Fed law trumps state law: no injunction for Amgen

February 2, 2018

Amgen Inc. v. Sandoz Inc.

2015-1499

Decided: December 14, 2017

Case Summary

 

Biopharmaceuticals, or “biologics” include drugs like vaccines, blood components

and proteins that are manufactured in, extracted or synthesized from biological

sources. The biologic at issue in this case is Filgrastim, which stimulates bone

marrow to produce white blood cells.

 

Like other drugs, biologics must be approved by the FDA; to make it easier to

introduce generic versions of these drugs, the Biologics Price Competition and

Innovation Act (BPCIA) provides a shortened approval pathway for biologics shown

to have no clinically meaningful differences from a “reference product”—a biologic

that has already been approved. A relevant portion of this shortened approval

pathway—42 U.S.C. §262(l)(2)(A)—says that the generic biologic applicant “shall

provide” its FDA application (which includes data from clinical studies) and

manufacturing information to the “reference product sponsor”—the manufacturer

of the approved biologic. 

 

When Sandoz filed an application for its generic version of Filgrastim, it refused

to provide Amgen (which sells an FDA-approved version of Filgrastim) with the

information required by the BPCIA. The Act contemplates this: §262(l)(9)(C) authorizes

the reference product sponsor (Amgen) to sue for patent infringement if the applicant

fails to produce the manufacturing and other information the Act requires. But Amgen

didn’t want to sue for patent infringement; it wanted an injunction to force Sandoz to

produce its FDA application and manufacturing information. It sued Sandoz for failing

to produce the information required by the BPCIA, alleging violations of both federal

and California law. 

 

After losing in the district court and at the U.S. Court of Appeals for the Federal Circuit,

Amgen’s quest for an injunction reached the Supreme Court, which held that no

injunction was available under federal law. The High Court declined to decide the state

law issues, instead remanding those issues to the Federal Circuit, which was directed

to determine whether California law would treat noncompliance with the BPCIA as an

“unlawful business practice,” and if so, whether the BPCIA preempts any state law

remedies for violations of the Act. 

 

In its remand briefing, Amgen argued that Sandoz had waived its preemption defense

by failing to raise it in the district court; the Federal Circuit disagreed, noting that

(1) Sandoz had preserved the issue by pleading a preemption defense in its answer;

and (2) the Supreme Court had expressly invited the Federal Circuit to address the

issue.

 

On the merits of the preemption issue, the court addressed two of the three types

of preemption included in the Constitution’s Supremacy Clause (Article VI, Clause 2):

field preemption and conflict preemption. The panel explained that field preemption

applies when state law “regulates conduct in a field that Congress intended the Federal Government to occupy exclusively,” such as when there is a “scheme of federal regulation . . . so pervasive as to make reasonable the inference that Congress left no room for the

States to supplement it;” and conflict preemption applies “where it is impossible for a

private party to comply with both state and federal requirements, or where state law

stands as an obstacle to the accomplishment and execution of the full purposes and

objectives of Congress.”

 

The Federal Circuit found that both types of preemption apply in this case, explaining

that Congress crafted the BPCIA to balance the interests of consumers (as represented

by generic drug companies) and the manufacturers of approved biologics. Because

“Congress made a deliberate choice not to impose” injunctions for noncompliance, state

laws imposing injunctions for the same noncompliant acts would “dramatically increase

the burdens” on applicants like Sandoz, upsetting the “careful framework Congress

adopted” when it drafted the Act.

Click here for the PDF

 

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