The Medicines Company v. Hospira, Inc.
791 F.3d 1368
Fed. Cir.2015Background
- The Medicines Company owns patents on a bivalirudin product-by-process limiting Asp[9]-bivalirudin impurity to ≤0.6%; patents filed July 2008.
- More than one year before filing, The Medicines Company contracted Ben Venue to make three commercial-scale bivalirudin batches using the claimed pH-adjusting method; invoices described charges to “manufacture Bivalirudin lot.”
- Each batch was assigned commercial product codes and customer lot numbers, released to The Medicines Company, and had commercial value exceeding $10 million; batches met the claimed impurity levels.
- District court found (1) the invention was ready for patenting but (2) no commercial sale occurred before the critical date because Ben Venue sold services (not product) and the experimental-use exception applied.
- The Federal Circuit reviewed de novo legal issues and for clear error on facts, and ultimately reversed, holding the on-sale bar invalidated the asserted claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a commercial sale occurred before the critical date (on-sale bar) | Medicines Co.: Ben Venue sold only services; no commercial sale of invention | Hospira: Payments and delivery to The Medicines Co. constituted a commercial sale of the invention | Court: Sale of manufacturing services that produced commercial batches constituted a commercial sale; district court clearly erred |
| Whether the experimental-use exception applies | Medicines Co.: Batches were part of experimental optimization, not commercial exploitation | Hospira: Batches were produced for commercial/validation purposes, not permissible experimentation | Court: Experimental-use defense fails because invention had been reduced to practice and batches were commercial/validation in nature |
| Whether the invention was ready for patenting before the critical date | Medicines Co.: No reduction to practice and inadequate enabling written description before filing | Hospira: The sold batches reduced the invention to practice, making it ready for patenting | Court: Invention was ready for patenting because the commercial batches reduced it to practice |
| Ultimate effect on validity and other issues | Medicines Co.: Claims valid; appealed claim construction and non-infringement | Hospira: Claims invalid under on-sale bar; cross-appealed other grounds | Court: Reversed district court, held asserted claims invalid under §102(b) on-sale bar; declined to address other issues |
Key Cases Cited
- Pfaff v. Wells Elecs., Inc., 525 U.S. 55 (1998) (articulates two-part on-sale bar test)
- D.L. Auld Co. v. Chroma Graphics Corp., 714 F.2d 1144 (Fed. Cir. 1983) (on-sale bar can apply where inventor commercially exploited invention even without transfer of title)
- Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353 (Fed. Cir. 2001) (no supplier exception to on-sale bar; sale of services can trigger the bar)
- Abbott Labs. v. Geneva Pharm., 182 F.3d 1315 (Fed. Cir. 1999) (product offered for sale that inherently possesses claimed limitations triggers on-sale bar)
- Scaltech, Inc. v. Retec/Tetra, LLC, 269 F.3d 1321 (Fed. Cir. 2001) (sale of invention can obviate need to prove conception for reduction to practice)