Roxane Laboratories, Inc. v. Abbott Laboratories

Filing 100

OPINION AND ORDER granting 82 motion to compel. Signed by Magistrate Judge Norah McCann King on 4/30/13. (rew)

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.

OPINION AND ORDER
This matter is before the Court on the motion to compel
production of documents filed on behalf of defendants Abbott
Laboratories and AbbVie Inc. (“Defendants’ Motion to Compel”), Doc.
No. 82, and memorandum in support (“Defendants’ Memorandum”), Doc. No.
83, plaintiff Roxane Laboratories, Inc.’s Opposition to Defendants’
Motion to Compel Production of Documents (“Plaintiff’s Response”),
Doc. No. 89, and defendants’ reply, Reply in Support of
Defendants’/Counter-Plaintiffs’ Motion to Compel Production of
Documents (“Defendants’ Reply”), Doc. No. 96.

For the reasons that

follow, Defendants’ Motion to Compel is GRANTED.
I.

Background
AbbVie is the holder of approved New Drug Application (“NDA”) No.

22-417 for ritonavir tablets, 100 mg, which defendants market and sell
under the tradename Norvir®.

Defendants’ Answer, Affirmative

Defenses, and Counterclaims to Plaintiff’s Amended Complaint
(“Defendants’ Answer”), Doc. No. 58, ¶ 13.

AbbVie also holds the

regulatory exclusivities associated with that NDA.

Id.

Plaintiff 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.”

Amended Complaint, ¶ 16.

Plaintiff instituted this action 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 defendants and relating to the drug Norvir®.
13.

See id. at ¶¶ 1, 11-

Plaintiff alleges, inter alia, that the asserted claims of the

’359 and ’752 patents are obvious over certain prior art references.
Id. at ¶¶ 22, 27.

Defendants have responded by asserting

counterclaims for patent infringement, alleging that plaintiff’s ANDA
filing infringed the ’359 and ’752 patents under 35 U.S.C. §
271(e)(2)(A).

Defendants’ Answer, pp. 6, 14.

Defendants now seek 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.”1

Defendants’ Memorandum, p. 2.

“Those

document requests sought, inter alia, documents pertaining to

1

Defendants’ current request is narrower in scope than the actual requests
made in Defendants’ Document Request Nos. 8-13, 15-19, 21-28, 30-31, 34-46,
48-57, 82-87, and 91. See Defendants’ Memorandum, pp. 4-5.

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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.”
II.

Defendants’ Memorandum, p. 3.

Standard
Rule 37 of the Federal Rules of Civil Procedure authorizes a

motion to compel discovery when a party fails to provide a proper
response to requests for production of documents under Rule 34.
R. Civ. Pro. 37(a)(3)(B).

Fed.

“The proponent of a motion to compel

discovery bears the initial burden of proving that the information
sought is relevant.”

Martin v. Select Portfolio Serving Holding

Corp., No. 1:05–cv–273, 2006 U.S. Dist. LEXIS 68779, at *2 (S.D. Ohio
Sept. 25, 2006) (citing Alexander v. Fed. Bureau of Investigation, 186
F.R.D. 154, 159 (D.D.C. 1999)).
Rule 26(b) provides that “[p]arties may obtain discovery
regarding any nonprivileged matter that is relevant to any party’s
claim or defense.”

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

purposes is extremely broad.
F.3d 389, 402 (6th Cir. 1998).

Relevance for discovery

Lewis v. ACB Bus. Servs., Inc., 135
“The scope of examination permitted

under Rule 26(b) is broader than that permitted at trial.

The test is

whether the line of interrogation is reasonably calculated to lead to
the discovery of admissible evidence.”

Mellon v. Cooper-Jarrett,

Inc., 424 F.2d 499, 500-01 (6th Cir. 1970).

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

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(6th Cir. 2007) (citing Fed. R. Civ. P. 26(b)(2)).

See also Lewis,

135 F.3d at 402 (determining the proper scope of discovery falls
within the broad discretion of the trial court).

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)).
Finally, the party moving to compel discovery must certify that
it “has in good faith conferred or attempted to confer with the person
or party failing to make disclosure or discovery in an effort to
obtain it without court action.”
S.D. Ohio Civ. R. 37.2.

