THERAVANCE BIOPHARMA R&D IP, LLC v. EUGIA PHARMA SPECIALTIES LTD.
1:23-cv-00926
D.N.J.Jun 9, 2025Background
- Plaintiffs (Theravance Biopharma US, Inc. and affiliates) developed and market YUPELRI®, a COPD medication protected by several patents listed in the FDA's Orange Book.
- Defendants (Eugia Pharma, Cipla, Mankind, and affiliates) submitted Abbreviated New Drug Applications (ANDAs) to the FDA with Paragraph IV certifications, seeking approval to market generic versions of YUPELRI® before the expiration of certain patents.
- Each defendant notified plaintiffs of their ANDA filings, asserting the patents were invalid, unenforceable, and/or not infringed.
- Plaintiffs amended their complaint to include additional “non-Orange Book” patents and subsequently filed two related actions that were later consolidated with this case.
- All parties filed unopposed motions to seal various documents containing confidential business information pursuant to New Jersey Local Civil Rule 5.3.
- The motions to seal are grounded in the need to protect trade secrets, proprietary research, development, and settlement communications from public disclosure.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Seal confidential documents under Rule 5.3 | Disclosure would cause serious, defined injury; all criteria met for sealing under Rule 5.3 | No opposition; support sealing proprietary, sensitive business information | Motions to seal granted |
| Legitimate business interests at stake | Documents contain trade secrets, regulatory, R&D information | Documents include confidential and strategic matters | Private interest in secrecy recognized |
| Specific injury if not sealed | Public disclosure would harm competitive position | Agrees; no substantive opposition | Sealing justified |
| Least restrictive means | Only limited, targeted redactions/sealing requested | Agrees; approach narrowly tailored | Redactions acceptable and sufficient |
Key Cases Cited
- In re Cendant Corp., 260 F.3d 183 (3d Cir. 2001) (addresses the public right of access to judicial proceedings and requirements for sealing)
- Pansy v. Borough of Stroudsburg, 23 F.3d 772 (3d Cir. 1994) (elaborates on the standard requiring specific, particularized showing of harm for good cause in sealing motions)
- Cipollone v. Liggett Group, Inc., 785 F.2d 1108 (3d Cir. 1986) (rejects broad, unsubstantiated claims of harm to support sealing)
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990) (discusses the concept of "artificial" infringement by filing Paragraph IV certifications)