(CN) – The Supreme Court has agreed to resolve a key dispute over whether applicants seeking to patent a biosimilar drug must go through the elaborate process outlined in federal law.
Per its custom, the justices did not issue any statement Friday alongside their order taking up the case, which involves the Federal Circuit’s first interpretation the Biologics Price Competition and Innovation Act of 2010.
Congress enacted the Biologics Act as part of the federal health care law, providing an accelerated pathway for FDA approval of drugs that are “highly similar” to a previously approved drug.
In removing regulatory hurdles, however, the law created procedural ones for the applicants – establishing an elaborate process by the original drugmaker and the biosimilar applicant discuss potential patent-infringement claims and negotiate the validity of those claims ahead of actual litigation.
Amgen brought the underlying lawsuit in California after Sandoz sought to make a filgrastim drug similar to its brand-name Neupogen drug. Before the launch, Amgen claimed, Sandoz failed to offer up any information about the new product.
Though a federal judge sided with Sandoz at summary judgment, the Federal Circuit in Washington granted both parties some relief in 2015.
Writing for a divided three-member panel, U.S. Circuit Judge Alan Lourie called the patent-dispute resolution procedure set forth in the act an optional “dance” for companies submitting a biosimilars application to the Food and Drug Administration.
“The BPCIA explicitly contemplates that an applicant might fail to disclose the required information by the statutory deadline,” and states that the original drugmaker may bring a patent-infringement suit upon such failure, Lourie added.
As the law provides now way to compel compliance with the disclosure requirement, reading the disclosure as mandatory would render other section of the law superfluous, the court found.
The majority also ruled, however, that an applicant must give the original drugmaker 180 days pre-marketing notice after its application has been approved by the FDA.
U.S. Circuit Judge Raymond Chen dissented from this portion of the decision, saying that the additional 180-day period gives Amgen an “extra-statutory exclusivity windfall” beyond the 12-year exclusivity period.
Sandoz and Amgen each filed separate petitions for certiorari.
The high court consolidated their cases for a total one hour of oral argument.