The mere sale of manufacturing services by a contract manufacturer to an inventor to create embodiments of a patented product for the inventor does not constitute a “commercial sale” of the invention. Here, for example, no on sale bar was found to be triggered by the patentee contracting with a supplier to make three batches of the patented product, even though the patentee did so to stockpile the product for building inventory rather than for experimental use. “[T]o be ‘on sale’ under § 102(b), a product must be the subject of a commercial sale or offer for sale, and … a commercial sale is one that bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code.” This would be a good case to consult and cite in response to a rejection under 35 U.S.C. § 102(b) predicated on an alleged offer for sale between the applicant / patentee and a manufacturer.
Background / Facts: The patent being asserted here is directed to pH-adjusted pharmaceutical batches of a drug product comprising bivalirudin, an anticoagulant used to prevent blood from clotting and regarded as highly effective for use during coronary surgery. More than one year before filing for the patent, the patentee contracted with a supplier to make three batches of the patented product, which the patentee stockpiled to build its inventory prior to making the product available to the public.
Issue(s): Whether the invention was the subject of a commercial offer for sale under 35 U.S.C. § 102(b).
Holding(s): No. “[T]he mere sale of manufacturing services by a contract manufacturer to an inventor to create embodiments of a patented product for the inventor does not constitute a ‘commercial sale’ of the invention.” Moreover, “‘stockpiling’ by the purchaser of manufacturing services is not improper commercialization under § 102(b). … [C]ommercial benefit—even to both parties in a transaction—is not enough to trigger the on-sale bar of § 102(b); the transaction must be one in which the product is ‘on sale’ in the sense that it is ‘commercially marketed.’” Here, the court noted that “[t]here are, broadly speaking, three reasons for our judgment in this case: (1) only manufacturing services were sold to the inventor—the invention was not; (2) the inventor maintained control of the invention, as shown by the retention of title to the embodiments and the absence of any authorization to [the supplier] to sell the product to others; and (3) ‘stockpiling,’ standing alone, does not trigger the on-sale bar.”