FDA, USPTO Data Show Earlier Small-Molecule Drug Patenting

By Omar Robles and Ji-Won Choi (December 16, 2020, 5:35 PM EST) -- The Drug Price Competition and Patent Term Restoration Act, known as the Hatch-Waxman Act, had a monumental impact on competition between branded and generic small-molecule pharmaceuticals.[1]

As a general matter, the act provided innovators with certain exclusivities that can prevent the approval and sale of generic versions of a drug product that has been approved under a new drug application, or NDA.[2]

However, patents also play a critical role in so-called brand-brand competition, i.e., competition between typically branded, NDA-approved drugs that are indicated for the same condition and that may have the same mechanism of action.[3]

In both circumstances, a patent...

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