FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Federal Court Rules Against Sun Pharmaceuticals in Oracea Patent Dispute

Oct. 22, 2019
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A Delaware federal court ruled that Sun Pharmaceuticals’ Oracea (doxycycline) biosimilar infringed upon three Galderma patents on the drug.

Galderma sued the biosimilar developer in 2016 alleging that Sun’s doxycycline hyclate infringed its patents on low-dose formulations of doxycycline with a combination of immediate-release and delayed-release beads. Galderma sought an injunction on Sun’s product.

In its defense, Sun argued that its version of the rosacea treatment — which the FDA tentatively approved in 2017 — did not infringe on the patents because it did not contain the claimed amount of immediate or delayed release formulations, and also that the patents were obvious. The case went to a three-day bench trial in December 2018.

In a Sept. 30 opinion, Judge Leonard Stark found that Sun’s product had the characteristics covered under the patents and that the company failed to prove the patents’ obviousness with “clear and convincing evidence.”

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