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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