H. Lundbeck A/S et al v. Apotex Inc., et al
MEMORANDUM ORDER regarding the Court's decisions on motions in limine, pretrial order issues, and other trial related matters. Signed by Judge Leonard P. Stark on 1/7/21. (ntl)
Case 1:18-cv-00088-LPS Document 990 Filed 01/07/21 Page 1 of 5 PageID #: 45575
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICTOF DELAWARE
H. LUNDBECK A/S, TAKEDA
PHARMACEUTICAL COMPANY LTD.,
TAKEDA PHARMACEUTICALS U.S.A.,
INC., TAKEDA PHARMACEUTICALS
INTERNATIONAL AG and TAKEDA
PHARMACEUTICALS AMERICA, INC.,
APOTEX INC., et al.,
C.A. No. 18-88-LPS
At Wilmington this 7th day of January, 2021:
Having reviewed the proposed pretrial order (“PTO”) submitted by Plaintiffs and
Defendants (D.I. 985, 985-1, 986-1, 987-1, 988-1), IT IS HEREBY ORDERED that:
Plaintiffs’ motion in limine (“MIL”) No. 1, to exclude obviousness theories (from
Defendants Zydus and Sigmapharm, relating to claims of the ’884 and ’279 patents) based on
undisclosed lead compounds, is DENIED. Plaintiffs have not met their burden to show that this
evidence and opinion should be excluded. While Defendants’ expert, Dr. Lepore, will not be
permitted to identify lead compounds “for the first time at trial,” as that would be substantially
and unfairly prejudicial to Plaintiffs, he will be permitted to opine on any lead compound and
“lead motif” he identified as a lead compound in his expert reports and/or deposition. To the
Case 1:18-cv-00088-LPS Document 990 Filed 01/07/21 Page 2 of 5 PageID #: 45576
extent there is a dispute as to the legal sufficiency of a theory based on a “lead motif,” the Court
will evaluate that issue post-trial based on a full record.
Plaintiffs’ MIL No. 2, to exclude “a new argument” that asserted claims of some
of the patents-in-suit would have been obvious over PCT Publication No. WO 2003/029232 A1
(“WO ’232”) “because a POSA would have screened all 24 preferred compounds listed in WO
’232,” is DENIED. By Plaintiffs’ own telling, they have not been recently surprised by the
“new” argument. Instead, Plaintiffs acknowledge “Defendants planted the seeds of this new
theory in the Reply Report of their expert” and later “during depositions, multiple Defendant
experts offered this new theory of how WO ’232 purportedly renders the claims of Plaintiffs’
patents obvious.” (D.I. 988-1 at p. 196 of 857) 1 Plaintiffs have failed to show that the
Pennypack factors favor exclusion. In particular, Plaintiffs have not persuaded the Court that its
decision today will unfairly prejudice Plaintiffs in the manner or to the degree that concerned the
Court when it granted an earlier defense motion (a decision which was supported by the
Pennypack factors). (See D.I. 801)
The parties shall be prepared to discuss at tomorrow’s pretrial conference
(“PTC”) the following issues raised in the PTO:
whether the Court should compel any party to include more “disputed
facts” as “undisputed facts” (see PTO ¶¶ 15-16);
Defendants’ contentions that these theories were adequately disclosed in opening reports, and
that Dr. Myerson’s responsive report proves this point (see D.I. 988-1 at p. 709 of 857), are
unpersuasive. While disclosure of a truly “new” theory of invalidity in a reply report and/or a
deposition will not always be acceptable, in the context of this case the applicable Pennypack
factors considered in combination do not warrant exclusion of the challenged evidence and
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whether there is a dispute as to whether fact witnesses should be
sequestered prior to their testimony (PTO ¶ 24);
the parties’ positions on how they will make motions for judgment on
partial findings under Rule 52(c) (PTO ¶ 103);
the procedure for closing the virtual courtroom for testimony that contains
Competitively Sensitive Confidential evidence (PTO ¶ 105); and
whether the Court should require Defendants to provide “clarity regarding
which invalidity defenses Defendants actually plan to pursue at trial” and whether Plaintiffs will
be reducing the number of asserted claims and/or patents (PTO ¶ 106).
