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Federal Circuit Provides Clarity For Contract Manufacturing On-Sale Invalidity Claims
In The Medicines Company v. Hospira, Inc., App. No. 14-1469, 14-1504 (Fed. Cir. July 11, 2016) (slip op.) (en banc), the Federal Circuit provided clarity and guidance to companies that rely on contract manufacturing, holding that “to be 'on sale' under '102(b), a product must be the subject of a commercial sale or offer for sale, and that a commercial sale is one that bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code.” Id. at 3.
The case arose in the context of Hospira's Abbreviated New Drug Application (ANDA) submissions seeking FDA approval to sell generic versions of The Medicines Company's (TMC) Angiomax', an anticoagulant used in heart surgery. In the ensuing litigation, alleging that Hospira's ANDA submissions infringed two of TMC's patents, Hospira raised several grounds of invalidity, including that TMC's inventions were sold or offered for sale before the critical date under '102(b).
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