AstraZeneca v Cochran: Government’s Brief in Support of Motion to Dismiss

Case 1:21-cv-00027-LPS

Document 56

Filed 05/04/21

Pages 1-37

PageIDs #: 3324-3360

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

ASTRAZENECA PHARMACEUTICALS LP,
Plaintiff,

v.

XAVIER BECCERA, et al.,
Defendants.

CASE NO.: 1:21-CV-00027-LPS

COMBINED BRIEF IN SUPPORT OF DEFENDANTS’ MOTION TO DISMISS OR,
IN THE ALTERNATIVE, MOTION FOR SUMMARY JUDGMENT AND BRIEF IN
OPPOSITION TO PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT

Table of Contents

TABLE OF AUTHORITIES

BACKGROUND

  1. STATUTORY AND REGULATORY BACKGROUND
  2. DRUG COMPANIES UNILATERIALLY RESTRICT ACCESS TO 340B DISCOUNTS
  3. COMPANIES SUE TO PREVENT HHS’S ENFORCEMENT OF THE 340B STATUTE

STANDARD OF REVIEW

ARGUMENT

  1. THE ADVISORY OPINION IS NOT REVIEWABLE
    1. The Advisory Opinion Does Not Constitute Final Agency Action
    2. Astra’s Challenge is Time-Barred
  2. EVEN IF THE ADVISORY WAS REVIEWABLE, ASTRA’S CLAIMS FAIL
    1. Notice-and-Comment Rulemaking is Not Required Because the Advisory Opinion Is An Interpretative Rule
    2. Astra Fails to State a Claim on the Merits
    3. The Advisory Opinion Was Neither Arbitrary Nor Capricious
  3. THE COURT LACKS JURISDICTION TO COMPEL AGENCY ACTION

CONCLUSION

Key Resources

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