United States District Court, D. Delaware
parties have submitted letter briefing related to two
disputes that arose at the pretrial conference. (D.I. 123,
124, 125, 126).
parties dispute whether Defendant may offer obviousness
combinations at trial that Plaintiff alleges were disclosed
for the first time in the Pretrial Order. (D.I. 117-1 at
389). Defendant states that it will rely only on the
Jain-O'Malley obviousness combination and purports to
identify the paragraphs in Dr. Ahima's expert report in
which the Jain-O'Malley combination was disclosed. (D.I.
123). Plaintiff argues this combination was never expressly
disclosed. (D.I. 125). I agree that this specific combination
of references was not expressly disclosed in Dr. Ahima's
report. It strains credulity for Defendant to suggest, for
example, that discussing Jain as one of three references
disclosing bupropion, followed by a list of five naltrexone
references, followed by O'Malley as one of three
references disclosing the combination of the two drugs,
constitutes a disclosure of the Jain-O'Malley
combination. (D.I. 125 at 3; D.I. 125-1 at 55, ¶118).
There are dozens of possible ways of combining the eleven
references from this one paragraph and I do not think
Plaintiff was fairly put on notice of any of them.
this failure to disclose, however, Plaintiff has not
demonstrated the kind of prejudice that would warrant
excluding this theory at trial. In fact, Plaintiff notes that
these two references were before the PTO during prosecution
of both of the patents in suit. Plaintiff also provides
specific reasons why these references do not render the
asserted claims obvious. Therefore, I will allow Defendant to
present this obviousness combination at trial.
Defendant's expert's testimony is limited to what is
fairly disclosed in his report. At Plaintiffs option, its
expert may submit a report of no more than fifteen pages in
length addressing this combination no later than Tuesday, May
30, 2017. Defendant will not be permitted to depose
Plaintiffs expert or submit a reply report.
objects to Plaintiffs inclusion of "certain highly
prejudicial new paragraphs of Contested Facts" in the
pre-trial order. (D.I. 124 at 1). Plaintiff contends that the
paragraphs were added in response to Defendant's
allegations of insufficiency of proof of infringement of
certain claim limitations, which, according to Plaintiff,
were made for the first time in the pretrial order. (D.I. 126
initial matter, I note that the "exclusion of critical
evidence is an 'extreme' sanction not normally to be
imposed absent a showing of willful deception or
'flagrant disregard' of a court order by the
proponent of the evidence." Meyers v. Pennypack
Woods Home Ownership Assn., 559 F.2d 894, 905
(3d Cir. 1977) (internal citation omitted). Factors to
consider when determining whether to exclude evidence
(1) the prejudice or surprise in fact of the party against
whom the excluded witnesses would have testified, (2) the
ability of that party to cure the prejudice, (3) the extent
to which [allowing late-offered contested facts] would
disrupt the orderly and efficient trial of the case or of
other cases in the court, and (4) bad faith or willfulness in
failing to comply with the court's order.
Id. at 904-05. I am hard pressed to see any
prejudice to Defendant from including these paragraphs.
Defendant argues "extreme prejudice" would result
from allowing Plaintiff to use these facts at trial
"under the guise of alleged 'background' and
invalidity rebuttal evidence of 'secondary
considerations.'" (D.I. 124 at 1). The relief
Defendant seeks appears to be to require that Plaintiffs
presentation of evidence be "[c]onsistent with the
Court's rulings and [Plaintiffs] representations."
(Id. at 2). Assuming Plaintiff does in fact present
its case consistent with my rulings, I fail to see any
prejudice to Defendant. I also fail to see any bad faith on
Plaintiffs part, as the allegedly "new" facts were
submitted in response to Defendant's new non-infringement
theories. I decline to strike these paragraphs from the
seems clear from the record that Defendant has, in fact,
raised new infringement defenses on the eve of trial. For
example, Interrogatory No. 6 states, "Describe in detail
the factual and legal bases for Actavis's contentions, if
any, that Actavis's ANDA Product would not infringe ...
any asserted claim of the patents-in-suit." (D.I. 126-1
at 3). The Interrogatory also specifically requested "a
claim chart showing the presence or absence in Actavis's
ANDA Product of each claim element of each asserted
claim" along with citations to evidence that would
support Defendant's non-infringement position.
(Id.). In response, Defendant failed to submit a
claim chart and also failed to address each limitation of the
asserted claims. As to the '111 patent, Defendant stated
that it did not infringe because the '111 patent is
invalid. (Id. at 4).
described no other bases for non-infringement of the '
111 patent. As to the '626 patent, in addition to
invalidity, Defendant stated it did not infringe because it
"will not administer any compounds" as required by
the asserted claims and because a single entity would not
perform all steps of the claimed method. (Id. at
5-6). Defendant further asserted that it would not induce
infringement because its product's proposed label
"does not include instructions to co-administer
naltrexone and bupropion ... 'to increase satiety in the
individual' or 'to suppress the appetite of the
individual, '" as required by the asserted claims.
(Id. at 6). As to the '195 patent, in addition
to invalidity, not administering any compounds, and no single
entity performing all steps, Defendant stated it did not
infringe because its product "does not meet the recited
dissolution profile using the recited dissolution test
parameters in claim 11." (Id. at 8).
Preliminary Infringement Contentions, Plaintiff stated that
Defendant had not contested infringement in its Paragraph IV
certification. (D.I. 119 at 350-55). Plaintiff included with
its Infringement Contentions a detailed claim chart
specifying its contentions for how Defendant's product
met each limitation of the asserted claims. (Id. at
357-90). Plaintiffs Interrogatory No. 7 asked Defendant to
provide its bases for any disagreement with Plaintiffs
infringement contentions. (D.I. 126-1 at 11). Defendant's
response was to incorporate its response to Interrogatory No.
6. (Id. at 12).
never alleged, prior to submitting the pre-trial order, that
its ANDA product did not meet the following claim limitations
of the '626 and '111 patents: (1) "bupropion ...
effective to induce weight loss"; and (2)
"naltrexone . . . effective to enhance the weight loss
effect of the bupropion." Nor did Defendant make any
allegations of non-infringement of the additional
"sustained release" limitation of the '111 and
'195 patents. Nor did Defendant make any allegations,
prior to submitting the pre-trial order, of any failure of
proof of infringement in response to Plaintiffs detailed
claim chart and infringement contentions. It would be
extremely prejudicial to allow Defendant to proceed at trial
with arguments of failure of proof and noninfringement that
were presented for the first time in the pre-trial order.
See Intellectual Ventures I LLC v. Symantec
Corp., 2015 WL 294240, at *1 (D. Del. Jan. 21, 2015)
(excluding marking defense to which defendant failed to
respond in interrogatories or provide expert discovery);
Vehicle IP, LLC v. Werner Enters., Inc., No.
10-503-SLR, D.I. 209 (D. Del. Sept. 20, 2013) (excluding
non-infringement arguments first raised in expert's
these reasons, Defendant has waived the right to contest the
following limitations of the asserted claims: (1)
"bupropion . .. effective to induce weight loss"
('626 and '111 patents); (2) "naltrexone ...
effective to enhance the weight loss effect of the
bupropion" ('626 and '111 ...