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Insite Vision, Inc. v. Sandoz, Inc.

United States Court of Appeals, Federal Circuit

April 9, 2015

INSITE VISION INCORPORATED, INSPIRE PHARMACEUTICALS, INC., PFIZER INC., Plaintiffs-Appellees
v.
SANDOZ, INC., Defendant-Appellant SANDOZ GMBH, SANDOZ INDUSTRIAL PRODUCTS S.A., Defendants

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[Copyrighted Material Omitted]

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Appeal from the United States District Court for the District of New Jersey in No. 3:11-cv-03080-MLC-LHG, Judge Mary L. Cooper.

DOMINICK A. CONDE, Fitzpatrick, Cella, Harper & Scinto, New York, NY, argued for plaintiffs-appellees. Also represented by DAVID E. DE LORENZI, Gibbons P.C., Newark, NJ. Plaintiffs-appellees Inspire Pharmaceuticals, Inc., Pfizer Inc. also represented by MARGARET A. SCOOLIDGE, Fitzpatrick, Cella, Harper & Scinto, New York, NY; DENNIS C. AELING, Costa Mesa, CA.

BRIAN ROBERT MATSUI, Morrison & Foerster LLP, Washington, DC, argued for defendant-appellant. Also represented by DEANNE E. MAYNARD; DAVID CLARENCE DOYLE, JAMES WEBB HUSTON, MARK ANDREW WOODMANSEE, SAN DIEGO, CA; MATTHEW D'AMORE, NEW YORK, NY.

Before PROST, Chief Judge, NEWMAN and LINN, Circuit Judges.

OPINION

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Linn, Circuit Judge.

In this Hatch-Waxman Act litigation, Sandoz, Inc. (" Sandoz" ) appeals the district court's decision in Insite Vision, Inc. v. Sandoz, Inc, No. 11-3080, 2013 WL 5975015 (D.N.J. Oct. 4, 2013), which held that Sandoz had not shown that the claims of U.S. Patents No. 6,861,411 (the " '411 patent" ); No. 6,239,113 (the " '113 patent" ); No. 6,569,443 (the " '443 patent" ); and No. 7,056,893 (the " '893 patent" ) (collectively " the patents-in-suit" ) asserted by Insite Vision, Inc. (" Insite" ); Inspire Pharm., Inc. (" Inspire" ); and Pfizer, Inc. (" Pfizer" ) (collectively " plaintiffs" ) are invalid as obvious. This court agrees that Sandoz failed to show that the asserted claims in the patents-in-suit would have been obvious to a person of ordinary skill in the art and therefore affirms.

I. Background

A. The Patents-in-Suit

The '411 patent issued from U.S. Patent Application No. 09/200,199 (the " '119 application" ), which was filed on November 25, 1998, claiming priority to a provisional application filed on December 2, 1997. It is owned by Pfizer. Insite owns the '113, '443 and '893 patents (the " ISV patents" ). The ISV patents claim priority to an application filed on March 31, 1999. Inspire is the exclusive sub-licensee of the '411 patent and the exclusive licensee of the ISV patents.

The '411 patent discloses methods of treating eye infections by the topical administration of azithromycin to the eye. '411 patent col.1 ll.8-10. The patent states that prior to the invention, azithromycin was commonly administered orally for the treatment of antibacterial infections, but was not known to be effective when topically administered to the eye. Id. at col.1 ll.22-27. Claim 1 of the '411 patent is representative and recites:

1. A method of treating an ocular infection, comprising topically administering to an eye of an animal in need of such treatment an ocular infection-treating amount of azithromycin.

The ISV patents disclose various formulations and methods of using topical azithromycin as a gel eyedrop for treating eye infections. Claim 1 of the '113 patent; claim 16 of the '443 patent; and claim 1 of the '893 patent are representative and recite:

1. A process for treating an eye, which comprises: topically applying an aqueous polymeric suspension of an azalide antibiotic, wherein said suspension comprises water, 0.01% to 1.0% of an azalide

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antibiotic, and 0.1 to 10% of a polymeric suspending agent.

'113 patent claim 1;

16. A topical ophthalmic composition comprising an aqueous polymeric suspension comprising water, 0.01% to 1.0% of an azalide antibiotic and 0.1 to 10% of a polymeric suspending agent, wherein said topical ophthalmic composition has an osmotic pressure of from 10 to 400 mOsM and wherein said composition does not contain constituents that are physiologically or ophthalmically harmful to the eye.

'443 patent claim 16;

1. A composition comprising water, a polymeric suspending agent and an azalide antibiotic, wherein said composition has a pH of about 6.0 to 6.6.

'893 patent claim 1.

B. History of the Dispute

Inspire markets a topical azithromycin solution, which is approved by the Food and Drug Administration (" FDA" ) and is distributed under the name " AzasiteĀ® ." The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the " Orange Book" ) lists all ...


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