September 21, 2017

Recent Cases Provide Hope For Reverse-Payment Defendants

David C. Kully | Charles A. Weiss

The Hatch-Waxman Act sought to encourage the production of low-cost generic drugs by simplifying the process for obtaining FDA approval for the manufacture of generic drugs. However, it has in fact had the effect of harming market competition by leading to a large number of reverse-payment patent settlements, where pharmaceutical patent holders are effectively forced to make payments to generic manufacturers to stay out of their markets. A number of recent decisions appear to indicate that the tides may now be changing in pharmaceutical patent-holders' favor.

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