U.S. District Court for the District of New Jersey dismisses patent infringement case against AV&H client Mutual Pharmaceuticals

Axinn, Veltrop & Harkrider succeeded in persuading the U.S. District Court for the District of New Jersey to dismiss a significant patent infringement case against their client, Mutual Pharmaceutical Co., Inc. 

In the case, Eisai Co. Ltd. sought declaratory and injunctive relief and damages because of Mutual’s filing of an abbreviated new drug application directed to a generic version of Eisai’s Aricept^® ODT product.  Aricept^® ODT is used to treat Alzheimer’s disease.  

Because Eisai delayed listing its patent in the FDA Orange Book, Mutual was not required to include a Paragraph IV certification in its ANDA.  Additionally, Mutual provided testimony that it has no current plans to launch its generic version of Aricept^® ODT, and Mutual agreed to provide 45 days warning prior to launching its product.  The New Jersey court therefore held that Mutual had not committed an act of patent infringement under the Hatch-Waxman Act and that Eisai’s allegations of apprehension the harm that might result from future infringement failed to “present the immediacy necessary for declaratory judgment jurisdiction.”  Once Mutual's product receives FDA approval and is launched, it will provide a lower-cost alternative to Aricept^® ODT. 

James P. Doyle of Axinn, Veltrop & Harkrider led the team on behalf of Mutual Pharmaceuticals.