Barbara R. Rudolph, Ph.D.

Lead counsel for Duchesnay in a Hatch-Waxman Act patent infringement litigation based on Actavis’s and Teva’s filing of an ANDA seeking to market a generic copy of Bonjesta®.  The case is currently pending in the District of Delaware.

Lead counsel for Vifor and American Regent in two Hatch-Waxman Act cases against Mylan and Sandoz regarding their attempts to obtain FDA approval for their respective ANDAs directed to generic copies of Injectafer®.  The cases are currently pending in the District of New Jersey.

Successfully represented Ajinomoto as trial counsel in an extremely rare biotech investigation at the U.S. International Trade Commission (ITC).  The investigation involved patents related to genetically modified organisms and the use thereof to make commercial quantities of tryptophan. After a full evidentiary hearing, the ITC issued a final determination finding the Ajinomoto patents valid and that Cheil Jedang (“CJ”) infringes the asserted patents. The commission issued limited exclusion and cease-and-desist orders barring CJ and other respondents from importing infringing products for sale in the United States, resulting in a victory for Ajinomoto. 

Lead counsel for AbbVie in multiple patent infringement actions in two district courts against several generic companies based on their respective efforts to market generic versions of AbbVie’s Norvir® tablet or capsule products.  Obtained favorable Markman rulings, and the cases all settled on favorable, confidential terms at various stages of litigation.

Lead counsel for AbbVie in a patent infringement action brought under the Hatch-Waxman Act against Mylan and Matrix, who sought to market generic versions of Kaletra® tablets.  The case settled prior to trial on confidential, favorable terms.  Assisted AbbVie in the settlement of later cases against other challengers involving Kaletra® tablets.

Successfully represented Cephalon as trial counsel against five generic companies in consolidated Hatch-Waxman Act litigations pertaining to Nuvigil®, Cephalon’s prescription medicine used to improve wakefulness. The district court found the asserted claim patents valid and infringed and enjoined the defendants from marketing generic versions until patent expiry. The case was ultimately settled on appeal.