The opinion
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
KING DRUG CO. OF FLORENCE, : CIVIL ACTION
INC., et al. :
:
v. :
: NO. 19-3565
ABBOTT LABORATORIES, et al. :
MEMORANDUM
Bartle, J. April 25, 2022
Plaintiffs are direct-purchase wholesalers of
pharmaceutical drugs. They bring this civil antitrust action
under the Sherman Act against defendants Abbott Laboratories,
AbbVie Inc., AbbVie Products LLC, and Unimed Pharmaceuticals LLC
(collectively “AbbVie”),1 Besins Healthcare Inc. (“Besins”),
Actavis Holdco U.S. Inc., Actavis Inc., Paddock Laboratories
Inc., Par Pharmaceutical Inc., and Teva Pharmaceuticals USA Inc.
who are brand and generic drug manufacturers. See 15 U.S.C.
§§ 1-2. This action concerns generic competition for AndroGel
1%, a brand-name transdermal testosterone gel product developed
by AbbVie and Besins and approved by the United States Food and
Drug Administration (“FDA”) in 2000. AbbVie and Besins together
own U.S. Patent No. 6,503,894 (“‘894 patent”) for AndroGel 1%.
1. The court will use “AbbVie” to generally refer to all the
subsidiaries and predecessors of AbbVie Inc. including Solvay
Pharmaceuticals LLC, Abbott Products LLC, AbbVie Products LLC,
Plaintiffs have filed a motion to compel defendants
AbbVie and Besins to produce documents responsive to request for
production No. 52. That request seeks:
All documents concerning Abbvie’s, Unimed’s,
Besins’s or their agents’ assessment of the
materiality of the 1995 Supply Agreement (or
details relating to the shipments of
testosterone gel pursuant to the 1995 Supply
Agreement) or the 1995 License Agreement, or
Abbvie’s, Unimed’s, Besins’s, or their
agents’ consideration of whether to disclose
either of those agreements to the PTO during
the prosecution of the AndroGel Patents
between August 30, 2000 and September 15,
2015.
AbbVie and Besins object to the extent that the
request seeks documents protected by the attorney-client
privilege or the work product doctrine. Defendants also object
to this request in its entirety based on the limitations on
discovery incorporated into a Stipulation which the parties
signed and the court approved on December 22, 2020. Plaintiffs
assert that the attorney-client privilege and work product
doctrine have been waived and that the Stipulation does not
prevent the discovery sought here.
In support of waiver, plaintiffs cite the testimony of
Joseph Mahoney, the attorney who prosecuted the ‘894 patent in
the United States Patent and Trademark Office (“PTO”) on behalf
of AbbVie, in a deposition taken in antitrust litigation
regarding AndroGel 1% in the Northern District of Georgia. In
that deposition, Mahoney was asked about the 1995 Supply
Agreement between Unimed and Besins which allegedly involved the
sale of Androgel 1% and about his decision not to provide it to
the examiner in the PTO who was reviewing the application to
determine whether a patent should be granted. Plaintiffs cite
the following dialogue:
Q: Mr. Mahoney, during the time which you
were [] prosecuting the application that
became the ‘894 patent, were you aware of a
Supply Agreement between Unimed and Besins?
A: Yes.
Q: And did you make a decision not to
disclose that Supply Agreement to the patent
office?
A: Yes.
Q: And can you tell me why you decided not
to disclose that Supply Agreement to the
patent office?
A: It is non-material to patentability.
Q: And what do you base that conclusion on?
A: The –- what I recall is that we –- and
this would have been Tom Stieble and myself
–- were made aware of the License and Supply
Agreement between Unimed and Besins during
the prosecution of the ‘894 patent, and
we -- we looked at those agreements and the
joint development nature of those
agreements. We also had discussions with
our client related to the relationship
between Unimed and Besins.
The attorney for AbbVie, Jeffrey Weinberger, then
interjected to caution Mahoney that he did not want Mahoney “to
get into the substantive conversations with [Mahoney’s] client.”
Later in the deposition, the following exchange occurred between
counsel for plaintiffs and counsel for AbbVie:
Q [to Mahoney]: So where are you drawing the
line for attorney-client privilege here? It
sounds like you are describing your work
product and the analysis of whether or not
the Supply Agreement was material; is that
correct?
