U.S. Pat. No. 6,315,720B2
October 27, 2015
Brief Summary: CA’s Petition to institute IPR against claims 1-32 of the ‘720 patent listed on the Orange Book for Celgene’s multiple myeloma drugs Thalomid®, Revlimid®, and Pomalyst® granted for obviousness.
Summary: CA petitioned for IPR of the ‘720 patent encompassing methods for avoiding side effects when delivering an undefined drug to patient, alleging claims 1-32 would have been obvious in view of one US patent and 12 non-patent references that “focus on controlling the distribution of a drug.” The patent is listed on the FDA’s Orange Book for Celgene’s multiple myeloma drugs Thalomid® (thalidomide), Revlimid® (lenalidomide), and Pomalyst® (pomalidomide). Celgene disputed whether CA’s declarant “has the knowledge of a person of ordinary skill in the art” but the Board disagreed based on the declarant’s “educational background and experience”. The Board determined the “identified claim terms [consulted, teratogenic effect, and adverse side effect] should be given their ordinary and customary meaning, as would be understood by one with ordinary skill in the art, and need not be construed explicitly at this time”. The Board explained it understood “Petitioner as contending that the challenged claims represent a combination of known prior art elements (identifying patient risk groups, collecting patient information relating to the risk, determining whether the risk is acceptable, and controlling dispensation of the drug using an approval code) for their known purpose (control distribution of drug) to achieve a predictable result (avoid giving patients drugs that have an unacceptable risk of side effects).” Celgene argued certain references are “not directed towards the same endeavor” and others taught away from its claimed system but the Board disagreed (e.g., “Patent Owner has failed to identify sufficient and credible evidence that the specific computerized system described by Dishman, which was approved by the U.S. manufacturer of clozapine, was considered by one of ordinary skill in the art to be a failure.”) The Board was also not persuaded by Celgene’s proferred evidence of unexpected results (“Patent Owner has filed to provide a sufficient and credible explanation that achieving the same result as the admitted prior art in an unexpected result.”) It also found Celgene had not shown that all the real parties in interest had not been named in the Petition. The Petition to institute IPR against claims 1-32 of the ‘720 patent was therefore granted.