AbbVie Inc. et al. v. Drew Wrigley et al.; AstraZeneca Pharmaceuticals LP v. Drew Wrigley et al.; Pharmaceutical Research and Manufacturers of America v. Drew Wrigley et al.

Summary

This order resolves cross-motions for summary judgment and a motion for judgment on the pleadings in consolidated cases challenging North Dakota House Bill 1473, which regulates manufacturers’ distribution and data conditions concerning drugs purchased through the federal 340B program. The court interprets the statute, addresses standing and federal preemption, and considers related constitutional claims. The order grants, denies, or finds moot the various motions in whole or in part, with the specific disposition depending on the claim and plaintiff.

Holdings

1. The statute unambiguously applies to drugs purchased under the 340B pricing scheme and does not extend to drugs merely 'to be purchased.'
2. H.B. 1473 is field preempted by the federal 340B statute because it changes the terms of a federal spending program and deters manufacturers from participating in that program.
3. H.B. 1473 violates the dormant Commerce Clause because it directly regulates the price and terms of transactions between out-of-state manufacturers and out-of-state wholesalers.
4. AstraZeneca plausibly stated claims that H.B. 1473 is preempted by patent law and the 340B statute, violates the Contracts Clause, and effects a taking; North Dakota was not entitled to judgment on the pleadings.
5. Declaratory judgment and a permanent injunction were appropriate, and the court declined to sever H.B. 1473 because the statute's provisions could not operate independently from its unconstitutional focus.

Questions Presented

1. Whether H.B. 1473's definition of 'drug' limits the statute to drugs already purchased under the 340B pricing scheme or also reaches drugs to be purchased.
2. Whether H.B. 1473 is field preempted by the federal 340B statute because it impermissibly alters a federal spending-program relationship and deters manufacturer participation.
3. Whether H.B. 1473 violates the dormant Commerce Clause by directly regulating the price and terms of interstate transactions involving out-of-state manufacturers and wholesalers.
4. Whether H.B. 1473 is preempted by federal patent law, conflicts with the 340B statute's data and audit provisions, violates the Contracts Clause, or constitutes a taking, such that AstraZeneca stated plausible claims.
5. Whether the plaintiffs were entitled to declaratory and permanent injunctive relief and whether the statute could be severed.

Disposition

other