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Fish Cases

Innovative Legal Strategies for a Branded Drug

Litigation, Hatch-Waxman, Patent Litigation
United States Court of Appeals for the Federal Circuit

Fish Cases

Innovative Legal Strategies for a Branded Drug

Litigation, Hatch-Waxman, Patent Litigation

United States Court of Appeals for the Federal Circuit
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In a series of cases beginning in 2002, Fish successfully navigated for Allergan a path to lasting exclusivity for its sight-saving glaucoma drug, Alphagan® P 0.1%.These cases culminated when the U.S. Supreme Court denied a petition for a writ of certiorari in in 2012 filed by generic drug maker Apotex. That petition grew out of a trial win by Fish in the District of Delaware in 2009, when that court concluded that five patents protecting Alphagan® P were valid and infringed. The Federal Circuit Court of Appeals affirmed four of the five patent’s validity on appeal.

"Fish’s innovative strategies and aggressive enforcement led the way in protecting the hard-won intellectual property that protects Allergan Alphagan® P 0.1%, which today enjoys market exclusivity until the last of its patents expires in 2022. "

In-Depth

In a series of cases beginning in 2002, Fish successfully navigated for Allergan a path to lasting exclusivity for its sight-saving glaucoma drug, Alphagan® P 0.1%.

These cases culminated when the U.S. Supreme Court denied a petition for a writ of certiorari in in 2012 filed by generic drug maker Apotex.   That petition grew out of a trial win by Fish in the District of Delaware in 2009, when that court concluded that five patents protecting Alphagan® P were valid and infringed.  The Federal Circuit Court of Appeals affirmed four of the five patent’s validity on appeal.

But, even before that, Allergan had tapped Fish to lead the charge on protecting the tens of millions in investment that Alphagan® P represents.   In 2004 through 2006, Fish led a case against generic drug applicant Alcon that culminated in settlement the morning of trial.   The non-confidential portions of settlement resulted in three additional years of exclusivity for Alphagan P 0.15% (until 2009), royalties for Allergan on Alcon’s generic drug sales of Alphagan® P 0.15%, and market exclusivity for Allergan on Alphagan® P 0.1%.

And still earlier, from 2002 to 2003, Fish litigated for Allergan cases and FDA citizen’s petitions involving the predecessor drug to Alphagan® P, Alphagan®.   That case resulted in ground-breaking opinions about the permissible assertion of off-label patents under the Hatch-Waxman Act, something that is still a hot button issue today, over a decade later.

Fish’s innovative strategies and aggressive enforcement led the way in protecting the hard-won intellectual property that protects Allergan Alphagan® P 0.1%, which today enjoys market exclusivity until the last of its patents expires in 2022.