ACORDA THERAPEUTICS, INC. v. ROXANE LABORATORIES, INC.

Before Newman, Dyk, and Taranto. Appeal from the United States District Court for the District of Delaware.

Summary: Pharmaceutical patents were obvious where the claims covered species of a genus taught by the prior art, the prior art taught achieving the claimed concentrations of the same compound but for a different indication, and a person of ordinary skill in the art would expect the claimed outcome. Evidence of secondary considerations of nonobviousness such as long-felt need carried diminished weight because there was a blocking patent that may have deterred investment in the “blocked” invention.

Acorda sued several ANDA filers for patent infringement of Orange Book patents directed to methods of using the drug sold as Ampyra^®. Acorda owned four asserted patents (“the Acorda patents”) and held an exclusive license to an additional broader asserted patent (“the blocking patent”). The defendants challenged the validity of each asserted claim. The district court held that the blocking patent was valid but the Acorda patents were obvious over the prior art.

The Federal Circuit affirmed. The district court did not clearly err in holding that there was motivation to combine the prior art references and a reasonable expectation of success. The district court also did not clearly err in holding that the Accorda patents were directed towards achieving a particular concentration of an active ingredient that was inherent in the prior art. Acorda had also argued the district court improperly applied a categorical rule that a blocking patent defeats the significance of objective indicia of nonobviousness, such as long-felt need. The Federal Circuit held that the district court did not apply a categorical rule, but properly held that, because a blocking patent may diminish commercial exploitation in the market, this discounts the significance of evidence supporting secondary considerations of nonobviousness.

Judge Newmann dissented to discuss the impact of a blocking patent in the obviousness analysis. She stated that because there is a statutory safe harbor for research on patented subject matter, a blocking patent did not deter research in this case. She points out that, had the court’s approach to blocking patents been in effect when Acorda took up its research on Ampyra^®, after decades of failures by others, it is questionable whether this new treatment would have been discovered, and the real loser is the afflicted public.