IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF ILLINOIS 

EASTERN DIVISION

CUMBERLAND PHARMACEUTICALS 

INC., 

Plaintiff,

v.

MYLAN INSTITUTIONAL LLC, and 

MYLAN INC.,

Defendants.

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NO. 1:12-CV-03846

JUDGE REBECCA PALLMEYER

MAGISTRATE JUDGE MARIA VALDEZ

DEFENDANTS MYLAN INSTITUTIONAL LLC AND MYLAN INC.’S MEMORANDUM IN 

SUPPORT OF ITS MOTION TO STRIKE CUMBERLAND PHARMACEUTICALS INC.’S 

FINAL INFRINGEMENT CONTENTIONS

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-iTABLE OF CONTENTS

I. INTRODUCTION .................................................................................................................... 1

II. BACKGROUND ...................................................................................................................... 1

III. CUMBERLAND’S NEW ALLEGATIONS SHOULD BE STRICKEN ................................ 3

A. Legal Standard .............................................................................................................. 3

B. Cumberland’s New Arguments Are Untimely And Prejudicial ................................... 4

C. Mylan Is Prejudiced By Cumberland’s Delay .............................................................. 5

IV. IN THE ALTERNATIVE, MYLAN SEEKS LEAVE TO WITHDRAW ITS 

MOTION FOR SUMMARY JUDGMENT AND MOVES FOR COSTS AND 

FEES RELATED TO THAT MOTION................................................................................... 5

V. CONCLUSION......................................................................................................................... 6

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-iiTABLE OF AUTHORITIES

CASES 

Connectel, LLC v. Cisco Sys., Inc., 

391 F.Supp.2d 526 (E.D. Tex. 2005)........................................................................................ 3

O2 Micro Int’l, Ltd. v. Monolithic Power Sys., Inc., 

467 F.3d 1355 (Fed. Cir. 2006)............................................................................................. 3, 4

The Nat’l Spiritual Assembly of the Baha‘is of the U. S. of Am. Under the Hereditary 

Guardianship, Inc., v. Nat’l Spritual Assembly of the Baha’is of the U. S. of 

Am., Inc., 

547 F.Supp.2d 879 (N.D. Ill. 2008).......................................................................................... 4

RULES 

Fed. R. Civ. P. 16(f).............................................................................................................................. 3

L.P.R. Preamble .................................................................................................................................... 3

L.P.R. 2.2-2.5 Comments...................................................................................................................... 3

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Defendants Mylan Institutional LLC and Mylan Inc. (“Mylan”), respectfully submit this 

memorandum in support of their motion to strike Plaintiff Cumberland Pharmaceuticals Inc.’s 

(“Cumberland”) Local Patent Rule 3.1 Final Infringement Contentions (“Final Infringement 

Contentions”) with regard to U.S. Patent No. 8,148,356 (“the ‘356 patent”). 

I. INTRODUCTION 

Cumberland filed this lawsuit more than a year ago alleging that Mylan is liable for 

infringement of the ‘356 patent. Despite filing a patent lawsuit in this district, Cumberland 

consistently failed to comply with the local rule that requires early disclosure of infringement 

allegations. Cumberland’s obviously deficient contentions are the subject of Mylan’s pending 

motion for summary judgment of non-infringement, which was filed on October, 2012.

After months of refusing to comply with the local rules, on May 8, 2013, nearly a year after it 

filed this case and at the last possible moment when its final infringement contentions were due, 

Cumberland, for the first time, provided its infringement contentions regarding all of the asserted 

claim limitations. This conduct is a violation of the local rules and the Court’s scheduling order. 

Accordingly, Mylan now moves to strike Cumberland’s belated contentions or, in the alternative, for 

leave to withdraw its Motion for Summary Judgment and for its costs associated with that motion.

II. BACKGROUND 

On May 17, 2012, Cumberland filed the present suit alleging that Mylan’s ANDA 203624 

generic acetylcysteine intravenous injection product (“ANDA product”) infringes the ‘356 patent. 

Cumberland did so after declining to accept Mylan’s offer of confidential access which would have 

permitted Cumberland to examine the confidential details of the accused product prior to alleging 

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that it infringed a patent. ¶¶ 20-21.1 On July 16, 2012, Cumberland provided its initial infringement 

contentions pursuant to the Local Patent Rules, stating only (1) the name of the ANDA product 

somehow demonstrated infringement; (2) a “lack of denial” of infringement in Mylan’s paragraph 

IV Notice Letter somehow functioned as an admission; and (3) bare citation to a statute, regulation 

and a handful of pages from Mylan’s ANDA. ¶ 28; D.I. 53 (“Motion For Summary Judgment”) at 7-

14. On July 30, 2012, Mylan served its Initial Non-Infringement Contentions which explained that 

Cumberland failed to meet its burden of proving infringement; Cumberland did not respond or 

remedy its failure. ¶¶ 43-51.

