Integral to the cautious stability Congress struck when passing the Hatch-Waxman Amendments, the patent time period extension (PTE) is meant to revive patent life that was consumed throughout regulatory overview of an FDA-regulated product. Although the PTE provisions established within the Drug Value Competitors and Patent Restoration Act are forty-plus years previous, courts are nonetheless grappling with questions on easy methods to finest implement the Patent Time period Extension. And simply final week, a brand new query was answered by the Federal Circuit: how is a patent time period extension calculated for a reissued patent? Is it based mostly on the problem date of the unique patent or the reissued patent?
On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (FDA has already been there, in fact, with respect to 180-day exclusivity.) In Merck Sharp & Dohme Corp. v. Aurobindo Pharma, Ltd. et al., the Courtroom appeared on the time period “the patent” within the PTE statute at 35 U.S.C. § 156(c) to evaluate whether or not the regulatory overview interval ought to be calculated utilizing the issuance date of the authentic patent or the reissued patent. The query is necessary as a result of the results of that willpower may drastically scale back the quantity of patent time period to be restored.
Questions of the applicability of the PTE statute to reissued patents arose as a result of Plaintiff-Appellee Merck sought extension of a patent listed within the Orange Guide after approval of its BRIDION (sugammadex), indicated to reverse neuromuscular blockade, that originally was issued in December 2003 however reissued in January 2014 with the unique claims and twelve new claims referring to the drug product. Merck utilized for a patent time period extension on the reissued patent, claiming the beginning of the regulatory overview interval as April 2004 and termination on the approval of the BRIDION NDA in December 2015. With this lengthy regulatory overview interval, the PTO granted the statutory-maximum five-year patent time period extension. This PTE calculation was based mostly on the authentic patent, however generic filers challenged that call, arguing that the issuance date of the reissued patent is the operative date for calculating the regulatory overview interval. Within the generic filers’ view, the regulatory overview interval ought to have began in January 2014 when the patent was reissued somewhat than in April 2004, when the IND was opened, as a result of the reissued patent didn’t exist in April 2004. The plain textual content of 35 U.S.C. § 156(c), the generic filers contended, required the PTO to calculate the regulatory overview interval based mostly on the problem date of “the patent” for which PTE was sought, which, on this case, was the reissued patent. The District Courtroom disagreed with generic filers, discovering that 35 U.S.C. § 156 ought to be learn in mild of the remainder of the statute, and that “the patent” in subsection 156(c) should check with the unique patent somewhat than the reissued patent.
The Federal Circuit upheld the District Courtroom’s place, noting that the language of 35 U.S.C. § 156 “standing alone is ambiguous” and “unclear whether or not ‘the patent’ refers back to the authentic or reissued patent.” So the Federal Circuit appeared on the “the precise context during which that language is used, and the broader context of the statute as a complete.” Particularly, the Courtroom centered on the aim: “to compensate pharmaceutical corporations for the efficient truncation of their patent phrases whereas ready for regulatory approval of recent drug purposes.” The Courtroom thus defined that deciphering “the patent” in 35 U.S.C. § 156(c) is the very best studying, because it “compensates Merck for the interval of exclusivity misplaced as a result of regulatory delay.” The Courtroom continued: “[t]right here isn’t any motive why the Hatch-Waxman Act’s goal could be served by disabling extensions of the unexpired time period solely based mostly on a patent holder’s choice to hunt reissue, and Aurobindo affords none.” Thus, “[t]he solely development that comports with the aim of the Hatch-Waxman Act is one which extends PTE to patent house owners who have been really disabled from benefiting from patent safety through the pendency of regulatory overview.” Accordingly, within the context of reissued patents, “the patent” in subsection 156(c) refers back to the authentic patent based mostly on the aim and context of the PTE provisions.
