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The Medicines Co. v. Mylan Inc.

United States District Court, N.D. Illinois, Eastern Division

March 19, 2013

THE MEDICINES COMPANY, Plaintiff,
v.
MYLAN INC., MYLAN PHARMACEUTICALS INC., and BIONICHE PHARMA USA, LLC, Defendants

As Redacted March 28, 2013.

Page 895

[Copyrighted Material Omitted]

Page 896

For The Medicines Company, Plaintiff, Counter Defendant: John Bostjancich, Patricia Susan Smart, Smart & Bostjancich, Chicago, IL; Mark P Walters, Frommer Lawrence & Haug LLP, Seattle, WA; Porter F. Fleming, Frommer Lawrence & Haug LLP, New York, NY.

For Mylan Inc., Mylan Pharmaceuticals Inc., Bioniche Pharma USA, LLC, Defendants: David E. Jones, LEAD ATTORNEY, PRO HAC VICE, Autumn N. Nero, PRO HAC VICE, David J. Harth, PRO HAC VICE, Emily J. Greb, PRO HAC VICE, Perkins Coie Llp, Madison, WI; James B Coughlan, Perkins Coie LLP, Chicago, IL; Scott D. Eads, PRO HAC VICE, Perkins Coie Llp, Portland, OR; Shannon M. Bloodworth, PRO HAC VICE, Perkins Coie Llp, Washington, DC.

For Bioniche Pharma USA, LLC, Mylan Pharmaceuticals Inc., Mylan Inc., Counter Claimants: Scott D. Eads, LEAD ATTORNEY, Perkins Coie Llp, Portland, OR; Autumn N. Nero, David J. Harth, Emily J. Greb, Perkins Coie Llp, Madison, WI; James B Coughlan, Perkins Coie LLP, Chicago, IL; Shannon M. Bloodworth, Perkins Coie Llp, Washington, DC.

For Bioniche Pharma USA, LLC, Counter Claimant: Autumn N. Nero, David J. Harth, Emily J. Greb, Perkins Coie Llp, Madison, WI; James B Coughlan, Perkins Coie LLP, Chicago, IL; Shannon M. Bloodworth, Perkins Coie Llp, Washington, DC.

OPINION

Page 897

AMY J. ST. EVE United States District Court Judge.

REDACTED MEMORANDUM OPINION AND ORDER

Before the Court is Defendants' motion to compel testimony and production of information withheld on the basis of privilege by Plaintiff pursuant to Federal Rule of Civil Procedure (" Rule" ) 37(a). (R. 184, Mot. to Compel.) Specifically, Defendants seek production of (1) privileged and non-privileged documents and items in Plaintiff's possession mentioning, discussing, listing, or otherwise relating to Angiomax® Lot No. 1344985; (2) privileged and non-privileged documents mentioning, reflecting, or relating to communications between attorneys or employees of Frommer Lawerence & Haug law firm (" Frommer" ) and The Medicine Company (" TMC" ) scientist Dr. Rajeshwar Motheram; (3) Dr. Motheram for a follow-up deposition on the subject of TMC's additional document production as described in this Order; and (4) all documents reflecting payment or non-payment for Lot No. 1344985 and any claim of loss TMC made for the Active Pharmaceutical Ingredient used in making that lot. ( Id. ) On January 17, 2013, the Court granted Defendants' motion to compel as to all documents reflecting payment or non-payment for Lot No. 1344985 in addition to any claim of loss TMC made for the active ingredients used in production. (1/17/13 Status Transcript at 7:18.) In addition, the Court granted the requests to re-depose Dr. Motheram regarding the non-privileged aspects of his conversation with Dr. Kuzmich. ( Id. at 11:5.) At issue here is Defendants' request to compel production of documents and communications related to Lot No. 1344985, documents related to communications between attorneys and employees at Fromer and Motheram, and the scope of the follow-up deposition of Dr. Motheram.

