Momenta Pharmaceuticals, Inc. (MNTA)

[mouton29]

Teva v. FDA.

Here is the docket, I've included the list of counsel, long and illustrious. Both Mylan and Momenta/Sandoz are represented.

U.S. District Court
District of Columbia (Washington, DC)
CIVIL DOCKET FOR CASE #: 1:14-cv-00786-ESH

TEVA PHARMACEUTICAL INDUSTRIES, LTD. et al v. SEBELIUS et al
Assigned to: Judge Ellen S. Huvelle
Cause: 05:702 Administrative Procedure Act
Date Filed: 05/09/2014
Jury Demand: None
Nature of Suit: 899 Administrative Procedure Act/Review or Appeal of Agency Decision
Jurisdiction: Federal Question
Plaintiff
TEVA PHARMACEUTICAL INDUSTRIES, LTD. represented by Jay P. Lefkowitz
KIRKLAND & ELLIS LLP
601 Lexington Avenue
New York, NY 10022
[phone]
Fax: [phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

John Kevin Dolan Crisham
KIRKLAND & ELLIS LLP
601 Lexington Avenue
New York, NY 10022
[phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

John Caviness O'Quinn
KIRKLAND & ELLIS LLP
655 Fifteenth Street, N.W.
Washington, DC 20005
[phone]
Fax: [phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Michael D. Shumsky
KIRKLAND & ELLIS, LLP
655 15th Street, NW
Suite 1200
Washington, DC 20005
[phone]
Fax: [phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Stephen S. Schwartz
KIRKLAND & ELLIS LLP
601 Lexington Avenue
New York, NY 10022
[phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Plaintiff
TEVA NEUROSCIENCE, INC. represented by Jay P. Lefkowitz
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

John Kevin Dolan Crisham
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

John Caviness O'Quinn
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Michael D. Shumsky
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Stephen S. Schwartz
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED


V.

Defendant
KATHLEEN SEBELIUS
in her official capacity as Secretary of Health and Human Services represented by Cindy Jane Cho
U.S. DEPARTMENT OF JUSTICE
450 Fifth Street, NW
Suite 6400 South
Washington, DC 20001
[phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrew E. Clark
US DEPARTMENT OF JUSTICE
Consumer Protection Branch
P.O. Box 386
Washington, DC 20044
[phone]
Fax: [phone]
Email: [e-mail]
ATTORNEY TO BE NOTICED

Defendant
MARGARET A. HAMBURG
M.D., in her official capacity as Commissioner of Food and Drugs represented by Cindy Jane Cho
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrew E. Clark
(See above for address)
ATTORNEY TO BE NOTICED

Defendant
UNITED STATES FOOD AND DRUG ADMINISTRATION represented by Cindy Jane Cho
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrew E. Clark
(See above for address)
ATTORNEY TO BE NOTICED


V.

Intervenor Defendant
MYLAN PHARMACEUTICALS INC. represented by Evan Robert Chesler
CRAVATH, SWAINE & MOORE LLP
825 Eighth Avenue
New York, NY 10019
[phone]
Fax: [phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Richard J. Stark
CRAVATH, SWAINE & MOORE LLP
825 Eighth Avenue
Suite 4070
New York, NY 10019
[phone]
Fax: [phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Shannon M. Bloodworth
PERKINS COIE, LLP
700 13th Street, NW
Suite 600
Washington, DC 20005-3960
[phone]
Fax: [phone]
Email: [e-mail]
ATTORNEY TO BE NOTICED

Intervenor Defendant
SANDOZ INC. represented by Philip Jonathan Perry
LATHAM & WATKINS
555 11th Street, NW
Suite 1000
Washington, DC 20004-1304
[phone]
Fax: [phone]
Email: [e-mail]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrew D. Prins
LATHAM & WATKINS LLP
555 11th Street, NW
Suite 1000
Washington, DC 20004-1304
[phone]
Email: [e-mail]
ATTORNEY TO BE NOTICED

