Teva Pharmaceuticals USA Inc. can attack the validity of Orexo AB’s patent covering the treatment of acute disorders, including opioid disorders.
Judge Colm F. Connolly of the U.S. District Court for the District of Delaware denied Orexo’s bid to keep Teva from arguing that the patented invention in question was obvious or wasn’t sufficiently described. Obviousness is when an invention would have been apparent to someone experienced in the technology at the time.
The validity of the patent wasn’t a single issue that would preclude Teva from challenging the patent in this case even though Teva had unsuccessfully attacked the patent’s validity in a prior case against Orexo over Teva’s generic Zubsolv products, he said.
The ruling is a win for Teva and its subsidiary Actavis Elizabeth LLC, which make generic versions of the opioid addiction treatments Suboxone (buprenorphine and naloxone) and Subutex (buprenorphine). Orexo is seeking damages based on the launch of those products. And big bucks are at stake: The market to treat opioid abuse has grown to $2.8 billion in the 12-month period ending in November 2018, according to Symphony Health data reported by Bloomberg Intelligence.
Suboxone is the best-selling opioid addiction treatment, and competes with Alkermes Plc’s Vivitrol (naltrexone for extended-release injectable suspension) and Orexo AB’s Zubsolv (buprenorphine and naloxone), Symphony data show. The active ingredient is available as a generic drug in tablets and injected treatments.
Opioid abuse affects about 2 million adults in the U.S., and the National Institute on Drug Abuse estimates 115 people die every day because of an opioid overdose.
The patent at issue is U.S. Patent No. 8,454,996. Orexo is seeking damages and an injunction against Teva’s continued sale of the generic products. Teva acquired Actavis in 2015.
Bloomberg Law reached out to the parties for comment, but no one was immediately available to respond.
Milbank, Tweed, Hadley & McCloy LLP and Morris, Nichols, Arsht & Tunnell LLP represented Orexo.
Winston & Strawn LLP and Phillips, Goldman, McLaughlin & Hall PA represent Teva and Actavis Elizabeth.
The case is Orexo AB v. Actavis Elizabeth LLC, 2019 BL 84009, D. Del., 17-205-CFC, 3/12/19.
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(In first and fourth paragraphs, deletes references to Orexo being the manufacturer of Suboxone and Subutex.)