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
The At-Risk Launch Damages Model Still Runs on 2015 Math
On September 12, 2025, a Delaware jury awarded Mallinckrodt Pharmaceuticals roughly $9.5 million against Airgas Healthcare for infringing patents covering
The At-Risk Launch Damages Model Still Runs on 2015 Math Read Post »
The Cell Therapy Manufacturing Patent Nobody Budgets For Until the CDMO Contract Falls Through
In January 2022, Lonza Walkersville and its joint-venture partner Octane Biotech sued Miltenyi Biotec in the District of Maryland, alleging
The Double Patenting Defense That Nearly Erased Tamiflu’s Last Patent
On April 22, 2014, the Federal Circuit vacated a patent infringement judgment that Gilead Sciences had already won. The drug
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mRNA Platform Patents Are Colliding. Here Is What That Means For The Next Filer
Nine separate patent holders have asserted rights against a single COVID-19 vaccine, Comirnaty, since August 2022. Two more have asserted
mRNA Platform Patents Are Colliding. Here Is What That Means For The Next Filer Read Post »
Bio-Betters Aren’t a Biosimilar Defense — They’re an Admission the Original Patent Wasn’t Strong Enough
On August 18, 2023, the FDA approved Eylea HD, Regeneron’s 8 mg reformulation of its blockbuster eye drug aflibercept. Nine
