Regeneron Pharmaceuticals, Inc. v. United States Department of Health and Human Services et al
Plaintiff: Regeneron Pharmaceuticals, Inc.
Defendant: United States Department of Health and Human Services, Seema Verma, Centers for Medicare and Medicaid Services and Alex M. Azar II
Amicus Curiae: American Society of Clinical Oncology
Case Number: 7:2020cv10488
Filed: December 11, 2020
Court: US District Court for the Southern District of New York
Office: White Plains Office
Presiding Judge: Kenneth M Karas
Nature of Suit: Other Statutes: Administrative Procedures Act/Review or Appeal of Agency Decision
Cause of Action: 05:551
Jury Demanded By: None
Docket Report

This docket was last retrieved on February 10, 2021. A more recent docket listing may be available from PACER.

Date Filed Document Text
February 5, 2021 Filing 59 LETTER RESPONSE in Opposition to Motion addressed to Judge Kenneth M. Karas from Lisa Newman dated February 5, 2021 re: #54 LETTER MOTION for Conference / request for pre-motion conference for leave to file a motion for summary judgment addressed to Judge Kenneth M. Karas from Robert W. Allen dated February 2, 2021. . Document filed by Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma..(Newman, Lisa)
February 4, 2021 Opinion or Order Filing 58 ORDER granting #57 CONSENT LETTER MOTION for Extension of Time to File Answer re: #1 Complaint. Granted. SO ORDERED. (Signed by Judge Kenneth M. Karas on 2/3/2021) (jca)
February 3, 2021 Filing 57 CONSENT LETTER MOTION for Extension of Time to File Answer re: #1 Complaint, addressed to Judge Kenneth M. Karas from Lisa Newman dated February 3, 2021. Document filed by Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma..(Newman, Lisa)
February 2, 2021 Set/Reset Deadlines: Responses due by 2/9/2021 (jca)
February 2, 2021 Opinion or Order Filing 56 ORDER with respect to #55 LETTER MOTION to Stay /request for pre-motion conference for leave to file motion to stay. Plaintiff is to respond to this letter by 2/9/21. So Ordered. (Signed by Judge Kenneth M. Karas on 2/2/2021) (jca)
February 2, 2021 Filing 55 LETTER MOTION to Stay /request for pre-motion conference for leave to file motion to stay addressed to Judge Kenneth M. Karas from Lisa Newman dated February 2, 2021. Document filed by Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma..(Newman, Lisa)
February 2, 2021 Filing 54 LETTER MOTION for Conference / request for pre-motion conference for leave to file a motion for summary judgment addressed to Judge Kenneth M. Karas from Robert W. Allen dated February 2, 2021. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
January 12, 2021 Filing 53 INTERNET CITATION NOTE: Material from decision with Internet citation re: #45 Memorandum & Opinion. (sjo)
January 12, 2021 Filing 52 INTERNET CITATION NOTE: Material from decision with Internet citation re: #45 Memorandum & Opinion. (sjo)
January 12, 2021 Filing 51 INTERNET CITATION NOTE: Material from decision with Internet citation re: #45 Memorandum & Opinion. (sjo)
January 12, 2021 Filing 50 INTERNET CITATION NOTE: Material from decision with Internet citation re: #45 Memorandum & Opinion. (sjo)
January 12, 2021 Filing 49 INTERNET CITATION NOTE: Material from decision with Internet citation re: #45 Memorandum & Opinion. (sjo)
January 12, 2021 Filing 48 INTERNET CITATION NOTE: Material from decision with Internet citation re: #45 Memorandum & Opinion. (sjo)
January 12, 2021 Filing 47 INTERNET CITATION NOTE: Material from decision with Internet citation re: #45 Memorandum & Opinion. (sjo)
January 4, 2021 Filing 46 DECLARATION of Daniel Cellucci Regarding Proof of Service re: #20 Order to Show Cause,,,,,,, Set Deadlines,,,,,, . Document filed by Regeneron Pharmaceuticals, Inc...(Cellucci, Daniel)
