The Value Of Prophetic Examples

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops against obviousness, written description, and enablement challenges. I previously wrote about the obviousness analysis. Here, I look at the court's discussion of the written description and enablement issues, and note its citation of prophetic examples.

The Lumigan Patent Claims At Issue

The claims challenged on written description and enablement grounds were claims 1, 7, and 8 of U.S. Patent No. 8,278,353, which recite compositions that achieve clinical paramaters:

1. A first composition administered once daily for lowering intraocular pressure in a person with glaucoma or ocular hypertension, the first composition comprising about 0.01% w/v bimatoprost and about 0.02% w/v benzalkonium chloride, wherein the first composition lowers intraocular pressure and results in less hyperemia as compared to the once daily administration of a second composition comprising 0.03% w/v bimatoprost and 0.005% w/v benzalkonium chloride.

Claim 7 is similar and recites that "the first composition lowers intraocular pressure without a substantial reduction in the intraocular pressure lowering benefit provided by the once daily administration of [the] second composition."

Claim 8 depends from claim 7 and recites that "the once daily administration of the first composition results in less hyperemia as compared to the once daily administration of the second composition."

The defendants challenged the written description and enablement of these claims because the specification "does not disclose any efficacy or hyperemia data of a formulation comprising 0.01% bimatoprost and 200 ppm BAK."

Written Description Of Clinical Parameters Is Met By Disclosure Of A Composition That Inherently Achieves The Results

The Federal Circuit decision was authored by Judge Lourie and joined by Judges Linn and Hughes.

The Federal Circuit rejected the premise of the written description challenge:

The specifications specifically describe a formulation comprising 0.01% bimatoprost and 200 ppm BAK as one of the best modes of the invention. .... 67. The Group II claims all require the same amounts of bimatoprost and BAK. The specifications thus disclose the claimed formulation as characterized by those ingredients, and the skilled artisan would immediately discern the claimed formulation in that...