McDermott Wins Reversal on Galderma Anti-Acne Patent

, The Litigation Daily


Galderma SA's monopoly on its brand-name acne treatment Differin Gel 0.3% went up in smoke on Wednesday, when the generic drug company Tolmar Inc. and its lawyers at McDermott Will & Emery persuaded the U.S. Court of Appeals for the Federal Circuit to invalidate Galderma's patents.

In a 2-1 decision, the Federal Circuit panel ruled that Galderma's four patents on Differin 0.3% are invalid on obviousness grounds. The ruling overturns a prior decision by U.S. District Judge Leonard Stark in Wilmington, Del. Tolmar and its corporate partner Sandoz Inc. are free to sell a generic version of Differin 0.3%, which has generated close to $100 million in annual sales for Galderma.

McDermott Will partner Thomas Steindler represented Tolmar at oral argument, squaring off against Galderma lawyer Charles Lipsey of Finnegan, Henderson, Farabow, Garrett & Dunner.

Way back in 1996, Galderma obtained regulatory approval to sell an acne treatment called Differin Gel 0.1%, which contains 0.1 percent of a chemical compound called adapalene. With its patents on that drug nearing expiration, Galderma filed patents on Differin Gel 0.3%, which -- no shock here -- contains a higher dose of adapalene. Tolmar sought to invalidate Galderma's new batch of patents, arguing that they are obvious in light of Galderma's earlier Differin patents.

While Differin Gel 0.3% wasn't exactly a scientific breakthrough, Stark decided in to uphold Galderma's patents on the drug in a September 2012 decision. The drug represented an innovation, Stark wrote, because at the time of its patenting scientists believed that a 0.3% dose of adapalene would cause less-than-ideal side effects.

In Wednesday's decision, the Federal Circuit concluded that Stark got it wrong. "Tolmar presented an obviousness case that is both straightforward and potent," Circuit Judge Sharon Prost wrote on behalf of the two-judge majority.

The decision drew a dissent from from Judge Pauline Newman, who wrote that her colleagues "foreclose patentability to a vast body of improvement patents." She added that "the losers are those afflicted by disease."

McDermott's Steindler declined to comment. Finnegan's Lipsey was not immediately available for comment.

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