TEVA PHARMACEUTICALS USA, INC. v. AZAR, II et al
Plaintiff: TEVA PHARMACEUTICALS USA, INC.
Defendant: SCOTT GOTTLIEB, M.D., ALEX M. AZAR, II and UNITED STATES FOOD AND DRUG ADMINISTRATION
Intervenor Defendant: FAMY CARE PRIVATE LIMITED, MYLAN PHARMACEUTICALS INC. and DEVA HOLDING AS
Case Number: 1:2018cv02394
Filed: October 17, 2018
Court: US District Court for the District of Columbia
Presiding Judge: Randolph D Moss
Nature of Suit: Administrative Procedure Act/Review or Appeal of Agency Decision
Cause of Action: 05:702
Jury Demanded By: None
Docket Report

This docket was last retrieved on February 26, 2019. A more recent docket listing may be available from PACER.

Date Filed Document Text
November 21, 2018 Filing 44 NOTICE of Joinder by FAMY CARE PRIVATE LIMITED re #25 MOTION to Dismiss , #27 Joint MOTION to Dismiss of Mylan Pharmaceuticals and Deva Holdings, #42 Reply to opposition to Motion, #26 Response to motion, #43 Reply to opposition to Motion (Rakoczy, William)
November 21, 2018 Set/Reset Deadlines: Famy Care Ltd. shall identify which portions of Defendants' briefing it is adopting by 11/23/2018. (lsj)
November 20, 2018 Filing 43 REPLY to opposition to motion re #27 Joint MOTION to Dismiss of Mylan Pharmaceuticals and Deva Holdings filed by MYLAN PHARMACEUTICALS INC.. (Schultz, William)
November 20, 2018 Opinion or Order MINUTE ORDER: Upon consideration of Famy Care Pvt. Ltd.'s Motion to Intervene #33 , it is hereby ORDERED that the motion is GRANTED. See Fed. R. Civ. P. 24(a). Famy Care Pvt. Ltd. may participate as a intervenor-defendant in this action. In light of the existing briefing schedule, it is further ORDERED that Famy Care Ltd. shall identify which portions of Defendants' briefing it is adopting on or before November 23, 2018, and shall join in any reply brief filed by the other intervening Defendants to Plaintiff's opposition to the Motion to Dismiss. Signed by Judge Randolph D. Moss on 11/20/2018. (lcrdm3, )
November 20, 2018 Filing 42 REPLY to opposition to motion re #25 MOTION to Dismiss filed by ALEX M. AZAR, II, SCOTT GOTTLIEB, M.D., UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: #1 Exhibit A, #2 Exhibit B)(Biro, Charles)
November 18, 2018 Opinion or Order MINUTE ORDER: Upon consideration of the Motions for Leave to Appear Pro Hac Vice #38 , #39 , #40 , #41 , it is hereby ORDERED that the motions are GRANTED in part and DENIED in part. Lara E. FitzSimmons and Kevin P. Burke may appear pro hac vice. William R. Zimmerman and Jonathan E. Bachand may appear pro hac vice in proceedings before this Court but may not file papers in this Court. See LCvR 83.2(c)(2) ("An attorney who engages in the practice of law from an office located in the District of Columbia must be a member of the District of Columbia bar and the Bar of this Court to file papers in this Court."). Signed by Judge Randolph D. Moss on 11/18/2018. (lcrdm3, )
November 16, 2018 Filing 41 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Jonathan E. Bachand, :Firm- Knobbe, Martens, Olson & Bear, LLP, :Address- 1717 Pennsylvania Avenue N.W., Suite 900, Washington, DC 20006. Phone No. - (202) 640-6400. Fax No. - (202) 640-6401 Filing fee $ 100, receipt number 0090-5795846. Fee Status: Fee Paid. by FAMY CARE PRIVATE LIMITED (Attachments: #1 Declaration, #2 Text of Proposed Order)(Rakoczy, William)
November 16, 2018 Filing 40 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- William R. Zimmerman, :Firm- Knobbe, Martens, Olson & Bear, LLP, :Address- 1717 Pennsylvania Avenue N.W., Suite 900, Washington, DC 20006. Phone No. - (202) 640-6400. Fax No. - (202) 640-6401 Filing fee $ 100, receipt number 0090-5795829. Fee Status: Fee Paid. by FAMY CARE PRIVATE LIMITED (Attachments: #1 Declaration, #2 Text of Proposed Order)(Rakoczy, William)