December 30, 2020 Opinion or Order Filing 45 OPINION & ORDER: For the reasons given, Plaintiff's application for a preliminary injunction is granted. Pursuant to Federal Rule of Civil Procedure 65(a), Defendants and their agents, servants, employees, attorneys, successors and assigns, and all persons acting in concert with them, are preliminarily enjoined from applying the MFN Rule to Regeneron's drug EYLEA (aflibercept) Injection, without bond. (Signed by Judge Kenneth M. Karas on 12/30/2020) (tro)
December 30, 2020 Filing 44 RESPONSE re: #43 Memo Endorsement, / Letter response to the government's December 29 letter regarding California Life Sciences Association v. Center for Medicare & Medicaid Services, No. 20-cv-08603-VC (N.D. Cal.).. Document filed by Regeneron Pharmaceuticals, Inc.. (Attachments: #1 Exhibit A, #2 Exhibit B).(Allen, Robert)
December 29, 2020 Opinion or Order Filing 43 MEMO ENDORSEMENT on re: #42 Notice (Other), filed by Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Alex M. Azar II, Seema Verma. ENDORSEMENT : Plaintiff is to reply to this letter by December 30, 2020 at 4PM EST. So Ordered. (Signed by Judge Kenneth M. Karas on 12/29/20) (yv)
December 29, 2020 Filing 42 NOTICE of Nationwide Preliminary Injunction. Document filed by Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma. (Attachments: #1 Exhibit, #2 Exhibit).(Newman, Lisa)
December 24, 2020 Filing 41 LETTER addressed to Judge Kenneth M. Karas from Robert W. Allen dated December 24, 2020 re: Notice of Supplemental Authority. Document filed by Regeneron Pharmaceuticals, Inc.. (Attachments: #1 Exhibit A).(Allen, Robert)
December 22, 2020 Minute Entry for proceedings held before Judge Kenneth M. Karas: Oral Argument held on 12/22/2020 re: #20 Order to Show Cause. Paul Clement appeared on behalf of Plaintiff. Lisa Newman appeared on behalf of Defendants. Angie Shaw-Crockett served as court reporter. Oral arguments were made on the Court's Order to Show Cause. (Dkt. No. 20.) The Parties may request a transcript of the record.(EJJ) Modified on 12/23/2020 (Landers, Rigoberto).
December 18, 2020 Filing 40 REPLY MEMORANDUM OF LAW in Support re: #20 Order to Show Cause,,,,,,, Set Deadlines,,,,,, #11 Proposed Order to Show Cause With Emergency Relief *REDACTED*. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 18, 2020 Filing 39 ***SELECTED PARTIES*** REPLY MEMORANDUM OF LAW in Support re: #20 Order to Show Cause,,,,,,, Set Deadlines,,,,,, #11 Proposed Order to Show Cause With Emergency Relief SEALED. Document filed by Regeneron Pharmaceuticals, Inc., American Society of Clinical Oncology, Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma. Motion or Order to File Under Seal: #23 .(Allen, Robert)
December 18, 2020 Set/Reset Hearings: Telephone Conference set for 12/22/2020 at 10:00 AM before Judge Kenneth M. Karas. (jca)
December 18, 2020 Opinion or Order Filing 38 ORDER: For the week of December 21, 2020, the Court will hold all civil conferences, hearings, and/or oral arguments by telephone. Counsel shall call the following number at the designated time: Meeting Dial-In Number (USA toll-free): (888) 363-4749 Access Code: 7702195. Please enter the conference as a guest by pressing the pound sign (#). Given that much of the Court is operating remotely and has limited mail capability, counsel involved in any pro se cases shall mail a copy of this Notice to or otherwise inform the pro se party of the above teleconference information. Counsel in any pro se inmate cases shall ensure that the pro se party is on the line before calling the above-referenced number. For initial conferences, counsel shall submit a proposed case management and discovery schedule via ECF by 5 p.m. on the evening before the initial conference. Any requests for adjournments should be filed as soon as possible and clearly explain why the conference should be adjourned. SO ORDERED (Signed by Judge Kenneth M. Karas on 12/18/2020) (jca)
