CSRxP: Myth vs. Fact

Brand name drug manufacturers game the patent system and drug approval process by presenting one narrative to the U.S. Food & Drug Administration (FDA) and another to the U.S. Patent and Trademark Office (USPTO).

While both agencies receive the same core information during the approval process – such as a drug’s composition and chemistry – brand name manufacturers abuse gaps in agency coordination by withholding key information from the USPTO. This deceptive strategy enables Big Pharma to secure secondary patents long after a drug’s original approval, artificially extending its market exclusivity. 

The result is the creation of overlapping or contradictory patents that unfairly prolong a product’s market dominance, blocking biosimilar and generic drugs from market entry, years after the drug’s original patent expired.