For the following reasons, the Court grants in part and denies in part the remaining aspects of Defendants' motion to compel.

BACKGROUND

I. Patents-in-Suit

Plaintiff TMC brought this lawsuit against Defendants Mylan Inc., Mylan Pharmaceuticals Inc., and Bioniche Pharma USA, LLC (collectively, " Mylan" ), asserting that Mylan infringed U.S. Patent Nos. 7,582,727 (the " '727 Patent" ) and 7,598,343 (the " '343 Patent," and collectively with the '727 Patent, the " patents-in-suit" ). The patents-in-suit pertain to pharmaceutical formulations of Bivalirudin and the processes of making Bivalirudin (the " New Process" ). (R. 1, Compl.) Bivalirudin is the active ingredient in Angiomax®, an anticoagulant drug used in patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty. ( Id. ¶ ¶ 11, 13.) TMC markets Angiomax® . ( Id. ¶ ¶ 11, 13.)

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TMC alleges that Mylan, before the expiration of the patents-in-suit, submitted Abbreviated New Drug Application (" ANDA" ) No. 202471 to the U.S. Food and Drug Administration (" FDA" ), seeking approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of its generic Angiomax® product. TMC avers that Mylan's ANDA No. 202471 infringes certain claims of the patents-in-suit.

In response to TMC's lawsuit, Mylan asserted, among others, a defense of inequitable conduct. (R. 185, Memo. Mot. to Compel at 1.) Mylan bases this defense on TMC's alleged deliberate failure to disclose highly material information to the United States Patent & Trademark Office (" PTO" ) during prosecution of the patents-in-suit. ( Id. ) Specifically, Mylan alleges that one of TMC's production batches of Bivalirudin--Lot No. 1344985--manufactured by Ben Venue Laboratories (" Ben Venue" ) violated a requirement of the patents-in-suit in that it contained a high level of the impurity Asp9. ( Id. at 3.) The patents-in-suit claim the New Process produces Bivalirudin with a maximum Asp9 impurity level of 0.6% Asp9, but Mylan alleges that Lot No. 1344985, manufactured using the New Process, produced an Asp9 impurity level of [TEXT REDACTED BY THE COURT] higher than the maximum level recited in the patent claims. ( Id. at 2-3; R. 199, Defs.' Reply at 5.) Mylan contends that TMC never disclosed the results of Lot No. 1344985 to the PTO. This failure serves as the basis for Mylan's inequitable conduct claim.

The Court presumes familiarity with the additional background of this litigation, and incorporates herein by reference the background information set forth in the Court's opinion dated August 6, 2012. (R. 119.)

II. Current Discovery Dispute

In August 2012 Mylan subpoenaed the deposition of Dr. Sandra Kuzmich, the attorney at Frommer who prosecuted the patents-in-suit before the PTO. Mylan allegedly had difficulty scheduling Dr. Kuzmich's deposition, finally deposing her on January 3, 2013-eight days before the close of the extended fact discovery period.

During her deposition Dr. Kuzmich testified about a conversation she had had with Dr. Rajashwar Motheram, a TMC scientist. Based on Dr. Kuzmich's testimony, Mylan alleges that after the issue fee for the patents-in-suit had been paid, but before the patents issued, Dr. Kuzmich received a spreadsheet (" the Spreadsheet" ) alerting her to Lot No. 1344985's irregular results. (Def.'s Reply at 4.) Mylan contends that in determining whether to report these results to the PTO, Dr. Kuzmich spoke with Dr. Motheram, who informed her that " the 'improved' process had not been followed" on Lot 1344985. ( Id. ) According to Mylan, based on this conversation Dr. Kuzmich decided that Lot No. 1344985 was immaterial to patentability and that TMC was not obliged to disclose it to the PTO. ( Id. )