December 18, 2020 Filing 37 BRIEF re: #20 Order to Show Cause,,,,,,, Set Deadlines,,,,,, (Brief of American Society of Clinical Oncology as Amicus Curiae in Support of Plaintiffs Motion for a Preliminary Injunction and Temporary Restraining Order). Document filed by American Society of Clinical Oncology..(Ryan, Meredythe)
December 17, 2020 Opinion or Order Filing 36 ORDER GRANTING UNOPPOSED MOTION OF AMERICAN SOCIETY OF CLINICAL ONCOLOGY FOR LEAVE TO FILE BRIEF AS AMICUS CURIAE IN SUPPORT OF PLAINTIFF'S REQUEST FOR A PRELIMINARY INJUNCTION AND TEMPORARY RESTRAINING ORDER granting #35 MOTION for Leave to File Brief as Amicus Curiae in Support of Plaintiff's Motion for a Preliminary Injunction and Temporary Restraining Order (Unopposed). The American Society of Clinical Oncology brought this unopposed motion for leave to file a brief as amicus curiae in support of Plaintiff's request for Preliminary Injunction and Temporary Restraining Order. This Court, having considered the instant motion and all other relevant factors, hereby GRANTS amicus's motion. The American Society of Clinical Oncology may file its brief. SO ORDERED. (Signed by Judge Kenneth M. Karas on 12/17/2020) (jca)
December 16, 2020 Filing 35 MOTION for Leave to File Brief as Amicus Curiae in Support of Plaintiff's Motion for a Preliminary Injunction and Temporary Restraining Order (Unopposed). Document filed by American Society of Clinical Oncology. (Attachments: #1 Brief of American Society of Clinical Oncology as Amicus Curiae, #2 Text of Proposed Order).(Ryan, Meredythe)
December 16, 2020 Filing 34 Amicus Curiae APPEARANCE entered by Meredythe Medford Ryan on behalf of American Society of Clinical Oncology..(Ryan, Meredythe)
December 16, 2020 Filing 33 OPPOSITION BRIEF re: #14 Memorandum of Law in Support, Defendants' Opposition to Plaintiff's Motion for Temporary Restraining Order and Preliminary Injunctive Relief. Document filed by Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma..(Newman, Lisa)
December 16, 2020 Filing 32 ELECTRONIC SUMMONS ISSUED as to United States Department of Health and Human Services..(dnh)
December 16, 2020 Opinion or Order Filing 31 ORDER granting #29 FIRST LETTER MOTION for Leave to File Excess Pages for Defendants Opposition to Plaintiffs Motion for Temporary Restraining Order and Preliminary Injunctive Relief. Granted. Plaintiff also is given five extra pages in its reply. SO ORDERED. (Signed by Judge Kenneth M. Karas on 12/15/2020) (jca)
December 15, 2020 Filing 30 REQUEST FOR ISSUANCE OF SUMMONS as to United States Department of Health and Human Services, re: #1 Complaint,. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 15, 2020 Filing 29 FIRST LETTER MOTION for Leave to File Excess Pages for Defendants Opposition to Plaintiffs Motion for Temporary Restraining Order and Preliminary Injunctive Relief addressed to Judge Kenneth M. Karas from Defendants dated December 15, 2020. Document filed by Alex M. Azar II, United States Department of Health and Human Services, Seema Verma..(Newman, Lisa)
December 15, 2020 ***NOTICE TO ATTORNEY REGARDING DEFICIENT REQUEST FOR ISSUANCE OF SUMMONS. Notice to Attorney Robert Allen to RE-FILE Document No. #28 Request for Issuance of Amended Summons,. The filing is deficient for the following reason(s): the wrong event type was used to file the request for issuance of summons;. Re-file the document using the event type Request for Issuance of Summons found under the event list Service of Process - select the correct filer/filers - and attach the correct summons form PDF. (jgo)
December 14, 2020 Filing 28 FILING ERROR - SUMMONS REQUESTED - WRONG EVENT TYPE SELECTED FROM MENU - REQUEST FOR ISSUANCE OF AMENDED SUMMONS as to United States Department of Health and Human Services, re: #1 Complaint,. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert) Modified on 12/15/2020 (jgo).
