Lead Compound Analysis Improper When Evaluating a Method of Use of a Compound

NOVARTIS PHAMACEUTICALS CORP V. WEST-WARD PHARMACEUTICALS

Before Stoll, Plager, and Clevenger.  Appeal from the United States District Court for the District of Delaware.

Summary: When a method of using a prior art compound is claimed rather than the compound itself, the standard for motivation to combine is whether a person of skill in the art would have been motivated to modify the prior art disclosing the compound.  A limited pharmaceutical study may not be enough to show that a person of ordinary skill in the art would have a reasonable expectation of success.

Novartis sued West-Ward to assert its patent on a method of using the drug Everolimus to treat advanced renal cell carcinoma (“RCC”).  The district court found that West-Ward failed to prove by clear and convincing evidence that the patent was invalid as obvious.  The Federal Circuit affirmed the district court’s decision, finding that while the district court erred in its motivation to combine analysis, the error was harmless because the District Court did not clearly err in its finding regarding the lack of a reasonable expectation of success.

With regard to the motivation to combine analysis, the Federal Circuit determined that the district court erred in applying a lead compound analysis to the claims at issue.  In particular, since the claims at issue were a method of using a compound rather than a claim to the compound itself, the proper standard is not whether a person of ordinary skill in the art would have selected the compound, but rather whether the person of ordinary skill in the art would have been motivated to modify the prior art disclosing the compound.  Since the district court found that a person of ordinary skill would have been motivated to pursue the drug as one of several options, the Federal Circuit found that the standard was met and there would have been a motivation to combine.

With regard to the reasonable expectation of success analysis, the Federal Circuit determined that the district court did not clearly err in its finding that a person of ordinary skill in the art would not have had a reasonable expectation of success because the molecular biology of the prior art compound was not fully understood and there were limitations in the available phase I data regarding the compound.  Thus, the Federal Circuit affirmed the district court’s conclusion that the patent at issue would not have been obvious in view of the asserted prior art.

Editor: Paul Stewart

Written by: Serah Friedman,Ph.D. and Christie Matthaei