Intervenor Defendant
MOMENTA PHARMACEUTICALS, INC. represented by Philip Jonathan Perry
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrew D. Prins
(See above for address)
ATTORNEY TO BE NOTICED


Date Filed # Docket Text
05/09/2014 1 UNOPPOSED MOTION for Leave to File INFORMATION UNDER SEAL by TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (Attachments: # 1 Memorandum in Support, # 2 Notice of Filing Under Seal, # 3 Text of Proposed Order)(rdj) (Entered: 05/09/2014)
05/09/2014 2 ORDER granting 1 Motion for Leave to File INFORMATION UNDER SEAL. Signed by Chief Judge Richard W. Roberts on 5/9/2014. (See Order for further details.)(rdj) (Entered: 05/09/2014)
05/09/2014 3 NOTICE of Appearance by Andrew E. Clark on behalf of All Defendants (Clark, Andrew) (Entered: 05/09/2014)
05/09/2014 4 COMPLAINT against MARGARET A. HAMBURG, KATHLEEN SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION ( Filing fee $ 400, receipt number 4616063679) filed by TEVA PHARMACEUTICAL INDUSTRIES, LTD., TEVA NEUROSCIENCE, INC.. (Attachments: # 1 Exhibit A - May 2 2014 Response, # 2 Exhibit B - Citizen Petition from TEVA Pharmaceuticals, # 3 Exhibit B-1, # 4 Exhibit B-2, # 5 Exhibit B-3, # 6 Exhibit B-4, # 7 Exhibit B-5, # 8 Exhibit B-6, # 9 Exhibit B-7, # 10 Exhibit B-8, # 11 Exhibit B-9, # 12 Exhibit B-10, # 13 Exhibit B-11, # 14 Exhibit B-12, # 15 Exhibit B-13, # 16 Exhibit B-14, # 17 Exhibit B-15, # 18 Exhibit B-16, # 19 Exhibit B-17, # 20 Exhibit B-18, # 21 Exhibit B-19, # 22 Exhibit B-20, # 23 Exhibit B-21, # 24 Exhibit B-22, # 25 Exhibit B-23)(rdj) (Entered: 05/09/2014)
05/09/2014 5 LARGE ADDITIONAL ATTACHMENT(S) by TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. 4 Complaint filed by TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (Exhibit B-24) (Attachments: # 1 Exhibit B-25, # 2 Exhibit B-26, # 3 Exhibit B-27, # 4 Exhibit B-28, # 5 Exhibit B-29, # 6 Exhibit B-30, # 7 Exhibit B-31, # 8 Exhibit B-32, # 9 Exhibit B-33, # 10 Exhibit B-34, # 11 Exhibit C CP1 - 9-26-2008, # 12 Exhibit D CP2 - 11-13-2009, # 13 Exhibit E CP3 - 12-10-2010, # 14 Exhibit F CP4 - 6-4-2012, # 15 Exhibit G CP5 - 12-31-2012, # 16 Exhibit H CP6 - 9-12-2013, # 17 Exhibit I Supplement from TEVA Pharmaceutical Industries Inc, # 18 Exhibit J Memorandum of Meeting Minutes February 25 2014, # 19 Exhibit K Supplement from Teva Pharmaceutical Industries Ltd, # 20 Exhibit K-1 Letter from Mylan Pharmaceuticals Inc. to FDA DDM, # 21 Exhibit L CP1 - FDA Denial - 3-25-2009, # 22 Exhibit M CP2 - FDA Denial - 5-11-2010, # 23 Exhibit N CP3 - FDA Denial - 6-8-2011, # 24 Exhibit O CP4 - FDA Denial - 11-30-2012, # 25 Exhibit P CP5 - FDA Denial - 3-27-2013, # 26 Civil Cover Sheet)(rdj) (Entered: 05/09/2014)
05/09/2014 6 MOTION for Temporary Restraining Order, MOTION for Preliminary Injunction by TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (Attachments: # 1 LCvR65 1(a) Certification, # 2 Memorandum in Support (REDACTED), # 3 Memorandum in Support (This document is SEALED and only available to authorized persons.), # 4 Exhibit A Oct 28 Hi-Tech transcript, # 5 Exhibit B Hatch Letter May 2014, # 6 Exhibit C Crowley letter May 2014, # 7 Exhibit D Oct 2 Hi-Tech transcript, # 8 Exhibit E Letter from J. Woodcock to D. Zuchero, et al., # 9 Exhibit F Letter from J. Woodcock to S. Rattray, # 10 Exhibit G (REDACTED), # 11 Exhibit G (This document is SEALED and only available to authorized persons.), # 12 Text of Proposed Order)(zrdj) (Entered: 05/09/2014)
