Teva's Actavis again loses bid to invalidate Quillivant ADHD drug patents

REUTERS/Brendan McDermid
  • Tris Pharma accused proposed Actavis generic of infringing patents
  • Federal Circuit upheld patents after second time hearing case

(Reuters) - A U.S. appeals court on Thursday upheld three Tris Pharma Inc patents covering a form of its ADHD drug Quillivant, rejecting a challenge from Teva Pharmaceuticals-owned generic drugmaker Actavis Laboratories FL Inc.

A Delaware federal court found in 2020 that Actavis' proposed generic of Quillivant XR infringed the patents. The U.S. Court of Appeals for the Federal Circuit affirmed the Delaware court's finding that Tris' innovations were patentable and not obvious.

Teva declined to comment. Tris attorney Errol Taylor of Milbank said the company was "pleased" with the decision, which he said "confirms the value of Tris’ unique controlled release drug delivery technology."

New Jersey-based Tris first sued Actavis for patent infringement in Delaware in 2014. The Delaware court initially invalidated the Quillivant patents in 2017.

The Federal Circuit sent the decision back the next year after ruling the court had failed to make "necessary factual findings" or "provide sufficient analysis of the parties' arguments to permit effective appellate review."

After reconsidering the case, the lower court said in 2020 that the patents were valid and that the Actavis generic would infringe. On appeal, Actavis again argued the patents should be canceled because the liquid, extended-release form of Quillivant they covered would have been obvious from combining elements of other ADHD drugs with the same active ingredient with concepts from scientific articles and another patent application.

The Federal Circuit on Thursday rejected Actavis' argument. It said a reasonable person in the field would not have thought to combine those elements to create the drug and expect it to work.

Earlier publications indicated that the patented formulation likely would not work, and previous attempts to make a similar formulation were "robust failures," the Federal Circuit said.

The case is Tris Pharma Inc v. Actavis Laboratories FL Inc, U.S. Court of Appeals for the Federal Circuit, No. 21-1495.

For Tris: Errol Taylor of Milbank

For Actavis: Brian Burgess of Goodwin Procter

Read more:

Actavis seeks to invalidate Tris patents on chewable ADHD drug

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Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets. Reach him at