November 16, 2018 Filing 39 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Kevin P. Burke, :Firm- Rakoczy Molino Mazzochi Siwik LLP, :Address- 6 West Hubbard Street, Suite 500, Chicago, IL 60654. Phone No. - (312) 222-5113. Fax No. - (312) 222-5114 Filing fee $ 100, receipt number 0090-5795814. Fee Status: Fee Paid. by FAMY CARE PRIVATE LIMITED (Attachments: #1 Declaration, #2 Text of Proposed Order)(Rakoczy, William)
November 16, 2018 Filing 38 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Lara E. FitzSimmons, :Firm- Rakoczy Molino Mazzochi Siwik LLP, :Address- 6 West Hubbard Street, Suite 500, Chicago, IL 60654. Phone No. - (312) 222-7507. Fax No. - (312) 222-7527 Filing fee $ 100, receipt number 0090-5795764. Fee Status: Fee Paid. by FAMY CARE PRIVATE LIMITED (Attachments: #1 Declaration, #2 Text of Proposed Order)(Rakoczy, William)
November 14, 2018 Filing 37 Memorandum in opposition to re #25 MOTION to Dismiss , #27 Joint MOTION to Dismiss of Mylan Pharmaceuticals and Deva Holdings filed by TEVA PHARMACEUTICALS USA, INC.. (Shumsky, Michael)
November 14, 2018 Filing 36 REPLY to opposition to motion re #2 MOTION for Preliminary Injunction filed by TEVA PHARMACEUTICALS USA, INC.. (Shumsky, Michael)
November 14, 2018 Filing 35 LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by FAMY CARE PRIVATE LIMITED (Rakoczy, William)
November 14, 2018 Filing 34 NOTICE of Appearance by William A. Rakoczy on behalf of FAMY CARE PRIVATE LIMITED (Rakoczy, William)
November 14, 2018 Filing 33 MOTION to Intervene by FAMY CARE PRIVATE LIMITED (Attachments: #1 Memorandum in Support, #2 Text of Proposed Order)(Rakoczy, William)
November 6, 2018 Filing 31 TRANSCRIPT OF PROCEEDINGS before Judge Randolph D. Moss held on November 5, 2018. Page Numbers: 1 - 81. Date of Issuance: November 6, 2018. Court Reporter: Jeff Hook. Contact Information: 202-354-3373 / jeff_hook@dcd.uscourts.gov. Transcripts may be ordered by submitting the #Transcript Order FormFor the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purch ased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter.NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 11/27/2018. Redacted Transcript Deadline set for 12/7/2018. Release of Transcript Restriction set for 2/4/2019.(Hook, Jeff)
November 5, 2018 Opinion or Order MINUTE ORDER: In light of the parties' submissions and oral argument, it is hereby ORDERED that the Court's Order dated October 26, 2018, Dkt. #15 , is VACATED. It is further ORDERED that, until further notice of the Court, the FDA shall provide the Court with 48 hours' notice before taking any final action that would directly impact Teva's claim to 180-day generic exclusivity. The FDA is directed to contact Judge Moss's chambers ex parte at (202) 3554-3020 for purposes of notifying the Court. Such notice is necessary to ensure that the Court is available and prepared to expeditiously hold a hearing in the event that Teva files a motion for a temporary restraining order in response to any such decision. Signed by Judge Randolph D. Moss on 11/5/2018. (lcrdm3, )
November 5, 2018 Filing 30 NOTICE of Appearance by Thomas J. Tobin on behalf of TEVA PHARMACEUTICALS USA, INC. (Tobin, Thomas)
November 5, 2018 Minute Entry for proceedings held before Judge Randolph D. Moss: Status Conference held on 11/5/2018. (Court Reporter: Jeff Hook.) (jl)
