Court of Appeals for the Federal Circuit Declines to Immediately Issue Mandate After Preliminary Injunction Ruling
Slough, UK, December 12, 2018 – Indivior PLC (LON: INDV) (“Indivior” or the “Company”) today announced that the U.S. Court of Appeals for the Federal Circuit (CAFC) has denied Dr. Reddy’s Laboratories (DRL’s) motion to immediately issue the mandate following the CAFC’s ruling vacating the preliminary injunction (PI). The mandate is a formal filing by the CAFC that returns the case to the District Court for actions consistent with the CAFC’s ruling. The CAFC also ordered that any petition for rehearing be submitted on or before December 20, 2018.
As a result of this ruling, the CAFC will not immediately issue the mandate, meaning that the PI will remain in place and DRL will remain enjoined from resuming their “at-risk” launch in the U.S. market of its generic buprenorphine-naloxone sublingual film until after the mandate issues. Indivior will file a petition for rehearing and rehearing en banc by December 20th, and the CAFC must rule on Indivior’s petition for rehearing and rehearing en banc before the mandate can be issued.
“We are pleased that the Court has denied DRL’s motion to immediately issue the mandate,” said Shaun Thaxter, CEO of Indivior. “We will continue to vigorously pursue our infringement cases against DRL to protect our SUBOXONE® (buprenorphine and naloxone) Sublingual Film patent portfolio.”
About Indivior
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. The name is the fusion of the words individual and endeavour, and the tagline “Focus on you” makes the Company’s commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and cooccurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more.
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