Indivior appeal fails to stop generic opioid addiction challenge

The US Court of Appeals for the Federal Circuit has upheld an earlier ruling that Indivior cannot stop two competitors from making a generic version of one of its drugs.

In a 2-1 majority decision on Friday July 12, the Federal Circuit said Dr Reddy’s generic does not infringe two of Indivior’s patents (US numbers 8,603,514 and 8,017,150) relating to Suboxone (buprenorphine), which is used to treat opioid addiction.

The court also found Alvogen’s generic does not infringe the ‘514 patent.

While the court found the patents to not be infringed, in a partial win for Indivior, it upheld the validity of the patents.

In its judgment, the court said Indivior had failed to prove that Dr Reddy’s and Alvogen’s generic used the same processes used in Suboxone. Additionally, it said Dr Reddy’s generic did not use the same polymer covered by Indivior’s patent.

The court’s dissent said Indivior’s patents should have been voided because they describe methods to produce sublingual films that were already known, and therefore obvious.

The ruling comes after Indivior obtained a temporary restraining order against Dr Reddy’s in June 2018.

But, in November, the Federal Circuit vacated the injunction against Dr Reddy’s. The injunction had stopped the India-based company from marketing its Suboxone generic in the US.

Indivior then petitioned the US Supreme Court to vacate the Federal Circuit’s motion, but this was dismissed.

Indivior previously predicted that its loss of market shzare for the drug could be up to 80% “within a matter of months” of generic versions of the drug being released.

The launch of the generic is expected to capture a share of the generic segment and generate net revenues in the tens of millions of dollars, according to the UK-based company.

Suboxone recently made the news after a developer of Suboxone Film, Reckitt Benckiser, entered into a settlement agreement with the US Department of Justice (DOJ) and the Federal Trade Commission (FTC), in which it must pay $1.4 billion.

The resolution came after it was accused of violating antitrust laws through a deceptive scheme to thwart lower-priced generic competition to Suboxone.

Indivior was previously a part of Reckitt Benckiser before it demerged from the company in 2014.

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