November 3, 2018 Filing 29 RESPONSE TO ORDER OF THE COURT re Order,, filed by MYLAN PHARMACEUTICALS INC.. (Schultz, William)
November 3, 2018 Filing 28 RESPONSE TO ORDER OF THE COURT re Order,, filed by TEVA PHARMACEUTICALS USA, INC.. (Shumsky, Michael)
November 2, 2018 Filing 32 Memorandum in opposition to re #2 MOTION for Preliminary Injunction filed by DEVA HOLDING AS, MYLAN PHARMACEUTICALS INC..; (See docket entry no. #27 to view.) (ztd)
November 2, 2018 Filing 27 Joint MOTION to Dismiss of Mylan Pharmaceuticals and Deva Holdings by MYLAN PHARMACEUTICALS INC. (Attachments: #1 Memorandum in Support of Motion to Dismiss and in Opposition to Motion for Prelim Injunction, #2 Exhibit A (FDA 2015 Letter), #3 Exhibit B (FDA 2018 Letter), #4 Declaration of K Meckstroth (Mylan), #5 Declaration of P. Haas (Deva), #6 Text of Proposed Order on Motion to Dismiss, #7 Text of Proposed Order on Motion for Prelim Inj)(Schultz, William)
November 2, 2018 Filing 26 RESPONSE re #2 MOTION for Preliminary Injunction filed by ALEX M. AZAR, II, SCOTT GOTTLIEB, M.D., UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Exhibit C, #4 Exhibit D, #5 Exhibit E, #6 Exhibit F, #7 Exhibit G, #8 Exhibit H)(Biro, Charles)
November 2, 2018 Filing 25 MOTION to Dismiss by ALEX M. AZAR, II, SCOTT GOTTLIEB, M.D., UNITED STATES FOOD AND DRUG ADMINISTRATION (Attachments: #1 Text of Proposed Order)(Biro, Charles)
November 1, 2018 Set/Reset Deadlines: Teva's supplemental brief due on or before 11/3/2018, at 1:00 p.m. (kt)
November 1, 2018 Opinion or Order MINUTE ORDER: In light of the government's response to the Court's October 26, 2018 order, Dkt. #19 , it is hereby ORDERED that Teva file a supplemental brief on or before November 3 at 1:00 p.m. responding to the government's contentions that (1) the Court lacks jurisdiction to enter an order similar to the one entered in AstraZeneca Pharmaceuticals LP v. Burwell, 197 F. Supp. 3d 53 (D.D.C. 2016), and (2) that the Court, in any event, should not enter such an order in the absence of a motion for a temporary restraining order. Intervenors may, but are not required to, file their own submissions addressing these issues on that same schedule. Signed by Judge Randolph D. Moss on 11/1/2018. (lcrdm2, )
October 31, 2018 Filing 24 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed as to the United States Attorney. Date of Service Upon United States Attorney on 10/22/2018. Answer due for ALL FEDERAL DEFENDANTS by 12/21/2018. (Shumsky, Michael)
October 31, 2018 Filing 23 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed on United States Attorney General. Date of Service Upon United States Attorney General 10/22/2018. (Shumsky, Michael)
October 31, 2018 Filing 22 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. UNITED STATES FOOD AND DRUG ADMINISTRATION served on 10/23/2018 (Shumsky, Michael)
October 31, 2018 Filing 21 RETURN OF SERVICE/AFFIDAVIT of Summons and Complaint Executed. ALEX M. AZAR, II served on 10/22/2018 (Shumsky, Michael)
October 31, 2018 Filing 20 RESPONSE TO ORDER OF THE COURT re #15 Order, filed by TEVA PHARMACEUTICALS USA, INC.. (Attachments: #1 Exhibit A)(Shumsky, Michael)
October 31, 2018 Filing 19 RESPONSE TO ORDER OF THE COURT re #15 Order, filed by ALEX M. AZAR, II, SCOTT GOTTLIEB, M.D., UNITED STATES FOOD AND DRUG ADMINISTRATION. (Attachments: #1 Exhibit A)(Biro, Charles)
October 31, 2018 Filing 18 RESPONSE TO ORDER OF THE COURT re #15 Order, filed by DEVA HOLDING AS. (Karnik, Sanjay)
October 31, 2018 Filing 17 RESPONSE TO ORDER OF COURT re #15 Order by MYLAN PHARMACEUTICALS INC. re #15 Order, (Schultz, William) Modified text on 11/1/2018 (ztd).
