Bayer Healthcare LLC v. Norbrook Laboratories Ltd et al

Filing 48

ORDER signed by Chief Judge Rudolph T Randa on 04/06/2009 granting in part and denying in part 41 Motion to Compel. Norbrook must respond to interrogatories numbers 3 and 5, and make their Rule 30(b)(6) witness available for deposition no later tha n 04/10/2009; The Court's 02/24/2009, Scheduling Order is modified to the extent Bayer's response to Norbrook's Rule 12(c) motion must be filed no later than 04/16/2009 and Norbrook's reply brief in support of their Rule 12(c) mot ion must be filed no later than 05/07/2009; The Clerk of Court is directed to add the markings "Request for Confidentially Pending" and to delete the markings "Filed Under Seal Pursuant to Civil L.R. 26.4" on the envelopes contain ing the Exhibit E and page three of Bayer's motion to compel; and, no later than 04/10/2009, Norbrook may file a statement of any facts that it believes provide the basis for sealing Exhibit E and excerpts or discussions of it in Bayer's expedited motion to compel. (cc: all counsel) (Koll, J)

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF WISCONSIN

B A Y E R HEALTHCARE, LLC, P l a i n t i f fC o u n t e r c l a i m Defendant, v. C a s e No. 08-C-0953 C o n s o l id a t e d With C a s e No. 09-C-0108

NORBROOK LABORATORIES, LTD., and, NORBROOK, INC. USA, DefendantsC o u n t e r c la i m a n t s .

DECISION AND ORDER

P la in tif f Bayer Healthcare, LLC ("Bayer") commenced this action for patent in f rin g e m e n t under the patent laws of the United States set forth in Title 35 of United States C o d e . The action arises out of the filing of an Abbreviated New Animal Drug Application (" A N A D A " ), with the United States Food and Drug Administration ("FDA") by the D ef en d an ts, Norbrook Laboratories, Ltd., and Norbrook, Inc. USA (collectively "Norbrook'), s e e k in g approval to manufacture and sell in the United States a generic version of the in j e c t a b le animal drug product BAYTRILŪ 100, prior to the expiration of United States P aten t Number 5,756,506 ("the `506 patent"). This Decision and Order addresses Bayer's C iv il Local Rule 7.4 expedited motions to compel discovery from Norbrook and to file m a te ria l under seal.

E x p e d ite d Motion to Compel B a ye r seeks an order compelling Norbrook to provide complete, substantive re sp o n se s to interrogatories numbers one through five of Bayer's first set of interrogatories to N o rb ro o k and to designate a witness to testify as a corporate representative in response to B a ye r's notice for a Rule 30(b)(6) deposition. Bayer maintains that Norbrook's factual re p re se n ta tio n s in their motion for judgment on the pleadings places in issue the matters upon w h ic h Bayer seeks discovery. The Federal Rules of Civil Procedure govern the scope and limits of discovery in civil cases. Rule 37(a)(3)(B) provides authority for Bayer's motion. Rule 26(b)(1) of the F e d e ra l Rules of Civil Procedure states: "Parties may obtain discovery regarding any

n o n p riv ile g e d matter that is relevant to any party's claim or defense ­ including the existence, d e sc rip tio n , nature, custody, condition, and location of any documents or other tangible things a n d the identity and location of persons who know of any discoverable matter." The Rule c o n tin u e s: "For good cause, the court may order discovery of any matter relevant to the subject m a tte r involved in the action. Relevant information need not be admissible at the trial if the d is c o v e ry appears reasonably calculated to lead to the discovery of admissible evidence." Fed. R . Civ. P. 26(b)(1). In this action, these broad parameters are restricted by the Court's

F e b ru a ry 24, 2009, Scheduling Order, that limits discovery prior to May 1, 2009, to ju ris d ic tio n a l or pleading issues raised by Norbrook's Rule 12(c) motion. Bayer asserts that the discovery sought by its motion to compel relates to N o rb ro o k 's motion for judgment on the pleadings that contends the Court lacks subject matter

2

ju ris d ic tio n over this action. In determining the relevance of a request for jurisdictional d is c o v e ry in patent actions, Federal Circuit law applies. See DDB Techs., L.L.C. v. MLB A d v a n c e d Media, L.P., 517 F.3d 1284, 1292 (Fed. Cir. 2008). The Court has reviewed Bayer's interrogatories numbers one through five and N o rb ro o k 's responses to those interrogatories. Interrogatories one, two, and four relate to N o rb ro o k 's submission of the paragraph IV certification, the reasons for its withdrawal, and w h e th e r any statements in that paragraph IV certification to the FDA were inaccurate and w ith d ra w n . Norbrook has withdrawn its paragraph IV certification. Therefore, Bayer has not estab lish ed a basis for this Court to conclude that interrogatories one, two, or four are re a so n a b ly calculated to lead to the discovery of admissible evidence relating to the issues ra is e d by Norbrook's Rule 12(c) motion. However, interrogatory number three which requests all bases for Norbrook's b e lie f that the paragraph IV certification has been withdrawn, and interrogatory number five w h ic h requests the bases for Norbrook's submission of a Section I Statement in connection w ith the ANADA appear reasonably calculated to lead to the discovery of admissible evidence re la tin g to the issues raised by Norbrook's motion for judgment on the pleadings. Therefore, w ith the exception of information which is protected by the attorney-client privilege or workp ro d u c t immunity, Bayer's motion to compel is granted as to interrogatories numbers three and f iv e and denied as to interrogatories numbers one, two, and four. Norbrook must respond to in te rr o g a to rie s numbers three and five no later than April 10, 2009.

