Medicines Company v. Hospira, Inc.
881 F.3d 1347
Fed. Cir.2018Background
- The Medicines Company owns patents (’727 and ’343) claiming an improved, “efficient mixing” process for manufacturing the anticoagulant bivalirudin (Angiomax); patent applications filed July 27, 2008 (critical date).
- The Medicines Co. put an improved mixing method into its master batch record in October 2006; contract manufacturer Ben Venue produced batches using that method beginning Oct. 31, 2006, and consistently achieved low impurity levels.
- On Feb. 27, 2007, The Medicines Co. signed a three‑year Distribution Agreement with Integrated Commercialization Solutions (ICS) that: stated the parties’ desire to sell/purchase product, set a commercial price, required weekly purchase orders, and transferred title to ICS upon receipt at the distribution center.
- Hospira filed an ANDA to market a generic and used a different mixing process (three additions, single paddle mixer) that the court concluded did not meet the patent’s “efficient mixing” limitation.
- District court held patents neither infringed nor invalid (found Distribution Agreement not an offer for sale); on appeal the Federal Circuit affirmed noninfringement but reversed the no‑offer finding and remanded to decide whether the on‑sale bar applies to the patented product.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Hospira infringes the patents | Medicines Co.: Hospira’s process falls within claimed "efficient mixing" | Hospira: Its three‑portion additions and single paddle mixer do not perform "efficient mixing" as claimed | Held: No infringement — Hospira does not perform "efficient mixing" (affirmed) |
| Whether the Distribution Agreement was an "offer for sale" before the critical date | Medicines Co.: Agreement was not an offer because it allowed rejection of ICS orders | Hospira: Agreement contained price, purchase schedule, title transfer → constituted an offer for sale | Held: Distribution Agreement was a commercial offer for sale (reversed district court) |
| Whether the Distribution Agreement covered product made by the patented process | Medicines Co.: Even if an offer, it covered only product generally, not necessarily product made by the new method | Hospira: Agreement supplied terms sufficient to cover sale of Angiomax including batches made by the new process | Held: Not decided — remanded for district court to determine whether the agreement covered the patented product |
| Whether the invention was ready for patenting before the critical date | Medicines Co.: Invention not ready; only manufacturing practice by Ben Venue | Hospira: Master batch record and Ben Venue’s reduction to practice show invention was ready | Held: Invention was ready for patenting before critical date (affirmed) |
Key Cases Cited
- Pfaff v. Wells Elecs., 525 U.S. 55 (1998) (two‑part on‑sale bar test: commercial offer for sale and ready for patenting)
- Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041 (Fed. Cir. 2001) (an offer for sale analyzed under general contract law/UCC principles)
- Medicines Co. v. Hospira, Inc., 827 F.3d 1363 (Fed. Cir. 2016) (en banc) (framework for determining whether communications constitute an offer for sale)
- Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc., 855 F.3d 1356 (Fed. Cir. 2017) (distribution agreement with price, delivery and obligation to meet orders can be an offer for sale)
- Enzo Biochem, Inc. v. Gen‑Probe Inc., 424 F.3d 1276 (Fed. Cir. 2005) (supply‑obligation contracts can constitute offers for sale)