Free Answering Brief in Opposition - District Court of Delaware - Delaware


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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE RELIANT PHARMACEUTICALS, INC., Plaintiff, v. PAR PHARMACEUTICAL, INC. Defendant.
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Civil Action No. 06-774-JJF

RELIANT PHARMACEUTICALS, INC.'S ANSWERING BRIEF IN OPPOSITION TO PAR PHARMACEUTICAL, INC.'S MOTION TO COMPEL DISCOVERY MORRIS, NICHOLS, ARSHT & TUNNELL LLP Jack B. Blumenfeld (No. 1014) Maryellen Noreika (No. 3208) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 Attorneys for Plaintiff

Of Counsel: John M. Desmarais Gerald J. Flattmann, Jr. Christine Willgoos KIRKLAND & ELLIS LLP Citigroup Center 153 E. 53rd Street New York, NY 10022 (212) 446-4800 September 7, 2007

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Table of Contents NATURE AND STAGE OF THE PROCEEDING.........................................................................1 SUMMARY OF ARGUMENT .......................................................................................................1 STATEMENT OF FACTS ..............................................................................................................3 ARGUMENT...................................................................................................................................5 CONCLUSION................................................................................................................................8

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Table of Authorities

No authorities are cited in this brief.

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NATURE AND STAGE OF THE PROCEEDING On December 19, 2006, Reliant Pharmaceuticals, Inc. ("Reliant") filed this action for infringement of U.S. Patent No. 5,681,588 ("the `588 patent") against Par Pharmaceutical, Inc. ("Par"), based on Par's filing of ANDA 78-540, which seeks to market generic versions of Reliant's drug Rythmol® SR. D.I. 1. Par answered Reliant's Complaint on February 9, 2007. D.I. 11. This action is currently in its first phase of discovery, directed to document production and contention interrogatories. Pursuant to Court Orders, document production and contention interrogatory responses must be exchanged by the parties by September 24, 2007. D.I. 27, 66. The parties have exchanged document requests and interrogatories, and have served their respective responses. Document production is ongoing. To date, Reliant has produced over 65,000 pages of documents. Reliant continues to produce documents, and it intends to provide supplemental interrogatory responses to Par prior to the September 24, 2007 deadline. Par filed its Rule 37 motion to compel supplemental interrogatory answers and responsive documents on August 23, 2007--one month prior to the cut-off date for this initial phase of discovery. This is Reliant's opposition to that motion. SUMMARY OF ARGUMENT Reliant has repeatedly made good faith representations to Par that Reliant would satisfy its discovery obligations -- including producing responsive documents and supplementing, as necessary, its interrogatory responses -- by September 24, 2007, the Court imposed cut-off date for the initial phase of discovery. Par's motion to compel was brought, not

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because Reliant is in default of its obligations, but because Par hoped to force Reliant to provide discovery prior to the Court-ordered deadline. Par simply had no basis for this premature motion to compel. To date, Reliant has produced more than 65,000 pages of responsive documents, and continues its document review and production. Reliant has also responded to Par's interrogatories and indicated that supplemental interrogatory responses are forthcoming. Reliant has repeatedly assured Par that it will meet its discovery obligations, and has demonstrated its good faith by responding to Par's requests. Given these repeated assurances, Par's motion will be moot before it is heard or decided. In an effort to avoid burdening the Court with this premature and baseless motion, Reliant has, on at least three separate occasions requested that Par withdraw its motion, assuring Par that Reliant intended to satisfy its discovery obligations and offering to meet and confer with Par immediately after the end of this phase of discovery to seek to resolve any perceived deficiencies with Reliant's document production or interrogatory responses. Par has refused this invitation, instead indicating that if Reliant would produce documents two weeks prior to the cut-off date, Par would "consider" withdrawing the motion. Par cannot unilaterally dictate when and how Reliant must respond to Par's discovery requests. Nor may Par improperly use this motion to compel to make an end-run around the Court's scheduling orders. Moreover, given that the Court-ordered September 24 deadline for this phase of discovery has not yet occurred, Par's motion is not ripe. Accordingly, the Court should deny Par's premature and baseless Motion to Compel.

