Alvogen Malta Operations Ltd. may be able to launch generic competition to Pernix Therapeutics LLC’s opioid capsule Zohydro soon.
Alvogen’s proposed generic version of the painkiller infringed Pernix’s patents, but those patents weren’t valid, a federal court in Delaware said. The ruling could mean Alvogen will be able to launch its generic version of Zohydro as early as Oct. 1, 2019, once the company gets final approval from the Food and Drug Administration.
But what’s good news for Alvogen is bad news for Pernix because Zohydro (hydrocodone bitartrate) is one of Pernix’s core products. In January, Pernix reorganized its operations to focus on Zohydro and its Silenor prescription sleep medication. Generic competition would slice into Pernix’s Zohydro sales, which totaled $24 million worldwide last year.
The fight isn’t over yet because Pernix is going to appeal the decision and try to undo the invalidity portion of the ruling, the company said in an Aug. 27 statement. Bloomberg Law contacted Alvogen for comment on the ruling and its effect on the company’s generic launch plans, but no one was available to respond.
Zohydro is an extended-release opioid capsule for chronic pain. The FDA approved Zohydro in 2013, and Pernix acquired it from Zogenix Inc. in 2015.
Pernix has fought to protect Zohydro from generic competition.
Pernix sued Alvogen for patent infringement in 2016 after Alvogen filed its generic drug application with the FDA. It settled litigation with Teva Pharmaceutical Products Ltd.'s Actavis unit in January, when the parties agreed to allow Actavis to introduce a generic version in 2029.
Patents Expire in 2033
The patents-in-suit, U.S. Patent Nos. 9,265,760 and 9,339,499, were invalid because all of the patent claims Pernix asserted were obvious, Judge William C. Bryson said. Obviousness is when an invention would have been apparent to someone experienced in the technology at the time.
The patents expire in 2033. The patents’ claims are directed to methods of treating pain in patients with hepatic impairment, or compromised liver function. The invention encompasses extended-release hydrocodone that allows it to be prescribed for patients with or without the condition.
The claims were also invalid because they didn’t adequately describe the covered inventions, Bryson said. Under the patent laws, patents must clearly describe the full scope of an invention to be valid.
Pernix is based in Morristown, N.J. Alvogen is based in Malta and has an office in Pine Brook, N.J., that manages operations in the Americas.
Bryson is a senior U.S. Circuit Judge of the U.S. Court of Appeals for the Federal Circuit who sat in to hear the case in the U.S. District Court for the District of Delaware.
Fitzpatrick, Cella, Harper & Scinto and McCarter & English LLP represented Pernix. Axinn, Veltrop & Harkrider LLP and Shaw Keller LLP represented Alvogen.
The case is Pernix Ireland Pain DAC v. Alvogen Malta Operations Ltd., D. Del., 16-139-WCB, 8/24/18.