Fed. R. Civ. P. 37(a)(1).

See also

This prerequisite has been met in this case.

III. Discussion
The parties disagree whether documents related to ritonavir
formulations other than those disclosed in ANDA 202573 are relevant in
this action.

Defendants argue that “the requested documents are

directly relevant to objective evidence of nonobviousness of the
inventions claimed in the [patents-in-suit], including the secondary
considerations of copying, commercial success, and benefits of the
claimed invention.”

Defendants’ Memorandum, p. 2.

Plaintiff argues

that documents relating to ritonavir formulations other than those in
ANDA 202573 “are not relevant to secondary considerations of nonobviousness of the patents-in-suit, and could not reasonably be used
to establish copying, commercial success, or benefits of the claimed
invention,” because defendants have “not articulated any nexus between
any other ritonavir formulation and the patents-in-suit.”

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Plaintiff’s

Response, PAGEID 2909.

Plaintiff also argues that the document

requests are “cumulative, duplicative, [] wholly unnecessary,” and
“unduly burdensome.”

Id. at PAGEID 2909, 2914.

A patent is invalid for obviousness “if the differences between
the claimed invention and the prior art are such that the claimed
invention as a whole would have been obvious before the effective
filing date of the claimed invention to a person having ordinary skill
in the art to which the claimed invention pertains.”

35 U.S.C. § 103.

Obviousness is a question of law with several underlying factual
inquiries, including “(1) the scope and content of the prior art; (2)
the level of ordinary skill in the pertinent art; (3) the differences
between the claimed invention and the prior art; and (4) evidence of
secondary factors, such as commercial success, long-felt need, and the
failure of others.”

In re Antor Media Corp., 689 F.3d 1282, 1293

(Fed. Cir. 2012) (citing Graham v. John Deere Co. of Kan. City, 383
U.S. 1, 17-18 (1966)).

The party asserting invalidity of a patent

based on obviousness must demonstrate by clear and convincing evidence
that the claimed patent would have been obvious to a person of
ordinary skill in the art at the time the invention was made.

See

Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120,
1124 (Fed. Cir. 2000).
Defendants argue, first, that copying is relevant to secondary
considerations of nonobviousness in an ANDA action.
Memorandum, pp. 6-7.

Defendants’

Defendants, they argue, “should be entitled to

obtain documents relevant to Roxane’s investigation of these

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alternative formulations, as they are relevant to the secondary
consideration of copying.”

Id. at p. 7.

Defendants’ argument fails to persuasively explain how the
requested documents, i.e, documents related to formulations other than
those in ANDA 202573, are relevant to whether the claimed invention
was copied.

A showing of bioequivalency is required for FDA approval

of an Abbreviated New Drug Application, Bayer Healthcare Pharm., Inc.
v. Watson Pharm., Inc., Nos. 2012-1397, 2012-1398, 2012-1400, 20121424, 2013 WL 1606014, at *7 (Fed. Cir. Apr. 16, 2013) (“Such evidence
of copying in the ANDA context is not probative of nonobviousness
because a showing of bioequivalence is required for FDA approval.”);
Purdue Pharma Prods. L.P. v. Par Pharm., Inc., 377 F. App’x 978, 983
(Fed. Cir. 2010), and plaintiff concedes that its ritonavir product is
the bioequivalent to Norvir®.

Amended Complaint, ¶ 16.

It is the

formulation in the ANDA that must be a bioequivalent and it is the
ANDA formulation that is relevant in determining whether plaintiff
copied the claimed invention.

Plaintiff’s other formulations are

simply not relevant to whether the claimed invention was copied by
plaintiff or any other entity.

Defendants are not precluded from

offering evidence of copying; plaintiff apparently concedes that
evidence of copying has some relevance in ANDA litigation.

See

Plaintiff’s Response, PAGEID 2913 (arguing that copying is “minimally
relevant” and of “limited relevance” in ANDA litigation because courts
have not found it to be “compelling”).

