Big Molecule Watch
September 27, 2016

FDA Denies AbbVie Citizen Petition on Fifth Amendment Takings

On September 23, the FDA denied a citizen petition from AbbVie submitted to the FDA on April 2, 2012, requesting that the FDA not implement the BPCIA as to any applications for biosimilar products referencing Humira (adalimumab), or any other product for which the BLA was submitted to the FDA prior to the enactment of the BPCIA.

AbbVie (formerly Abbott Laboratories) argued that permitting such a reference would constitute a taking under the Fifth Amendment to the U.S. Constitution. The Petition asserted that each BLA contains trade secret and confidential commercial or financial information, and that the “approval of a biosimilar necessarily relies on and uses the trade secrets that the innovator sponsor submitted in support of the BLA” to show that the reference product was safe, pure, and potent. The Petition stated that manufacturers who submitted BLAs prior to the enactment of the BPCIA reasonably expected that such confidential information “would not be used to benefit a competitor.”

The FDA, however, found that there was no protected property interest in the information that AbbVie sought to claim as trade secrets, and that even if there were, there was no use of that information that qualified as a taking. Furthermore, the FDA stated that even if there were a taking of a protected property interest, it did not qualify as a regulatory taking under the Penn Central factors.

Note to our readers: Kurt Karst at FDA Law Blog has published an analysis of the petition and the FDA’s decision that is well worth checking out.