On Sept. 4, 2012, Mylan filed a Motion to Dismiss Cumberland’s complaint and, pursuant to 

the Court’s order, re-filed its motion as a Motion for Summary Judgment on Sept. 10, 2012. ¶¶52-

54. On October 31, 2012, Cumberland opposed Mylan’s Motion for Summary Judgment, making 

new arguments and ignoring the content of its own Initial Infringement Contentions. D.I. 72 

(“Opp.”). On November 15, 2012, Mylan replied, noting that even considering the information 

provided for the first time in Cumberland’s Opp., Cumberland still did not state why it contends that 

Mylan’s ANDA product meets every limitation of the asserted claims. D.I. 82 (“Rep.”). In the 6 

months that followed, Cumberland did not amend its contentions.

On May 8, 2013, almost a full year after this case was filed, Cumberland served its Final 

Infringement Contentions containing multiple new arguments and citations.2 Ex. 13. In doing so, 

 1 Citations to “¶ __” refers to paragraphs in Mylan’s Rule 56.1 Statement of Facts filed with 

Mylan’s Motion for Summary Judgment (D.I. 54)

2 Despite these new arguments, Cumberland’s still has not demonstrated infringement; however 

claim construction is now required to resolve the remaining issues. 

3 Citations to “Ex.” refers to exhibits attached to the Declaration of Wendy Devine, filed 

herewith.

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Cumberland violated the letter and spirit of the local rules and forced Mylan to wait a year to 

discover why Cumberland brought this suit, thereby causing unnecessary delay and Mylan resources.

III. CUMBERLAND’S NEW ALLEGATIONS SHOULD BE STRICKEN 

A. Legal Standard

The Local Patent Rules “require the parties to provide the particulars behind allegations of 

infringement...at an early date. Because Federal Rule of Civil Procedure 11 requires a party to have 

factual and legal support for allegations in its pleadings, early disclosure of the basis for each side’s 

allegations will impose no unfair hardship...at an early stage of the case.” See LPR, Preamble 

(emphasis added). Generally, patent rules are “designed specifically to require the parties to 

crystallize their theories of the case early in the litigation so as to prevent the ‘shifting sands’ 

approach to claim construction.” O2 Micro Int’l, Ltd. v. Monolithic Power Sys., Inc., 467 F.3d 1355, 

1364 (Fed. Cir. 2006). Indeed, “[t]o accomplish this purpose, the parties disclosures must be 

meaningful – as opposed to boilerplate – and non-evasive.” See LPR 2.2-2.5 Comments; see also

Connectel, LLC v. Cisco Sys., Inc., 391 F.Supp.2d 526, 527-28 (E.D. Tex. 2005) (“‘The Patent Rules 

demonstrate high expectations as to plaintiffs’ preparedness before bringing suit, requiring plaintiffs 

to disclose their preliminary infringement contentions before discovery has even begun.’.... 

Plaintiffs are expected to rigorously analyze all publicly available information before bringing suit 

and must explain with great detail their theories of infringement.”). Therefore, when initial 

infringement contentions are not specific, it prejudices the alleged infringer in preparation for the 

case. See id. at 528 (“Because of these deficiencies, [the alleged infringer] is unable to crystallize its 

non-infringement and invalidity theories, and the parties are hindered in identifying what claim 

terms need construction.”).

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The Court has the inherent ability to “issue any just orders...if a party...(c) fails to obey a 

scheduling or other pretrial order.” Fed. R. Civ. P. 16(f); see also, e.g., O2 Micro, 467 F.3d at 1363 

(“The court may impose any ‘just’ sanction for the failure to obey a scheduling order, including 

‘refusing to allow the disobedient party to support...designated claims or defenses, or prohibiting 

that party from introducing designated matters in evidence.’”); The Nat’l Spiritual Assembly of the 

Baha‘is of the U. S. of Am. Under the Hereditary Guardianship, Inc., v. Nat’l Spritual Assembly of 

the Baha’is of the U. S. of Am., Inc., 547 F.Supp.2d 879, 884 (N.D. Ill. 2008) (it is an “axiom that 

‘courts have inherent power to enforce compliance with their lawful orders through civil contempt’”) 

(internal citation omitted).

B. Cumberland’s New Arguments Are Untimely And Prejudicial

The Local Patent Rules require disclosure of infringement contentions early in the case, yet 

Cumberland did not provide contentions regarding all elements of the asserted claims until nearly a 

year after filing its complaint. Further, Cumberland’s Final Infringement Contentions allege – for 

the first time – a new theory of infringement: contributory infringement. Ex. 1 at 6 (“Mylan and 

Mylan’s Accused Instrumentality...contributorily infringes the patents-in-suit.”) Nowhere in 

Cumberland’s Initial Infringement Contentions is there even a reference to contributory 

infringement.4 Likewise, Cumberland’s Final Infringement Contentions also add multiple additional 

arguments, citations and documents that were not addressed in its Initial Infringement Contentions. 

