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30 January 2020AmericasSarah Morgan

Fed Circuit hands win to Galderma in Teva suit

The US Court of Appeals for the Federal Circuit has revived patent infringement litigation brought against Teva by dermatological company Galderma, a former subsidiary of Nestlé Skin Health.

In a non-precedential decision issued yesterday, January 29, the Federal Circuit concluded that a Delaware judge erred in finding that three Galderma patents on Soolantra were invalid as anticipated by an earlier patent.

Galderma, which has formerly been a subsidiary of L'Oreal and then of Nestlé, had filed suit after Teva submitted an Abbreviated New Drug Application in December 2016, seeking approval to market a generic version of anti-rosacea cream Soolantra (ivermectin).

The US District Court for the District of Delaware held a bench trial in June 2019 and concluded that Galderma’s patents (US numbers 9,089,587; 9,233,117; and 9,233,118) were anticipated by US patent number 5,952,372 (McDaniel).

Galderma subsequently filed a notice of appeal and, shortly after, Teva launched its generic drug product.

In response, Galderma filed an emergency motion for a stay pending appeal. The court granted the stay, enjoining Teva from marketing its generic cream. But, after an appeal, the Federal Circuit stayed the district court’s injunction before its recent decision.

Galderma appealed against the district court’s finding of anticipation and, yesterday, the Federal Circuit sided with the dermatology company.

According to Galderma, the district court had erred in by finding the asserted claims anticipated based on disclosures found in two references, in contravention of settled law that anticipation must be based on the disclosure in a single reference.

“Here, the district court erred by finding the asserted claims anticipated by the disclosures of McDaniel and Manetta [another patent], in contravention of settled law,” said the court, adding that the Delaware court’s conclusion that McDaniel discloses the Soolantra formulation “conflates the principles of enablement and anticipation”.

The Federal Circuit reversed and remanded the case for the district court to consider Teva’s remaining invalidity defences.

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More on this story

Americas
17 December 2019   Nestlé Skin Health will not face claims that it misappropriated trade secrets related to a training platform for teaching medical professionals how to perform facial injections, a US court has ruled.
Generics
7 December 2021   Galderma Laboratories has sued Lupin Pharmaceuticals alleging that it plans to manufacture and sell a generic version of Oracea prior to the expiration of key patents.
Big Pharma
29 June 2023   Board did not violate procedure regarding ‘preliminary guidance’ say Federal Circuit judges | Medytox’s substitute claims found to be ‘unpatentable’.