In each Final Decision, we denied Petitioner’s motion to seal portions of its sur- sur-reply that reference Exhibits 2065–2069 without prejudice to Patent Owner.
That standard includes a showing that “(1) the information sought to be sealed is truly confidential, (2) a concrete harm would result upon public disclosure, (3) there exists a genuine need to rely in the trial on the specific information sought to be sealed, and (4) on balance, an interest in maintaining confidentiality outweighs the strong public interest in having an open record.” Argentum Pharms.
In particular, Patent Owner represents that Petitioner’s sur-sur-reply “summarizes and quotes confidential submissions made by Hoechst Marion Roussel to, and records of correspondence with, the FDA regarding the approval of its insulin glargine product.” Id. Patent Owner further states that the sur-sur-reply “summarizes confidential and proprietary research and development, testing procedures, analyses and results regarding [Patent Owner’s] Lantus [product]” and that the updated exhibit list “refers to and describes now sealed EX2065–EX2069.” Id. (noting further that the sur-sur-reply and updated exhibit list refer to research, development, testing, clinical, manufacturing, packaging, and pharmacological information).
We further note that the record of each proceeding shall be preserved in its entirety and that no sealed document will be expunged or made public, pending the outcome of any appeal taken from the Final Decision.
Jeffrey Guise Douglas Carsten Richard Torczon Lorelei Westin Clark Lin Nancy Zhang Alina Litoshyk Nicole W. Stafford