Lupin Ltd. v. Salix Pharmaceuticals, Inc.
1:22-cv-07656
S.D.N.Y.May 9, 2024Background
- Defendants Salix Pharmaceuticals and Bausch Health US are seeking the court's permission to redact trade secret information from a document filed as Dkt. 82-1.
- The document in question is an Exhibit attached to a Letter of Request addressed to Italian authorities, relating to the manufacturing specifications for rifaximin (an active pharmaceutical ingredient).
- The redacted information includes API specifications and proprietary process flow sheets, which are considered trade secrets under FDA and prior court rulings.
- The trade secrets have been previously protected under a court-ordered Protective Order and designated confidential during discovery.
- Plaintiff Lupin Ltd. does not object to Defendants' proposed redactions.
- The primary legal issue is whether this Exhibit, used only for foreign discovery and not central to any dispositive motion, should be treated as a judicial document subject to a presumption of public access under the Second Circuit standard.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Should trade secret info in Dkt. 82-1 be sealed? | No objection | Redactions protect trade secrets | Redactions permitted |
| Is Exhibit a "judicial document" under access doctrine? | N/A | Not a judicial document | Presumption of access does not apply |
| If access applies, should it outweigh privacy interest? | N/A | Privacy interests outweigh | Trade secrets protected from access |
| Should foreign discovery material be public? | N/A | Exhibit aids foreign discovery | Public access is weak here |
Key Cases Cited
- Lugosch v. Pyramid Co. of Onondaga, 435 F.3d 110 (2d Cir. 2006) (articulates standard for sealing documents and presumption of public access)
- Appleton v. Food & Drug Admin., 451 F. Supp. 2d 129 (D.D.C. 2006) (establishes that drug manufacturing secrets are protectable trade secrets)
- United States v. Smith, 985 F. Supp. 2d 506 (S.D.N.Y. 2013) (discovery materials linked to non-dispositive issues not entitled to public access)
