ABRAXIS BIOSCIENCE, LLC et al v. ACTAVIS LLC
MEMORANDUM OPINION. Signed by Magistrate Judge Mark Falk on 5/25/2017. (JB, )
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
ABRAXIS BIOSCIENCE, LLC,
Civil Action No. 16-1925 (JMV)
Before the Court is the motion of Plaintiffs, Abraxis BioScience LLC and Celgene
Corporation (together “Celgene”), for the issuance of a letter rogatory to a third-party
company in Canada, BioVectra, Inc. Defendant Actavis opposes the motion. No oral
argument is necessary. For the reasons stated below, the motion is GRANTED.
This Hatch-Waxman patent infringement case arises out of Actavis’s filing of an
Abbreviated New Drug Application (“ANDA”) with the United States Food and Drug
Administration (“FDA”) seeking approval to market a generic version of Celgene’s
Abraxane® product, which is used to treat breast, lung, and pancreatic cancer.
Abraxane® is comprised of two ingredients: (1) the anti-cancer drug paclitaxel, which
was approved by the FDA more than 20 years ago and sold under a different name; and
(2) human serum albumin, a naturally occurring protein made by the liver in the human
body.1 In Abraxane®, the paclitaxel is bound to the albumin in what are referred to as
albumin-bound paclitaxel particles.
The Complaint was filed on April 6, 2016. Celgene contends that Actavis’s
accused ANDA product would infringe four patents: U.S. Patent Nos. 8,853,260 (“‘260
patent”); 7,820,788 (“‘788 patent”); 7,923,536 (“‘536 patent”); and 8,138,229 (“‘229
patent”). The initial scheduling conference was held on August 3, 2016, and an initial
scheduling order was entered on August 18, 2016. Discovery technically closes on June
29, 2017. However, as the Court recently explained in a separate Opinion granting a
recent motion by Actavis to amend its invalidity contentions, Abraxis BioScience, LLC v.
Actavis, LLC, 2017 WL 2079647 (D.N.J. May 15, 2017), discovery is really still in the
The current motion2 is Celgene’s request for the issuance of a letter rogatory
seeking discovery in Canada from a third-party, BioVectra Inc. BioVectra is a
pharmaceutical company that performs part of the manufacturing of Actavis’s ANDA
product, and Celgene claims that it is the only source of certain relevant materials,
including samples of the starting materials comprising the ANDA product. Celgene’s
The two ingredients are, at times, referred to as the “starting materials.”
The “motion” is comprised of four letters dated March 10, 2017; March 16, 2017;
March 27, 2017; and April 7, 2017.
request is comprised of seven document requests and three categories of deposition
testimony that closely track the requests. Celgene contends that Actavis lacks standing to
object to its letter rogatory to a third-party, and that Actavis itself has conceded that the
raw materials used to produce its ANDA product are not in its possession, custody or
control, but rather reside with BioVectra.
Actavis counters that Celgene’s proposed discovery is expensive, time-consuming,
overbroad, irrelevant, and duplicative. It claims that Celgene could obtain any relevant
discovery more effectively through party-discovery in the case. Actavis also claims that
Celgene delayed in seeking to issue letters rogatory and that allowing foreign discovery
would jeopardize the schedule and timing of the case.
Federal Rule of Civil Procedure 28(b)(2)(A) provides that a discovery may be had
in a foreign country pursuant to a letter rogatory “on appropriate terms after an
application and notice of it.” Fed. R. Civ. P. 28(b)(2)(A); see also 28 U.S.C. § 1781. In
effect, the party seeking to issue a letter rogatory is asking the United States, through this
Court, to request the assistance of a foreign country in obtaining discovery:
A letter rogatory is defined as the medium, in effect, whereby one
country, speaking through one of its courts, requests another
country, acting through its own courts and by methods of court
procedure peculiar thereto and entirely within the latter’s control,
to assist the administration of justice in the former country; such
request being made, and being usually granted, by reason of the
comity existing between nations in ordinary peaceful times.
DBMS Consultants Ltd. v. Computer Assoc., Int’l, 131 F.RD. 367, 369 (D. Mass. 1990)
(internal quotes omitted).
“On an application for the issuance of a letter rogatory seeking a deposition in a
foreign country, the Court will not ordinarily weigh the evidence to be elicited by
deposition and will not determine whether the witness will be able to give the anticipated
testimony.” Id. “[S]ome good reason must be shown by the opposing party for a court to
deny an application for a letter rogatory.” Jovanovic v. Northrop Grumman Corp., 2008
WL 4950064, at *1 (D.N.J. Nov. 18, 2008). Ultimately, the decision to issue letters
rogatory is a discretionary one. Id.; see also Leasco Data Processing Equip. Co. v.
Maxwell, 63 F.R.D. 94 (S.D.N.Y. 1973).
Celgene claims that the letter rogatory process is necessary in this case
because, during discovery, it has become apparent that important materials, including
samples of the starting materials, are in the possession of BioVectra. Celgene claims that
it requested samples of each ingredient used to manufacture the ANDA product from
Actavis, but that Actavis ultimately advised, in March 2017, that it did not have the
materials and that BioVectra is the only source. According to Celgene, “[f]or that
reason,” it “promptly prepared the attached Letter Rogatory seeking discovery from
BioVectra.” (Pl.’s Letter dated March 10, 2017 at 2.). While the proposed letter seeks
more than samples of the core ingredients, it is certainly the driving force behind the
application. For the reasons that are detailed below, the Court is satisfied that Celgene
has made a sufficient showing to proceed with the letter rogatory proposed.
