Difluprednate – USA

Difluprednate – USA

On Aug 08, 2018, The Federal Circuit in one-liner decision affirmed the Patent Trial and Appeal Board’s decision (IPR2015-01205) to invalidate several claims in a patent covering Alcon Laboratories’ Durezol eye drops.

PTAB on Nov 22, 2016 issued final written decision that the challenged claims are unpatentable. Akorn, Inc. (“Petitioner”) challenged claims 1–4, 6–10, 12–14, and 18 of U.S. Patent No. 6,114,319 under 35 U.S.C. § 103 as being obvious over the combination of the teachings of U.S. Patent 5,556,848 and WO 95/31211 (Ding). The ’319 patent is directed to compositions of difluprednate, a steroid drug that was known to have superior anti-inflammatory action for skin disorders. The inventors of the ’319 patent explain that difluprednate has extremely low solubility in water, making it difficult to prepare a stable eye, nose, or ear drop and resulting in aqueous suspensions that are uncomfortable and delivered unevenly. The inventors solved this problem by preparing a composition of difluprednate as an emulsion with oil, water, and an emulsifier. However, PTAB was persuaded by the evidence presented by Petitioner. Specifically that the ’848 patent shows that difluprednate was a known drug, useful for treating various eye ailments & Ding, that disclosed emulsions as recited in the challenged claims were known for solving the formulation problems of similar steroids in ocular treatments.

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