December 14, 2020 Filing 27 ***SELECTED PARTIES*** MEMORANDUM OF LAW in Support re: #20 Order to Show Cause,,,,,,, Set Deadlines,,,,,, . Document filed by Regeneron Pharmaceuticals, Inc., Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma. Motion or Order to File Under Seal: #23 .(Allen, Robert)
December 14, 2020 Filing 26 ***SELECTED PARTIES***DECLARATION of Richard ONeal in Support re: #20 Order to Show Cause,,,,,,, Set Deadlines,,,,,,. Document filed by Regeneron Pharmaceuticals, Inc., Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma. Motion or Order to File Under Seal: #23 .(Allen, Robert)
December 14, 2020 ***NOTICE TO ATTORNEY REGARDING DEFICIENT REQUEST FOR ISSUANCE OF SUMMONS. Notice to Attorney Robert Allen to RE-FILE Document No. #25 Request for Issuance of Summons,. The filing is deficient for the following reason(s): 'As to' Party Error; the party name listed in the as to docket entry text and on the summons PDF must exactly match the caption on the pleading. Re-file the document using the event type Request for Issuance of Summons found under the event list Service of Process - select the correct filer/filers - and attach the correct summons form PDF. (dnh)
December 14, 2020 Filing 25 FILING ERROR - DEFICIENT PLEADING - SUMMONS REQUEST As To - REQUEST FOR ISSUANCE OF SUMMONS as to U.S. Department of Health & Human Services, re: #1 Complaint,. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert) Modified on 12/14/2020 (dnh).
December 14, 2020 Filing 24 NOTICE OF APPEARANCE by Lisa Newman on behalf of Alex M. Azar II, Centers for Medicare and Medicaid Services, United States Department of Health and Human Services, Seema Verma..(Newman, Lisa)
December 11, 2020 Opinion or Order Filing 23 ORDER granting #8 Letter Motion to Seal. Granted. SO ORDERED. (Signed by Judge Kenneth M. Karas on 12/11/2020) (rro)
December 11, 2020 Opinion or Order Filing 22 ORDER FOR ADMISSION PRO HAC VICE granting #19 Motion for George W. Hicks, Jr. to Appear Pro Hac Vice. (Signed by Judge Kenneth M. Karas on 12/11/2020) (rro)
December 11, 2020 Opinion or Order Filing 21 ORDER FOR ADMISSION PRO HAC VICE granting #18 Motion for Paul D. Clement to Appear Pro Hac Vice. (Signed by Judge Kenneth M. Karas on 12/11/2020) (rro)
December 11, 2020 Opinion or Order Filing 20 ORDER TO SHOW CAUSE FOR PRELIMINARY INJUNCTION, TEMPORARY RESTRAINING ORDER, AND EXPEDITED BRIEFING SCHEDULE: It is hereby: ORDERED that Plaintiff has demonstrated good cause for setting an expedited briefing schedule in this proceeding due to the January 1, 2021 implementation date of the MFN Rule; ORDERED that Defendants show cause before the Honorable Kenneth M. Karas, U.S.D.J. located at the United States Courthouse, 300 Quarropas St., in White Plains, New York, Courtroom 521, on 12/22/2020, at 10 a.m. as to why an Order should not be issued pursuant to Rule 65 of the Federal Rules of Civil Procedure preliminarily enjoining and/or temporarily restraining, without bond, Defendants, including their agents, servants, employees, attorneys, successors and assigns, and all persons acting in concert with them, from implementing and enforcing the MFN Rule, and vacating and setting the MFN Rule aside; IT IS FURTHER ORDERED that Defendants' answering papers shall be filed and served upon Plaintiff's counsel by e-mail not later than the 16th day of December, 2020, and any reply papers shall be filed and served not later than the 18th day of December, 2020. It is further ordered that Plaintiff is to serve this order via email on Defendants by 12/11/20. (Show Cause Hearing set for 12/22/2020 at 10:00 AM in Courtroom 521, 300 Quarropas Street, White Plains, NY 10601 before Judge Kenneth M. Karas.), ( Replies due by 12/18/2020.) Show Cause Response due by 12/16/2020. (Signed by Judge Kenneth M. Karas on 12/11/2020) (rro)