As an example, Cumberland presents several new arguments and rationales regarding the claim 

limitation “free from a chelating agent.” Id. at Exhs. 1 & 2. As another example, Cumberland, for 

the first time, fully addresses the claim limitation requiring “a headspace volume occupied by a 

pharmaceutically inert gas.” Id. Notably, the majority of the Mylan documents that Cumberland 

 4 Indeed, nowhere in Cumberland’s Final Infringement Contentions is there any explanation for 

how or why Mylan would contributorily infringe the ‘356 patent. 

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cites in support of these new arguments were already in Cumberland’s possession when it provided 

its Initial Infringement Contentions. Id.; ¶ 26. 

There is no reason why the basis for Cumberland’s infringement allegation was not included 

in its Initial Infringement Contentions or any supplement thereto. To hide the basis of Cumberland’s 

infringement allegations until a year into the case violates the letter and spirit of the Local Patent 

Rules.

C. Mylan Is Prejudiced By Cumberland’s Delay

The importance of the infringement contentions cannot be understated and Mylan is aware of 

the seriousness of the remedy requested by this motion and the pending Motion for Summary 

Judgment. Mylan, however, has already been prejudiced by Cumberland’s delay tactics. 

Specifically, Mylan requires this basic information to properly prepare its defenses and has been 

hindered in its ability to formulate noninfringement theories and identify terms for construction. 

Mylan therefore, requests that the Court strike Cumberland’s Final Infringement Contentions 

regarding the ‘356 patent and grant Mylan’s pending Motion for Summary Judgment for the ‘356 

patent.

IV. IN THE ALTERNATIVE, MYLAN SEEKS LEAVE TO WITHDRAW ITS 

MOTION FOR SUMMARY JUDGMENT AND MOVES FOR COSTS AND 

FEES RELATED TO THAT MOTION 

In the event that the Court decides not to strike Cumberland’s Final Infringement 

Contentions, Mylan requests leave to withdraw its Motion for Summary Judgment and recover the 

costs and fees incurred by Mylan in connection with the motion. It is through no fault of Mylan’s 

that Cumberland chose to wait over a year into the case to provide disclosure of its basis for bringing 

suit. During this time, Mylan spent resources boxing shadows including filing the original Motion to 

Dismiss, the subsequent Motion for Summary Judgment and engaging in related communications 

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with Cumberland – all in an effort to obtain an understanding of why Cumberland brought this case 

in the first place. ¶¶ 52-57. This situation is exactly what the Local Patent Rules were designed to 

avoid. At the Court’s request, Mylan will file supplemental papers that detail the precise fees and 

costs for which it seeks reimbursement due to Cumberland’s abuse of the local rules.

V. CONCLUSION 

For the reasons set forth above, Mylan respectfully requests that the Court strike 

Cumberland’s Final Infringement Contentions for the ‘356 patent and grant Mylan’s Motion for 

Summary Judgment. In the alternative, Mylan respectfully requests that the Court grant it leave to 

withdraw its Motion for Summary Judgment and award Mylan its fees and costs associated with the 

motion.

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Dated: May 24, 2013

Of Counsel:

T.O. Kong (tkong@wsgr.com)

WILSON SONSINI GOODRICH & ROSATI

PROFESSIONAL CORPORATION

One Market Street

Spear Tower, Suite 3300

San Francisco, California 94105

(415) 947-2000

Nicole Stafford (nstafford@wsgr.com)

Robert A. Delafield II (bdelafield@wsgr.com)

WILSON SONSINI GOODRICH & ROSATI

PROFESSIONAL CORPORATION

900 South Capital of Texas Highway

Las Cimas IV, Fifth Floor

Austin, Texas 78746-5546

Telephone: 512-338-5400

Facsimile: 512-338-5499

Elham Steiner (esteiner@wsgr.com)

Wendy Devine (wdevine@wsgr.com)

WILSON SONSINI GOODRICH & ROSATI

PROFESSIONAL CORPORATION

12235 El Camino Real, Suite 200

San Diego, California 92130

Telephone: 858-235-2300

Facsimile: 858-350-2399

Nancy Zhang (nzhang@wsgr.com)

WILSON SONSINI GOODRICH & ROSATI

PROFESSIONAL CORPORATION

650 Page Mill Road

Palo Alto, California 94304-1050

Telephone: 650-849-3073

Facsimile: 650-493-6811

Respectfully submitted,

By: /s/ Steven P. Mandell_______

Steven P. Mandell (ARDC #6183729)

Steven L. Baron (ARDC #6200868)

Elizabeth Morris (ARDC #6297239)

MANDELL MENKES LLC

1 N. Franklin, Suite 3600

Chicago, IL 60606

Telephone: 312-251-1000

Facsimile: 312-251-1010

Attorneys for Defendants Mylan Institutional LLC. 

and Mylan Inc. 

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CERTIFICATE OF SERVICE

The undersigned hereby certifies that a true and correct copy of the above and foregoing 

document has been served on May 24, 2013 to all counsel of record deemed to have consented to 

electronic service via the Court’s CM/ECF system. 

Any other counsel of record will be served by electronic mail and regular mail.

/s/ Steven P. Mandell

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