AstraZeneca Pharmaceuticals LP v. Anne E. Lopez

Summary

The United States District Court for the District of Hawai‘i denied AstraZeneca Pharmaceuticals LP’s motion for a preliminary injunction against enforcement of Hawai‘i Act 143. The court concluded that AstraZeneca had not shown a likelihood of success, or serious questions going to the merits, on its claims that Act 143 was preempted by the federal Section 340B drug-pricing program or federal patent law. The order addresses whether Act 143 regulates drug pricing or delivery conditions and applies the federal preliminary-injunction standard.

Holdings

1. AstraZeneca was not entitled to a preliminary injunction because it failed to demonstrate a likelihood of success on the merits or serious questions going to the merits of its preemption claims.
2. At the preliminary-injunction stage, Act 143 is properly characterized as regulating delivery and availability of 340B drugs, not the federally established price of those drugs.
3. The presumption against preemption applies to Act 143 because the statute regulates drug delivery and access in an area involving traditional state public-health and safety powers, even though it operates only within the Section 340B program.
4. AstraZeneca failed to show a likelihood of success or serious questions that Act 143 is an obstacle to the purposes and objectives of Section 340B.
5. AstraZeneca failed to show that Act 143 is preempted by federal patent law because the statute regulates commercial delivery terms without authorizing copying, compulsory licensing, or interference with the patent holder’s exclusionary right.

Questions Presented

1. Whether AstraZeneca was entitled to a preliminary injunction based on its claim that Hawai‘i Act 143 is preempted by Section 340B through obstacle or purposes-and-objectives preemption.
2. Whether the presumption against preemption applies to Act 143.
3. Whether Act 143 regulates drug pricing rather than delivery conditions.
4. Whether Act 143 is preempted under intergovernmental-immunity principles as a direct regulation of federal contractors.
5. Whether Act 143 is preempted by federal patent law because it allegedly diminishes the economic rewards or incentives associated with AstraZeneca’s patents.

Disposition

other