Allergan, Inc. v. Sandoz, Inc., No. 14-1275 (Fed. Cir. 2015)
Annotate this CaseGlaucoma is an eye disease associated with elevated intraocular pressure (IOP). Treatments that effectively reduce IOP can slow the progression of the disease. In 2001, the FDA approved Lumigan 0.03%®, a topical solution developed by Allergan, for treating open angle glaucoma and ocular hypertension. Although Lumigan 0.03% was effective at lowering IOP, it also caused frequent, severe hyperemia. Many patients stopped using it without consulting their physicians, causing gradual vision loss. Allergan explored alternative formulations and developed Lumigan® 0.01%, which has a three-fold lower bimatoprost concentration than Lumigan 0.03%, and a four-fold higher concentration of a preservative for inhibiting bacterial growth. In 2010, the FDA approved Allergan’s New Drug Application for Lumigan 0.01% for the same approved uses as Lumigan 0.03%. Allergan’s patents are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as claiming Lumigan 0.01% and its approved uses. Generic manufacturers submitted Abbreviated New Drug Applications to the FDA, for generic versions of Lumigan 0.01% before expiration of the patents. Allergan sued, asserting infringement. The district court held, and the Federal Circuit affirmed that, the patents were not shown to be invalid for obviousness under 35 U.S.C. 103, and that claims of two patents were not shown to be invalid for lack of an adequate written description under 35 U.S.C. 112.
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