Case No. 17-1229 | Fed. Cir.
Preview by Michelle Divelbiss, Online Editor
This case threatens to shake up established patent law. Under 35 U.S.C. § 102, “[a] person shall be entitled to a patent unless . . . the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public.” This rule, which specifies just one of several requirements for patentability, is “subject to a grace period” of one year. Brief for Respondents at i, Helsinn Healthcare S.A. v. Teva Pharms. USA Inc., No. 17-1229 (U.S. filed Oct. 9, 2018); see 35 U.S.C. § 102(b)(1) (2018). For an invention to be “on sale” and therefore ineligible for a patent, “the product must be the subject of a commercial offer for sale,” and “the invention must be ready for patenting.” Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998).
Petitioner, Helsinn Healthcare, is a Swiss pharmaceutical company, and its product Aloxi, a treatment for nausea and vomiting associated with chemotherapy, is at the center of this dispute. Petitioner sued Respondent, Teva Pharmaceuticals, for patent infringement based on Teva filing a drug application with the FDA to market their generic version of the drug. At issue is whether Helsinn’s patented product was “on sale” more than one year prior to the patent application.
Research and development efforts for Aloxi had been abandoned by another company so Helsinn acquired rights to develop it. Helsinn, however, faced difficulty navigating the expense and complexity of bringing a drug to market in the United States, and entered licensing and purchase agreements with a U.S.-based pharmaceutical company. The existence of the agreement was made public, but the actual invention was kept confidential. The Federal Circuit held the patent invalid because the existence of the purchase agreement was public, triggering the one-year timer for filing the patent; the patent was filed more than one year after the sale.
Helsinn argues that because the private sale agreement did not make the invention available to the public, the licensing and purchase agreements do not trigger the on-sale bar to patentability. Teva disagrees and claims that 200 years of precedent have established that “[t]he on-sale bar is triggered by commercial exploitation—not public dissemination of every detail of the invention.” Brief for Respondents at 1, Helsinn Healthcare S.A. v. Teva Pharms. USA Inc., No. 17-1229 (U.S. filed Oct. 9, 2018) (emphasis in original). Dozens of intellectual property professors agree with Teva; as amici curiae they explain that the “on sale” issue has been settled and that a change to the precedent would “cause all manner of mischief” by “sweep[ing] away scores of cases [] accumulated over two centuries.” Brief Amici Curiae of 45 Intellectual Property Professors in Support of Respondents at 11, Helsinn Healthcare S.A. v. Teva Pharms. USA Inc., No. 17-1229 (U.S. filed Oct. 9, 2018). Given the potential to radically shake up patent law, lawyers, inventors, and pharmaceutical companies are watching this case closely.