United States District Court, E.D. Pennsylvania
ongoing antitrust case involves four Hatch-Waxman
reverse-payment settlement agreements entered into by
Cephalon, Inc., the manufacturer of the brand-name
pharmaceutical Provigil, and four generic drug companies.
These companies are Barr Pharmaceuticals, Inc.; Mylan
Laboratories, Inc. and Mylan Pharmaceuticals, Inc.
(“Mylan”); Teva Pharmaceutical Industries, Ltd.
and Teva Pharmaceuticals USA, Inc.; and Ranbaxy Laboratories,
Ltd. and Ranbaxy Pharmaceuticals, Inc.
(“Ranbaxy”). Plaintiffs allege that these
settlements unlawfully delayed the market entry of generic
Provigil in violation of the Sherman Act.
parties have submitted numerous motions in limine in
anticipation of the liability trial scheduled for June 12,
2017. The only plaintiffs in the upcoming trial are Apotex,
Inc., a generic competitor, and a group of owners and
operators of retail pharmacies who filed their own separate
actions and were excluded from the definition of the Direct
Purchaser Litigation Class.The only defendants in the June
trial are Mylan and Ranbaxy.
opinion addresses the omnibus motion filed on behalf of all
Plaintiffs, which contains ten separate motions in
limine. For the reasons that follow, the motions
will be granted in part and denied in part.
1997, Cephalon was issued U.S. Patent No. 5, 618, 845,
covering specific formulations of modafinil, the active
pharmaceutical ingredient (“API”) in Provigil.
Cephalon was granted a reissue patent on modafinil, U.S.
Patent No. RE 37, 516 (“the RE ‘516
patent”) in 2002. Modafinil is a wakefulness-promoting
agent used to treat narcolepsy and other sleep disorders.
December 24, 2002, the Generic Defendants each filed an
Abbreviated New Drug Application (“ANDA”) seeking
to market a generic version of Provigil along with a
Paragraph IV certification indicating that Cephalon's RE
‘516 patent was either invalid or the generic products
did not infringe the patent. In 2003, Cephalon filed suit
against the Generic Defendants for patent infringement
(“the Paragraph IV litigation”).
Paragraph IV litigation between Cephalon and the Generic
Defendants settled between December 2005 and February 2006,
with the Generic Defendants agreeing to forego releasing
their generic modafinil products until April 6, 2012.
Plaintiffs in the antitrust case allege that in return for
the Generic Defendants agreeing to settle the Paragraph IV
litigation and stay off of the market until 2012, Cephalon
paid the Generic Defendants millions of dollars in violation
of various antitrust laws. This type of settlement-referred
to as a reverse-payment settlement-was analyzed by the United
States Supreme Court in Federal Trade Commission v.
Actavis, Inc., 133 S.Ct. 2223 (2013).
STANDARD OF REVIEW
purpose of a motion in limine is “to narrow the
evidentiary issues for trial and to eliminate unnecessary
trial interruptions.” Bradley v. Pittsburgh Bd. of
Educ., 913 F.2d 1064, 1069 (3d Cir. 1990). The moving
party bears the burden of demonstrating that the challenged
evidence is inadmissible “on any relevant ground, and
the court may deny a motion in limine when it lacks the
necessary specificity with respect to the evidence to be
excluded.” Leonard v. Stemtech Health Scis.,
Inc., 981 F.Supp.2d 273, 276 (D. Del. 2013).
“Evidentiary rulings, especially ones that encompass
broad classes of evidence, should generally be deferred until
trial to allow for the resolution of questions of foundation,
relevancy, and potential prejudice in proper context.”
Motion in Limine Number 1
their first motion, Plaintiffs request that Defendants be
precluded from offering direct or indirect evidence of their
subjective beliefs regarding the merits of the RE ‘516
Patent because Defendants asserted the attorney-client
privilege to block inquiry into those subjective views.
Plaintiffs state that it would be unfair to allow Defendants
to waive the privilege at the eleventh-hour because
Plaintiffs have prepared their case without the benefit of
knowing the content of the privileged information.
example, Plaintiffs urge that Defendants should be prevented
from offering evidence suggesting that their pleadings in the
Paragraph IV litigation were “mere advocacy or lawyer
arguments” because such evidence would suggest that
Defendants' subjective beliefs differed from the
positions their attorneys took in court. (Pls.' Mot. pp.
respond that they do not intend to introduce testimony or
evidence previously withheld as privileged. Rather,
Defendants state that they intend to present non-privileged
information that was made available to Plaintiffs during
discovery. For example, Defendants state that they will offer
testimony from fact witnesses regarding actions they took
during the Paragraph IV litigation and subsequent settlement.
Defendants contend that such evidence is relevant to their
defense that the outcome of the Paragraph IV litigation was
uncertain and that legitimate considerations motivated their
decision to settle. Defendants argue that there is no legal
authority to support Plaintiffs' request to preclude
Defendants from introducing non-privileged evidence in this
conclude that Defendants may present this type of
non-privileged evidence despite their invocation of the
attorney-client privilege. In fact, Plaintiffs themselves
have argued that they are entitled to offer expert testimony
on the absence of non-privileged documents concerning
Defendants' due diligence and what that means in terms of
the reasonableness of the side agreements. (See
Pls.' Resp. to Defs.' Mot. to Exclude Testimony of
Thomas Hoxie, pp. 16-17.) I agree with Plaintiffs that this
type of evidence is admissible and, as such, Defendants may
present relevant non-privileged information to rebut
Plaintiffs' arguments in this manner.
Plaintiffs have failed to support their broad request for a
sweeping pre-trial prohibition, their concerns can, if
necessary, be addressed in the context of a developed record
and with the benefit of a concrete understanding of the
proffered testimony as well as the purpose for which it is
being presented. If Plaintiffs believe that Defendants are
attempting to present evidence previously withheld as
privileged, I will certainly entertain objections to specific
lines of questioning at trial. Defendants are directed to
question their witnesses with careful attention to these
issues and any attempts to introduce evidence previously
withheld will not be countenanced. For the foregoing reasons,
Plaintiffs' Motion in Limine Number 1 will be denied.
Motion in Limine Number 2
seek an order precluding Defendants from presenting opinion
evidence from fact witnesses that I previously precluded
Defendants' experts from offering in the November 5, 2015
Daubert Opinion and Order. See King Drug Co. of
Florence, Inc. v. Cephalon, Inc., 2015 WL 6750899, at *2
(E.D. Pa. Nov. 5, 2015). Plaintiffs urge that Defendants
should not be able to elicit the following previously
excluded expert opinions through fact witnesses:
1. [A]ny expert opinion contrary to [the] holdings [that
‘(1) the RE ‘516 patent is invalid due to the
on-sale bar, derivation and obviousness; and (2) the
materiality prong of Walker Process fraud has been
established'] will not be permitted.
2. Cephalon [cannot] attempt to justify the reverse-payment
settlement agreements with evidence that it sought to avoid
the risk of invalidation of the RE ‘516 patent.
3. [A]n expert will not be permitted to testify at trial that
certain legal arguments made during the Paragraph IV
litigation were ‘reasonable' or that Cephalon could
have reasonably had a realistic expectation of success on the
4. [T]he validity experts will not be permitted to testify as
to any legal standard that was explicitly rejected by this
Court during the Apotex litigation.
5. Cephalon's experts will not be permitted to opine that
the Generic Defendants' products presently infringe the
RE ‘516 patent.
6. Dr. Bugay's conclusions stemming from his testing of
the Generic Defendants' generic Provigil API and tablets
using the Hiac/Royco brand light obscuration ...