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 AND ORDER CONCERNING DOC. NO. 69.
HONORABLE RICHARD A. LLORET UNITED STATES MAGISTRATE JUDGE.
AbbVie has moved under Fed. R. Civ.
Pro. 26(b)(2)(C) for a protective orderstaying responses
to eight third-party subpoenas issued by
Boehringer. Doc. No. 69 (“AV Mot.”).
Boehringer has responded. Doc. No. 76 (“BI
Res.”). AbbVie filed a reply. Doc. No. 84 (“AV
third party subpoenas seek information related to three
clinical studies related to adalimumab, known as HUMIRA, the
drug at the center of this case. The three studies are the
ARMADA study, which concerned rheumatoid arthritis (number
DE009), a continuation of the ARMADA study (number DE009X),
and the ATLAS study, which concerned ankylosing spondylitis
(number M03-607). AbbVie Mot. at 4. AbbVie argues that these
subpoenas are duplicative of information already requested
from AbbVie, are unduly burdensome, and seek irrelevant
information. Id. AbbVie also claims that the
subpoenas jeopardize AbbVie's “key
relationships” with customers and clinical
investigators. Id. Boehringer disputes AbbVie's
contentions. BI Mem. at 6-9.
26(c) places the burden of persuasion on the party seeking
the protective order. . . [T]he party seeking the protective
order must show good cause by demonstrating a particular need
for protection. Broad allegations of harm, unsubstantiated by
specific examples or articulated reasoning, do not satisfy
the Rule 26(c) test.
v. Liggett Grp., Inc., 785 F.2d 1108, 1121 (3d Cir.
1986). “Good cause is established on a showing that
disclosure will work a clearly defined and serious injury to
the party seeking closure. The injury must be shown with
specificity.” Pansy v. Borough of Stroudsburg,
23 F.3d 772, 786 (3d Cir. 1994) (internal quotation and
factors guide the evaluation of good cause: “relevance,
need, confidentiality and harm.” Mannington Mills,
Inc. v. Armstrong World Industries, Inc., 206 F.R.D.
525, 529 (D.Del. 2002) (citing to Micro Motion, Inc. v.
Kane Steel Co., Inc., 894 F.2d 1318, 1323 (Fed. Cir.
1990). “[E]ven if the information sought is relevant,
discovery is not allowed where no need is shown, or where
compliance is unduly burdensome, or where the potential harm
caused by production outweighs the benefit.”
is a forgiving standard, even when evaluating evidence to be
admitted at trial. Fed.R.Evid. 401. During discovery the
question is whether the information sought is “relevant
to any party's claim or defense and proportional to the
needs of the case . . .” Fed. R. Civ. Pro. 26(b)(1).
Boehringer explains that the clinical trial documents it
seeks from third parties may be relevant to its public use
defense. BI Res. at 6-7; see 35 U.S.C. § 102(b)
(2000). The documents are also directed to obtaining
documents AbbVie is unlikely to have, and to check the
completeness of the discovery produced by AbbVie.
Id. at 7-9.
public use defense is available if an “invention was .
. . in public use or on sale in this country, more than one
year prior to the date of the application for patent in the
United States.” Invitrogen Corp. v. Biocrest Mfg.,
L.P., 424 F.3d 1374, 1379 (Fed. Cir. 2005) (quoting 35
U.S.C. § 102(b)) (emphasis omitted). Boehringer's
theory of relevance is that details about the use of the drug
during the clinical trial process may establish the defense.
How the clinical trials were conducted - “the nature of
the activity that occurred in public; public access to the
use; confidentiality obligations imposed on members of the
public who observed the use; and commercial
exploitation” - may bear on a public use defense.
Id. at 1380 (citing to Allied Colloids, Inc. v.
Am. Cyanamid Co., 64 F.3d 1570, 1574 (Fed.Cir. 1995)).
argues that the “proper focus of any public use inquiry
was on the party in control of the clinical trials, ”
not the patients. AV Rep. at 2 (citing Dey, L.P. v.
Sunovion Pharmaceuticals, Inc., 715 F.3d 1351, 1358
(Fed. Cir. 2013)). AbbVie overstates the holding in
Dey. The Federal Circuit held only that patient
“clinical trial at-home use of the formulation of Batch
3501A without an affirmative confidentiality
obligation” did not doom Dey's patents.
Id. at 59. The decision did not hold that
communications with patients were categorically irrelevant.
Instead, it held only that the district court could not
“discount the relevance of the study participants'
limited knowledge of Batch 3501A's formulation or . . .
sidestep disputed factual questions about the nature of the
allegedly public use[, ]” because “a reasonable
jury could conclude that if members of the public are not
informed of, and cannot readily discern, the claimed features
of the invention in the allegedly invalidating prior art, the
public has not been put in possession of those
features.” Id. This is a far cry from holding
that communications between health care providers and
participants in a clinical study are irrelevant.
theory of relevance is not make-weight. Details of the
clinical testing process and protocols, and communications
with patients, are reasonably calculated to produce relevant
evidence concerning a public use defense. See Fed.
R. Civ. Pro. 26(b)(1) (“Parties may obtain discovery
regarding any nonprivileged matter that is relevant to any
party's claim or defense and proportional to the needs of
the case . . . [i]nformation within this scope of discovery
need not be admissible in evidence to be
is enhanced when information is uniquely available from the
party from whom it is sought. The corollary is that need is
diminished when the information is available
elsewhere.” Avago Technologies U.S., Inc. v.
IPtronics Inc., 309 F.R.D. 294, 299-300 (E.D.Pa., 2015)
(quoting American Standard Inc. v. Pfizer Inc., 828
F.2d 734, 743 (Fed. Cir. 1987)). Need is especially salient
when a subpoena to third parties covers information available
from a litigant. AbbVie contends that the clinical trial
information is available from AbbVie, and has been requested
by Boehringer. AV Mot. at 1. A review of the subpoenas,
compared to Boehringer's requests for production, reveal
that there is considerable overlap, although not exact
congruence. Id. at 2-3.
argues that the discovery seeks information related to patent
invalidity - their “public use” defense. BI Res.
at 7-8. Boehringer points out that the subpoenas seek
information that AbbVie has refused to produce, and that some
of the information is unlikely to be in AbbVie's
possession. Id. at 8. The ...