However, the documents related

to plaintiff’s “investigation of and/or decision not to pursue” other

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ritonivar formulations are not likely to lead to the discovery of
evidence of copying.
Defendants next argue that the requested documents are relevant
to the issue of commercial success, another secondary consideration.
Defendants’ Memorandum, p. 9.

Specifically, defendants argue that the

requested documents concern plaintiff’s “investigation into
alternative formulations, including market analyses, financial models
or surveys into the relevant market and sales of the alternative
ritonavir formulations.”

Id.

Plaintiff respond that the requested

documents are not relevant to the issue of commercial success because
defendants have not established a nexus between other ritonavir
formulations and the patents-in-suit.
2909, 2911-12.

Plaintiff’s Response, PAGEID

Defendants reply that such a nexus is not a necessary

predicate to the discovery of otherwise discoverable information;
defendants insist that they are “seeking the requested documents to
further support the nexus between Norvir® tablets and the claimed
inventions of the ’359 and ’752 patents.”

Defendants’ Reply, p. 4.

“Evidence of commercial success, or other secondary
considerations, is only significant if there is a nexus between the
claimed invention and the commercial success.”

Ormco Corp v. Align

Tech., Inc., 463 F.3d 1299, 1311-12 (Fed. Cir. 2006).

“The term

‘nexus' is used, in this context, to designate a legally and factually
sufficient connection between the proven success and the patented
invention, such that the objective evidence should be considered in
the determination of nonobviousness.”

In re Paulsen, 30 F.3d 1475,

1482 (Fed. Cir. 1994) (quotations omitted) (quoting Demaco Corp v. F.

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Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)).
The patentee bears the burden of proving the existence of that nexus.
See, e.g., Crocs, Inc. v. Int’l Trade Comm’n, 598 F.3d 1294, 1310-11
(Fed. Cir. 2010).

Nevertheless, a patentee need not prove the

existence of a nexus in order to discover otherwise relevant
information; the information sought to be discovered need only be
relevant to a party’s claim or defense.

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

Defendants contend that the information sought is relevant to the
issue of commercial success.

Defendants’ Memorandum, p. 9.

Commercial success is based on the conduct of consumers relative to
the success of competitors.

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.
Having determined that the information defendants seek is
relevant, and thus discoverable, the Court must now consider

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plaintiff’s argument that the document requests are “cumulative,
duplicative, [] wholly unnecessary,” and “unduly burdensome.”
Plaintiff’s Response, PAGEID 2909-11, 2914.

Plaintiff’s argument that

the document requests seek cumulative, duplicative, and wholly
unnecessary information is premised on its argument that the documents
are not relevant.

See id.

This argument is without merit because, as

discussed supra, defendants’ document requests seek relevant
information.
Plaintiff next argues that the requests are unduly burdensome
because “Roxane does not have a centralized electronic document
system,” it “would have to ask hundreds of employees to search their
electronic documents,” and it would “require significant effort to
review and produce.”

Id. at PAGEID 2909, 2914.

Plaintiff also

suggests that a Rule 30(b)(6) deposition “would be a far less
burdensome method of obtaining [this] discovery.”

Id. at PAGEID 2914.

Plaintiff has not demonstrated that the requested discovery would
be unduly burdensome.

Specifically, plaintiff has provided no

information regarding the number of documents that might fall within
the scope of the challenged document requests, the time and expenses
that would be required to compile response to those requests, or the
potential disruption of plaintiff’s business operations caused by its
efforts to respond to defendants’ document requests.

The mere fact

that a party may not have a centralized electronic document system
does not insulate that party from all discovery efforts and does not
itself establish that the current discovery requests are unduly
burdensome.

Although plaintiff asserts that a Rule 30(b)(6)

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deposition would be less burdensome, absent a demonstration that
defendants’ document requests in this regard pose unreasonable burden,
defendants will be permitted to pursue the particular method of
discovery preferred by them.
Accordingly, Defendants’ Motion to Compel, Doc. No. 82, is
GRANTED.
Plaintiff is ORDERED 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.

April 30, 2013

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

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