Pharmaceutical salts: Are they patentable or obvious?

CHAL 2

Steven J. Sarussi, sarussi@mbhb.com, McDonnell Boehnen Hulbert & Berghoff LLP, 300 South Wacker Drive, Chicago, IL 60606
In 1971 the Court of Customs and Patent Appeals decided the case of In re Papesch by stating that a compound and its properties are inseparable. In that case, a comparison of the activity of a prior art trimethyl compound and the applicant's triethyl compound showed unexpected activity of the latter, and the triethyl compound was found patentable. A pharmaceutical salt is certainly a chemical compound and, in view of the Papesch case, should be patentable with a showing of unexpected results. But, in the recent Pfizer v Apotex case, the Court of Appeals for the Federal Circuit (CAFC) reached a decision different than the U.S. Patent Office and a district court. The CAFC appears to have disregarded evidence of improved characteristics of a besylate salt compared with a maleate salt of the same parent amine. Or did it? This talk will delve into the facts of these cases and will offer guidance to improve the chances that important chemical compounds that happen to be salts will be found patentable.