Court Opinion

ID: 810412
Source: CourtListenerOpinion
Date Created: 2012-10-17 19:04:47+00
Date Added: 2024-06-11T18:00:37.888525
License: Public Domain

Case: 12-131      Document: 12    Page: 1    Filed: 10/17/2012

            NOTE: This order is nonprecedential.

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      for tbe jfeberaI qctrcutt

          IN RE IMPAX LABORATORIES, INC.,
                      Petitioner.

                Miscellaneous Docket No. 131

       On Petition for Writ of Mandamus to the United
 States District Court for the District of Delaware in case
         no. 11-CV-1152, Judge Sue L. Robinson.

                        ON PETITION

       Before LINN, DYK, and WALLACH, Circuit Judges.
DYK,   Circuit Judge.

                         ORDER

    Impax Laboratories, Inc. petitions for a writ of man-
damus to direct the United States District Court for the
District of Delaware to vacate its order declining to enter
a protective order with a Food and Drug Administration
(FDA) bar. Cephalon and CIMA LABS, Inc. (Cephalon)
oppose. Impax replies.
Case: 12-131     Document: 12     Page: 2   Filed: 10/17/2012

IN RE IMPAX LABORATORIES                                  2
    This petition arises from a Hatch-Waxman suit
brought by Cephalon, Inc. to prevent Impax from bringing
to market a generic version of Fentora, which are fentanyl
buccal tablets. Impax argues that Cephalon, simultane-
ously with its patent enforcement proceedings, has
launched a campaign with the FDA to oppose the ap-
proval of generic fentanyl buccal tablets. Because of the
overlap of the matters and the attorneys involved, Impax
urged the district court to adopt an FDA bar in the protec-
tive order, which would generally prohibit any recipient
of designated material in the litigation from participating
in FDA correspondence relating to generic fentanyl buccal
tablets for one year after final termination of the action.

    The district court held a hearing and allowed both
sides to present arguments relating to an FDA bar, but it
declined to adopt such a provision. It held that there is
no support for Impax's argument that the risk of inadver-
tent disclosure of confidential material to the FDA war-
rants the substantial burden that such a bar would
impose. The district court also held that the other provi-
sions in the existing protective order already govern the
use of litigation-generated information.

    Mandamus requires the petitioner to establish: (1)
there are no alternative means of obtaining the relief
desired, Mallard v. U.S. District Court, 490 U.S. 296, 309
(1989), and (2) the right to the relief sought is "clear and
undisputable," Allied Chemical Corp. v. Daiflon, Inc., 449
U.S. 33, 35 (1980).      Mandamus is an "extraordinary
remedy," justifiable only in "exceptional circumstances,
amounting to a judicial usurpation of power ...." Id.

    Impax's petition fails to meet this high standard. The
district court found Impax's concerns about the lack of an
FDA bar to be unpersuasive given the other provisions
protecting sensitive material. Namely, the court noted
Case: 12-131         Document: 12   Page: 3   Filed: 10/17/2012

3                                   IN RE IMPAX LABORATORIES

that these other provisions would require both Cephalon
and its attorneys to ask for and receive permission from
the district court before disclosing any litigation-
generated information.

     The court also acknowledged that it had not yet re-
ceived "an explanation of what circumstances would allow
[Cephalon's] counsel to be interfacing with the FDA about
a competitor's ANDA, resulting in a risk of an inadvertent
disclosure of confidential, litigation-generated informa-
tion. Until such time, if ever, that I am so informed, I
decline to put a FDA bar in place." The district court thus
left open the possibility that Impax could present specific
circumstances to the district court for reconsideration.

      Accordingly,

      IT Is ORDERED THAT:

      The petition for a writ of mandamus is denied.

                                     FOR THE COURT

      OCT 112m2                       lsI Jan Horbaly
         Date                        Jan Horbaly
                                     Clerk

      cc: Roger J. Chin, Esq.
          Jonathan Elliot Singer, Esq.

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