No Generic Waiting in the Wings: Why the Gene Therapy Patent Cliff Isn’t a Small-Molecule Patent Cliff
Casgevy lists for $2.2 million a dose. Lyfgenia lists for $3.1 million. Lenmeldy launched at roughly $4.25 million, the highest
The First Filer Doesn’t Always Keep the 180 Days: The Forfeiture Triggers Nobody Tracks
On August 25, 2026, the D.C. Circuit told the FDA it had been reading its own forfeiture statute wrong for
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The PTAB’s Pharma Paradox: Why Drug-Patent Denials Are Rising Even as the Topline Number Holds
On July 24, 2025, the Acting Director of the U.S. Patent and Trademark Office denied two of Amgen’s three petitions
The Trial You Win Can Still Break Your Balance Sheet: What 15 Years of Latisse Litigation Teaches Generic Drugmakers
The Short Answer A courtroom win in Hatch-Waxman litigation only resolves the specific patent claims that went to trial. It
The File Wrapper Problem: Why “We’ll Settle Before Trial” Stops Working Once Someone Reads Your Prosecution History
On May 13, 2026, the Federal Circuit closed out a patent fight that had already run for more than six
The Next Patent Cliff Isn’t Small Molecules — It’s the First Wave of Approved Cell and Gene Therapies
Zolgensma’s seven-year orphan drug exclusivity expired in May 2026. Novartis has faced this moment for a year without a single
Stop Budgeting for Generic Entry as a Single Date: Multi-Source Entry Happens in Waves
Ranbaxy launched generic Lipitor on November 30, 2011. Pfizer’s exclusivity ended that day. If a payer or brand team modeled
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The Three-Year Explosion: Why “File Early, File Often” Bankrupts Small IP Budgets
USPTO maintenance fees on a single utility patent jump from $2,150 to $4,040 to $8,280 across three fixed windows for
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Your Litigation Budget Assumes One Case. Most Blockbusters Draw Five to Fifteen Simultaneous Challengers
In February, March, and April 2017, twenty-five generic drug companies sent Bristol-Myers Squibb and Pfizer formal notice that they had
