The expense of developing a new product can tempt innovators to wait for market proof before filing for patent protection. Waiting beyond the statutory bars of 35 U.S.C. 102 can be devastating to a patent, even if already issued. Specifically, these statutory bars prohibit obtaining a patent if priority is not established before one year after public disclosure, publication, sale, or offer for sale.
Helsinn Healthcare S.A. designed a drug with 0.25mg of palonosetron to treat chemo-induced nausea. Helsinn immediately began developing the market for the new product. Helsinn entered into several sales agreements for the new drug, although the dosage information remained undisclosed. Helsinn waited for several years after the after the agreements before applying for a patent.
Upon patent issue, Helsinn sued Teva Pharmaceuticals USA, Inc. for infringement. Teva argued that Helsinn’s patent was invalid due to the statutory bar in that the drug was “on sale” under 35 U.S.C. 102 for more than one year before Helsinn filed the patent application. Helsinn argued that the “on sale” bar was not applicable because the sales agreements did not publicly disclose dosage information. The district court agreed that the America Invents Act (AIA) changed the “on sale” bar to require public disclosure to invalid the patent. However, the Federal Circuit and the Supreme Court of the United States held that there was no Congressional intent to change the history of the “on sale” bar, which did not previously require public disclosure of every aspect of the product sold. See Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. ___, 2019 WL 271945 (2019). Helsinn lost both the infringement claim and its patent.
Helsinn may have kept its patent and a monopoly on the market, if the patent application had been filed sooner. Generally, statutory bars to patentability under 35 U.S.C. 102 requires that a patent application be filed (or establishes priority through an earlier filing) before one year after the invention is publicly disclosed, sold, or offered for sale. However, filing the patent application as soon as possible can help reduce the validity of later challenges to the patent in court.If you need help with your patents, trademarks, copyright, or trade secrets, please contact us.
Jeremy I. Maynard
Registered U.S. Patent Attorney
Troutman & Napier, PLLC
4740 Firebrook Blvd.
Lexington, KY 40513
Web: Troutman & Napier, PLLC
Originally Published at: Maynard.Law
Originally Published by: Maynard.Law