In the context of a proceeding brought pursuant to the NOC Regulations, Mylan sought a confidentiality that would allow it to designate portions of its Notice of Allegation (NOA) as confidential and shield it from public disclosure.
The Court refused to grant a confidentiality order covering portions of the NOA, as Mylan did not treat the information as confidential at all material times. It held that Mylan had voluntarily sent it to Takeda with no reasonable expectation of it being kept confidential. Furthermore the Court refused to allow Mylan to mark as confidential a fact affidavit attesting to why the NOA should be confidential. The Court held that Mylan had no real expectation that the affidavit would be kept confidential, and furthermore, it did not contain any confidential information.
The Court also considered and rejected Mylan’s argument that it being the first to enter a generic market is sufficiently important a commercial interest to justify the confidentiality order. The Court held that other generic companies are part of the “public”, and they have an interest in this material.