The Federal Circuit recently refused to rehear a panel decision that affirmed a district court’s finding that the existence of a blocking patent negated the patent owner’s argument that commercial success, failure of others, and long-felt but unmet need showed the patents-in-suit were non-obvious. Acorda Therapeutics, Inc. et al. v. Roxane Labs., Inc. et al. (original decision available here).

Specifically, the case involved patents owned by Acorda Therapeutics, Inc. that claimed the administration of a medication containing the active ingredient 4-aminopyridine (4-AP) to improve walking in individuals with multiple sclerosis that covered the commercial product Ampyra^®.  Acorda also held an exclusive license to an earlier, broader blocking patent that claimed methods of treating patients using 4-AP.

The district court discounted Ampyra^® sales of $1.7 billion, and evidence of the failure of others and long-felt but unmet need based on this blocking patent.  The Federal Circuit affirmed this finding and denied Acorda’s petition for rehearing.  Acorda argued that existing federal circuit law confirmed that a dominating compound patent, without more, does not diminish commercial success.  The panel had distinguished this case law, holding that the ultimate inquiry was whether the blocking patent caused such a “magnitude of diminution in incentive” that it “deter[red] activity that otherwise would have occurred.”  The panel said this was a “fact-specific inquiry” and the district court’s finding that the patent would have deterred others from developing the inventions of the patents-in-suit was supported by the record.  The full federal circuit refused to rehear the panel’s decision.

This case suggests that defendants would be wise to identify any blocking-patents to undermine allegations of secondary considerations.  In doing so, generic drug companies should be sure to provide evidence that the blocking patents actually deterred research and development.  For example, in this case the Federal Circuit was persuaded by evidence that development incentives emanating from extensive clinical research in this area became much more limited after the blocking patent was issued.