Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc.
805 F.3d 1092
| Fed. Cir. | 2015Background
- Prometheus owned U.S. Patent No. 6,284,770 (the ’770 patent) claiming methods of treating female, diarrhea‑predominant IBS patients (IBS‑D) with alosetron, with limits including ≥6 months of symptoms and at least moderate pain; dependent claims limited the salt form.
- Prometheus also owned earlier U.S. Patent No. 5,360,800 (the ’800 patent), which broadly claimed treating IBS (including with alosetron); the ’800 patent was prior art to the ’770 patent.
- After reexamination Prometheus amended and added the asserted claims; Lotronex (alosetron) had been approved, withdrawn for safety, and reintroduced with a restricted label limiting use to women with severe chronic IBS‑D, matching many ’770 claim features.
- Roxane filed an ANDA seeking to market a generic Lotronex and made a Paragraph IV certification; Prometheus sued for patent infringement under 35 U.S.C. § 271(e)(2).
- The district court held the asserted claims of the ’770 patent obvious over the ’800 patent and other prior art (and alternatively invalid for obviousness‑type double patenting); it rejected plaintiff’s secondary‑considerations evidence (nexus for commercial success, unexpected results, long‑felt need).
- On appeal the Federal Circuit affirmed, concluding the claimed species was an obvious variation of the earlier genus and that secondary considerations did not overcome the prima facie case of obviousness.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the asserted claims of the ’770 patent are obvious over the ’800 patent and other prior art under 35 U.S.C. § 103 | The ’770 claims narrow a genus to a patentable species (women with IBS‑D, ≥6 months symptoms, ≥moderate pain) and produced unexpected safety/efficacy benefits and commercial success attributable to those claim limitations | The ’770 claims are an obvious species of the ’800 genus because the prior art taught treating women, IBS‑D patients, symptom duration standards, and assessing pain; asserted secondary considerations lack nexus | Affirmed: claims are obvious over the ’800 patent and other prior art; secondary considerations did not overcome obviousness |
| Whether commercial success and other secondary considerations establish nonobviousness (nexus) | Lotronex’s post‑relaunch sales, label restrictions, and market performance demonstrate a nexus to the claimed treatment method | Sales and safety improvements were attributable to the drug and extrinsic factors (marketing, labeling, REMS), not the claimed method; Prometheus failed to show a probative nexus | Held against Prometheus: insufficient evidence of nexus or unexpected results to rebut prima facie obviousness |
| Whether the district court improperly shifted burden on secondary considerations | Prometheus claims court required it to disprove invalidity rather than requiring defendants to prove invalidity | Defendants maintain challenger bore burden to prove invalidity but patentee must produce rebuttal evidence once a prima facie case is made | No reversible error; court applied correct allocation and required clear and convincing proof of invalidity |
| Whether obviousness‑type double patenting independently invalidates the ’770 claims | Prometheus argued the ’770 claims are patentable despite overlap with the ’800 patent | Defendants argued the ’770 claims are unpatentable as an obvious variation of the ’800 patent | District court held alternatively that claims are invalid for obviousness‑type double patenting; Federal Circuit affirmed invalidity on obviousness and did not reach double‑patenting issue |
Key Cases Cited
- MeadWestVaco Corp. v. Rexam Beauty & Closures, Inc., 731 F.3d 1258 (Fed. Cir.) (standard of review on bench trial: facts for clear error, law de novo)
- Power Integrations v. Fairchild Semiconductor Int’l, Inc., 711 F.3d 1348 (Fed. Cir.) (obviousness and underlying factual inquiries)
- AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366 (Fed. Cir.) (species‑vs‑genus and obvious variation analysis)
- KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (Sup. Ct.) (framework for obviousness and Graham factors)
- Graham v. John Deere Co., 383 U.S. 1 (Sup. Ct.) (Graham factual inquiries for obviousness)
- In re Cyclobenzaprine Hydrochloride Extended‑Release Capsule Patent Litig., 676 F.3d 1063 (Fed. Cir.) (consideration of secondary factors)
- Microsoft Corp. v. i4i Ltd. P’ship, 131 S. Ct. 2238 (Sup. Ct.) (clear and convincing burden for proving patent invalidity)