The District Court of Delaware has ruled in favour of Dr. Reddy’s Laboratories Ltd. against Reckitt Benckiser for the blockbuster drug Suboxone.
BloombergQuint accessed the court ruling and here are the key points.
- Judge Richard Andrews, who presided over the hearing, said that plaintiffs failed to meet their burden of showing Dr. Reddy’s infringes the asserted claims of the patent.
- Judge rules that Dr. Reddy’s version uses different process to make its film
- Judge had previously said other generic-drug makers infringe Suboxone patent
- Plaintiffs are directed to submit an agreed upon form of final judgement within two weeks.
Dr. Reddy's bought Suboxone Film’s abbreviated new drug application (ANDA) from Teva Pharmaceuticals for $70 million in June 2016 with seven generic filers. The key patent expires in April 2024.
Suboxone Film treats opioid addiction and has a brand size of $1.7 billion in America, as per IMS Health data. Credit Suisse, in its note released on August 23, said that the upside for Dr. Reddy’s could be significant on non-infringement.
Actavis, acquired by Teva in August 2016, was the first to file and that is likely the key reason Teva divested its own ANDA to Dr. Reddy's in June 2016, Credit Suisse said
Upside in this case will be higher as the number of players will be limited before 2024.Anubhav Aggarwal, Analyst At Credit Suisse
Even with the assumption that three generics version of the drug hit the market - manufactured by Dr. Reddy’s, Actavis and Par Pharmaceutical - Suboxone could add Rs 30 to its EPS, the broking firm said.
However, this upside may take some time as the innovator may likely appeal the decision in a higher court. Dr. Reddy’s, on the other hand, still needs to get an approval from the U.S. Food and Drug Administration.