The Gap Between a Defensible Drug Patent and a Listed Patent Is Bigger Than Most Portfolios Admit
The Short Answer A patent’s presence in the FDA Orange Book proves it was submitted and accepted for listing. It […]
One Day Late, Nine Figures Short: What Being the Second First-to-File Actually Costs
The Short Answer: Under FDA’s interpretation of the Hatch-Waxman Act, “first applicant” status on a Paragraph IV certification is determined
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The Three-Year Head Start: How to Spot a Skinny-Label Opportunity Before Anyone Else Reads the Patent
In March 2002, Teva filed an ANDA for generic carvedilol targeting a patent that would not expire for five more
The Myth of the Stable Drug Patent: Why IPRs Change the Game Overnight
On October 31, 2025, the director of the U.S. Patent and Trademark Office denied institution of thirteen inter partes review
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Predictable by Design: How Brands Outmaneuver Your Paragraph IV Strategy
A Paragraph IV certification feels like an ambush when a generic company files it. It rarely is one for the
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The First-Filer’s Trap: Why 180-Day Exclusivity Fails Without a Supply Chain Moat
Ranbaxy won the most valuable prize in generic pharmaceuticals — first-to-file exclusivity on generic Lipitor — while two of its
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Stop Chasing Blockbusters: The High-Margin World of Unloved Orphan Drug Patents
Catalyst Pharmaceuticals sells a drug for Lambert-Eaton myasthenic syndrome, a disease that affects roughly 3 people per million. In the
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Why Your Regulatory Team Needs to Think Like Drug Patent Litigators
On November 7, 2023, the Federal Trade Commission sent warning letters to ten pharmaceutical manufacturers over more than 100 patents
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The Late-Pivot Tax: Why Drug Patent Intelligence Belongs at the Start of R&D, Not the End
Eli Lilly spent fourteen years and four separate Phase 3 populations trying to make solanezumab work, and the compound never
