Radius Health, Inc. v. Orbicular Pharmaceutical Technologies Private Limited
1:22-cv-11546
| D. Mass. | Jul 30, 2025Background
- Radius Health, Inc. and Ipsen Pharma S.A.S. (plaintiffs) filed a patent infringement suit against Orbicular Pharmaceutical Technologies Private Limited (defendant) after Orbicular filed an ANDA seeking to market a generic version of Tymlos (abaloparatide).
- The disputed patents cover formulations and methods related to abaloparatide, a synthetic peptide for the treatment of osteoporosis, marketed as Tymlos, notable for its room-temperature stability and multi-dose pen delivery.
- By trial, the parties contested only certain claims from five patents, focusing on issues of obviousness, enablement, and written description under U.S. patent law.
- Bench trial was conducted, with Orbicular having stipulated that its generic would infringe if the claims were valid, so trial focused on validity defenses.
- Key factual determinations included the complexity of peptide drug formulation, the prior art references raised, and the industry knowledge about stability and excipients for such formulations.
- The court reached different outcomes for the various claims, with some found invalid as obvious and others upheld as not obvious or otherwise valid.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Obviousness (dosage/formulation) | Prior art did not teach claims; technical differences significant | Prior art made invention obvious; elements routine | Most claims not obvious except certain claims of ’333 patent |
| Enablement (’208/’041 patents) | Sufficient disclosure to enable skilled artisan | Not enough disclosure for practical implementation | Patents are enabled; skilled artisan could practice claims |
| Written Description ('208/'041) | Written description adequate per § 112 | No adequate description of invention or its scope | No invalidity for inadequate written description |
| Secondary Considerations | Commercial success, industry praise, unmet need | No nexus between considerations and specific claims | Did not outweigh obviousness where found by clear evidence |
Key Cases Cited
- Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91 (2011) (clear and convincing evidence required to prove patent invalidity)
- Graham v. John Deere Co., 383 U.S. 1 (1966) (sets out factual framework for evaluating patent obviousness)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (elements known in prior art must be shown to be combined with reasonable expectation of success)
- Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (written description requirement distinct from enablement)
- In re Wands, 858 F.2d 731 (Fed. Cir. 1988) (enablement requires disclosure sufficient to practice invention without undue experimentation)
- Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009) (obviousness under § 103 to person of ordinary skill in the art)