‐infringement and invalidity. See Purdue
Pharma L.P. v. Impax Labs., Inc., No. 11 Civ. 2400 (S.D.N.Y.); Purdue Pharma
L.P. v. Mylan Pharm. Inc., No. 12 Civ. 2959 (S.D.N.Y.).
In April 2013, before any of these cases had reached a final resolution,2
the FDA determined in April 2013 that original OxyContin had been
withdrawn from sale for reasons of safety or effectiveness. This
determination means that original OxyContin is no longer a “listed drug”
that can be the subject of an ANDA. See 21 U.S.C. § 355(j)(2)(A)(i), (j)(7)(C).
As such, the FDA announced that it would “not accept or approve ANDAs
that refer to” original OxyContin. FDA Determination, 78 Fed. Reg. at
23,275.
In light of the FDA Determination, this Court ordered Mylan and
Impax to show cause as to why the suits concerning original OxyContin
should not be dismissed as moot. Mylan filed a two‐page response saying
simply that the FDA Determination did not moot its declaratory judgment
counterclaim for invalidity. Impax did not respond at all.
The Court did hold a trial in three actions in November 2012: Purdue Pharma L.P.
v. Ranbaxy Inc., No. 10 Civ. 3734; Purdue Pharma L.P. v. Ranbaxy Inc., No. 11 Civ. 2401;
and Purdue Pharma L.P. v. Ranbaxy Inc., No. 11 Civ. 7104. Mylan is a named defendant
in the 2010 action, but did not participate at trial.
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II. DISCUSSION
“Article III of the Constitution restricts the power of federal courts to
‘Cases’ and ‘Controversies.’ Accordingly, to invoke the jurisdiction of a
federal court, a litigant must have suffered, or be threatened with, an
actual injury traceable to the defendant and likely to be redressed by a
favorable judicial decision.” Chafin v. Chafin, 133 S. Ct. 1017, 1023 (2013)
(quotation marks and alteration omitted). “A case becomes moot—and
therefore no longer a ‘Case’ or ‘Controversy’ for purposes of Article III—
when the issues presented are no longer ‘live’ or the parties lack a legally
cognizable interest in the outcome. No matter how vehemently the parties
continue to dispute the lawfulness of the conduct that precipitated the
lawsuit, the case is moot if the dispute is no longer embedded in any
actual controversy about the plaintiffs’ particular legal rights.” Already,
LLC v. Nike, Inc., 133 S. Ct. 721, 726–27 (2013) (quotation marks and citation
omitted).
There can be no doubt that Purdue’s infringement actions and
defendants non‐infringement counterclaims are moot. The FDA
Determination meted out all of the infringement‐related relief that is
available in these Hatch‐Waxman Act actions.3 See 35 U.S.C. § 271(e)(4);
Apotex, Inc. v. Thompson, 347 F.3d 1335, 1346–47 (Fed. Cir. 2003) (challenge
to legality of regulation concerning Hatch‐Waxman Act 30‐month stays
was mooted when the FDA removed all the stays at issue).
Whether the FDA Determination mooted defendants’ declaratory
judgment counterclaims for invalidity is a separate question. For purposes
of this Opinion, the Court presumes that defendants’ invalidity
counterclaims are not moot, see Alvater v. Freeman, 319 U.S. 359, 363 (1943),
but the Court declines to exercise its discretionary jurisdiction to hear
these claims.
Because the FDA, and not this Court, changed the legal relationship among the
parties, none of them is a “prevailing party” for the purposes of awarding attorneys’
fees. See 35 U.S.C. §§ 271(e)(4), 285; Grober v. Mako Prods., Inc., 686 F.3d 1335, 1347–48
(Fed. Cir. 2012); Highway Equip. Co., Inc. v. FECO, Ltd., 469 F.3d 1027, 1034–35 (Fed.
Cir. 2006).
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This Court has the discretion to decline to exercise jurisdiction over a
Hatch‐Waxman Act declaratory judgment action, even though the Court
has constitutional jurisdiction over that action. See Teva Pharm. USA, Inc. v.
Novartis Pharm. Corp., 482 F.3d 1330, 1338 n.3 (Fed. Cir. 2007). The Court
can make this discretionary decision even if the dismissed claim is at an
advanced procedural posture. See Wilton v. Seven Falls Co., 515 U.S. 277,
288 (1995); Apple, Inc. v. Motorola, Inc., 869 F. Supp. 2d 901, 924 (N.D. Ill.
2012) (Posner, J.) (stating that the court would decline to exercise
declaratory judgment jurisdiction following its decision of motion for
summary judgment).
The Federal Circuit requires that a court base its discretionary decision
to decline jurisdiction on sound legal and factual grounds, and for reasons
that are not “clearly unreasonable, arbitrary, or fanciful.” Micron Tech., Inc.
v. Mosaid Techs., Inc., 518 F.3d 897, 905 (Fed. Cir. 2008). In addition, “[i]f a
district court’s decision is consistent with the purposes of the Declaratory
Judgment Act and considerations of wise judicial administration, it may
exercise its discretion to dismiss” the case. Sony Elecs., Inc. v. Guardian
Media Techs., Ltd., 497 F.3d 1271, 1288 (Fed. Cir. 2007). “The purpose of the
declaratory action is to allow a party who is reasonably at legal risk
because of an unresolved dispute, to obtain judicial resolution of that
dispute without having to await the commencement of legal action by the
other side.” Capo, Inc. v. Dioptics Med. Prods., Inc., 387 F.3d 1352, 1354 (Fed.
Cir. 2004) (quotation marks omitted).
The purpose underlying declaratory judgment actions and wise
judicial administration both counsel in favor of dismissing defendants’
invalidity counterclaims. Defendants’ currently infringing conduct—their
ANDAs seeking to make generic versions of Reformulated OxyContin—
has already prompted Purdue to initiate separate lawsuits against them.
See Purdue Pharma L.P. v. Impax Labs., Inc., No. 11 Civ. 2400 (S.D.N.Y.);
Purdue Pharma L.P. v. Mylan Pharm. Inc., No. 12 Civ. 2959 (S.D.N.Y.). These
suits will give defendants the opportunity to contest the validity of the
Low‐ABUK Patents in this district. Further, allowing the actions
concerning defendants’ Reformulated OxyContin ANDAs to go forward
will not cause any of the parties to expend any additional resources. In
short, the actions concerning defendants’ Reformulated OxyContin
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