The Hatch-Waxman Act allows patent owners to extend their patent term due to delays from premarket regulatory review, addressing distortions caused by patent expiration.
Nonstatutory obviousness-type double patenting does not invalidate patent term extensions granted under 35 U.S.C. 156 if the claims remain valid before PTE expiration.
The first distortion addressed by Hatch-Waxman is the inability for competitors to enter the market post-patent expiration without prior FDA approval or testing.
The second distortion involves the patent owner losing valuable patent term during the initial years due to regulatory delays in obtaining FDA approval.
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