October 31, 2018 Set/Reset Hearings: Status Conference set for 11/5/2018, at 10:00 AM, in Courtroom 21, before Judge Randolph D. Moss. (kt)
October 30, 2018 Opinion or Order MINUTE ORDER: It is hereby ORDERED that the parties shall appear for a status conference on November 5, 2018 at 10:00 a.m. in Courtroom 21 to discuss further proceedings in this case. Signed by Judge Randolph D. Moss on 10/30/2018. (lcrdm3, )
October 30, 2018 Filing 16 TRANSCRIPT OF PROCEEDINGS before Judge Randolph D. Moss held on October 26, 2018. Page Numbers: 1 - 47. Date of Issuance: October 30, 2018. Court Reporter: Jeff Hook. Contact Information: jeff_hook@dcd.uscourts.gov / 202-354-3373. Transcripts may be ordered by submitting the #Transcript Order FormFor the first 90 days after this filing date, the transcript may be viewed at the courthouse at a public terminal or purch ased from the court reporter referenced above. After 90 days, the transcript may be accessed via PACER. Other transcript formats, (multi-page, condensed, CD or ASCII) may be purchased from the court reporter.NOTICE RE REDACTION OF TRANSCRIPTS: The parties have twenty-one days to file with the court and the court reporter any request to redact personal identifiers from this transcript. If no such requests are filed, the transcript will be made available to the public via PACER without redaction after 90 days. The policy, which includes the five personal identifiers specifically covered, is located on our website at www.dcd.uscourts.gov. Redaction Request due 11/20/2018. Redacted Transcript Deadline set for 11/30/2018. Release of Transcript Restriction set for 1/28/2019.(Hook, Jeff)
October 29, 2018 Opinion or Order MINUTE ORDER: Upon consideration of the Motions for Leave to Appear Pro Hac Vice #12 , #13 , #14 , it is hereby ORDERED that the motions are GRANTED. Shashank Upadhye, Joseph E. Cwik, and Erin R. Conway may appear pro hac vice in this case. Signed by Judge Randolph D. Moss on 10/29/2018. (lcrdm2, )
October 29, 2018 Set/Reset Deadlines: Parties' Briefs due by 10/31/2018. (kt)
October 26, 2018 Opinion or Order Filing 15 VACATED PURSUANT TO MINUTE ORDER DATED 11/5/2018.....ORDER: It is hereby ORDERED that the parties shall adhere to the following order. See document for details. Signed by Judge Randolph D. Moss on 10/26/2018. (lcrdm2, ) (Main Document 15 replaced on 10/29/2018 to remove repetition/correct formatting) (kt). Modified on 11/26/2018 (kt).
October 26, 2018 Minute Entry for proceedings held before Judge Randolph D. Moss: Status Conference held on 10/26/2018. The Court GRANTS the #6 and #10 respective Motions to Intervene as a Defendant. Defendants and Intervenors Motions to Dismiss and/or Oppositions to the Motion for Preliminary Injunction, due on or before 11/2/2018; Opposition/Reply due on or before 11/14/2018; Final Replies due on or before 11/20/2018. (Court Reporter: Jeff Hook.) (kt)
October 24, 2018 Filing 14 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Erin Conway, :Firm- Amin Talati Upadhye, :Address- 100 S. Wacker Dr., Ste. 2000, Chicago, IL 60606. Phone No. - 312.466.1033. Fax No. - 312.884.7352 Filing fee $ 100, receipt number 0090-5757226. Fee Status: Fee Paid. by DEVA HOLDING AS (Attachments: #1 Declaration of Erin Conway in Support, #2 Text of Proposed Order)(Karnik, Sanjay)
October 24, 2018 Filing 13 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Joseph Cwik, :Firm- Amin Talati Upadhye, :Address- 100 S. Wacker Dr., Ste. 2000, Chicago, IL 60606. Phone No. - 312.466.1033. Fax No. - 312.884.7352 Filing fee $ 100, receipt number 0090-5757225. Fee Status: Fee Paid. by DEVA HOLDING AS (Attachments: #1 Declaration of Joseph Cwik in Support, #2 Text of Proposed Order)(Karnik, Sanjay)
October 24, 2018 Filing 12 MOTION for Leave to Appear Pro Hac Vice :Attorney Name- Shashank Upadhye, :Firm- Amin Talati Upadhye, :Address- 100 S. Wacker Drive, Ste. 2000, Chicago, IL 60606. Phone No. - 312.466.1033. Fax No. - 312.884.7352 Filing fee $ 100, receipt number 0090-5757224. Fee Status: Fee Paid. by DEVA HOLDING AS (Attachments: #1 Declaration of Shashank Upadhye in Support, #2 Text of Proposed Order)(Karnik, Sanjay)
October 24, 2018 Filing 11 NOTICE of Appearance by Sanjay Satish Karnik on behalf of DEVA HOLDING AS (Karnik, Sanjay)
October 24, 2018 Filing 10 MOTION to Intervene as a Defendant by DEVA HOLDING AS (Attachments: #1 Memorandum in Support, #2 Text of Proposed Order, #3 Intervenor-Defendant Deva Holding AS's LCvR 26.1 Disclosure Certificate)(Karnik, Sanjay)
October 24, 2018 Filing 9 REPLY to opposition to motion re #6 MOTION to Intervene as a Defendant filed by MYLAN PHARMACEUTICALS INC.. (Schultz, William)
October 23, 2018 Filing 8 RESPONSE re #6 MOTION to Intervene as a Defendant filed by TEVA PHARMACEUTICALS USA, INC.. (Shumsky, Michael)
October 23, 2018 Set/Reset Hearings: Status Conference set for 10/26/2018, at 2:30 PM, in Courtroom 21, before Judge Randolph D. Moss. (kt)
October 23, 2018 Opinion or Order MINUTE ORDER: It is hereby ORDERED that counsel for the parties and the proposed intervenor shall appear for a status conference at 2:30 p.m. October 26, 2018 in Courtroom 21 and shall be prepared to address the schedule for briefing the pending motions. Signed by Judge Randolph D. Moss on 10/23/2018. (lcrdm2, )
October 23, 2018 Filing 7 NOTICE of Appearance by Charles John Biro on behalf of All Defendants (Biro, Charles) (Main Document 7 replaced on 10/23/2018) (ztd).
