Source: http://www.fdalawblog.net/2018/04/multiple-interim-patent-term-extensions-revisited-and-the-rule-of-three/
Timestamp: 2019-04-20 12:20:17+00:00

Document:
Fast-forward to 2018. . . .
The calls we received were the result of the PTO’s March 27, 2018 decisions to grant an interim PTE for each of U.S. Patent Nos. 7,619,001 (“the ‘001 patent”), 7,803,840 (“the ‘840 patent”), 7,320,999 (“the ‘999 patent”), and 6,509,376 (“the ‘376 patent”). These patents are listed in the Orange Book for the blockbuster drug TECFIDERA (dimethyl fumarate) delayed-release capsules, 120 mg and 240 mg (NDA 204063; approved on March 27, 2013) with either an April 1, 2019 expiration date (the ‘376, ‘001, and ‘840 patents) or an October 20, 2019 expiration date (the ‘999 patent); however, that’s with the one-year interim PTE period added. With about 25 ANDA first-filers, and one subsequent filer who has sued over a late filing (see here), interest in TECFIDERA and its patents is pretty high.
That raises a few questions: (1) Are the TECFIDERA interim PTEs precedent-setting?; (2) Does the PTO view multiple interim PTEs under 35 U.S.C. § 156(e)(2) differently than interim multiple PTEs under 35 U.S.C. § 156(d)(5)?; and (3) If not, then was the SURFAXIN case wrongly decided? We address these questions below.
Interim PTEs granted in May 2017 for U.S. Patent Nos. 5,792,795 and 5,948,818 for EPANOVA (omega-3-carboxylic acids).
None of these recent instances provide any insight into when or why the PTO considered multiple interim PTEs under 35 U.S.C. § 156(e)(2). So we scoured patent image file wrappers on Public PAIR. Finally, we came upon what we think is the source of the PTO’s decision to grant multiple PTEs under 35 U.S.C. § 156(e)(2) . . . and perhaps justification for multiple PTEs under 35 U.S.C. § 156(d)(5) and overturning the PTO’s SURFAXIN multiple interim PTE denial.
On July 9, 2014, the PTO granted an interim PTE for U.S. Patent No. 5,693,326 (“the ‘326 patent”) covering the licensed vaccine MENHIBRIX (PSC-TT, PSY-TT and PRP-TT) (BLA 125363; initially licensed on June 14, 2012). Two PTE requests were submitted to the PTO with respect to patents covering MENHIBRIX: a request for interim extension of the ‘326 patent (following the initial PTE request) under 35 U.S.C. § 156(e)(2), and a “regular” PTE request for U.S. Patent No. 5,955,079 (“the ‘079 patent”). Although the patent owner, the Henry M. Jackson Foundation for the Advancement of Military Medicine (“Foundation”), ultimately elected a PTE for the ‘079 patent, the PTO’s consideration (and subsequent grant) of the patent owner’s request for an interim PTE for the ‘326 patent seems to be the basis for the PTO’s subsequent decisions granting multiple interim PTEs under 35 U.S.C. § 156(e)(2).
The Foundation calls the attention of the Office to the concurrently-filed application for extension of the patent term of U.S. Patent No. 5,955,079 (“the ‘079 patent”). Although both the ‘326 and ‘079 applications for patent term extension rely on the same regulatory review period for MENHIBRIX, the Foundation believes that this should not be a barrier to interim extension of the ‘326 patent under 35 U.S.C. § 156(d)(5). The limitation in § 156 regarding the extension of one patent per regulatory review period applies only to final extensions under § 156(e)(1) and not interim extensions under § 156(d)(5).
The rationale proffered by the Foundation also seems to apply to interim PTEs requested under 35 U.S.C. § 156(d)(5), thus calling into question whether the PTO would decide the SURFAXIN multiple interim PTE request differently today. Time will almost certainly resolve the matter, and perhaps we will be blogging on the topic again in another 10 years.

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