Roxane Laboratories, Inc. v. Abbott Laboratories

Filing 186

ORDER granting in part (172) Sealed Motion in case 2:12-cv-00312-MHW-NMK; granting in part (124) Sealed Motion in case 2:13-cv-00645-MHW-NMK. AbbVie's request for an award of attorneys' fees incurred in connections with its motion is DENIED. Discovery due by 5/19/14; Primary expert reports due by 6/16/14. Signed by Magistrate Judge Norah McCann King on 4/4/14. (jr1)

IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF OHIO
EASTERN DIVISION

ROXANE LABORATORIES, INC.,
Plaintiff,
vs.

Civil Action 2:12-cv-312
Judge Watson
Magistrate Judge King

ABBOTT LABORATORIES, et al.,
Defendants.

ABBVIE, INC.,
Plaintiff,
Civil Action 2:13-cv-645
Judge Watson
Magistrate Judge King

vs.

ROXANE LABORATORIES, INC.,
Defendant.

OPINION AND ORDER
I.

Background
The Court has previously set forth the background of this

consolidated action:
[AbbVie, Inc.] is the holder of approved New Drug
Application (“NDA”) No. 22-417 for ritonavir tablets, 100
mg, which is marketed and sold under the trade name
Norvir®.
No. 2:12-cv-312 (S.D. Ohio), Doc. No. 58, ¶ 13.
[AbbVie, Inc.] also holds the regulatory exclusivities
associated with that NDA. Id. [Roxane Laboratories, Inc.]
has submitted Abbreviated New Drug Application No. 202573
(“ANDA 202573”) to the United States Food and Drug
Administration in order “to obtain regulatory approval to
engage in the commercial manufacture, use, or sale of
generic oral ritonavir tablets, 100 mg,” which are the
“bioequivalent” to Norvir®, “before the expiration of the

Listed Patents.”
No. 2:12-cv-312
Complaint, Doc. No. 56, ¶ 16.

(S.D.

Ohio),

Amended

Roxane filed suit in this Court on April 10, 2012 at 4:25
p.m., seeking a declaration of invalidity and noninfringement in connection with Patent Nos. 7,148,359 (the
“̔359 patent”) and 7,364,752 (the “̔752 patent”) held by
[Abbott and AbbVie, Inc.] and relating to the drug Norvir®.
See id. at ¶¶ 1, 11-13.
At 11:51 pm on that same day,
Abbott filed suit in the United States District Court for
the District of Delaware, alleging that Roxane’s ANDA
infringed Abbott’s ‘359 patent, ‘752 patent, and Patent
Nos. 5,648,497 (the “̔497 patent”), 6,037,157 (the “̔157
patent”), and 6,703,403 B2 (the “̔403 patent”), all related
to the drug Norvir®.
2:13-cv-645 (S.D. Ohio), Complaint,
Doc. No. 1, ¶ 3; 2:13-cv-645 (S.D. Ohio), Amended
Complaint, Doc. No. 8, ¶ 3. That action was transferred to
this Court on June 18, 2013. Id., Order, Doc. No. 65.
. . .
On July 23, 2013, the parties’ July 9, 2013 joint motion to
consolidate the Ohio action and the transferred action was
granted. No. 2:12-cv-312 (S.D. Ohio), Doc. No. 120; No.
2:13-cv-645 (S.D. Ohio), Doc. No. 69.
No. 2:12-cv-312 (S.D. Ohio), Opinion and Order, Doc. No. 128, pp. 2-5.
On February 26, 2013, AbbVie, Inc., and Abbott Laboratories, Inc.
(collectively “AbbVie”), filed a motion to
compel production of documents related to plaintiff’s
“investigation of and/or decision not to pursue: (1) a
ritonavir oral solution and/or capsule formulation and (2)
a non-solid dispersion tablet formulation of ritonavir,
which fall within the scope of Defendants’ Document Request
Nos. 8-13, 15-19, 21-28, 30-31, 34-46, 48-57, 82-87, and
91.”
“Those document requests sought, inter alia,
documents pertaining to ritonavir formulations other than
the formulation Roxane disclosed in its [ANDA] 202573,
which Roxane filed with the FDA to seek approval to sell a
generic version of Defendants’ Norvir® solid-dispersion
tablets.”
Opinion and Order, Doc. No. 100, pp. 2-3 (internal citations and
footnote omitted).