05/09/2014 SUMMONS (5) Issued as to MARGARET A. HAMBURG, KATHLEEN SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (rdj) (Entered: 05/09/2014)
05/09/2014 7 LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (rdj) (Entered: 05/09/2014)
05/09/2014 8 NOTICE of Appearance by Michael D. Shumsky on behalf of TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (rdj) (Entered: 05/09/2014)
05/09/2014 9 NOTICE of Appearance by Stephen S. Schwartz on behalf of TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (rdj) (Entered: 05/09/2014)
05/09/2014 10 NOTICE of Appearance by John Caviness O'Quinn on behalf of TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (rdj) (Entered: 05/09/2014)
05/09/2014 11 NOTICE of Appearance by Jay P. Lefkowitz on behalf of TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (rdj) (Entered: 05/09/2014)
05/09/2014 12 NOTICE of Appearance by John Kevin Dolan Crisham on behalf of TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (rdj) (Entered: 05/09/2014)
05/09/2014 Minute Entry for proceedings held before Judge Beryl A. Howell: Motion for a Temporary Restraining Order Hearing held on 5/9/2014 re 6 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction filed by TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD. (Order forthcoming.) (Court Reporter Chantal Geneus.) (tg, ) (Entered: 05/09/2014)
05/09/2014 MINUTE ORDER denying 6 plaintiffs' motion for a temporary restraining order. For the reasons stated on the record during the hearing held this day, plaintiffs' motion for a temporary restraining order is DENIED. Defendants' opposition to 6 plaintiffs' motion for a preliminary injunction, along with an outline of the administrative record, is due Monday, May 12, 2014 at 5:00 p.m. A motions hearing on plaintiffs' motion for a preliminary injunction is set before the Honorable Ellen Segal Huvelle on Wednesday, May 14, 2014, at 2:00 p.m. in Courtroom 23A. Signed by Judge Beryl A. Howell on May 9, 2014. (lcesh1) (Entered: 05/09/2014)
05/09/2014 13 NOTICE of Appearance by Cindy Jane Cho on behalf of All Defendants (Cho, Cindy) (Entered: 05/09/2014)
05/09/2014 14 NOTICE of Appearance by Evan Robert Chesler on behalf of MYLAN PHARMACEUTICALS INC. (Chesler, Evan) (Entered: 05/09/2014)
05/09/2014 15 NOTICE of Appearance by Richard J. Stark on behalf of MYLAN PHARMACEUTICALS INC. (Stark, Richard) (Entered: 05/09/2014)
05/09/2014 16 Unopposed MOTION to Intervene ("Mylan Pharmaceuticals Inc.'s Unopposed Motion to Intervene as a Defendant") by MYLAN PHARMACEUTICALS INC. (Attachments: # 1 Memorandum in Support, # 2 Text of Proposed Order)(Stark, Richard) (Entered: 05/09/2014)
05/09/2014 17 LCvR 7.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by MYLAN PHARMACEUTICALS INC. (Stark, Richard) (Entered: 05/09/2014)
