On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue patents. PTE was established under the Hatch-Waxman Act as a mechanism by which the term of a patent may be extended for up to five years to compensate for delays in obtaining regulatory approval for certain products such as pharmaceuticals and medical devices. PTE therefore can be an important mechanism for extending exclusivity for valuable products in the life sciences. Notably, the amount of PTE available for any given patent depends upon the issue date of the patent, which is the subject that the Court addressed in this decision.
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