In an en banc opinion, the Federal Circuit unanimously ruled that the mere sale of manufacturing services to create embodiments of a patented product is not a "commercial sale" that triggers the on-sale bar of 35 USC 102(b) (pre-AIA). Medicines Co. v. Hospira Inc., No. 14-1469 (Fed. Cir. July 11, 2016). The Federal Circuit identified several factors to be considered in determining whether a transaction is a commercial sale or offer under Section 102(b) such as (1) whether the transaction is between a supplier and inventor; (2) whether the inventor has transferred title to the supplier; (3) whether the transaction is confidential; and (4) whether the transaction is a sale of a product at full market value or a "pre-commercial investment."
In this case, the en banc Court affirmed the lower court's determination that The Medicines Company's use of contract manufacturing services did not invalidate the patents-in-suit under the on-sale bar. The en banc Court vacated a prior panel's decision that the asserted claims were invalid under 102(b) based on transactions between the patentee and a third-party manufacturing company that was hired to make patentee's blood thinner drug.
In this case, the en banc Court affirmed the lower court's determination that The Medicines Company's use of contract manufacturing services did not invalidate the patents-in-suit under the on-sale bar. The en banc Court vacated a prior panel's decision that the asserted claims were invalid under 102(b) based on transactions between the patentee and a third-party manufacturing company that was hired to make patentee's blood thinner drug.
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