Patentees Have Burden to Produce Objective Evidence of Nonobviousness When Accused Infringers Establish Prima Facie Case of Obviousness

December 11, 2013

Wei (William) Zhang PhD

What This Means To You

  • Patentees are compelled to provide sufficient objective evidence probative of nonobviousness when accused infringers establish a prima facie case of obviousness.
  • A prima facie case of obviousness is established when there is a range disclosed in the prior art and the claimed invention falls within the range.

Overview

In Galderma Laboratories, L.P. v. Tolmar, Inc., the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) clarified that, when an accused infringer establishes a prima facie case of obviousness in a patent validity litigation, the burden of production—not the burden of persuasion—shifts to the patentee to come forward with objective evidence of nonobviousness.

Case Background

Galderma was the owner of five U.S. patents covering Differin® Gel 0.3, a pharmaceutical composition comprising 0.3% by weight of adapalene, for treating acne. Tolmar filed an Abbreviated New Drug Application (ANDA) under the Hatch-Waxman Act seeking approval to market a generic version of Differin® Gel 0.3%.

Galderma sued Tolmar in district court, alleging Tolmar’s ANDA product infringed certain claims of Galderma’s patents. Tolmar counterclaimed that Galderma’s patents were invalid as being obvious because the prior art disclosed pharmaceutical compositions comprising between 0.01% and 1% by weight of adapalene for treating acne.

The district court found for Galderma, and Tolmar appealed to the Federal Circuit.

Decision Analysis

In reversing the district court’s decision, the Federal Circuit determined that Galderma’s claimed invention fell within the range disclosed in the prior art, placing the burden on Galderma to produce evidence of (1) teaching away, (2) new and unexpected results, or (3) other pertinent objective evidence.

The Federal Circuit further held that Galderma failed to satisfy the burden of production because (1) the prior art did not teach away the claimed invention; (2) the tolerability of 0.3% adapalene was unexpected but not probative of nonobviousness because it was only a difference in degree, but not in kind, from the prior art; and (3) the fact that Tolmar and another ANDA filer sought approval to market a generic version of 0.3% adapalene was not evidence of commercial success probative of nonobviousness, and Galderma’s prior patents blocked the market entry of 0.3% adapalene until their expiration in 2010, long after Galderma invented the 0.3% adapalene.

Takeaway

A patentee must provide objective evidence probative of nonobviousness when an accused infringer establishes prima facie case of obviousness.