Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., U.S., No. 17-1229, amicus brief supporting a petition for certiorari, filed 3/30/2018. March 30, 2018

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The Federal Circuit failed to give effect to a revision of the “on sale” doctrine made by the America Invents Act (AIA) which imposed a “public availability” requirement not only on the fact of an early sale but also on the subject matter of the sale, i.e., the “claimed invention,” according to an AIPLA amicus brief supporting a petition for Supreme Court review.

The revision was intended to bring transparency, objectivity, and predictability to the patent system, consistent with the AIA’s conversion of U.S. patent law from a “first to invent” system to a “first inventor to file.” Although the statutory term “available to the public” may need case-by-case development for different types of inventions, this cannot justify turning a blind eye to the express language of the statute. That language, at a minimum, requires that the “claimed invention”—with all of its claim limitations—be “available to the public.”

The Federal Circuit decision will convert what should be a legal issue in most cases into a fact-intensive issue in many cases, not only jeopardizing the prior investment in inventions claimed in the patent(s)-in-suit, but also increasing the time and expense required for discovery, motion practice, trial, and appellate review.

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