United States: Federal Circuit Mostly Affirms Suboxone Generics Do Not Infringe Indivior's Patents

Last Updated: July 24 2019
Article by Clyde A. Shuman

The Federal Circuit ruled that generic versions of the opioid addiction treatment Suboxone marketed by Dr. Reddy's and Alvogen do not infringe patents held by Indivior; however, a planned generic by a unit of Teva does infringe. In Indivior Inc. et a. v. Dr. Reddy's Laboratories SA et al., case number 2017-2587, the Court, 2-1, affirmed a series of bench trial ruling from the District of Delaware, allowing Dr. Reddy's and Alvogen to continuing selling their generic Suboxone products, launched months ago. The Court also affirmed a bench trial ruling from the same district court that a planned Suboxone product by Watson (owned by Teva), infringes one of Indivior's patents.

By way of background, Indivior markets and holds the New Drug Application ("NDA") for Suboxone® sublingual film ("Suboxone Film"), an opioid addiction treatment that combines two active ingredients: buprenorphine and naloxone. Suboxone Film is applied below a patient's tongue, where it then rapidly dissolves to release the active ingredients. Suboxone Film was approved by the Food and Drug Administration ("FDA") in 2010, the first such product to gain FDA approval.

According to its annual report, Indivior had total revenue of $1 billion in 2018, most of it in the U.S. and most of that from sales of Suboxone Film. Indivior had predicted that the launch of Suboxone generics would cause "significant market share loss," but this turned out not to be the case.

Several generic drug companies filed Abbreviated New Drug Applications ("ANDAs") to market generic versions of Suboxone Film prior to the expiration of the asserted patents in suit. Indivior brought several actions for patent infringement, asserting a total of four patents.

In one trial, the district court found that Watson infringed Indivior's '514 patent, denying Watson's motion for Rule 59 relief. In a second trial, the district court found that Dr. Reddy's drying process was such that it did not infringe the asserted claims of the '514 patent. The court also found that neither Dr. Reddy's nor Watson infringed the asserted claim of Indivior's '497 patent. Indivior amended the claims of a pending continuation application and filed an infringement suit in the District of New Jersey. On appeal from that court's grant of preliminary injunction, the Federal Circuit held that the New Jersey claims likely were barred by claim preclusion and remanded the case.

In a third trial on Indivior's '514 patent, the Delaware court held that Alvogen's film manufacturing process did not meet the patent's drying limitation and thus did not infringe. Finally, the Delaware court held that Dr. Reddy did not infringe any claims to Indivior's '150 patent.

On appeal, the Federal Circuit affirmed the district court's decisions that Dr. Reddy's and Alvogen do not infringe one of Indivior's patents because their versions of Suboxone Film are dried in a different way than is required by the patent. However, the Court also agreed with the Delaware court that Watson, which did not make the same claim construction argument about how the film is dried that Dr. Reddy's and Alvogen made, does infringe the patent. The Court disagreed that it was "unjust that different generic products will be treated differently depending on how their cases were litigated," saying, "It is neither unusual nor unjust for a party to be bound by its litigation decisions, particularly here where Watson was fully aware of but did not request the claim construction it now seeks."

Dr. Reddy's launched its generic version of Suboxone Film last year following the bench trial in Delaware, but was then sued by Indivior in a the New Jersey case, mentioned above. Dr. Reddy's generic version went back on the market in February after the U.S. Supreme Court refused to review the Federal Circuit's ruling vacating the New Jersey court's preliminary injunction.

Indivior was indicted in April by a federal grand jury in the Western District of Virginia on charges that it made unsubstantiated claims that Suboxone Film was less prone to abuse than cheaper tablet forms of the drug. A trial is set for next year, and with the government seeking $3 billion, triple Indivior's annual revenue.

The Federal Circuit's decision here also comes one day after Reckitt Benckiser, formerly part of Indivior, agreed to pay $1.4 billion to settle a case brought by Department of Justice and the Federal Trade Commission involving similar claims about its marketing of Suboxone.

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