December 11, 2020 >>>NOTICE REGARDING PRO HAC VICE MOTION. Regarding Document No. #19 MOTION for George W. Hicks, Jr. to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-22997429. Motion and supporting papers to be reviewed by Clerk's Office staff.. The document has been reviewed and there are no deficiencies. (bcu)
December 11, 2020 Filing 19 MOTION for George W. Hicks, Jr. to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-22997429. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by Regeneron Pharmaceuticals, Inc.. (Attachments: #1 Declaration of George W. Hicks, Jr., #2 Certificate of Good Standing, #3 Certificate of Good Standing, #4 Text of Proposed Order).(Hicks, George)
December 11, 2020 >>>NOTICE REGARDING PRO HAC VICE MOTION. Regarding Document No. #18 MOTION for Paul D. Clement to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-22996788. Motion and supporting papers to be reviewed by Clerk's Office staff.. The document has been reviewed and there are no deficiencies. (bcu)
December 11, 2020 Filing 18 MOTION for Paul D. Clement to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-22996788. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by Regeneron Pharmaceuticals, Inc.. (Attachments: #1 Declaration of Paul D. Clement, #2 Certificate of Good Standing, #3 Certificate of Good Standing, #4 Certificate of Good Standing, #5 Text of Proposed Order).(Clement, Paul)
December 11, 2020 ***NOTICE TO COURT REGARDING PROPOSED ORDER TO SHOW CAUSE WITH EMERGENCY RELIEF. Document No. #11 Proposed Order to Show Cause With Emergency Relief was reviewed and approved as to form. (dt)
December 11, 2020 Filing 17 ELECTRONIC SUMMONS ISSUED as to Alex M. Azar II..(pc)
December 11, 2020 Filing 16 ELECTRONIC SUMMONS ISSUED as to Seema Verma..(pc)
December 11, 2020 Filing 15 ELECTRONIC SUMMONS ISSUED as to Centers for Medicare and Medicaid Services..(pc)
December 11, 2020 Case Designated ECF. (pc)
December 11, 2020 Magistrate Judge Judith C. McCarthy is so designated. Pursuant to 28 U.S.C. Section 636(c) and Fed. R. Civ. P. 73(b)(1) parties are notified that they may consent to proceed before a United States Magistrate Judge. Parties who wish to consent may access the necessary form at the following link: #https://nysd.uscourts.gov/sites/default/files/2018-06/AO-3.pdf. (pc)
December 11, 2020 CASE OPENING INITIAL ASSIGNMENT NOTICE: The above-entitled action is assigned to Judge Kenneth M. Karas. Please download and review the Individual Practices of the assigned District Judge, located at #https://nysd.uscourts.gov/judges/district-judges. Attorneys are responsible for providing courtesy copies to judges where their Individual Practices require such. Please download and review the ECF Rules and Instructions, located at #https://nysd.uscourts.gov/rules/ecf-related-instructions..(pc)
December 11, 2020 ***NOTICE TO ATTORNEY REGARDING PARTY MODIFICATION. Notice to attorney Robert Allen. The party information for the following party/parties has been modified: ALEX M. AZAR II, in his official capacity as Secretary of the United States Department of Health and Human Services, SEEMA VERMA, in her official capacity as Administrator of Centers for Medicare & Medicaid Services, United States Department of Health and Human Services (HHS). The information for the party/parties has been modified for the following reason/reasons: party name contained a typographical error; party name was entered in all caps; party text was omitted;. (pc)