First, samples of the starting materials are sufficiently relevant, see, e.g.,
SmithKline Beecham Grp. v. Apotex Corp., 1999 WL 311697, at *6 (N.D. Ill, May 13,
1999); see also Medtronic Ave, Inc., v. Advanced Cardiovascular Sys., 2004 WL 115594,
at *3 (D. Del. Jan. 13, 2004), especially since there are disputes over the adequacy of the
sample ANDA product defendant has provided.3 And there is no dispute that, if anyone,
BioVectra would be the company that has the materials.4 That alone is a compelling
reason to grant Celgene’s request.
Second, the Court is satisfied that the request is timely. The record shows that the
discussion relating to samples of the underlying starting materials started around
September 20, 2016, and that meet-and-confer conversation about the issue lasted until
March 1, 2017. (See Pl.’s Letter dated March 27, 2017, at 3.) Celgene’s opening
The parties have a separate discovery dispute, currently being briefed, in which
Celgene claims that Actavis provided effectively-expired samples of its ANDA product and
should be compelled to create new, unexpired product or incur a spoliation reference. This
dispute was discussed on-the-record with the Court at a recent case management conference.
See Transcript of Case Management Conference dated April 25, 2017, at 9-11. And, in the
course of that discussion, it seemed possible, whether through the letter rogatory process or
otherwise, communication with, and the involvement of, BioVectra could be necessary.
While that dispute will be decided separately, it does provide some context for the letter
rogatory request in this case.
In its April 7, 2017 letter, Actavis states that ingredients are “unavailable” from
BioVectra, and that the letter request should be denied on that basis. (Id. at 3.) However,
during the subsequent case management conference on April 25, Actavis’s counsel conceded
he was not sure what ingredients BioVectra has, see Transcript of Case Management
Conference dated April 25, 2017, at 9:9-17.
application was filed less than 10 days later.
Third, the standard for the issuance of letters rogatory is relatively lenient and
discretionary, and the Court is satisfied that allowing Celgene to serve its letter will not
unduly delay the case, as there remains other discovery to complete before the case is
ready for motion practice and trial. Indeed, the fact that the case is still in the early stages
was an important factor in granting Actavis’s request for leave to amend its invalidity
contentions, which was filed after Celgene’s current request for foreign discovery, see
Abraxis BioScience, LLC v. Actavis, LLC, 2017 WL 2079647, at *3 (D.N.J. May 15,
Fourth, even assuming that Actavis has standing to object to the letter rogatory,
which the parties dispute,5 the Court finds both the samples and documents requested to
be sufficiently relevant within the scope of Rule 26. In the context of an application for a
letter rogatory, the request may be granted even if “the admissibility is not immediately
apparent, as long as the inquiry is reasonably calculated to lead to the discovery of
admissible evidence.” See, e.g., Brake Parts, Inc. v. Lewis, 2009 WL 1939039, at *4
(E.D. Ky. July 6, 2009)6; see also DBMS Consultants, 131 F.RD. at 369-70. Schedule A
Celgene claims that Actavis lacks standing to object to a letter rogatory directed to
a third-party; Actavis contends otherwise. No binding authority is cited and non-binding
cases have been cited for both views. For purposes of completeness, the Court assumes that
Actavis has standing.
The quoted Brake Parts language traces a prior version of Rule 26’s well-known
relevance standard that governed the scope of discovery prior to amendments to the Federal
Rules of Civil Procedure effective December 1, 2015. However, the current language of
to the letter request contains 7 demands that seek documents and communications relating
to, inter alia, manufacture of albumin-bound paclitaxel nanoparticles; stability studies
regarding same; comparative studies relating to the active ingredients; and testing
regarding any albumin-bound paclitaxel nanoparticles. (Pl.’s Letter dated March 27,
2017, at Ex. 3.) The deposition topics cover the same ground. (Id.) While the parties
engage in argument regarding the true benefit of the information and whether it would be
ultimately be admissible, there is nothing facially improper or overbroad about the
requests, which seem targeted to the subject matter involved and proportionate to the
needs of this large patent case.
Fifth, to the extent there is any burden involved with complying with the request it
would be on BioVectra, not Actavis. The Court has not received any papers from
BioVectra stating that compliance with the letter rogatory would be unduly burdensome
or expensive. There are limited document demands and deposition topics. And the
parties are seemingly speculating about what kind of burden this will impose on
BioVectra. More fundamentally, much of Actavis’s claim of burden is based on its
argument that it can provide some of the discovery requested, and therefore, there is no
need for BioVectra to be involved. Plaintiff is not, however, required to accept
information only from Defendant, and is within its rights to seek relevant discovery from
Rule 26 would also support the request, especially considering “the importance of the issues
at stake in the action, the amount in controversy, the parties’ relative access to relevant
information, [and] the parties’ resources.” Fed. R. Civ. P. 26(b)(1). This is a patent case
involving substantial sums, in monetary terms.
non-parties, including BioVectra. See, e.g., Brake Parts, 2009 WL 1939039, at *4 (“The
Magistrate Judge is also unpersuaded . . . that [applicant] should first make efforts to
obtain the discovery from [defendant] before it would be entitled to [letters rogatory].
The fact that the same information may be available from two different sources does not
excuse one of those sources from producing the information.”).
Based on the above, Celgene’s motion for the issuance of a letter rogatory is
GRANTED. An appropriate order will be entered.
Counsel should arrange issuance of the executed Letter Rogatory. Any delay may
cause the Court to reconsider its decision.
United States Magistrate Judge
DATED: May 25, 2017
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