Mr. Weinberger: Well, I think –- I think
it’s up to us to draw the line, and we are
not allowing him to testify as to any
specific communications that he had with the
client, but I think the work product behind
the determinations made with respect to the
patent office is discoverable. So that’s
the line I am trying to draw.
Plaintiffs maintain that the information sought in
request No. 52 about the 1995 Supply Agreement is highly
relevant to their assertion that the ‘894 patent is invalid
because the invention claimed therein was on sale more than a
year before the patent’s filing date of August 30, 2000. See
35 U.S.C. § 102.
To decide the pending motion, it is important to
review the contours of the attorney-client privilege, the work
product doctrine, and the issue of waiver. The attorney-client
privilege protects from discovery confidential communications
between an attorney and client. Rhone-Poulenc Rorer, Inc. v.
Home Indem. Co., 32 F.3d 851, 862 (3d Cir. 1994). The client of
course may always waive the privilege. Id. at 863-64.2 The
party seeking to obtain privileged information has the burden of
proving that a waiver has occurred. Brigham & Women’s Hosp.
Inc. v. Teva Pharm. USA, Inc., 707 F. Supp.2d 463, 469 (D. Del.
2010).
The privilege, however, does not extend so far as to
protect the fact that communications between attorney and client
took place or the general nature or topics of those
communications. GFI, Inc. v. Franklin Corp., 265 F.3d 1268,
1273 (Fed. Cir. 2004). Rather it protects from disclosure the
substance of these conversations unless the privilege is waived.
Id.
Here, Mahoney, the attorney representing AbbVie in the
patent prosecution, did not cross the line at his deposition.
While he disclosed that conversations with the client occurred
concerning the relationship between Unimed and Besins, he did
not disclose the substance of those conversations. Hence the
attorney-client privilege was not waived.
2. Although neither plaintiffs nor defendants have raised the
issue of whether the client in this instance was the one to
waive any privilege, the court notes that an attorney may waive
attorney-client privilege when acting on behalf of the client.
See e.g., Shaffer v. Pennsbury Sch. Dist., 525 F. Supp. 3d 573,
577 (E.D. Pa. 2021) (citing Westinghouse Elec. Corp. v. Republic
of the Philippines, 951 F.2d 1414, 1420, 1431 (3d Cir. 1991);
Fid. & Deposit Co. of Md. v. McCulloch, 168 F.R.D. 516, 523
(E.D. Pa. 1996)).
The work product doctrine is distinct from the
attorney-client privilege. Westinghouse Elec. Corp. v. Republic
of the Philippines, 951 F.2d 1414, 1427-28 (3d Cir. 1991); In re
Grand Jury Proceedings, 604 F.2d 798, 801 (3d Cir. 1979);
Praxair, Inc. v. ATMI, Inc., 445 F. Supp. 2d 473, 480 n.9
(D. Del. 2006). The work product doctrine is designed to
protect the papers prepared by the attorney or on behalf of an
attorney in anticipation of litigation. Unlike the waiver of
the attorney-client privilege, a waiver related to an attorney’s
work product extends only to the documents disclosed and not
beyond. 6 James Wm. Moore et al., Moore’s Federal Practice
§ 26.70[6][c] (3d ed. 2022). Absent evidence to the contrary, a
patent prosecution before the PTO is not litigation or in
anticipation of litigation. See FTC v. AbbeVie, Inc., 2015 WL
8623076, at *4 (E.D. Pa. Dec. 14, 2015); see also Burroughs
Wellcome Co. v. Barr Labs., Inc., 143 F.R.D. 611, 617-18
(E.D.N.C. 1992). There is nothing before the court that
demonstrates there was any protectable attorney work product in
connection with the prosecution of the ‘894 patent. Thus there
can be no waiver of the attorney work product doctrine.
Even if there is no waiver here, there are documents
subject to the request for production No. 52 that are not
confidential communications between attorney and client and are
not papers that are an attorney’s work product. Defendants, in
opposing the motion to compel, rely on the Stipulation of the
parties putting limits on the voluminous discovery in this
action. The Stipulation was designed to avoid duplicative and
unnecessary production of documents that were already produced
and available from earlier related lawsuits in the federal
courts in the Northern District of Georgia and in this court,
the Eastern District of Pennsylvania. See In re AndroGel
Antitrust Litig. (No. II), Civil Action No. 09-2084 (N.D. Ga.);
FTC v. AbbVie Inc., Civil Action No. 14-5151 (E.D. Pa.).