With respect to Defendants’ objection in PTO ¶ 39, the parties are directed that
should they be unable to resolve objections with respect to any intended use of any deposition
testimony, that objection shall be raised and argued consistent with the procedures set out in the
PTO for resolution of deposition objections (see id. ¶¶ 40-44).
With respect to the dispute in PTO ¶ 55, the Court adopts Defendants’ proposal,
meaning that exhibits may be used on cross-examination (even for non-impeachment purposes)
without necessarily having been listed in the pretrial order.
All objections to admissibility of exhibits and expected use of demonstrative
exhibits that the parties are unable to resolve without judicial intervention must be raised with
the Court at the beginning of the trial day on which it is anticipated that the exhibit is to be used.
Failure to comply with this Order will result in waiver of the objection. A party will be charged
for all time it spends arguing for or against such objections and for half of the time the Court
requires to resolve such objections.
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The Court will confer with the parties at the conclusion of trial to determine an
appropriate schedule and all necessary page limits for post-trial briefing and other submissions.
The parties shall submit to the Court, no later than January 13, 2021 at 12 p.m.,
(i) two sets of binders containing hard copies of all trial exhibits organized in numerical order,
separated into PTX, DTX, and JTX; and (ii) a single bookmarked PDF document containing all
trial exhibits, via FTP. Credentials may be directly emailed to Chambers. The PDF containing
the trial exhibits must include both a linked index and a bookmark for each exhibit, and the
exhibits should be organized in numerical order, separated by PTX, DTX, or JTX. Each party
shall submit to the Court via e-mail full color copies of any demonstrative exhibits that each
intends to use at trial by 8 a.m. on the calendar day such demonstrative exhibit is expected to be
used. At the end of trial, the parties shall submit to the Court two sets of hard copies of all
demonstrative exhibits, organized in an easily identifiable manner.
Based on the Court’s understanding of the number and scope of the parties’
disputes – which include allegations of infringement of at least 23 claims of at least eight patents
against seven sets of Defendants as well as invalidity based on at least obviousness, anticipation,
and lack of adequate written description – and considering the parties’ requests for time
(Plaintiffs seek 63 hours for trial and Defendants request 70) (see PTO ¶ 95), the Court will
allocate between 22 and 25 hours per side, with the final amount to be determined at the PTC.
The Court recognizes this is a large case even among ANDA cases over which it has presided.
Nevertheless, the requested amount of hours is significantly greater than the amounts the Court
has permitted in recent years. In the Court’s view, this case can be effectively litigated, with
both sides having the opportunity to make full and fair presentations, in the hours being allocated
by the Court.
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Trial will be held at some or all of the following times, subject to the parties’ time
limits and the Court’s other commitments:
Friday, January 15:
9 a.m. to 5:30 p.m.
Tuesday, January 19:
9 a.m. to 5:30 p.m.
Wednesday, January 20:
8:30 a.m. to 11:30 a.m. and 2 p.m. to 4 p.m.
Thursday, January 21:
9:00 a.m. to 5:30 p.m.
Friday, January 22:
8:30 a.m. to 1:30 p.m. and 4 p.m. to 6 p.m.
Monday, January 25:
12:30 p.m. to 5:30 p.m.
Tuesday, January 26:
9 a.m. to 5:30 p.m.
Wednesday, January 27:
8:30 a.m. to 4 p.m.
Thursday, January 28:
8:30 a.m. to 5:30 p.m.
Friday, January 29:
8:30 a.m. to 5:30 p.m.
HONORABLE LEONARD P. STARK
UNITED STATES DISTRICT JUDGE
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