Amneal Swipe at Alkermes’ Opioid Overdose Rx Patent Goes Ahead

The U.S. Patent Trial and Appeal Board agreed Nov. 7 to review whether Alkermes Pharma Ireland Ltd.'s patent on its opioid overdose treatment Vivitrol is valid.

It’s a win for Amneal Pharmaceuticals LLC, which asked the board to take a fresh look at the Vivitrol patent. Amneal established a “reasonable likelihood” it can knock out U.S. Patent 7,919,499 as invalid, PTAB said and instituted a review of the patent.

Amneal hopes to launch a generic version of Vivitrol as early as 2020, when other patents on the drug expire. The ‘499 patent doesn’t expire until October 2029 and covers a method of treating addiction by an injection of long-acting form of naltrexone, the active ingredient in Vivitrol. Because all other patents on the drug expire by 2020, invalidating the later-expiring patent will move Amneal closer to launching a generic version in 2020.

Vivitrol net sales in 2017 totaled $269.3 million. And those numbers are poised to increase: Alkermes said it expects Vivitrol net sales to range from $300 million to $330 million in 2018.

Opioid Epidemic Creating Market

Amneal wants to capture a piece of the huge market for drugs to treat opioid abuse. That market totaled almost $2.8 billion during 12-month period ending in July 2018, according to Symphony Health data reported by Bloomberg Intelligence. And the market is likely growing because of the nationwide opioid epidemic.

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. Naltrexone can suppress withdrawal symptoms and decrease cravings.

The PTAB is set to consider additional arguments from the parties and issue a final decision within a year.

The PTAB launches the review proceedings, called inter partes review, if it determines there’s a reasonable likelihood the patent challenge will succeed.

Amneal says the invention covered by the patent isn’t new and is obvious. An invention isn’t new if others knew about it or used it before the patent applicant claimed it. Obviousness is when an invention would have been apparent to someone experienced in the technology at the time.

The PTAB review process was created by the America Invents Act—passed in 2011 and effective in 2012—to allow challenges of the validity of existing patents. The PTAB was intended to be a way to speed resolution of patent disputes by offering an administrative alternative to lengthy court proceedings. It applies a different standard than courts do when evaluating the validity of patents.

An Alkermes spokesperson told Bloomberg Law the company doesn’t comment on pending litigation. Bloomberg Law contacted Amneal for comment, but no one was available immediately to respond.

Lerner, David, Littenberg, Krumholz & Mentlik LLP represents Amneal.

Paul Hastings LLP represents Alkermes.

The case is Amneal Pharmaceuticals LLC vs. Alkermes Pharma Ireland Ltd., P.T.A.B., No. IPR2018-00943, decision granting institution 11/7/18.