Mind The Gap: Helsinn Healthcare v. Teva Pharmaceuticals

In Helsinn Healthcare S.A.  v. Teva Pharmaceuticals USA, Inc. et al., 586 U.S. ____ (2019) [hereinafter ‘Helsinn’ and ‘Teva’], the United States Supreme Court [hereinafter ‘the Court’] held that the term “on sale” in 35 U.S.C. 102(a)of the American Invents Act [hereinafter ‘the AIA’] includes both confidential and public commercial sales of an invention. Under this section, together with section 102(b), a sale or offer for sale of an invention triggers a maximum one-year period for submission of a patent application to the United States patent office. After this one year elapses an applicant may no longer submit an application for that particular invention. The pre-AIA statute expressly provided that on sale activities and public use trigger this one-year period.  AIA section 102(a) now expressly reads “public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention [Emphasis added].”  The issue in Helsinn became whether the ‘on sale’ term of the AIA excludes confidential sales because of this additional “or otherwise available to the public” category of activities.

Helsinn originally owned patents for a pharmaceutical that decreases adverse side effects from chemotherapy. Helsinn entered into an agreement with another company to (i) distribute this pharmaceutical at specific doses and (ii) preserve Helsinn’s confidential information received under the agreement. The agreement’s existence was announced in a joint press release, and the actual  agreement was submitted to Securities & Exchange Commission [hereinafter SEC] with the dosages redacted. Nearly two years later Helsinn submitted its first patent application for this pharmaceutical to the U. S. patent office. Thereafter, Helsinn sued Teva for patent infringement when Teva requested government permission to market the pharmaceutical at a dose disclosed in Helsinn’s patents. However, Teva contended that in addition to its three earlier patents, Helsinn’s U.S. Patent No.  8, 598,219 [hereinafter ‘Pat. No. ‘219’] was invalid, because it was submitted after a gap of more than one year after the distribution agreement’s effective date.

Pat. No. ‘219 was the only patent in the litigation governed by AIA 35 U.S.C. 102(a). The district court held that the AIA ‘on sale’ deadline did not apply, because the SEC filing and joint press release did not disclose the claimed dosages. The Court of Appeals for the Federal Circuit reversed, because (i) the existence of the ‘on sale’ event (i.e., the distribution agreement) was publicly disclosed, and (ii) this ‘on sale event’ triggered a one-year application submission deadline even if invention details remained confidential. Because the Federal Circuit held that the sale was public, it did not address whether confidential sales trigger application submission deadlines under section 102(a) of the AIA.

Before the Court, Helsinn contended that under the AIA confidential sales do not trigger a one-year filing deadline, because “or otherwise available to the public” means that only public sales now trigger this deadline.  Nevertheless, the Court held that a commercial sale to a third party who is required to preserve the invention as confidential is also within the scope of the “on sale” AIA deadline.  The Court observed that under pre-AIA precedent a sale or offer of sale does not require that invention details be publicly available to trigger this deadline.   Congress also re-enacted the same ‘on-sale’ language into the AIA, and which is consistent with earlier judicial construction of that phrase.  In sum, the addition of “or otherwise available to the public” is not a sufficient change to conclude that Congress intended to alter the original scope of the term “on sale.”

© 2019 Adrienne B, Naumann, Esq. All rights reserved. Ms. Naumann does not endorse or sponsor advertisements at adriennebnaumann@wordpress.com


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