KUNDU et al v. RAGUNATHAN et al - Page 19




                Interference No. 104,843                                                                       Paper 51                  
                Kundu v. Ragunathan                                                                             Page 19                  
                unless the intervening period were spent "perfecting" the invention.  Lutzker, 843 F.2d at 1367,                         
                6 USPQ2d at 1372.                                                                                                        
                        Kundu's problem in this case, however, is that the standard indicium of perfecting                               
                efforts--a reflection of such work in the patent application--has less credibility than usual.  First,                   
                the perfecting in the present case is defined in terms of having a successful ANDA batch, the                            
                stated trigger for the ultimate instruction to draft an application.  A successful ANDA batch                            
                indicates greater interest in achieving a critical commercialization milestone (a demonstrated                           
                ability to meet the rigorous requirements of drug approval) than in satisfying the very different                        
                patentability requirements of utility and enablement.  On the question of commercialization,                             
                Lutzker cites Fitzgerald v. Arbib, 268 F.2d 763, 766, 122 USPQ 530, 532 (CCPA 1959), which                               
                holds that investigating manufacturing details does not excuse delay, yet much of Alpharma's                             
                effort was directed to developing an ANDA-sufficient method of manufacturing its MEGACEŽ-                                
                equivalent megestrol formulation.  Second, in Lutzker and the cases it cites on reporting                                
                perfecting work in the application, the applicants did not have Kundu’s advantage of knowing                             
                what was in the other parties’ disclosures when they filed.  Applications filed after the other                          
                side's patent has issue have the lowered credibility of any post litem motam statement,                                  
                particularly when as in this case the applicant seeks to provoke a patent interference.  The case                        
                law provides ample motivation for a new applicant seeking to provoke an interference with a                              
                patent, and facing the need to overcome an appearance of suppression, to include any and all                             
                remotely related work in the specification.                                                                              









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