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STATEMENT OF FACTS Reliant markets the life-saving drug Rythmol® SR. Rythmol® SR is covered by the `588 patent, and is listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluations" (referred to as the "Orange Book"). On November 7, 2006 and January 10, 2007, Par sent Reliant Paragraph IV notice letters challenging the validity and enforceability of the `588 patent, and stating that its generic tablets do not infringe. Exs. 1, 2. Reliant brought suit against Par on December 19, 2006, and amended its Complaint after receipt of Par's second Paragraph IV notice letter. See D.I. 1, 8. On March 14, 2007, Reliant moved the Court to disqualify Frommer Lawrence & Haug LLP ("FLH") from representing Par in this litigation due to FLH's prior representation of Reliant regarding Reliant's acquisition of the same drug and the same patent at issue here. D.I. 18. On March 23, 2007, Par served Reliant with its first set of document requests and first set of interrogatories. D.I. 24. Reliant provided its written responses to Par's requests on June 11, 2007, and included the following general objection: Reliant objects to [Par's document requests and interrogatories] to the extent that they purport to require Reliant to produce information to Frommer Lawrence & Haug LLP, Reliant's former counsel and counsel to Par in this substantially related matter, prior to the Court's decision on Reliant's Motion for Disqualification. (Ex. 3 at 4; Ex. 4 at 3-4). That objection made clear that Reliant did not intend to produce documents or provide other discovery to Par's counsel FLH until the Court decided Reliant's pending motion.1

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Notably, Reliant did not object to producing documents to Par, but only to FLH. Reliant later suggested that it produce documents to John Harris, Par's other counsel named in this action, but Par did not accept this offer.

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On April 25, after several requests by Reliant, and more than five months after notifying Reliant of its Paragraph IV certification regarding the `588 patent, Par finally produced ANDA 78-540. By Order dated July 25, 2007, the Court denied Reliant's motion to disqualify FLH with leave to renew, allowed limited discovery on the disqualification issue, and expressly permitted either party, without leave of Court, to extend by 30 days the August 24, 2007 deadline in paragraph 3(a) of the Court's Rule 16 Scheduling Order. D.I. 66. On August 1, 2007, in response to the Court's Order, the parties met and conferred. During that call, Reliant informed Par that it was extending the discovery deadline until September 24, 2007 pursuant to the Court's Order, and stated that it would promptly begin producing documents to FLH and would supplement its interrogatory responses as necessary. See, e.g. Ex. 7. In response, Par demanded that Reliant complete its document production and provide supplemental interrogatory responses by an arbitrarily imposed deadline of the middle of August. See, e.g., Ex. 8. On August 8, 2007, Par sent a letter demanding that Reliant immediately inform Par of the exact date that documents would be produced and the interrogatories would be supplemented. Ex. 6. Reliant responded on August 10, 2007, again assuring Par that documents would be forthcoming and that it would supplement interrogatory responses as required by the Court's ordered date for the end of this phase of discovery. Ex. 7. Reliant also said that, because the Protective Order had recently been entered and it could now begin to share Par's ANDA with its experts, Reliant would supplement its interrogatories to provide more detailed responses. Id. On August 20, 2007, despite Reliant's assurances, Par attempted to set August 22, 2007 as the deadline for Reliant's completion of this phase of discovery. Ex. 8. Par stated that Reliant's failure to meet Par's arbitrary deadline would result in Par moving the Court for an

