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. 138
RICHARD A. LLORET, U.S. MAGISTRATE JUDGE.
defendants (collectively, “Boehringer”) have
moved to compel the production of prelitigation disclosures
from another suit between the plaintiffs (collectively,
“AbbVie”) and Amgen, as well as settlement
agreements that AbbVie concluded with potential biosimilar
competitors to its drug, Humira. Doc. No. 138 at
(“BI. Mot.”). I have reviewed the parties'
submissions and will grant Boehringer's motion, with
provision for the parties' counsel to meet and confer
about confidentiality terms.
3B and 3C contentions are discoverable.
and Amgen engaged in prelitigation disclosures and litigation
under the Biosimilar Price Competition and Innovation Act
(“BPCIA”) starting in 2016. The case concerned
seven of the eight patents in suit in this case. Id.
AbbVie and Amgen settled the case in 2018. Id. at 3;
see Doc. No. 138-2 (press release). The
prelitigation disclosures in the Amgen case spelled out the
parties' contentions regarding validity and infringement.
argues that the “BPCIA provides a carefully balanced
mechanism for parties to make a confidential and informal
exchange of positions to facilitate potential agreement on
the scope of litigation.” Doc. No. 140 at 2-3
(“AV Opp.”). AbbVie also argues that Boehringer
fails to establish the “relevance and proportionality
of the BPCIA exchanges under Rule 26.” Id. at
3. AbbVie particularly objects to providing Amgen's
contentions, questioning how Amgen's contentions could be
relevant, since they have no tendency to make a fact of
consequence to this litigation more or less likely.
Id. at 4 (citing to Fed.R.Evid. 401).
BPCIA requires a biosimilar applicant (such as Amgen, in the
previous litigation) to disclose confidential information
about its drug to the reference product sponsor (in both the
Amgen case and in this one, AbbVie). 42 U.S.C. § 262
(1)(1)(B)(i), (1)(2). The purpose is to permit the reference
product sponsor to figure out which patents it claims are
infringed by the biosimilar drug. Id. at § 262
(1)(1)(D), (1)(2). The disclosures by the biosimilar
applicant are to be kept confidential and used by the
reference product sponsor only for the purpose intended under
the statute. Id. at § 262 (1)(1)(C) and (D).
The information may be disclosed with the consent of the
biosimilar applicant, which must not be unreasonably
withheld. Id. at § 262 (1)(1)(C). Amgen has
consented to the disclosure sought by Boehringer, subject to
court order and the maintenance of
the biosimilar applicant's information has been turned
over to the reference product sponsor, the sponsor must give
the applicant a list of patents it claims are infringed by
the biosimilar. Id. at § 262 (1)(3)(A). The
applicant then provides a claim-by-claim, detailed
explanation of its contentions about the patents that it
argues are invalid or not infringed (or both). Id.
at 262 (1)(3)(B). The sponsor then provides the applicant a
detailed explanation of why the patents identified by the
applicant under § 262 (1)(3)(B) are valid and infringed.
Id. at § 262(1)(3)(C). These last two
conflicting sets of contentions - the so-called 3B and 3C
contentions - are what Boehringer seeks. The BPCIA has much
to say about the confidentiality of the biosimilar
applicant's (Amgen) information disclosed under 42 U.S.C.
§ 262(1)(1) but does not provide for separate or
additional confidentiality for the contentions required under
§ 262(1)(3)(B) and (C).
contentions by AbbVie are statements by a party that may be
used against the party, provided they are relevant.
Fed.R.Evid. 801(d)(2)(A). Since seven of the eight patents in
suit were also part of the Amgen case, it is likely that the
3C contentions are relevant, at least in part, under
Fed.R.Evid. 401's liberal standard of relevance.
contentions by Amgen likely are relevant to supply the
context of the 3C contentions. Producing the 3C contentions
without the 3B contentions would be like producing a
transcript of one side of a telephone conversation, or
producing the answer to a complaint without the complaint.
The exercise seems fruitless. Both sides of the dialogue are
relevant and admissible, for different reasons. If the party
statement is relevant, it is admissible non-hearsay when used
against the party making the statement. Fed.R.Evid.
801(d)(2)(A). The other side of the dialogue is relevant and
admissible not for its truth, but because it makes the party
statements understandable by putting them in context. See
United States v. Hendricks, 395 F.3d 173, 184 (3d Cir.
2005) (a cooperating witness' side of a taped
conversation was not hearsay because it was not introduced
for its truth, but to place the defendant's side of the
conversation in context).
and 3C disclosures are reasonably relevant to this case. They
can be disclosed with minimal burden, provided reasonable
confidentiality protections are followed. The minimal burden
of production is far outweighed by the potential probative
value of the disclosures to resolution of the issues in this
case. See Fed. R. Civ. Pro. 26(b)(1). AbbVie will
produce the requested 3B and 3C disclosures, subject to the
terms of the current protective order entered in this case,
and subject to its confidentiality obligations under the
protective order in the Amgen case, as described in
footnote 3, supra. The parties' counsel will
meet and confer to iron out the terms of disclosure, which
should include review by outside counsel only. If they cannot
agree I will impose terms.
settlement agreements are discoverable.
also moves to compel the production of settlement agreements
that AbbVie reached with Amgen, Samsung Bioepis, and Mylan,
companies who seek to market a biosimilar drug in competition
with adalimumab. BI. Mot. at 2. I find that the settlement
agreements are likely to be relevant to Boehringer's
invalidity and unenforceability defenses, are easily
identifiable and producible without undue burden, are within
the control of AbbVie and not accessible to Boehringer, and
are routinely produced in patent litigation, with adequate
confidentiality protections. See Allergan, Inc. v. Teva
Pharmaceuticals USA, Inc., 2017 WL 132265, at *1 (E.D.
Tex. Jan. 12, 2017) (“Courts have frequently ordered
the production of such agreements, subject to appropriate
guarantees of confidentiality”) (collecting cases);
Fed. R. Civ. Pro. 26(b)(1) (listing factors that must be
considered when ruling on the scope of discovery). That is
not the end of the analysis, however.
cites to the opinion in Spear v. Fenkell, 2015 WL
3947559, at *2 (E.D. Pa. June 26, 2015), arguing that
Boehringer has not borne its burden to make a particularized
showing that the settlement agreements are likely to be
relevant to a permitted purpose under Fed.R.Evid. 408. Rule
408(a) bars the introduction of agreements, conduct, or
statements made as part of compromise negotiations. The rule
excepts such evidence for “another purpose, ” and
provides examples, though the examples are not meant to be
exclusive. Fed.R.Evid. 408(b). Spear was an ERISA
case decided under Third Circuit law. There is a legitimate
question whether the heightened standard explained in
Spear is applicable in this patent case, subject as
it is to Federal Circuit law. BI Mot. at 3 n.2 (citing to
Blue Gentian, LLC v. Tristar Prods., Inc., 2017 WL
5203044 at *3 (D.N.J. Mar. 21, 2017) (“federal circuit
law governs disputes over the discoverability” of a
settlement agreement in a patent case).
the frequency with which courts have ordered the production
of settlement agreements in patent cases, see
Allergan, 2017 WL 132265, at *1, and cases cited, it may
be that the discovery rule in the Federal Circuit is less
demanding than that described in Spear.
Nevertheless, the Federal Circuit has rejected discovery of
settlement agreements where there has been no showing of the
“materiality of the settlement agreement[, ]”
being “mindful, as was the district court, of the
policy in favor of protecting settlement negotiations from
being admitted as evidence, thus ...