In re Dexilant Antitrust Litigation

Background

The court considered four motions concerning sealed filings related to a sanctions motion brought by Defendants TWi Pharmaceuticals, Inc. and TWi Pharmaceuticals USA, Inc. (“TWi”). TWi filed three motions to file documents under seal. Plaintiffs filed the fourth motion, seeking provisional sealing of documents filed with their opposition to TWi’s sanctions motion because TWi had designated the documents as “confidential” or “highly confidential.”

Legal standard

The court explained that judicial records are generally presumed to be available to the public. Because the materials related more than tangentially to the merits of the antitrust case, the court applied the “compelling reasons” standard to TWi’s requests. Under that standard, the party seeking secrecy must provide specific facts showing that the need for sealing outweighs the public’s interest in access. The court also applied Civil Local Rule 79-5, which requires the request to identify the private or public interests supporting secrecy, the injury that would result from disclosure, and why redaction or another less restrictive option would not be sufficient.

The court noted that the Food and Drug Administration’s disclosure rules generally make information about an approved abbreviated new drug application available to the public. The rules nevertheless allow some information to remain undisclosed, including formulas and manufacturing methods or processes.

TWi’s motions

TWi sought to seal information about its abbreviated new drug application, including product characteristics, testing, development, and efforts to obtain Food and Drug Administration approval. TWi argued that the information was competitively sensitive and that disclosure would cause substantial competitive harm.

The court denied sealing for information eligible for public disclosure under the Food and Drug Administration’s rules for approved applications. It specifically denied sealing for a portion of TWi’s sanctions motion because the information had already been publicly discussed in the proceedings. It also denied sealing for other portions because correspondence and written summaries of discussions between the Food and Drug Administration and the applicant are available to the public after approval.

The court granted sealing for specified portions of Exhibits G, H, J, and K, and for the entirety of Exhibit I, because those materials contained information relating to formulas or manufacturing methods or processes that are not automatically available to the public under the applicable regulation.

The court therefore ruled that TWi’s motions to file under seal were PARTIALLY GRANTED and PARTIALLY DENIED.

Plaintiffs’ motion

Plaintiffs asked the court to consider whether documents designated confidential by TWi should remain provisionally sealed. Under the applicable local rule, TWi—as the party designating the materials—had to file a statement or declaration explaining why sealing was justified. TWi filed no such statement.

The court DENIED Plaintiffs’ motion because TWi failed to provide reasons for keeping the material under seal. The order disposed of Docket Nos. 194, 197, 200, and 201.