3

W ith respect to the Rule 30(b)(6) deposition notice, the parties' arguments are lim ite d . Bayer requests only that the Court order Norbrook to designate a witness for e x a m in a tio n . Norbrook asserts that Bayer does not need a Rule 30(b)(6) deposition to simply r e p e a t information in Norbrook's sworn interrogatory response; i.e., that Norbrook has not b e g u n any marketing plans for Norbrook's product pending the regulatory approval process. B a ye r's Rule 30(b)(6) notice lists nine topics. The topics are not limited to the su b jec t of Norbrook's marketing plans. Furthermore, based on Norbrook's responses to B ayer's first set of interrogatories, the Rule 30(b)(6) issue will not be resolved if this Court d ire c ts only that Norbrook designate a Rule 30(b)(6) witness. The Court concludes that topics n u m b e rs three and six of Bayer's 30(b)(6) notice are likely to lead to the discovery of a d m is s ib l e evidence on the issues raised by Norbrook's motion for judgment on the pleadings.1 T h e re f o re , to that extent, Bayer's motion to compel as to the Rule 30(b)(6) notice is granted, b u t is denied in all other respects as to that notice. Norbrook must make their Rule 30(b)(6) w itn e s s available for deposition no later than April 10, 2009. In light of its ruling on Bayer's motion to compel, the Court has determined that g o o d cause exists for modifying the briefing schedule for the Rule 12(c) motion. Therefore, th e April 6, 2009, deadline for Bayer's response to Norbrook's Rule 12(c) motion is extended to April 16, 2009, and the April 27, 2009, deadline for Norbrook's reply brief in support of th e ir Rule 12(c) motion is extended to May 7, 2009.

Topic number three is Norbrook's knowledge and projections regarding the anticipated timing of FDA a p p r o v a l of the ANADA and topic number six relates to Norbrook's decision to file a "Section I statement" with the FD A.

1

4

E x p e d ite d Motion to Seal C itin g Civil Local Rule 26.4 of this District, Bayer seeks an order permitting it to file under seal page three of its motion to compel discovery, along with Exhibit E to the D e c la ra tio n of Jamie L. Simpson. As grounds for its motion, Bayer states that Exhibit E was p rod u ce d by Norbrook under a confidentiality designation and that page three of Bayer's m o tio n discusses the substance of that exhibit. Bayer notes that no confidentiality order has b e e n entered in this case. However, Bayer states that it understands the importance, in the m e a n tim e , of preserving the confidentiality of both parties' sensitive material. Bayer has filed E x h ib it E and page three of its motion in envelopes marked "Filed Under Seal Pursuant to C iv il L.R. 26.4." Norbrook has not filed any response to the motion. Because no sealing order has been entered in this action, General Local Rule 7 9 . 4 provides the procedure for submission of the documents that Bayer seeks to seal.2 G e n e ra l Local Rule 79.4 requires that "[a]ll documents which a party seeks to have treated as c o n f id e n tia l, but as to which no sealing order has been entered, must be filed in a sealed e n v e lo p e conspicuously marked `Request for Confidentiality Pending.'" Thus, with respect to the envelopes containing Exhibit E and page three of Bayer's motion to compel, the Court d i r e c t s the Clerk of Court to add the markings "Request for Confidentially Pending,"and to d e le te the markings "Filed Under Seal Pursuant to Civil L.R. 26.4"

Civil Local Rule 26.4 provides for the entry of a protective order regarding the confidentiality of all d o c u m e n ts produced during discovery, answers to discovery requests, and deposition, and sets forth a model form for a protective order.

2

5

This Circuit's case law emphasizes the Court's role in sealing documents that a re filed. See e.g., Baxter Int'l, Inc. v. Abbott Labs., 297 F.3d 544, 546 (7th Cir. 2002); J e p so n , Inc. v. Makita Elec. Works, Ltd., 30 F.3d 854, 858-59 (7th Cir. 1994). The Court must h a v e sufficient factual information to independently determine whether "good cause" exists f o r sealing a document that has been filed or a portion of a motion or brief setting forth the c o n ten ts of that document. Since Norbrook designated the information as confidential, N o rb ro o k is in the best position to provide the Court with a brief statement of any facts which N o rb ro o k believes establish good cause to seal Exhibit E, and discussions of it on page three o f Bayer's motion to compel. Norbrook may file that statement of facts by April 10, 2009. A f te r that date, the Court will decide the expedited motion to seal. NOW, THEREFORE, BASED ON THE FOREGOING, IT IS HEREBY O R D E R E D THAT: Bayer's expedited motion to compel (Docket No. 41) is GRANTED as to in te rro g a to rie s numbers three and five of Bayer's first set of interrogatories to Norbrook and a s to topics numbers three and six of Bayer's Rule 30(b)(6) notice to Norbrook and DENIED in all other respects; Norbrook must respond to interrogatories numbers three and five, and make th e ir Rule 30(b)(6) witness available for deposition no later than April 10, 2009; The Court's February 24, 2009, Scheduling Order is modified to the extent B a ye r's response to Norbrook's Rule 12(c) motion must be filed no later than April 16, 2009;

6

a n d Norbrook's reply brief in support of their Rule 12(c) motion must be filed no later than M a y 7, 2009; The Clerk of Court is directed to add the markings "Request for Confidentially P e n d in g " and to delete the markings "Filed Under Seal Pursuant to Civil L.R. 26.4" on the e n v e lo p e s containing the Exhibit E and page three of Bayer's motion to compel; and, No later than April 10, 2009, Norbrook may file a statement of any facts that it believes provide the basis for sealing Exhibit E and excerpts or discussions of it in Bayer's e x p e d ite d motion to compel. Dated at Milwaukee, Wisconsin this 6th day of April, 2009. BY THE COURT s / Rudolph T. Randa_______________ H o n . Rudolph T. Randa C h ie f Judge

7