“When is a reissue patent ‘issued’ for purposes of calculating a patent term extension under 35 U.S.C. § 156?”
“The sole issue on appeal is whether PTE for a reissued patent should be calculated based on the issue date of the original patent or the reissued patent; in other words, whether the reference to ‘the patent’ in subsection 156(c) is to the original patent or the reissued patent. Using the issue date of the reissued patent would usually result in shorter PTE because review that occurs before the issue date does not affect PTE because review that occurs before the issue date does not affect PTE. . . . The only construction that comports with the purpose of the Hatch-Waxman Act is one that extends PTE to patent owners who were actually disabled from benefiting from patent protection during the pendency of regulatory review. We thus conclude that, in the context of reissued patents, ‘the patent’ in subsection 156(c) refers to the original patent. A reissued patent is entitled to PTE based on the original patent’s issue date where, as here, the original patent included the same claims directed to a drug product subject to FDA review.”
