The $50 Million Notice Letter: What a Bad Paragraph IV Filing Actually Costs a Generic Drugmaker
In 2007, a federal judge in the Southern District of New York ordered two generic drug companies to pay Takeda […]
The Safe Patent Portfolio Trap: Why Minimal Filing Costs Pharma a Decade of Growth
AbbVie’s core patent on Humira, the one covering the adalimumab molecule itself, expired in January 2016. U.S. biosimilars did not
The Safe Patent Portfolio Trap: Why Minimal Filing Costs Pharma a Decade of Growth Read Post »
The At-Risk Launch: When the Math Says Go, Even If the Court Says No
Teva Pharmaceutical Industries paid Pfizer and Takeda $1.6 billion in 2013. Sun Pharma paid another $550 million. The combined $2.15
The At-Risk Launch: When the Math Says Go, Even If the Court Says No Read Post »
Sue Early, Win Big: The Hidden ROI of Challenging Weak Method-of-Use Drug Patents
Every generic and biosimilar developer knows the standard playbook. Wait for the composition-of-matter patent to run out, clear the Orange
Sue Early, Win Big: The Hidden ROI of Challenging Weak Method-of-Use Drug Patents Read Post »
The Evergreening Myth: How to Spot the Cracks in a 20-Patent Thicket
Every generics attorney has heard some version of the same sentence from a nervous client: “They have over a hundred
The Evergreening Myth: How to Spot the Cracks in a 20-Patent Thicket Read Post »
Why Drug Patent Settlement Shouldn’t Be Your Default Strategy: The Math of Winning in Court
Settling a Paragraph IV patent case feels like the safe choice. It ends the uncertainty, it gets a launch date
The 180-Day Exclusivity Trap: Why First-to-File Winners Still Lose Money
A generic company spends four years and fifteen million dollars fighting for the right to be first. It wins. It
The 180-Day Exclusivity Trap: Why First-to-File Winners Still Lose Money Read Post »
Why Device Patents Crack First: The Weakest Wall in Your Drug’s Patent Fortress
EpiPen’s last patent expired on September 11, 2025. Epinephrine has been off patent since the 1980s. For close to two
Why Device Patents Crack First: The Weakest Wall in Your Drug’s Patent Fortress Read Post »
The Salt Change Trap: When a New Patent Buys You Nothing
A drug goes off patent. The originator swaps the salt form, files a new patent, and tells investors the franchise
The Salt Change Trap: When a New Patent Buys You Nothing Read Post »
