Free Letter - District Court of Delaware - Delaware

Case 1:07-cv-00250-GMS

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Filed 10/22/2007

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YOUNG CONAWAY STARGATT & TAYLOR, LLP
BENT. CASTLE SHELDON N ANGLER RICHARD A. LEVINE RICHARD A. ZAPPA FREDERICK W. IOBST RICHARD H. MORSE DAVID C. MCBRIDE JOSEPH M. NICHOLSON CRAIG A. KARSNITZ BARRY M . W ILLOUGHBY JOSY W . INGERSOLL ANTHONY G. FLYNN JEROME K . GROSSMAN EUGENE A. DIPRINZIO JAMES L. PATTON, JR. ROBERT L. THOMAS WILLIAM D. JOHNSTON TIMOTHY J. SNYDER BRUCE L. SILVERSTEIN WILLIAM W. BOWSER LARRY J. TARABICOS RICHARD A. DILIBERTO, JR. MELANIE K SHARP CASSANDRA F. ROBERTS RICHARD J. A. POPPER TERESA A. CHEEK NEILLI MULLEN WALSH JANET Z. CHARLTON ROBERT S . BRADY JOEL A. WAITE BRENT C . S HAFFER DANIEL P. JOHNSON CRAIG D. GREAR TIMOTHY JAY HOUSEAL MARTIN S . LESSNER PAULINE K. MORGAN C . BARR FLINN NATALIE WOLF LISA B. GOODMAN JOHN W. SHAW JAMES P. HUGHES, JR. EDWIN J. HARRON
MICHAEL R. NESTOR MAUREEN D . L UKE

THE BRANDYWINE BUILDING 1000 WEST STREET, 17TH FLOOR WILMINGTON, DELAWARE 19801 P.O. Box 391
WILMINGTON , DELAWARE

19899-0391

(302) 571-6600 (800) 253-2234 (DE ONLY) FAX: (302)571-1253
110 WEST PINE STREET

ROLIN P. BISSELL SCOTT A. HOLT JOHN T. DORSEY M. BLAKE CLEARY CHRISTIAN DOUGLAS W RIGHT DANIELLE GIBBS JOHN J. PASCHETTO NORMAN M. POWELL ELENA C . NORMAN

P.O. Box 594
GEORGETOWN, DELAWARE 19947

(302) 856-3571 (800) 255-2234 (DE ONLY) FAX: (302 ) 856-9338
W W W. YOUNGCONA WAY.COM

JOSEPH M. BARRY SEAN M. BEACH SANJAY BHATNAGAR DONALD J . BOWMAN , JR . MICHELE SHERRETTA BUDICAK JEFFREY T. CASTELLANO KARA HAMMOND COYLE KRISTEN SALVATORE DEPALMA MARGARET M. DIBIANCA MARY F . DUGAN ERIN EDWARDS KENNETH J. ENOS IAN S. FREDERICKS JAMES J. GALLAGHER SEAN T. GREECHER STEPHANIE L. HANSEN PATRICK A . JACKSON DAWN M. JONES KAREN E. KELLER J EN NI FER M . K INK U S EDWARD J. KOSMOWSKI JOHN C . KUFFEL

TIMOTHY E. LENGKEEK ANDREW A . LUNDGREN MATTHEW B. LUNN ADRIA B . MARTINELLI KATHALEEN MCCORMICK MICHAEL W. MCDERMOTT TAMMY L. MERCER MARIBETH L . MINELLA EDMON L. MORTON D . PON MUTTAMARA - WALKER JENNIFER R . NOEL ADAM W. POPP SETH J. REIDENBERG SARA BETH A. REYBURN CHERYL A. SANTANIELLO

(NJ & PA ONLY)
MONTE T. SQUIRE MICHAEL P. STAFFORD CHAD S.C. STOVER J O HN E . T RACE Y TRAVIS N. TURNER MARGARET B . WHITEMAN SHARON M. ZIEG SENIOR COUNSEL CURTIS J. CROWTHER OF COUNSEL BRUCE M. STARGATT STUART B. YOUNG EDWARD B . MAXWELL, 2ND

