As we highlighted yesterday, three cases being argued next month at the Federal Circuit attracted amicus briefs. One of these cases is Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., a patent case. In it, the Federal Circuit will review a district court’s determination that, when calculating a patent term extension for a reissued patent, the U.S. Patent and Trademark Office is statutorily required to base its calculation on the original patent’s issue date and not its reissue date. This is our argument preview.
In its opening brief, Aurobindo Pharma USA argued “[t]his appeal presents a straightforward question of statutory construction: When is a reissue patent ‘issued’?” Moreover, it explained why this question is important: “This answer matters because the Patent Act refers to ‘the date the patent is issued’ to determine a patent term extension (PTE) under 35 U.S.C. § 156(c).” According to Aurobindo Pharma USA, “the ‘issue date’ [is] displayed in bold print on the cover of every certified copy of a patent.” Thus, the issue date of a reissue patent, according to Aurobindo Pharma USA, is the date the reissue patent is “issued.”
Aurobindo Pharma USA criticized the district court for finding that “a reissue patent is not ‘issued’ on the day the PTO issued it” but rather “that a reissue patent ‘inherits’ the issue date of the surrendered patent from which it derived.” Ultimately, Aurobindo Pharma USA argued, “[t]he fact that a reissue patent inherits ‘the unexpired part of the term of the original patent’ does not suggest that the reissue patent inherits the issue date of the original patent.” In addition, Aurobindo Pharma USA argued, “Skidmore deference does not apply here” because “[d]eference has no place at all when, as here, there is no ambiguity in the relevant statutory text.”
In its response brief, Merck Sharp argued “[t]he district court correctly held that patentees can get patent term extension credit regardless of the date the PTO reissues a patent.” It contended “[t]hat holding accords with statutory text, history, and the purpose of patent term extension.” Moreover, Merck Sharp argued, “[t]he PTO’s consistent policy and practice of using the original issue date to calculate patent term extension further support affirmance.”
Merck Sharp argued that Aurobindo’s position “creates statutory anomalies” because such an interpretation “makes the length of patent term extension turn on the arbitrary order in which administrative officials approve pending reissue and regulatory review applications.” According to Merck Sharp, “if reissue and original patents were truly separate,” then “patentees could potentially seek more than one patent term extension on a single patent,” which is a “result Congress expressly barred.”
In its reply brief, Aurobindo Pharma USA maintained its position that the word “issued” has a “readily ascertainable meaning” and that, therefore, 35 U.S.C. § 156(c) has a “plain meaning: The term of a patent may be extended for a time ‘equal to the regulatory review period for the approved product which period occurs after the date the patent is [put forth officially].’” According to Aurobindo Pharma USA, “Congress said PTE must be calculated from ‘the date the patent is issued,’ and the plain meaning of that command must control.”
Aurobindo Pharma USA suggested that “Merck and the Director ask” the Federal Circuit “to supplant the plain text of the statute with the legal fiction that a reissued patent ‘inherits’ the issue date of the original patent that is extinguished upon promulgation of the new patent.” It also argued “the Director fails to demonstrate why the PTO’s vague and ever-changing position” on the treatment of reissue patents “warrants Skidmore deference.”
The Director of the U.S. Patent and Trademark Office filed an amicus brief in support of Merck Sharp and affirmance. According to the brief, “‘the date the patent is issued’ in section § 156(c) for the calculation of the PTE of a reissue patent unambiguously refers to the issue date of the original patent.” The Director maintained that, “[e]ven if the statutory language were ambiguous, this Court should accord the USPTO’s interpretation Skidmore deference.” The brief explained that “[t]he agency’s longstanding and consistent approach to calculating PTE for reissue patents reflects its expertise and a careful consideration of the relevant issues.”
Oral argument is scheduled for Tuesday, February 4. We will keep track of this case and report on any developments.