05/10/2014 MINUTE ORDER granting 16 Mylan's Pharmaceutical Inc.'s Unopposed Motion to Intervene: Upon consideration of Mylan Pharmaceuticals Unopposed Motion To Intervene as a Defendant, it is hereby ORDERED that the motion is GRANTED; it is further ORDERED that Mylan Pharmaceuticals is allowed to intervene as a defendant in the above-captioned action; and it is further ORDERED that Mylan's opposisiton to plaintiffs' motion for a preliminary injunction shall be filed by no later than 5:00 p.m. on Monday, May 12, 2014, with two courtesy paper copies of the filing hand-delivered to Chambers. Signed by Judge Ellen S. Huvelle on May 10, 2014. (AG) (Entered: 05/10/2014)
05/11/2014 18 NOTICE of Appearance by Philip Jonathan Perry on behalf of SANDOZ INC., MOMENTA PHARMACEUTICALS, INC. (Perry, Philip) (Entered: 05/11/2014)
05/11/2014 19 NOTICE of Appearance by Andrew D. Prins on behalf of MOMENTA PHARMACEUTICALS, INC., SANDOZ INC. (Prins, Andrew) (Entered: 05/11/2014)
05/11/2014 20 Unopposed MOTION to Intervene as Defendants and to Defer Filing of Answer by MOMENTA PHARMACEUTICALS, INC., SANDOZ INC. (Attachments: # 1 Memorandum in Support, # 2 Text of Proposed Order)(Perry, Philip) (Entered: 05/11/2014)
05/11/2014 21 Corporate Disclosure Statement by SANDOZ INC.. (Perry, Philip) (Entered: 05/11/2014)
05/11/2014 22 Corporate Disclosure Statement by MOMENTA PHARMACEUTICALS, INC.. (Perry, Philip) (Entered: 05/11/2014)
05/11/2014 MINUTE ORDER granting 20 Momenta Pharmaceuticals Inc. and Sandoz Inc.'s Unopposed Motion to Intervene. Upon consideration of Momenta Pharmaceuticals and Sandoz's Unopposed Motion To Intervene as Defendants, it is hereby ORDERED that the motion is GRANTED; it is further ORDERED that Momenta Pharmaceuticals and Sandoz are allowed to intervene as defendants in the above-captioned action; and it is further ORDERED that their opposition to plaintiffs' motion for a preliminary injunction shall be filed by no later than 5:00 p.m. on Monday, May 12, 2014, with two courtesy paper copies of the filing hand-delivered to Chambers. Signed by Judge Ellen S. Huvelle on May 11 2014. (lcesh1) (Entered: 05/11/2014)
05/11/2014 MINUTE ORDER setting length of intervenor-defendants' briefs. It is hereby ORDERED that intervenor-defendants' briefs in opposition to plaintiffs' motion for preliminary injunction shall be limited to 20 pages each. Signed by Judge Ellen S. Huvelle on May 11, 2014. (lcesh1) (Entered: 05/11/2014)
05/12/2014 Set/Reset Deadlines/Hearings: Response to motion for preliminary injunction and outline of administrative record due by 5/12/2014. Preliminary Injunction Hearing set for 5/14/2014 02:00 PM in Courtroom 23A before Judge Ellen S. Huvelle. (zmm, ) (Entered: 05/12/2014)
05/12/2014 23 Memorandum in opposition to re 6 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction filed by MYLAN PHARMACEUTICALS INC.. (Attachments: # 1 Declaration of Tony Mauro in Support of Mylan Pharmaceuticals Inc.'s Opposition to Teva's Motion for a Preliminary Injunction, # 2 Declaration of Richard J. Stark in Support of Mylan Pharmaceuticals Inc.'s Opposition to Teva's Motion for a Preliminary Injunction, # 3 Exhibit A to Declaration of Richard J. Stark, # 4 Exhibit B to Declaration of Richard J. Stark, # 5 Exhibit C to Declaration of Richard J. Stark, # 6 Exhibit D to Declaration of Richard J. Stark, # 7 Exhibit E to Declaration of Richard J. Stark, # 8 Exhibit F to Declaration of Richard J. Stark, # 9 Exhibit G to Declaration of Richard J. Stark, # 10 Text of Proposed Order)(Chesler, Evan) (Entered: 05/12/2014)