December 11, 2020 Filing 14 MEMORANDUM OF LAW in Support re: #11 Proposed Order to Show Cause With Emergency Relief . Document filed by Regeneron Pharmaceuticals, Inc.. (Attachments: #1 Exhibit 1 - Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Rules and Regulations).(Allen, Robert)
December 11, 2020 Filing 13 DECLARATION of Richard ONeal in Support re: #11 Proposed Order to Show Cause With Emergency Relief. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 11, 2020 Filing 12 DECLARATION of Robert W. Allen in Support re: #11 Proposed Order to Show Cause With Emergency Relief. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 11, 2020 Filing 11 PROPOSED ORDER TO SHOW CAUSE WITH EMERGENCY RELIEF. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert) Proposed Order to Show Cause to be reviewed by Clerk's Office staff.
December 11, 2020 Filing 10 MEMORANDUM OF LAW in Support re: #8 MOTION to Seal / Redact. . Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 11, 2020 Filing 9 DECLARATION of Daniel Cellucci in Support re: #8 MOTION to Seal / Redact.. Document filed by Regeneron Pharmaceuticals, Inc...(Cellucci, Daniel)
December 11, 2020 Filing 8 MOTION to Seal / Redact. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 11, 2020 Filing 7 NOTICE OF APPEARANCE by Daniel Ryan Cellucci on behalf of Regeneron Pharmaceuticals, Inc...(Cellucci, Daniel)
December 11, 2020 Filing 6 REQUEST FOR ISSUANCE OF SUMMONS as to SEEMA VERMA, in her official capacity as the Administrator of the Centers for Medicare and Medicaid Services, re: #1 Complaint,. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 11, 2020 Filing 5 REQUEST FOR ISSUANCE OF SUMMONS as to CENTERS FOR MEDICAREAND MEDICAID SERVICES, re: #1 Complaint,. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 11, 2020 Filing 4 REQUEST FOR ISSUANCE OF SUMMONS as to ALEX M. AZAR II, in his official capacity as Secretary of the United States Department of Health and Human Services, re: #1 Complaint,. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 11, 2020 Filing 3 RULE 7.1 CORPORATE DISCLOSURE STATEMENT. No Corporate Parent. Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)
December 11, 2020 Filing 2 CIVIL COVER SHEET filed..(Allen, Robert)
December 11, 2020 Filing 1 COMPLAINT against ALEX M. AZAR II, in his official capacity as Secretary of the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, SEEMA VERMA, in her official capacity as Administrator of Centers for Medicare & Medicaid Services, United States Department of Health and Human Services (HHS). (Filing Fee $ 402.00, Receipt Number ANYSDC-22994852)Document filed by Regeneron Pharmaceuticals, Inc...(Allen, Robert)

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Defendant: United States Department of Health and Human Services
Represented By: Lisa Newman
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Defendant: Seema Verma
Represented By: Lisa Newman
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Defendant: Centers for Medicare and Medicaid Services
Represented By: Lisa Newman
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Defendant: Alex M. Azar II
Represented By: Lisa Newman
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Plaintiff: Regeneron Pharmaceuticals, Inc.
Represented By: Paul D. Clement
Represented By: Daniel Ryan Cellucci
Represented By: George W. Hicks, Jr.
Represented By: Robert Allen
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Amicus curiae: American Society of Clinical Oncology
Represented By: Meredythe Medford Ryan
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