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 

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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®. See id. at ¶¶ 1, 11-

13. 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.” Defendants’ Memorandum, p. 3. 

II. 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. Fed. 

R. Civ. Pro. 37(a)(3)(B). “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). Relevance for discovery 

purposes is extremely broad. Lewis v. ACB Bus. Servs., Inc., 135 

F.3d 389, 402 (6th Cir. 1998). “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.” Fed. R. Civ. P. 37(a)(1). See also

S.D. Ohio Civ. R. 37.2. 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.” Plaintiff’s 

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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. Defendants’ 

Memorandum, pp. 6-7. 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, 2012-

1424, 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. Plaintiff’s Response, PAGEID 

2909, 2911-12. 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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