Viswanath Pilla
Moneycontrol News
The US Court of Appeals for the Federal Circuit (CAFC) on Monday accepted drug maker Dr Reddy's Laboratories' appeal to expedite proceedings against a preliminary injunction that prevents it from selling its generic Suboxone sublingual film in the US.
Under the expedited schedule, arguments will be held during the first week of October this year. Dr Reddy's has been prevented from re-launching its generic Suboxone until it prevails in an appeal to stay the preliminary injunction.
The Indian drug maker on July 13 received a setback when the District Court of New Jersey converted a temporary injunction against it into a preliminary injunction that prevents it from launching the drug in the US until the patent litigation pertaining to US Patent No. 9,931,305 is concluded.
Dr. Reddy's launched its generic buprenorphine/naloxone sublingual film or Suboxone, which is used in the treatment of opioid dependence, "at-risk" in the US after it got a final approval from the US FDA on June 15.
An "at-risk" launch of a generic drug is when a company launches the drug for sale while the patent litigation is still ongoing.
Specialty drug maker Indivior, which British drug maker Reckitt Benckiser spun off as a separate company four years ago, approached the court and secured an immediate injunction against Dr Reddy's from on the grounds of pending patent litigation.
Suboxone had sales of around $1.86 billion in the US for the 12 months ended April, according to IQVIA. The drug accounts for about 80 percent of Indivior's sales.
The Hyderabad-based drug maker is pinning hopes on the quick launch of generic Suboxone sublingual film to revive its sagging fortunes in US market, where it was bogged down by lack of significant approvals and regulatory compliance issues for last three years.
However delay in launch will be detrimental for Dr Reddy’s as it will have to face intense competition from rivals.
Indivior said it will continue to vigorously defend its patent rights to Suboxone film, including opposing Dr Reddy's preliminary injunction appeal.
"We continue to pursue the appeal of the District of Delaware's non-infringement ruling related to U.S. Patent No. 8,603,514 (the '514 Patent), and the recently filed litigation asserting U.S. Patent Nos. 9,931,305, 9,687,454, and 9,855,221 in the District of New Jersey," Indivior said in a statement.
The crucial US Patent No. 9,931,305 is valid through 2022. However, generic filers like Dr Reddy's have challenged those patents and are fairly confident of invalidating them.
Shares of Dr Reddy's fell 0.57 percent on the news and were trading at around Rs 2,070 at 13.32 IST on BSE.
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