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order to compel discovery. See id. Reliant responded the next day and again assured Par that it intended to meet its discovery obligations by the Court-ordered September 24, 2007 deadline. Ex. 9. On August 23, 2007, Reliant informed Par that it would begin producing documents the next day. Ex. 10. Par disregarded Reliant's repeated assurances and good faith efforts to meet its discovery obligations, and filed its Motion to Compel. Since Par filed this motion, Reliant has produced over 65,000 pages of documents. Ex. 11. Based in part on those productions, Reliant, on at least three separate occasions, requested that Par withdraw its premature and baseless Motion to Compel, noting that: (a) the issue was not ripe; (b) the motion, even if successful, would only waste judicial resources; (c) Reliant intended to satisfy its discovery obligations by September 24, as demonstrated by its productions to date; (d) Reliant would continue to produce responsive documents on a rolling basis; (e) that the time and focus of the parties would be better served by completing this phase of discovery rather than engaging in needless motion practice; and (f) it was the Court's schedule -- not Par's ­ by which Reliant would abide. Exs. 11, 12, 13. Reliant also offered Par the opportunity to meet and confer after September 24 to amicably resolve any of Par's perceived insufficiencies. Ex. 12. Initially, Par responded that it would "consider" withdrawing its motion if Reliant completed its discovery obligations by September 14, 2007. Ex. 14. Par later reneged on even that self-serving offer and refused to withdraw its motion. Ex. 15. ARGUMENT Par seeks an Order requiring Reliant to immediately produce documents and supplement its responses to Par's Interrogatory Numbers 3-5 and 7. Par's motion is illogical and without basis because it prematurely moves for discovery prior to the time Reliant is required to provide it. 5

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Reliant began producing documents to Par on August 24, 2007 and, to date, has produced over 65,000 pages of documents. Ex. 11. Reliant's document review and production is ongoing, and Reliant expects that it will be complete by September 24, 2007. Notably, Par fails to point out any specific categories of documents that Reliant has failed to produce. Par cannot do so, and has no basis to do so, until the September 24 initial discovery deadline. Par's half-hearted complaint about its need to go through the Hague Convention to obtain extra-jurisdictional discovery from foreign non-parties provides no support for its motion to compel. Reliant acquired the drug Rythmol® SR and the `588 patent from Abbott after the patent had issued and after the NDA was approved. D.I. 27 at pp. 3-5. Reliant has represented to Par that, subject to Reliant's objections to Par's request for documents, Reliant will produce documents in its possession, custody and control that relate to Abbott, its predecessors-in-interest Knoll AG and/or BASF AG, and the inventors. See Ex. 7. Reliant has produced, and will continue to produce, such documents to Par. That Reliant may not have the information Par seeks is not a valid basis for Par's motion to compel. Reliant is not withholding responsive, non-privileged documents in its possession that relate to the acquisition of the drug or patent, or that relate to Abbott, Knoll, BASF or the inventors. And Par cannot obtain what it seeks--documents from non-party foreign persons and companies--through a motion to compel Reliant to produce documents it does not have. Par's own actions indicate that its motion has no basis and is premature. Yesterday, Par -- for the first time -- proposed that the parties exchange search terms for their respective review and production of electronic documents. Ex. 16. Par's proposal belies its assertions in its motion that Reliant should have already produced these documents. Moreover,

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Par indicated that it had not yet begun review and production of its own electronic documents. Id. Par's request that the Court compel Reliant to supplement its interrogatory responses is equally unavailing. Reliant provided its initial responses to Par's interrogatories on June 11, 2007. Ex. 4. Reliant's initial responses were appropriate for that early stage of discovery, when no documents other than Par's ANDA had been produced. Notably, at that time Reliant was unable to consult with its experts regarding Par's ANDA because Par produced the ANDA pursuant to its Offer of Confidential Access, not this litigation. See Ex. 7. Accordingly, Reliant will be in a better to position to provide fuller answers to its interrogatories now that the Protective Order has been entered and it can rely on its experts to help sort through the lengthy and complex ANDA.2 Reliant intends to supplement its interrogatory responses, including its responses to Interrogatories Nos. 3-5 and 7, prior to the September 24, 2007 deadline for responses to contention interrogatories. Reliant has repeatedly represented as much to Par. Exs. 7, 9. Despite Reliant's repeated assurances that it would comply with its discovery obligations, and multiple requests that Par withdraw its premature motion to compel, Par has steadfastly refused to withdraw its baseless motion. Par is wasting the parties' and the Court's time and resources. If, after the September 24, 2007 deadline, Par still believes that Reliant's good faith efforts to provide Par the discovery it seeks fall short, the parties should meet and confer in an attempt to resolve the issue. Only after that would Par's motion to compel additional discovery be ripe.