LEGAL STANDARD

The federal discovery rules liberally assist in preparation for trial and settlement of disputes. See Bond v. Utreras, 585 F.3d 1061, 1075 (7th Cir. 2009); see also Kodish v. Oakbrook Terrace Fire Prot. Dist., 235 F.R.D. 447, 450 (N.D. Ill. 2006) (" the scope of discovery should be broad in order to aid in the search for truth" ). Federal Rule of Civil Procedure 26(b)(1) provides that " [p]arties may obtain discovery regarding any nonprivileged matter that is relevant to any party's claim or defense . . . Relevant information need not be admissible at the trial if the discovery appears reasonably calculated to

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lead to the discovery of admissible evidence." Fed.R.Civ.P. 26(b)(1). " The burden rests upon the objecting party to show why a particular discovery request is improper." Kodish, 235 F.R.D. at 450. The Seventh Circuit instructs that in a motion to compel " a district court may grant or deny the motion in whole or in part, and similar to ruling on a request for a protective order under Rule 26(c), the district court may fashion a ruling appropriate for the circumstances of the case." Gile v. United Air Lines, Inc., 95 F.3d 492, 496 (7th Cir. 1996). As with all discovery matters, courts have broad discretion in determining motions to compel. See James v. Hyatt Regency Chi., 707 F.3d 775, 2013 WL 514097, at *7 (7th Cir. Feb. 13, 2013); Peals v. Terre Haute Police Dep't, 535 F.3d 621, 629 (7th Cir. 2008).

ANALYSIS

Mylan contends that during the January 3, 2013, deposition, Dr. Kuzmich waived the attorney-client privilege--either through waiver by disclosure or implied waiver --with regard to Lot No. 1344985 and all communications between Frommer and Dr. Motheram. In response TMC argues that: (1) the conversation between Dr. Kuzmich and Dr. Motheram is not privileged; (2) even if the conversation was privileged, Dr. Kuzmich's January 3, 2013, testimony did not waive the privilege; and (3) if waiver did occur, the Court should narrowly construe the scope of the waiver. TMC does not directly address Mylan's argument of implied waiver. Given that TMC has opposed waiver in general, however, the Court will not consider the argument waived and will address the merits of Mylan's implied waiver argument.[1]

I. Choice of Law

Before addressing the waiver issue, however, the Court must first determine whether to apply Federal Circuit law or Seventh Circuit law. This case involves claims under the federal patent laws, and consequently the federal common law of privilege governs. See Fed.R.Evid. 501; United States v. Zolin, 491 U.S. 554, 562, 109 S.Ct. 2619, 105 L.Ed.2d 469 (1989) (" Questions of privilege that arise in the course of the adjudication of federal rights are governed by the principles of the common law . . ." ) (internal quotations omitted). In patent cases regional circuit law governs non-patent issues, while Federal Circuit law governs issues of substantive patent law. In re Spalding Sports Worldwide, Inc., 203 F.3d 800, 803 (Fed. Cir. 2000). Federal Circuit law may also govern any substantive or procedural issues " intimately involved in the substance of enforcement of the patent right." Flex-Foot, Inc. v. CRP. Inc., 238 F.3d 1362, 1365 (Fed. Cir. 2001). Regional circuit law, however, applies to procedural questions not themselves issues of substantive patent law unless they (1) pertain to patent law, (2) bear an essential relationship to matters committed by statute to the exclusive control of the Federal Circuit, or (3) clearly implicate the responsibilities of the Federal Circuit in a field within its exclusive jurisdiction. GFI, Inc. v. Franklin Corp., 265 F.3d 1268 (Fed. Cir. 2001).

The present discovery dispute is governed in part by Seventh Circuit law and in part by Federal Circuit law. Mylan's claim of inequitable conduct--the defense underlying the discovery dispute--implicates substantive patent law. See In re Spalding, 203 F.3d at 803-04 (recognizing inequitable conduct as an issue of substantive patent law). Furthermore, the discoverability of evidence ...


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