SPECIAL COUNSEL JOHN D . MCLAUGHLIN, JR. KAREN L. PASCALE PATRICIA A . WIDDOSS

DIRECT DIAL: (302)576-3587 DIRECT FAX: (302) 576-3551 [email protected]

October 22, 2007 BY CM/ECF
The Honorable Mary Pat Thynge United States District Court

844 North King Street Wilmington, DE 19801 Re:
Dear Judge Thynge: Please find enclosed a document setting forth each side's proposed scheduling dates for the above-captioned case, prepared in anticipation of this afternoon's teleconference with the Court. Sincerely,

Abbot Labs. v. Teva Pharms. USA, Inc., 07-250-* * * -- Scheduling Dates

JTC.jtc Enclosure cc:

U.S. District Court Clerk (By CM/ECF and Hand Delivery) Paul E. Crawford (By CM/ECF)

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UNITED STATES DISTRACT COURT FOR THE DISTRICT OF DELAWARE

ABBOTT LABORATORIES, an Illinois corporation, Plaintiff, V. TEVA PHARMACEUTICALS USA, INC., a Delaware corporation, Defendant. Civil Action No. 07-250-***

PROPOSED DATES FOR SCHEDULING ORDER
In preparation for the October 22, 2007 scheduling conference, counsel for Abbott Laboratories ("Abbott") and counsel for Teva Pharmaceuticals USA, Inc. ("Teva") respectfully submit the following proposal relating to scheduling for this matter.l A. Nature of the Case This is a patent infringement case arising under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2). Abbott markets a prescription medication known as DEPAKOTE®ER (extendedrelease), which has been approved by FDA for treatment of epilepsy, bipolar disorder, and prophylaxis of migraine headaches. Abbott owns certain patents, including U.S. Patent No. 6,410,953 ("the `953 patent"), that are listed in the FDA's "Orange Book" in conjunction with DEPAKOTE"'ER. The `953 patent covers a formulation for achieving the extended release of a drug product over time, and the patent expires December 18, 2018.

1 For convenience and ease of reading, the parties have submitted a single, condensed proposal rather than submitting two full-length versions of this Court's Draft Scheduling Order. However, the parties will provide a complete proposed scheduling order once the Court determines what dates are appropriate for this case going forward.

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Teva has filed Abbreviated New Drug Application No. 78-700 (the "ANDA"), seeking FDA approval of a proposed generic version of DEPAKOTEOER. In the ANDA, Teva included a certification (known as a Paragraph IV Certification) stating that its proposed product, if allowed on the market , would not infringe any valid claim of, among other things, the `953 patent. Thus, Teva seeks approval to market its product prior to the expiry of the patent. As required by statute, Teva provided notice to Abbott about the filing of the ANDA and the Paragraph IV Certification. Within 45 days of receiving that notice, Abbott filed this action, alleging that Teva' s proposed generic product would, if allowed on the market, infringe the `953 patent . As a result of Abbott' s timely.filing , there is currently in place a statutory stay that will prevent FDA approval of the ANDA for a period of 30 months (until September 2009), absent some earlier resolution of this matter on the merits. Teva has answered the complaint, denying infringement, and has asserted a counterclaim seeking a declaratory judgment that its proposed product does not infringe any claim of the ` 953 patent. S. Prior Scheduling Order After a June 13, 2007 scheduling conference, the Court ordered the following schedule: Proposed Date Event

6.18.07 6.25.07
10.19.07 10.22.07

Teva must produce ANDA to Abbott Initial Rule 26(a)(1) disclosures due
Deadline to amend the pleadings or join additional parties Status/scheduling conference with the Court

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C.

