Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.
731 F.3d 1271
| Fed. Cir. | 2013Background
- Sunovion owns the ’673 patent directed to eszopiclone dextrorotatory isomer formulations for Lunesta.
- Reddy sought FDA approval via ANDA 091024 to market generic eszopiclone; the request included a paragraph IV certification.
- The district court construed “essentially free” to mean less than 0.25% levorotatory isomer, relying on prosecution history and declarations.
- Reddy amended its ANDA to 0.0–0.6% levorotatory isomer; the FDA later required tightening to not more than 0.3%.
- The district court granted summary judgment of noninfringement based on Reddy’s internal guidelines and Cappuccino certification claiming 0.3% minimum.
- On appeal, the Federal Circuit reverses, holding the district court erred and Reddy’s ANDA specification infringes as a matter of law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper construction of ‘essentially free’ | Sunovion contends the term means largely pure dextrorotatory isomer. | Reddy argues it means less than 0.25% levorotatory isomer. | Construction: less than 0.25% levorotatory isomer. |
| Infringement after claim construction | Reddy’s ANDA specification could infringe under the construed claim. | Reddy claims manufacturing guidelines avoid the range and Cappuccino certification prevents infringement. | Reddy’s ANDA specification infringes as a matter of law. |
| Effect of Cappuccino certification on infringement | Certification cannot override infringement when seeking FDA approval for a product within the claim scope. | Certification shows intent to avoid infringement by limiting product. | Certification cannot shield infringement under Hatch-Waxman when the spec covers the claimed invention. |
| Hatch-Waxman framework and infringement timing | FDA approval within the claim scope should trigger infringement. | Infringement should be determined post-approval under traditional patent law. | FDA consent to market a product within the claim scope constitutes infringement as a matter of law. |
Key Cases Cited
- Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295 (Fed. Cir. 2007) (defining claim terms by intrinsic evidence and prosecution history)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (prosecution history can define claim scope)
- Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) (importance of intrinsic evidence in claim construction)
- Deering Precision Instruments, L.L.C. v. Vector Distrib. Sys., Inc., 347 F.3d 1314 (Fed. Cir. 2003) (interpretation of terms with limitation on ambiguity)
- Bayer AG v. Elan Pharmaceutical Research Corp., 212 F.3d 1241 (Fed. Cir. 2000) (ANDA specification can define infringement narrowly)
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997) (ANDA data can control infringement inquiry)
- Abbott Labs. v. TorPharm, Inc., 300 F.3d 1367 (Fed. Cir. 2002) (infringement depends on ANDA scope aligning with claims)
- Computer Docking Station Corp. v. Dell, Inc., 519 F.3d 1366 (Fed. Cir. 2008) (consideration of evidentiary record in claim construction)