05/12/2014 24 NOTICE of Appearance by Shannon M. Bloodworth on behalf of MYLAN PHARMACEUTICALS INC. (Bloodworth, Shannon) (Entered: 05/12/2014)
05/12/2014 25 RESPONSE re 6 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction filed by MOMENTA PHARMACEUTICALS, INC., SANDOZ INC.. (Perry, Philip) (Entered: 05/12/2014)
05/12/2014 26 SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by MOMENTA PHARMACEUTICALS, INC., SANDOZ INC. (This document is SEALED and only available to authorized persons.) (Attachments: # 1 Memorandum in Support, # 2 Exhibit A, # 3 Exhibit B, # 4 Text of Proposed Order)(Perry, Philip) (Entered: 05/12/2014)
05/12/2014 27 SEALED MOTION FOR LEAVE TO FILE DOCUMENT UNDER SEAL filed by MARGARET A. HAMBURG, KATHLEEN SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION (This document is SEALED and only available to authorized persons.) (Attachments: # 1 Exhibit Mem. in Supp. Mtn. to Dismiss and in Opp. to Pl. Mtn. for Prelim. Inj., # 2 Text of Proposed Order)(Cho, Cindy) (Entered: 05/12/2014)
05/12/2014 28 MOTION to Dismiss and Mem. in Support of Mtn. to Dismiss and in Opp. to Mtn. for Prelim. Inj. by MARGARET A. HAMBURG, KATHLEEN SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION (Attachments: # 1 Exhibit, # 2 Exhibit, # 3 Text of Proposed Order)(Cho, Cindy) (Entered: 05/12/2014)
05/12/2014 29 NOTICE of Filing Exhibit 3 to Mem. in Support of Mtn. to Dismiss and in Opp. to Mtn. for Prelim. Inj. by MARGARET A. HAMBURG, KATHLEEN SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION re 28 MOTION to Dismiss and Mem. in Support of Mtn. to Dismiss and in Opp. to Mtn. for Prelim. Inj. (Attachments: # 1 Exhibit Ex. 3 to Mem. in Supp. of Mtn. to Dismiss and in Opp. to Mtn. for Prelim. Inj.)(Cho, Cindy) (Entered: 05/12/2014)
05/12/2014 MINUTE ORDER granting 26 Unopposed Motion for Leave to File Document Under Seal. Signed by Judge Ellen S. Huvelle on May 12, 2014. (lcesh1) (Entered: 05/12/2014)
05/12/2014 MINUTE ORDER granting 27 Unopposed Motion for Leave to File Document Under Seal. Signed by Judge Ellen S. Huvelle on May 12, 2014. (lcesh1) (Entered: 05/12/2014)
05/12/2014 30 Memorandum in opposition to re 6 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction filed by MARGARET A. HAMBURG, KATHLEEN SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION. (See Docket Entries 28 and 29 to view documents). (znmw, ) (Entered: 05/13/2014)
05/12/2014 31 SEALED DOCUMENT (Exhibits A and B) filed by MOMENTA PHARMACEUTICALS, INC.. re 25 Response to motion filed by SANDOZ INC., MOMENTA PHARMACEUTICALS, INC.. (This document is SEALED and only available to authorized persons.)(znmw, ) (Entered: 05/13/2014)
05/12/2014 32 SEALED DOCUMENT (Memorandum in Support of Motion to Dismiss and in Opposition to Motion for Preliminary Injunction) filed by MARGARET A. HAMBURG, KATHLEEN SEBELIUS, UNITED STATES FOOD AND DRUG ADMINISTRATION. re 6 MOTION for Temporary Restraining Order MOTION for Preliminary Injunction filed by TEVA NEUROSCIENCE, INC., TEVA PHARMACEUTICAL INDUSTRIES, LTD., 28 MOTION to Dismiss and Mem. in Support of Mtn. to Dismiss and in Opp. to Mtn. for Prelim. Inj. filed by UNITED STATES FOOD AND DRUG ADMINISTRATION, MARGARET A. HAMBURG, KATHLEEN SEBELIUS. (This document is SEALED and only available to authorized persons.)(znmw, ) (Entered: 05/13/2014)