October 22, 2018 Filing 6 MOTION to Intervene as a Defendant by MYLAN PHARMACEUTICALS INC. (Attachments: #1 Memorandum in Support of Mylan Pharmaceuticals Inc.'s Motion to Intervene as a Defendant, #2 Intervenor-Defendant Mylan Pharmaceuticals Inc.'s LCvR 26.1 Disclosure Certificate, #3 Text of Proposed Order Proposed Order)(Schultz, William)
October 22, 2018 Filing 5 SUMMONS (4) Issued Electronically as to ALEX M. AZAR, II, SCOTT GOTTLIEB, M.D., UNITED STATES FOOD AND DRUG ADMINISTRATION, U.S. Attorney and U.S. Attorney General (Attachments: #1 Summons 2nd, #2 Summons 3rd, #3 Summons 4th, #4 Notice and Consent) (zmd)
October 22, 2018 Opinion or Order Filing 4 STANDING ORDER: The parties are hereby ORDERED to comply with the directives set forth in the attached Standing Order. See document for details. Signed by Judge Randolph D. Moss on 10/22/2018. (lcrdm2, )
October 19, 2018 Case Assigned to Judge Randolph D. Moss. (zmd)
October 19, 2018 Filing 3 LCvR 26.1 CERTIFICATE OF DISCLOSURE of Corporate Affiliations and Financial Interests by TEVA PHARMACEUTICALS USA, INC. identifying Corporate Parent TEVA PHARMACEUTICAL INDUSTRIES, LTD. for TEVA PHARMACEUTICALS USA, INC.. (zmd)
October 17, 2018 Filing 2 MOTION for Preliminary Injunction by TEVA PHARMACEUTICALS USA, INC. (Attachments: #1 Memorandum in Support, #2 Text of Proposed Order)(Shumsky, Michael)
October 17, 2018 Filing 1 COMPLAINT For Declaratory and Injunctive Relief against ALEX M. AZAR, II, SCOTT GOTTLIEB, M.D., UNITED STATES FOOD AND DRUG ADMINISTRATION ( Filing fee $ 400 receipt number 0090-5744967) filed by TEVA PHARMACEUTICALS USA, INC.. (Attachments: #1 Exhibit A, #2 Exhibit B, #3 Summons Attorney General, #4 Summons FDA Counsel, #5 Summons HHS Counsel, #6 Summons US Atty for DC, #7 Corporate Disclosure, #8 Civil Cover Sheet)(Shumsky, Michael)

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Defendant: SCOTT GOTTLIEB, M.D.
Represented By: Charles John Biro
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Defendant: ALEX M. AZAR, II
Represented By: Charles John Biro
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Defendant: UNITED STATES FOOD AND DRUG ADMINISTRATION
Represented By: Charles John Biro
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Plaintiff: TEVA PHARMACEUTICALS USA, INC.
Represented By: Michael D. Shumsky
Represented By: Thomas J. Tobin
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Intervenor defendant: FAMY CARE PRIVATE LIMITED
Represented By: Kevin P. Burke
Represented By: William A. Rakoczy
Represented By: Lara E. FitzSimmons
Represented By: Jonathan E. Bachand
Represented By: William R. Zimmerman
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Intervenor defendant: MYLAN PHARMACEUTICALS INC.
Represented By: William Barnett Schultz
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Intervenor defendant: DEVA HOLDING AS
Represented By: Shashank Upadhye
Represented By: Joseph E. Cwik
Represented By: Sanjay Satish Karnik
Represented By: Erin R. Conway
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