Otsuka Pharmaceutical Co., Ltd. v. Sandoz, Inc.

In discerning obviousness, the court looks to whether one of ordinary skill would have had reasonable motivation to modify the earlier claimed compound to make the compound of the asserted claim.

Opinion (Lourie): Sandoz, Inc. (“Sandoz”) appealed a district court decision that found infringement on prior art, and failed to hold invalid claims of an asserted patent for non-statutory obviousness-type double patenting (“NODP”). In April 1991, Otsuka Pharmaceutical (“Otsuka”) was issued a patent for the antipsychotic drug compound commonly known as apropazole, a carbostyril derivative and the active ingridient in the brand-named drug Abilify. Sandoz, along with co-defendants, applied for an Abbreviated New Drug Application with the FDA in 2010 for manufacture and sale of generic apropazole products. The Court of Appeals upheld the infringement, and the finding on NODP for the substituted butoxy. Asking whether one of ordinary skill would have had reasonable motivation to modify the earlier claimed compound to make the compound of the asserted claim with reasonable expectation of success, the Court of Appeals determined that apropozale was not an obvious improvement from the “unsubstituted butoxy attachments” utilized in antipsychotics prior to the Otsuka patent for apropazole. Judgment was AFFIRMED.