Products embodying the invention and prepared by a supplier for commercial exploitation by the patentee trigger the on-sale bar. Here, for example, a batch of pharmaceuticals marked by the supplier with commercial product codes and customer lot numbers and sent to the patentee for commercial and clinical packaging was found to trigger the on-sale bar. “[N]o ‘supplier’ exception exists for the on-sale bar.” It may therefore be best when counseling clients to advise filing a patent application prior to contracting with a commercial supplier, at least other than for mere prototyping.
Background / Facts: The patents being asserted here relate to the drug bivalirudin, a synthetic peptide used as an anti-coagulant. Over one year before filing the corresponding applications, the patentee hired a supplier to prepare three batches of bivalirudin using an embodiment of the patented method. Each invoice for these services identifies a “charge to manufacture Bivalirudin lot.” Each lot was marked with a commercial product code and a customer lot number, and was released to the patentee for commercial and clinical packaging.
Issue(s): Whether the contracted actions of the supplier constitute a commercial offer for sale of the claimed invention.
Holding(s): Yes. “The [patentee] paid [the supplier] for performing services that resulted in the patented product-byprocess, and thus a ‘sale’ of services occurred. … [T]he sale of the manufacturing services here provided a commercial benefit to the inventor more than one year before a patent application was filed. … [The supplier] marked the batches with commercial product codes and customer lot numbers and sent them to [the patentee] for commercial and clinical packaging, consistent with the commercial sale of pharmaceutical drugs. … This is not a case where the inventors have requested another entity’s services in developing products embodying the invention without triggering the on-sale bar. [] The batches were prepared for commercial exploitation, and this is not the type of ‘secret, personal use’ described in Trading Technologies.”