United States District Court, D. Delaware
ABBVIE INC. and ABBVIE BIOTECHNOLOGY LTD
BOEHRINGER INGELHEIM INTERNATIONAL GMBH, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., and BOEHRINGER INGELHEIM FREMONT, INC.
MEMORANDUM OPINION CONCERNING DOC. NO. 326
RICHARD A. LLORET U.S. MAGISTRATE JUDGE.
plaintiffs (collectively, “AbbVie”) have moved to
compel deposition testimony. Doc. No. 326 (“AV
Mot.”). AbbVie argues that the defendants'
(collectively, Boehringer) attorney improperly directed Dr.
Dougherty and Mr. Blanarik not to answer certain questions at
their depositions. Id. at 1. In addition, AbbVie
contends that various witnesses were not properly prepared to
testify about their designated topics. AV Mot. at 3-5.
to AbbVie, the questions directed to Dr. Dougherty
“related to the status of formulations for the accused
product, BI 695501.” Id. at 1. AbbVie alleges
that information about alternative formulations of
Boehringer's product developed by Boehringer may reveal
information relevant to secondary considerations of
non-obviousness, such as copying or commercial success. AV
Mot. at 2. As for Mr. Blanarik, the questions “related
to the launch and release of the accused product, BI
695501.” Id. at 1. AbbVie contends that
directing the witnesses not to answer was inappropriate, as
there was no protective order filed or granted. Id.
contends that it “did not instruct Dr. Dougherty not to
answer about ‘the status of formulations for the
accused product,' as AbbVie asserts.” Doc. No. 336,
at 2 n.2 (“BI Opp.”). Boehringer also argues that
before the depositions commenced, it had “agreed to
designate a witness to testify regarding formulations
considered in the course of development of the accused aBLA
product, but objected to discovery of unaccused potential
future products.” Id. at 1. Boehringer
contends that “potential launch-related
information” sought from Mr. Blanarik should be
off-limits, for reasons described in its earlier motion (Doc.
No. 243) objecting to AbbVie's Interrogatory No. 21.
Id. at 3. Finally, Boehringer asserts that its
designated witnesses were properly prepared to testify.
Id. at 3-5.
Civ. Pro. 30(c)(2) prohibits instructing a deposition witness
not to answer a question except to preserve a privilege,
enforce a limitation ordered by the court, or present a
motion to terminate or limit the deposition under R.
30(d)(3). Boehringer was not preserving a privilege, but
claims it was enforcing a limitation that it had sought
through a motion previously filed with the court that had not
been decided. BI Opp. at 1-2. Boehringer did not file a
motion to terminate or limit the depositions. Under the
circumstances I find that Boehringer acted in good faith, and
that the purpose of the rule will not be subverted by
deciding the motion on its merits.
to the merits, AbbVie does not elaborate on its argument that
questioning Dr. Daugherty about unaccused formulations might
uncover evidence of copying, from which favorable inferences
might be drawn about the non-obviousness of its inventions.
AV Mot. at 2. The argument is that evidence that one of
AbbVie's inventions or discoveries has been copied might
tend to rebut a contention that prior art made AbbVie's
patents obvious, and therefore invalid. AbbVie has made no
showing that copying has taken place in connection with the
accused product. Nor has there been any showing that copying
would be more likely in connection with the development of
unaccused but related products.
possible that evidence of copying may turn up, but the
possibility is disproportionate to the value of such
evidence, even if uncovered. “[P]roof of copying is
currently best viewed as only a weak form of circumstantial
proof of non-obviousness.” 3 Moy's Walker on
Patents, at 9-130 (West, 4th Ed. 2012); see
Ecolochem, Inc. v. Southern California Edison Co., 227
F.3d 1361, 1380 (Fed. Cir. 2000) (“a showing of copying
is only equivocal evidence of non-obviousness in the absence
of more compelling objective indicia of other secondary
considerations.”). In the context of biosimilar
litigation under the BPCIA, an inference of non-obviousness
from copying evidence is likely to be even less compelling
than usual. Cf. Santarus, Inc. v. Par Pharmaceutical,
Inc., 720 F.Supp.2d 427, 455 (D. Del. 2010) (copying is
“not compelling evidence of non-obviousness” due
to the nature of the ANDA process in Hatch-Waxman cases),
aff'd in part, rev'd in part on other grounds,
Santarus, Inc. v. Par Pharmaceutical, Inc., 694 F.3d
1344, 1347 (Fed. Cir. 2012); Purdue Pharma
Products L.P. v. Par Pharmaceutical, Inc., 377
Fed.Appx. 978, 983 (Fed. Cir. 2010) (not precedential)
(“we do not find compelling Purdue's evidence of
copying in the ANDA context where a showing of bioequivalency
is required for FDA approval.”). A kind of
“copying” is, in a sense, the foundation of the
BPCIA process. An applicant must show biosimilarity to a
reference drug to qualify for the aBLA pathway to approval.
The inference as to non-obviousness from evidence of copying
in this context would be feeble, at best.
also contends that discovery of unaccused products will bear
on Humira's commercial success, a recognized secondary
consideration. AV Mot. at 2. It is not immediately
apparent how discovery of non-public information about
products that may or may not be marketed by Boehringer in the
future will reflect in any useful way on the commercial
success of Humira. Neither is it immediately apparent why
AbbVie needs additional proof of the overwhelming commercial
success of Humira. The parties have from time to time bandied
about the annual revenues generated by Humira - an estimated
$13 billion per year. There is no legitimate dispute that
Humira has been commercially successful. Additional, marginal
evidence on the subject would not be worth the trouble it
takes to collect.
deny AbbVie's motion, insofar as it seeks to re-depose
Dr. Daugherty. The likely probative value of the inquiry
AbbVie seeks is negligible and is outweighed by the
likelihood of unfair harm to Boehringer through the
disclosure of sensitive competitive information.
questions about future launch plans, I ruled on AbbVie's
motion to compel an answer to their Interrogatory No. 21,
which concerned launch plans. See Doc. No. 429
(Order of February 25, 2019). I have also ruled on related R.
30(b)(6) deposition topics. See Doc. No. 359 (Order
of January 17, 2019), at 5, Topic 41 (concerning launch
plans). The Order of January 17, 2019 is presently before
Judge Goldberg, who will rule on AbbVie's objections. As
I have previously denied a deposition on launch plans (Topic
41, Order of January 17, 2019), I will deny the motion to
re-depose Mr. Blanarik. If my Order as to Topic 41 is
upended, or good cause for the deposition can be shown after
proceeding with the written discovery permitted in my Order
of February 25, 2019 concerning Interrogatory No. 21, AbbVie
may file a motion to reconsider this denial.
the alleged failure to properly prepare Fed. R. Civ. Pro.
30(b)(6) witnesses, the resolution of the dispute over
deposition topics may go far to resolve the dispute over
whether to re-depose Drs. Buske, Happersberger, and Studt. I
will deny AbbVie's motion with leave to reinstate the
motion after Judge Goldberg's ruling. After Judge
Goldberg's ruling and before filing a motion to reinstate
the motion to compel, counsel for ...