August 22, 2017
Budd Larner Secures Trial Victory for Dr. Reddy's Laboratories in Guaifenesin Patent Infringement Litigation
Budd Larner P.C. achieved a win for firm client Dr. Reddy's Laboratories (“DRL”) against Reckitt Benckiser (“Reckitt”). After a four-day trial, the court held that DRL’s ANDA product did not infringe Reckitt’s patent-in-suit.
The case arose when DRL filed an ANDA seeking regulatory approval to market a generic version of Mucinex® D, a bi-layer extended-release guaifenesin/pseudoephedrine tablet. Reckitt filed a Hatch-Waxman suit against DRL, alleging that DRL’s ANDA product infringed its patents because the product contained distinct immediate release and sustained release formulations. The U.S. District Court for the District of New Jersey held a four-day bench trial in May 2017, followed by post-trial briefing, closing argument and supplemental briefing.
On August 10, Judge Renée Marie Bumb ruled in favor of DRL, concluding that there was no literal infringement because DRL’s ANDA product was a single formulation matrix tablet and did not contain two distinct formulations. Additionally, the court held that Reckitt failed to meet its burden of proving infringement under the doctrine of equivalents. The Court’s decision was unsealed today.
The Budd Larner trial team was headed by partners Constance Huttner and Michael Imbacuan with associates Anandita Vyakarnam, Gaudenis Vidugiris and Mansi Parikh.
Click HERE for the Opinion.
Andrew J. Miller, Esq.