Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.
855 F.3d 1356
| Fed. Cir. | 2017Background
- Helsinn owned four patents claiming an IV palonosetron formulation (primarily a 0.25 mg dose) to reduce chemotherapy‑induced nausea and vomiting; priority date: provisional filed Jan 30, 2003, making the critical on‑sale date Jan 30, 2002.
- In April 2001 Helsinn and MGI executed a License Agreement and a Supply and Purchase Agreement (publicly disclosed via MGI Form 8‑K, but with price and specific dosages redacted); MGI agreed to buy Helsinn’s requirements of the 0.25 mg and 0.75 mg products if FDA approved them.
- Helsinn had Phase II data (Study 2330) supporting efficacy of the 0.25 mg dose and preliminary Phase III data (Jan 7, 2002) showing 81% complete response for the 0.25 mg dose (post‑critical‑date submission to FDA occurred in Feb 2002).
- Teva filed an ANDA for a generic 0.25 mg product and challenged the patents via an on‑sale bar defense under 35 U.S.C. § 102; district court found a pre‑critical‑date commercial agreement but held the invention was not ready for patenting and ruled AIA altered the on‑sale analysis for the ’219 patent.
- The Federal Circuit reversed: it held the Helsinn–MGI Supply Agreement constituted an invalidating sale/offering before the critical date and that the invention was ready for patenting before Jan 30, 2002; it also held the AIA did not change the result in these circumstances.
Issues
| Issue | Helsinn (Plaintiff) | Teva (Defendant) | Held |
|---|---|---|---|
| Did the April 2001 Supply & Purchase Agreement constitute a sale/offer for sale under pre‑AIA §102(b)? | Agreement was contingent on FDA approval and/or ambiguous (covered 0.25 and 0.75 mg), so not an invalidating sale. | Contract was a binding commercial contract to sell future goods; contingencies and requirement‑type quantities do not avoid the on‑sale bar. | Held: Yes — under contract law/UCC analysis the agreement was a commercial sale/offer for sale prior to the critical date. |
| Did the AIA (35 U.S.C. §102(a)(1)) change the on‑sale bar so secret or dose‑redacted sales do not invalidate (i.e., must disclose invention details publicly)? | AIA requires public disclosure of invention details; redactions (dose) prevent on‑sale bar for the ’219 patent. | AIA did not meaningfully change the meaning of "on sale" here; public announcement of the contract suffices even if some terms were redacted. | Held: AIA did not change outcome — public existence of sale suffices; specific claim details need not be disclosed in sale documents. |
| Was the invention "ready for patenting" by the critical date (Pfaff second prong)? | Not ready — district court applied FDA‑level efficacy standard (Phase III/final analysis) and found insufficient testing before the critical date. | Reduction to practice shown: Phase II and other data, inventor declarations, and preliminary Phase III results established the claimed purpose (reducing likelihood of CINV). | Held: Ready for patenting — reduced to practice before the critical date; FDA approval/complete Phase III not required. |
| Do conditions precedent (FDA approval) or purchaser choice between doses prevent a binding sale? | Yes — regulatory contingency and buyer option create uncertainty so no binding sale. | No — contracts contingent on regulatory approval are valid contracts to sell under the UCC; option between doses does not prevent on‑sale bar. | Held: Contingencies (including regulatory approval) and choice among doses do not defeat a binding contract for sale that triggers the on‑sale bar. |
Key Cases Cited
- Pfaff v. Wells Elec., 525 U.S. 55 (1998) (two‑part test for on‑sale bar: commercial offer for sale and ready for patenting)
- Medicines Co. v. Hospira, Inc., 827 F.3d 1363 (Fed. Cir. 2016) (contract/UCC framework for analyzing offers for sale under pre‑AIA §102)
- Enzo Biochem, Inc. v. Gen‑Probe, Inc., 424 F.3d 1276 (Fed. Cir. 2005) (requirement/quantity‑of‑requirements contracts can trigger the on‑sale bar)
- In re Caveney, 761 F.2d 671 (Fed. Cir. 1985) (secret sale to an exclusive U.S. seller can bar patentability)
- RCA Corp. v. Data Gen. Corp., 887 F.2d 1056 (Fed. Cir. 1989) (sale documents need not disclose every claim element for on‑sale bar to apply)
- Abbott Labs. v. Geneva Pharm., 182 F.3d 1315 (Fed. Cir. 1999) (on‑sale bar applies even when the parties do not know whether the sold product embodies the claimed invention)
- Z4 Techs., Inc. v. Microsoft Corp., 507 F.3d 1340 (Fed. Cir. 2007) (reduction to practice and possession standard for ready for patenting)
- In re Omeprazole Patent Litig., 536 F.3d 1361 (Fed. Cir. 2008) (declining to impose a per se rule that Phase III completion is required; readiness depends on case specifics)