KUNDU et al v. RAGUNATHAN et al - Page 2




                Interference No. 104,843                                                                       Paper 51                  
                Kundu v. Ragunathan                                                                              Page 2                  
                        against Kundu for abandonment, suppression, or concealment (Paper 3).  This proceeding                           
                        followed.                                                                                                        
                                                              FINDINGS                                                                   
                        The subject matter of the interference                                                                           
                [02]    Both Ragunathan and Kundu engaged in an effort to produce a commercial, oral                                     
                        formulation for the drug megestrol acetate that would not infringe a Bristol-Myers Squibb                        
                        Company patent [2004].3  Bristol-Myers Squibb has a product, MEGACE®, within the                                 
                        scope of its patent that the Food and Drug Administration [FDA] has already approved                             
                        and that could thus provide the basis for an abbreviated new drug application [ANDA]                             
                        [2003 at ¶¶2, 5, & 7].  Bristol-Myers Squibb's early disclosure of an invention (its                             
                        Atzinger patent) without have fully exhausted all possible avenues of development                                
                        appears to have promoted the useful arts by enabling and inspiring others (Kundu and                             
                        Ragunathan) to explore its possibilities as well.                                                                
                [03]    Count 1, the sole count, is "An oral pharmaceutical composition of Ragunathan 065                                
                        claim 1."  Ragunathan 065 claim 1 is:                                                                            
                                An oral pharmaceutical composition in the form of a stable flocculated                                   
                        suspension in water capable of being redispersed after being allowed to settle at                                
                        40° C. and 75% relative humidity for a period of three months, said composition                                  
                        comprising:                                                                                                      
                        (a) about 10 to 200 mg per ml micronized megestrol acetate;                                                      




                        3   A.E. Atzinger et al., "Megestrol Acetate Formulation", U.S. Patent 5,338,732 (16 August 1994) [2004].        
                Exhibits numbered 2xxx are Kundu exhibits; 1xxx, Ragunathan exhibits.                                                    





Page:  Previous  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  Next 

Last modified: November 3, 2007