The Court granted AbbVie’s motion to compel on

April 30, 2013, reasoning that the requested discovery was relevant to
the secondary consideration of commercial success of the Norvir®

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tablets.

Id. at pp. 7-10.

The Court ordered Roxane “to produce

documents in its possession, custody, or control that relate to its
investigation of and/or decision not to pursue: (1) a ritonavir oral
solution and/or capsule formulation and (2) a non-solid dispersion
tablet formulation of ritonavir.”

Id.

Roxane’s objections to that

order, Doc. No. 105, were overruled on July 23, 2013.

Doc. No. 120.

This matter is now before the Court for consideration of AbbVie’s
motion to compel Roxane to comply with the Court’s April 30, 2013
order.

Abbott Laboratories and AbbVie Inc.’s Motion to Compel Roxane

Laboratories, Inc.’s Compliance with the Court’s Prior Orders
(“AbbVie’s Motion to Compel”), 2:12-cv-312, Doc. No. 172; 2:13-cv-645,
Doc. No. 124.
II.

Standard
Rule 26(b) provides that parties may “obtain discovery regarding

any nonprivileged matter that is relevant to any party’s claim or
defense.”

Fed. R. Civ. P. 26(b)(1).

is extremely broad.
(6th Cir. 1998).

Relevance for discovery purposes

Lewis v. ACB Bus. Servs., Inc., 135 F.3d 389, 402

However, “district courts have discretion to limit

the scope of discovery where the information sought is overly broad or
would prove unduly burdensome to produce.”

Surles ex rel. Johnson v.

Greyhound Lines, Inc., 474 F.3d 288, 305 (6th Cir. 2007) (citing Fed.
R. Civ. P. 26(b)(2)).

In determining the proper scope of discovery, a

district court balances a party’s “right to discovery with the need to
prevent ‘fishing expeditions.’”

Conti v. Am. Axle & Mfg. Inc., 326 F.

App’x 900, 907 (6th Cir. 2009) (quoting Bush v. Dictaphone Corp., 161
F.3d 363, 367 (6th Cir. 1998)).

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Rule 37 of the Federal Rules of Civil Procedure authorizes
sanctions when a party fails to obey an order to provide or permit
discovery, including an order under Rule 37(a).
37(b)(2)(A).

Fed. R. Civ. P.

A court has wide discretion in determining an

appropriate sanction under Rule 37.

Nat’l Hockey League v. Metro.

Hockey Club, 427 U.S. 639 (1976); First Bank of Marietta v. Hartford
Underwriters Ins. Co., 307 F.3d 501, 510 (6th Cir. 2002).
III. Discussion
AbbVie’s February 2013 motion to compel sought the production of
documents on the presumption that Roxane had made the decision not to
pursue other ritonavir formulations.

It is now apparent that Roxane

did in fact pursue a ritonavir capsule formulation; Roxane filed an
ANDA on a ritonavir capsule formulation in December 2013.
In the instant motion, AbbVie seeks to compel production of
documents relating to Roxane’s “ongoing investigation of a ritonavir
capsule formulation, including documents that mention, support, or
comprise its ritonavir capsule ANDA.”
4.

AbbVie’s Motion to Compel, p.

AbbVie argues that Roxane’s failure to produce the requested

documents violates the Court’s April 30, 2013 order requiring Roxane
to “produce documents in its possession, custody, or control that
relate to its investigation of and/or decision not to pursue” a
ritonavir capsule formulation.

Roxane opposes AbbVie’s motion,

arguing that the requested discovery falls outside the scope of the
Court’s order and is not otherwise relevant to the consolidated
action.

Roxane Laboratories, Inc.’s Opposition to Abbott Laboratories

and AbbVie Inc.’s Motion to Compel (“Roxane’s Response”), 2:12-cv-312,

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Doc. No. 176; 2:13-cv-645, Doc. No. 128.

Specifically, Roxane argues

that “[t]he capsule ANDA itself is not part of the decision-making
process to pursue the ANDA.

