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The Medicines Co. v. Mylan Inc.

United States District Court, Seventh Circuit

June 13, 2013



AMY J. ST. EVE, District Judge.

Before the Court is Plaintiff The Medicines Company's ("TMC") motion to compel testimony and production of information withheld on the basis of privilege by Defendant Mylan Inc., Mylan Pharmaceuticals Inc., and Bioniche Pharma USA, LLC (collectively, "Mylan"), pursuant to Federal Rule of Civil Procedure ("Rule") 37(a). (R. 225, Mot. to Compel.) Specifically, Plaintiff seeks production of (1) Mylan's expert, Dr. Fred E. Regnier, for a continuation of his deposition and (2) draft expert reports and attorney-expert communications related to Dr. Regnier's opening and reply expert reports. For the following reasons, the Court denies Plaintiff's motion to compel in its entirety.


I. Patents-in-Suit

Plaintiff TMC brought this lawsuit against Defendants, asserting that they 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.)

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 asserts, 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 1.5% Asp9-150% 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

On February 8, 2013, Mylan's expert in high performance liquid chromatography ("HPLC"), Dr. Fred E. Regnier, served an opening expert report that included his opinions regarding the patents-in-suit. On March 8, 2013, TMC's expert, Dr. Alexander Klibanov, submitted a rebuttal report that responded to Dr. Regnier's opening report and then Dr. Regnier submitted a reply report on April 8, 2013. On April 26, 2013, counsel for TMC deposed Dr. Regnier. Prior to Dr. Regnier's deposition, TMC did not request Mylan to produce any additional documents relating to Dr. Regnier's expert reports. During the deposition, TMC's counsel interrogated Dr. Regnier regarding his opening report because it appeared to use language from a 2011 declaration in another case submitted by a different party's expert, Bernard A. Olsen, Ph.D. (the "Olsen declaration"). The Olsen declaration pertained to the same patents-in-suit involved in a case pending in the District of Delaware. See The Medicines Co. v. Teva Parental Medicines, Inc., et al., No. 09-cv-750-ER (D. Del.). In total, Dr. Regnier used approximately 4 to 5 pages of text from the Olsen declaration in his export report that was 33 pages in length. The text appears to pertain to basic scientific principles that underlie HPLC. Dr. Regnier did not cite or quote the language from the Olsen declaration but did list the Olsen declaration as a document that he considered to formulate his opinions. (R. 234, Defs.' Response to Mot. to Compel at 9.) In addition, TMC's counsel alleges that Dr. Regnier also used language from Dr. David Auslander, another expert retained by Mylan, regarding the definition of a person of ordinary skill in the art ("POSA"). Dr. Regnier testified that Mylan's counsel provided Dr. Regnier with a copy of the Olsen Declaration and communicated Dr. Auslander's definition of a POSA to him. ( Id. at 8.) He testified, however, that the report states his opinions and that his opinions do not rely upon communications with Mylan's counsel. ( Id. at 9.) During the deposition, Defendant Mylan's attorney instructed Dr. Regnier not to answer the inquiry of authorship, asserting work-product protection under Rule 26(b)(4).

At the end of Dr. Regnier's deposition, TMC asserted that the deposition would remain open and that TMC is entitled to testimony concerning authorship of Dr. Regnier's export report. On May 3, 2013, TMC's counsel requested Dr. Regnier for a second deposition as well as Dr. Regnier's draft reports and all associated communications between Dr. Regnier and Mylan's counsel. Mylan's counsel responded on May 6, stating that they were available to discuss the matter on the afternoon of May 7. TMC ignored Mylan's request and filed the motion to compel without conferral.


This motion implicates standards that govern discovery as it relates to testifying experts. The Supreme Court amended Rule 26(b)(4), effective December 1, 2010, by adding Rule 26(b)(4)(B) to provide work product protection under Rule 26(b)(3)(A) and (B) for drafts of expert reports. Rule 26(b)(4)(C) extends work product protection to most communications between trial counsel and experts. Fed.R.Civ.P. 26(b).

Three exceptions apply to the protections afforded under Rule 26(b)(4)(C). First, attorney-expert communications that relate to expert compensation. Fed.R.Civ.P. 26(b)(4)(C)(i). Second, communications that identify facts or data that the party's attorney provided and that the expert considered in forming the opinions to be expressed. Fed.R.Civ.P. 26(b)(4)(C)(ii). Third, communications that identify the assumptions that the party's attorney provided and that the expert relied upon in forming his opinions. Fed.R.Civ.P. 26(b)(4)(C)(iii). Discovery concerning attorney-expert communications on subjects outside the three exceptions as articulated above, or regarding draft expert reports or disclosures, is permitted only when a party makes a showing of substantial need and cannot obtain the substantial equivalent without undue hardship. Fed.R.Civ.P. 26(b)(3)(A)(ii). Further, when there is such a showing, the advisory committee notes show that "[i]n the rare case in which a party does make this showing, the court must protect against disclosure of the attorney's mental impressions, conclusions, opinions, or legal theories under Rule 26(b)(3)(B)." Fed.R.Civ.P. 26(b)(3)(B) advisory committee's note (2010). 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 ...

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