Bayer Healthcare LLC v. Perrigo Company plc

Background

Perrigo’s counsel asked the court to permit filing selected materials under seal in connection with Perrigo’s opposition to Bayer’s motion for a preliminary injunction. The request concerned Exhibit E and Exhibit F to the declaration of Valerie Gallagher, along with citations to those exhibits in paragraphs 13 and 14 of the declaration.

Perrigo said it would file redacted versions publicly and provide unredacted versions, with proposed redactions highlighted, to the court and all counsel of record. It described Exhibit E as a summary of clinical studies and other information about the efficacy of Nasonex. It described Exhibit F as a nonpublic reviewer’s guide summarizing documents and studies submitted to the Food and Drug Administration with Perrigo’s application for approval of Nasonex.

Arguments for sealing

Perrigo argued that the materials contained nonpublic, commercially sensitive research and development information, including clinical and performance testing, product efficacy research, and testing results. It also argued that the materials included information submitted confidentially to the Food and Drug Administration about Nasonex’s safety and effectiveness.

Perrigo acknowledged that materials filed in support of a preliminary-injunction motion are judicial documents and that the public-access presumption is strong. It argued that sealing was narrowly limited to selected portions of the filing and was justified by the confidential nature of the information.

Ruling

Judge Paul A. Engelmayer entered the order: “Granted, SO ORDERED.” The opinion does not provide a longer explanation of the court’s reasoning or separately describe the precise scope of each approved redaction. The disposition was an order granting Perrigo’s request to file the specified materials under seal.