Agreed- Matters Counsel for the parties previously conferred and agree that 70 hours per side for

depositions should be sufficient.'` If there is a need to expand this time allotment as the case progresses, the parties will work together in good faith to address the issue. D. Contested Matters The parties were unable to agree on a joint schedule for pretrial and trial activities. The primary areas of dispute are (i) the appropriate length of time for fact and expert discovery; and (ii) whether there should be a separate claim construction process undertaken during the fact discovery period (Teva advocates such a procedure, but Abbott disagrees). The parties' respective proposed schedules are set forth below. Abbott's Proposal In terms of the ordering of proceedings, Abbott proposes the following schedule: Proposed Date 3.28.08 3.31.08 4.07.08 4.21.08 4.21.08 5.05.08 5.25.08 624,08 8.25.08 9.22.08 10.27.08 Event Close of Fact Discovery Parties Exchange Proposed Claims Constructions Tutorial Describing Technology & Matters at Issue Due Comment to Opposing Party's Tutorial Due Parties Submit a Joint Claim Construction Chart Opening Briefs on Claim Construction Due Responsive Briefs on Claim Construction Due Hearing on Claim Construction and Summary Judgment Initial Expert Reports Due Responsive Expert Reports Close of Expert Discovery

Time consumed by the party in actual questioning of the witness shall count against that party's time, regardless of which party noticed the deposition.

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11.17.08 12.08.09 1.20.09 1.26.09 2.17.09 Teva's Proposal

Deadline for any Daubert Challenges to Expert Testimony Responses to Daubert Challenges Final Pretrial Order (Including Motions in Lirnine) Due Final Pretrial Conference Trial

Teva proposes the following schedule: Proposed Date 11.08.07 11.16.07 11.30.07 Event Parties Exchange Proposed Claims Constructions Parties Submit Joint Claim Construction Chart Discovery (including depositions) Relating To Claim Construction Must Be Complete 12.04.07 Individual Briefs on Claire Construction Due Responsive Briefs on Claim Construction Due Tutorial Describing Technology & Matters at Issue Due Comment to Opposing Party's Tutorial Due Following Claim Construction Order: + 30 days + 60 days x-90 days +120 days +150 days +180 days 9.08 9.08 10.08 Close of Fact Discovery Expert Reports Due Responsive Expert Reports Close of Expert Discovery Deadline for any Daubert Challenges to Expert Testimony Responses to Daubert Challenges Final Pretrial Order (Including Motions in Linrine) Due Final Pretrial Conference Trial

1.03.08
1.16.08 1.23.08

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Dated: October 22, 2007

Respectfully submitted, YOUNG, CONAWAY, STARGATT & TAYLOR, LLP

OF COUNSEL:
John L. North Jeffrey J. Toney Jackie L. Toney Kristin E. Goran David A. Reed Sutherland Asbill & Brennan LLP 999 Peachtree Street

By: /s/Jeff·ev.T_. Castellano Jeffrey T. Castellano (No. 4837) The Brandywine Building

1000 West Street, 17`" Floor P.O. Box 391
Wilmington, DE 19899-0391 (302) 571-6600 E-mail: jcastellanoQvcst.com Attorne}^s for Teva USA Pharmaceuticals USA, Inc.

Atlanta, Georgia 30309-3996 Phone. 404-853-8000 404-853-8006 Fax:
Katherine R. Lahnstein Sutherland Asbill & Brennan LLP 1275 Pennsylvania Avenue, NW Washington, DC 20004-2415 Phone: 202-383-0100

OF COUNSEL:
Daniel E. Reidy (admitted pro hac vice) E-mail. dereidy a jonesday.com James R. Daly (admitted pro hac vice) E-mail : [email protected] Jason G . Winchester (admittedpro hac vice) E-mail: i!zwincliester cr jonesday.com Jeremy P. Cole (admitted pro hac vice) E-mail: jpcole a jonesday.com Melissa B. Hirst (admitted pro hac vice) E-mail: [email protected] JONES DAY 77 West Wacker Drive, Suite 3500 Chicago, Illinois 60601-1692

CONNOLLY BOVE LODGE & HUTZ LLP

By: Isl Pmtl L. Crailforc(,,,...Paul E. Crawford (No. 0493) 1007 N. Orange St.
P.O. Box 2207 Wilmington, DE 19899 (T) 302.658.9141 (F) 302.658.5614 E-mail. [email protected] Attorneys for Abbott Laboratories

(T) 312.782.3939 (F) 312.782.8585

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