The ‘investigation’ had already concluded

and Roxane never made a ‘decision not to pursue’ the product.”

Id. at

PAGEID 13282.
The parties essentially dispute whether Roxane’s ritonavir
capsule ADNA falls within the scope of the “investigation of . . . a
ritonavir . . . capsule formulation.”

If the capsule ADNA is part of

the “investigation,” then the Court’s prior order requires its
production; if the capsule ADNA is not part of the “investigation,”
then AbbVie’s request falls outside the scope of the Court’s order.
In granting AbbVie’s February 2013 motion to compel, the Court’s
April 2013 Opinion and Order found that documents related to Roxane’s
“investigation of and/or decision not to pursue . . . a ritonavir oral
solution and/or capsule formulation” were relevant to the issue of
commercial success:
In this case, the commercial success of defendants’
ritonavir tablets is considered in relation to the success
of competing formulations of ritonavir, presumably other
oral solutions or capsules or non-solid dispersion tablets.
See Ormco Corp., 463 F.3d at 1311-12 (commercial success is
usually shown by significant sales in a relevant market).
If plaintiff investigated and decided not to pursue other
formulations of ritonavir, then it likely developed or
obtained market analyses, financial models, or surveys into
the relevant market and, in doing so, compiled sales data
of
the
alternative
ritonavir
formulations.
This
information is directly relevant to whether the claimed
invention is, or is not, commercially successful because,
as noted supra, the commercial success of a claimed
invention is to be measured relative to the commercial
success of its competition.
Opinion and Order, Doc. No. 100, p. 8.

Although the Opinion and Order

phrased relevancy in terms of Roxane’s decision “not to pursue other

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formulations of ritonavir,” the rationale underlying that Opinion and
Order is equally applicable to Roxane’s apparent decision to pursue
other formulations of ritonavir: If Roxane investigated and decided to
pursue other formulations of ritonavir, then it likely developed or
obtained market analyses, financial models, or surveys of the relevant
market and, in doing so, compiled sales data of the alternative
ritonavir formulations.

This information is directly relevant to

whether the claimed invention is, or is not, commercially successful
because, as noted supra, the commercial success of a claimed invention
is to be measured relative to the commercial success of its
competition.
Roxane argues that the capsule ADNA falls outside the scope of
the Court’s April 2013 Opinion and Order because the ADNA is not
relevant to commercial success, which was the basis for the Court’s
relevancy determination.
not well taken.

Roxane’s Response, p. 4.

This argument is

Although the Court articulated relevancy in terms of

commercial success when ruling on AbbVie’s February 2013 motion to
compel, the Court’s April 2013 Opinion and Order was not so limited;
the Court ordered Roxane “to produce documents in its possession,
custody, or control that relate to its investigation of . . . a
ritonavir . . . capsule formulation.”

Opinion and Order, Doc. No.

100, p. 10.
The parties disagree whether Roxane’s capsule ADNA falls within
the “investigation” of a capsule ritonavir formulation or whether the
“investigation” had concluded before Roxane drafted the ADNA.
distinction is, however, inconsequential, as the ADNA, and the

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The

documents referenced in the ADNA, are certainly “relate[d] to
[Roxane’s] investigation of . . . a ritonavir . . . capsule
formulation.”

Id. (emphasis added).

Accordingly, AbbVie’s Motion to Compel, 2:12-cv-312, Doc. No.
172; 2:13-cv-645, Doc. No. 124, is GRANTED in part.

Because the Court

also finds that Roxane’s interpretation of the Court’s April 30, 2013
order was substantially justified, AbbVie’s request for an award of
attorneys’ fees incurred in connection with its motion is DENIED.

See

Fed. R. Civ. P. 37(a)(5)(A)(ii).
Roxane is ORDERED to produce its capsule ADNA by April 18, 2014.
The pretrial schedule in these consolidated cases is MODIFIED as
follows:
The date by which all fact discovery must be completed is
EXTENDED to May 19, 2014.
The date by which each party must produce the report of primary
experts on issues on which that party bears the burden of proof is
EXTENDED to June 16, 2014.

April 4, 2014

s/Norah McCann King_______
Norah McCann King
United States Magistrate Judge

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