Source: https://www.complexip.com/offer-sale-product-one-year-patent-filed-invalidates-patent/
Timestamp: 2019-04-26 02:14:34+00:00

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an invention is made available to the public, such as when there is a commercial offer or contract to sell a product embodying the invention and that sale is made public, and the invention is ready for patenting “by proof of reduction to practice before the critical date; or by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.” “After the AIA, if the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale.” Helsinn Healthcare S.A., v. Teva Pharmaceuticals USA, Inc., Case No. 2016-1284 (Federal Cir. May 1, 2017) (Available Here).
Helsinn Healthcare S.A. (“Helsinn”) is the owner of the four patents-in-suit directed to intravenous formulations for reducing or reducing the likelihood of chemotherapy-induced nausea and vomiting. Helsinn brought suit against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. (“Teva”) alleging that the filing of Teva’s Abbreviated New Drug Application (“ANDA”) constituted a patent infringement. Teva defended on the ground that the asserted claims were invalid under the on-sale bar under 35 U.S.C. 102.
ready for patenting prior to the critical date.” See 35 U.S.C. § 102(a)(1); AIA, Pub. L. No. 112-29, § 3(n), 125 Stat. 284, 293 (2011).
clinical trials and stated that in the event that the results were unfavorable and FDA did not approve the sale of either dosage of the product, Helsinn could terminate the agreement. After the signing of the agreements, and still before the critical date, Helsinn prepared preliminary statistical analysis of the earliest Phase III trial on January 7, 2002. The data showed that 81% of patients who received the 0.25 mg dose of palonosetron experienced relief. On January 30, 2003, Helsinn filed a provisional patent application.
for patenting for the on-sale bar under 35 U.S.C. § 102 to apply.
Medicines also discussed other factors important to the onsale analysis but no factor is individually determinative. Like UCC itself, the absence of the passage of title, the confidential nature of a transaction, and the absence of commercial marketing of the invention all counsel against applying the onsale bar.
Helsinn commercially marketed its invention before the critical date. It publicly sought marketing partners for its patented product and ultimately contracted with a distributor to distribute, promote, market, and sell the claimed invention.
The Federal Circuit also confirmed the holding in Medicines that “stockpiling,” including purchases from a supplier, “does not trigger the on-sale bar.” Medicines, 827 F.3d at 1374. By enacting the AIA, Congress amended § 102 to bar the patentability of an “invention [that] was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.” 35 U.S.C. § 102(a)(1). Helsinn argued that the on-sale bar under the AIA does not encompass secret sales and requires that a sale make the invention available to the public in order to trigger application of the on-sale bar. Teva asserted that by reenacting the existing statutory term, “on sale,” Congress did not change the meaning of the on-sale bar.
As for whether the invention was ready for patenting as of the critical date of January 30, 2002, under Pfaff, “there are at least two ways in which an invention can be shown to be ready for patenting: ‘by proof of reduction to practice before the critical date; or by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.’ Pfaff, 525 U.S. at 67–68. We conclude that the invention here was ready for patenting because it was reduced to practice before the critical date.” There was considerable evidence supporting the Federal Circuit’s decision. These results consistently showed that the invention worked for its intended purpose, from the final report for the 1995 Phase II trial to the preliminary results in January 2002 from a Phase III trial.

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