United States District Court, D. Delaware
Sandoz, having exhausted legitimate means to seek a
postponement of a trial scheduled for April 24, 2017 (D.I.
23), now seeks to dismiss the case against it for lack of
subject matter jurisdiction. (D.I. 156). Sandoz's view is
that it should be able to decide when, if ever, the trial
takes place. For the reasons that follow, I DENY Sandoz's
owns various patents that it asserts covers its branded drug,
Multaq. Some of them were listed in the Orange Book, and,
after Sandoz filed ANDA No. 205744 seeking FDA approval to
market a generic version of Multaq, Sanofi filed suit. The
result was a trial in June 2016. I eventually found in favor
Sanofi, and against Sandoz, on the Â§ 167 and '800
patents, and on September 22, 2016, enjoined Sandoz from
commercializing the proposed ANDA generic before April 16,
2029. (No. 14-264-RGA, D.I. 336, ¶¶ 14-15). Sandoz
has appealed from that judgment. (Id., D.I. 339).
on August 18, 2015, Sanofi was issued another patent, the
'900 patent, which Sanofi listed in the Orange Book as
covering Multaq. On December 23, 2015, Sanofi filed the
instant suit against Sandoz, asserting the '900 patent,
which also expires on April 16, 2029. (No. 15-1207, D.I. 1,
¶ 20). That case, along with similar cases against two
other generics, is now proceeding under the above caption.
made a "Paragraph IV" certification in relation to
the '900 patent on February 17, 2016. (D.I. 157, p. 4).
On October 7, 2016, Sandoz and the other two defendants
requested a stay of this case pending resolution of the
multiple appeals from the earlier trial. (D.I. 144). I denied
the request for a stay on October 14, 2016. (D.I. 150). On
October 28, 2016, Sandoz changed the Paragraph IV
certification to a "Paragraph III" certification.
(D.I. 159-1). On December 8, 2016, the instant motion was
basis for Sandoz's motion is simple. A Paragraph IV
certification creates subject matter jurisdiction. A
Paragraph III certification does not, because it represents
that the generic will not market its product before the
relevant patents expire. Thus, the parties agree that, since
there was a Paragraph IV certification by Sandoz on the
'900 patent, the Court has had subject matter
jurisdiction over the case against Sandoz. (D.I. 157, p. 7;
D.I. 167, p. 2). Thus, I think the precise issue raised here
is whether a generic who has filed a Paragraph IV
certification divests the district court of jurisdiction by
the mere act of converting the Paragraph IV certification to
a Paragraph III certification.
see two arguments in the briefing that are germane
and therefore need to be considered.
a purely legal statutory interpretation argument. What
exactly is the basis for subject matter jurisdiction in the
first place? The other is a mootness argument. Under what
circumstances can the unilateral actions of one party divest
a court of jurisdiction?
statutory interpretation argument, as I understand it, is not
entirely settled. See Stephen R. Auten & Jane S.
Berman, ANDA LITIGATION 149-74 (Kenneth L. Dorsney et al.
eds., 2nd ed. 2016) (discussing related topics).
Nonetheless, I am not deprived of jurisdiction under 35
U.S.C. § 271(e)(2) and 35 U.S.C. § 1338(a) because
it is sufficient that the case was initially certified under
Paragraph IV. Cf. Cephalon, Inc. v. Sandoz, Inc.,
2012 WL 682045, at *4-5 (D. Del. Mar. 1, 2012) (finding that
the absence of a Paragraph IV certification does not, as a
matter of law, automatically deprive the court of subject
matter jurisdiction under both 35 U.S.C. § 271(e)(2) and
28 U.S.C. § 2201). It also appears that 28 U.S.C. §
2201 may confer jurisdiction. Cf. Id. at *5
("[S]o long as there is an actual controversy, that is,
there is a sufficient allegation of immediacy and reality,
the exercise of jurisdiction over such an action is within
the discretion of the district court." (internal
I do not think Sandoz's mootness argument has any merit.
The standard for deciding whether Sandoz's actions have
mooted this case are straightforward.
A case becomes moot when interim relief or events have
eradicated the effects of a defendant's act or omission,
and there is no reasonable expectation that the alleged
violation will recur. In cases where a defendant voluntarily
ceases the challenged practice, it is necessary for the court
to determine whether "there is no reasonable expectation
that the wrong will be repeated." As a result,
'"a defendant claiming that its voluntary compliance
moots a case bears the formidable burden of showing that it
is absolutely clear the alleged wrongful behavior could not
reasonably be expected to recur.'"
Ferring B. V. v. Watson Labs, Inc.-Fla.,
764 F.3d 1382
the record makes clear that Sandoz's Paragraph III
certification is a matter of convenience and expedience on
Sandoz's part. It is asserted, without contradiction,
that Sandoz's conversion to Paragraph III certification
is "wholly revocable." (D.I. 164, p.l). Indeed,
Sandoz admits, "Of course Sandoz could, and very well
might, convert its Paragraph III certification back to a
Paragraph IV at some future date under certain
circumstances." (D.I. 167, p. 5). In my opinion, this is
essentially a concession that the case is not moot. Sandoz
argues that any generic that from the outset gives a
Paragraph III certification could later change the
certification to Paragraph IV. (D.I. 167, p. 5). I assume
this is true, but the difference is that the statutory
structure shows that there is no jurisdiction over an initial
Paragraph III certifier, whereas there is jurisdiction over
an initial Paragraph IV certifier. The specific facts leading
to the finding that the case was moot in Ferring are
not analogous here. See Ferring, 764 F.3d at
1388-91. Unlike in Ferring, Sanofi makes an
adequately supported argument that Sandoz would reconvert
back to Paragraph IV. See Id. at 1391 ("Ferring
makes no argument that Apotex would file an ...