Medicines Co. v. Mylan Inc.

936 F. Supp. 2d 894, 2013 WL 1283480, 2013 U.S. Dist. LEXIS 37329
District Court, N.D. Illinois·Decided March 19, 2013·No. Case No. 11-cv-1285·Published·Cited by 8 cases

Opinion

REDACTED MEMORANDUM OPINION AND ORDER

AMY J. ST. EVE, District Judge.

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 Plaintiffs 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.)

[898] 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 [Redacted] 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, 2012 WL 3234282. (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

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Medicines Co. v. Mylan Inc., 936 F. Supp. 2d 894, 2013 WL 1283480, 2013 U.S. Dist. LEXIS 37329 (N.D. Ill. 2013).

936 F. Supp. 2d 894 (Medicines Co. v. Mylan Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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