Ex Parte Friddle et al - Page 9


                Appeal No. 2005-0731                                                                        Page 9                             
                Application No. 09/974,712                                                                                                     

                pharmaceutical compositions that were disclosed to be useful in treating acute                                                 
                myeloblastic leukemia.  See id. at 1323, 206 USPQ at 886.  The active ingredients in                                           
                the compositions were closely related to daunorubicin and doxorubicin, both of which                                           
                were “well recognized in the art as valuable for use in cancer chemotherapy.”  Id., 206                                        
                USPQ at 887.  The applicant also submitted declaratory evidence showing that eight of                                          
                the claimed compositions were effective in treating tumors in a mouse model, and one                                           
                was effective in treating humans.  See id. at 1323-24, 206 USPQ at 887-88.  The court                                          
                noted that the data derived from the mouse model were “relevant to the treatment of                                            
                humans and [were] not to be disregarded,” id. at 1327, 206 USPQ at 890, and held that                                          
                the evidence was sufficient to support the asserted therapeutic utility.  See id. at 1327-                                     
                28, 206 USPQ at 891.                                                                                                           
                         The Federal Circuit held in Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed.                                        
                Cir. 1985), that in vivo testing (as in Jolles) was not necessarily required to show utility                                   
                in the pharmaceutical context.  The Cross court stated that “[it] is axiomatic that an                                         
                invention cannot be considered ‘useful,’ in the sense that a patent can be granted on it,                                      
                unless substantial or practical utility for the invention has been discovered and disclosed                                    
                where such utility would not be obvious.”  Id. at 1044, 224 USPQ at 742 (citing Brenner                                        
                v. Manson).  The court “perceive[d] no insurmountable difficulty, under appropriate                                            
                circumstances, in finding that the first link in the screening chain, in vitro testing, may                                    
                establish a practical utility for the compound in question.”  Id. at 1051, 224 USPQ at                                         
                748.  Successful in vitro testing could provide an immediate benefit to the public, by                                         
                “marshal[ling] resources and direct[ing] the expenditure of effort to further in vivo testing                                  
                of the most potent compounds . . ., analogous to the benefit provided by the showing of                                        





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