Helsinn Healthcare S.A. v. Teva Pharms. USA, Inc. - 855 F.3d 1356 (Fed. Cir. 2017)

Rule:

Before the Leahy-Smith America Invents Act (AIA), 35 U.S.C.S. § 102(b) barred the patentability of an invention that was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent. 35 U.S.C.S. § 102(b) (2006). Under that earlier provision, the Federal Circuit concluded that, although confidentiality weighs against application of the on-sale bar, that fact alone is not determinative. 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.

Facts:

Helsinn Healthcare S.A., plaintiff, was the owner of the four patents-in-suit directed to intravenous formulations of palonosetron for reducing or reducing the likelihood of chemotherapy-induced nausea and vomiting (CINV). Plaintiff brought suit against defendants, Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd., alleging that the filing of defendants Abbreviated New Drug Application constituted an infringement of various claims of those patents. Defendants argued on the ground that the asserted claims were invalid under the on-sale bar provision of 35 U.S.C. § 102. The district court found that the patents-in-suit were not invalid. With respect to three of the patents, which are governed by the pre-Leahy-Smith America Invents Act version of § 102, the district court concluded that there was a commercial offer for sale before the critical date, but that the invention was not ready for patenting before the critical date. With respect to the fourth patent, which is governed by the AIA version of § 102, Pub. L. No. 112-29, § 3(b), 125 Stat. 284, 285-86 (2011), the district court concluded that there was no commercial offer for sale because the AIA changed the relevant standard and that, in any event, the invention was not ready for patenting before the critical date.

Issue:

Did the district court err in its decision regarding the four patents-in-suit?

Answer:

Yes. The district court decision was reverse. Patent claims held invalid.

Conclusion:

The court held that in a case where the four patents-in-suit involved a pharmaceutical product, the district court erred when it concluded, as to three patents governed by the pre-Leahy-Smith America Invents Act (pre-AIA) version of 35 U.S.C.S. § 102(b), and that the invention was not ready for patenting before the critical date because the fact that the sale contract made the selection of which doses to supply contingent on regulatory approval did not create an ambiguity with respect to whether what was on sale fell within the bounds of the patents' claims. With respect to the patent governed by the AIA, the court found that the AIA did not change the meaning of the on-sale bar and the district court clearly erred by applying too demanding a standard because the evidence was overwhelming that before the critical date it was established that the patented invention was reduced to practice and ready for patenting.