As previously stated, in their request for production
No. 52, plaintiffs seek the following:
All documents concerning Abbvie’s, Unimed’s,
Besins’s or their agents’ assessment of the
materiality of the 1995 Supply Agreement (or
details relating to the shipments of
testosterone gel pursuant to the 1995 Supply
Agreement) or the 1995 License Agreement, or
Abbvie’s, Unimed’s, Besins’s, or their
agents’ consideration of whether to disclose
either of those agreements to the PTO during
the prosecution of the AndroGel Patents
between August 30, 2000 and September 15,
2015.
The plaintiffs in the Georgia litigation previously
sought in July 2010 from Unimed and Solvay, now AbbVie, the
following:
All documents relating to communications
with counsel (both in-house and outside)
regarding: (a) your basis for any belief
held at any time that the ‘894 patent was or
was not valid, enforceable and/or infringed;
(b) your investigation of any Paragraph IV
certification made with respect to the ‘894
patent; (c) your decision to initiate the
AndroGel Patent Litigation; (d) the reasons
for settling the AndroGel Patent Litigation;
(e) your consideration of whether any of the
Generic Defendants would seek to market a
generic “at risk” at any time while the
AndroGel Patent Litigation was pending;
(f) the likely outcome(s) of the AndroGel
Patent Litigation.
In that same request for production, the plaintiffs sought from
Unimed and Solvay “[f]or the period starting in August 30, 2000,
all documents relating to any discussion, communication, or
question relating to disclosure of information to the U.S.
Patent and Trademark Office during prosecution of the ‘777
Application or any related application.”3 Similarly, the
plaintiffs in the Georgia litigation subpoenaed Besins in August
2010 for “[a]ll documents relating to any discussion,
communication, or question relating to disclosure of information
to the U.S. Patent and Trademark Office during prosecution of
the ‘777 Application or any related application.”
Plaintiffs’ present request for production No. 52 to
AbbVie and Besins is duplicative of the production sought in
2010 in the Georgia litigation and therefore is barred by the
Stipulation. The Stipulation signed by the parties in this
action states that “[t]he parties agree that all documents . . .
produced in the Georgia Action by any Defendant in the
Pennsylvania Action (or by any affiliate or predecessor of any
3. The application number for the ‘894 patent was 09/651,777.
Defendant) shall be deemed produced in the Pennsylvania Action.”
The Stipulation further provides that “Plaintiffs agree that
AbbVie, Actavis, Inc., Par and Paddock, and Besins (“Georgia
Entities”) will not be required to conduct a re-search of their
files for categories of documents related to the 2006 Agreements
or otherwise duplicative of discovery already produced in the
Georgia Action.”
Plaintiffs argue that Judge Thomas W. Thrash in the
Georgia litigation denied plaintiffs’ February 2016 request for
production which sought from AbbVie:
Describe any good faith justifications for
(1) Dr. Dudley’s and Mr. Mahoney’s failure
to disclose to the USPTO during the
prosecution of the ‘894 Patent (a) the
Supply Agreement, and (b) the Pre-Critical
Date Transfers of testosterone gel pursuant
to the Supply Agreement; (2) Mr. Mahoney’s
statement to the USPTO during the
prosecution of the ‘894 Patent that “the
claimed invention was not sold, offered for
sale, or used publicly before the critical
date” . . . and (3) Dr. Dudley’s statement
to the USPTO during the prosecution of the
‘894 Patent that “at no time before
AndroGel’s approval by the FDA did Unimed or
Besins sell or offer to sell the AndroGel
formulation to any third party.
Plaintiffs in the Georgia litigation, however, had
already sought this information from both AbbVie and Besins in
their 2010 requests for production. Plaintiffs argue that
defendants did not produce the information sought in those 2010
requests. There is no evidence before the court, however, that
plaintiffs moved within a reasonable time to compel the
requested information. The fact that they later sought the
information in 2016 and were denied as out of time does not
change the fact that they previously sought this information in
2010 in the Georgia litigation.
For the foregoing reasons, the court will deny
plaintiffs’ motion to compel production of documents responsive
to request for production No. 52.