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Par's suggestion that Reliant has not met its obligations under Rule 11 are entirely unsupported and without any basis in fact.

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CONCLUSION Accordingly, Reliant requests that the Court deny Par's motion to compel discovery.

MORRIS, NICHOLS, ARSHT & TUNNELL LLP /s/ Jack B. Blumenfeld (#1014) Jack B. Blumenfeld (No. 1014) Maryellen Noreika (No. 3208) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 Attorneys for Plaintiff

Of Counsel: John M. Desmarais Gerald J. Flattmann, Jr. Christine Willgoos KIRKLAND & ELLIS LLP Citigroup Center 153 E. 53rd Street New York, NY 10022 (212) 446-4800

September 7, 2007
1229553

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CERTIFICATE OF SERVICE I hereby certify that on September 7, 2007 I electronically filed the foregoing with the Clerk of the Court using CM/ECF, which will send notification of such filing to:. Josy W. Ingersoll, Esquire YOUNG, CONAWAY, STARGATT & TAYLOR I further certify that I caused to be served copies of the foregoing document on September 7, 2007 upon the following in the manner indicated: Josy W. Ingersoll, Esquire Karen L. Pascale, Esquire YOUNG, CONAWAY, STARGATT & TAYLOR The Brandywine Building 1000 West Street, 17th Floor Wilmington, DE 19801 Edgar H. Haug, Esquire FROMMER LAWRENCE & HAUG LLP 745 Fifth Avenue New York, NY 10151 VIA ELECTRONIC MAIL and HAND DELIVERY

VIA ELECTRONIC MAIL

/s/ Jack B. Blumenfeld (#1014 Jack B. Blumenfeld (#1014)

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Exhibit 7

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Exhibit 8

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Exhibit 9

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Exhibit 10

Christine Willgoos /New York/Kirkland-Ellis 08/23/2007 11:46 AM

To "Taylor, John" cc [email protected], [email protected], "Ingersoll, Josy" , "Stronski, James" , "Pascale, Karen" , "Jabri, Omar" Subject Re: Reliant v. Par

John -The current addresses for Drs. Frike, Kolter, Mueller-Peltzer, Bueller, Pich and Moest are set forth in Reliant's initial disclosures. Regarding your intent to seek the Court's assistance to proceed under the Hague convention, we would like to review your proposed request prior to determining whether or not to oppose it. We will not oppose your motion if the request is reasonable. Further, Reliant expects to begin producing documents tomorrow. Regards, Christine "Taylor, John"
"Taylor, John" 08/22/2007 09:04 PM

To , "Christine Willgoos" cc , "Ingersoll, Josy" , "Pascale, Karen" , "Stronski, James" , "Jabri, Omar" Subject Reliant v. Par

Dear Gerald and Christine, In light of Reliant's position that it has no control over BASF and Knoll and the inventors' refusal to appear voluntarily for depositions and, we presume, to produce documents, Par intends to move the Court for judicial assistance. In particular, Par will ask the Court to issue a Request for International Judicial

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Assistance to the German authorities pursuant to the Hague Convention seeking documents and depositions of the inventors, BASF and Knoll. Please advise us whether Reliant will consent to such a motion. Please also provide us with the addresses of the inventors represented by Kirkland & Ellis, as requested in our August 13 letter. Sincerely, John G. Taylor Frommer Lawrence & Haug LLP 745 Fifth Avenue New York, NY 10151 Tel: 212-588-0800 Fax: 212-588-0500 E-Mail: [email protected]

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Exhibit 14

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Exhibit 15

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Exhibit 16

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