viernes, 6 de abril de 2018

Multiple Interim Patent Term Extensions Revisited and the Rule of Three

Multiple Interim Patent Term Extensions Revisited and the Rule of Three

Link to FDA Law Blog

Posted: 06 Apr 2018 03:23 AM PDT
By Kurt R. Karst —
The so-called “Rule of Three” is that the first instance of something occurring is chance; the second instance is considered a coincidence; while the third instance is perceived as a pattern. This rule comes into play every so often in this blogger’s practice when I receive calls from different folks asking essentially the same question.  That’s when I know something is amiss.  The most recent occurrence of the “Rule of Three” happened when three different attorneys from different firms asked essentially the same question: “Kurt, is the Patent and Trademark Office’s November 2009 decision denying multiple interim patent term extensions, and that you blogged on in December 2009, still the Office’s position?”

By way of background, there are two types of interim patent extensions under the Patent Term Extension (“PTE”) statute (35 U.S.C. § 156): (1) interim patent extensions granted during the “review phase” of the statutory “regulatory review period” (35 U.S.C. § 156(d)(5)); and (2) interim patent extensions granted during the PTO’s review of an application for a PTE (35 U.S.C. § 156(e)(2)). The PTE statute also states at 35 U.S.C. § 156(c)(4) that “in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product.”

In November 2009, the Patent and Trademark Office (“PTO”) addressed, apparently for the first time, the issue of the availability of multiple interim PTEs based on the same regulatory review period. (The PTO has previously ruled that multiple PTEs are available, under certain circumstances, once a drug product has been approved.)  The interim PTE requests were made under 35 U.S.C. § 156(d)(5) and in the context of patents covering SURFAXIN (lucinactant) Intratracheal Suspension (NDA 021746), which was under review at FDA at the time.  Although the PTO granted an interim PTE for U.S. Patent No. 5,407,914, the Office deniedinterim extensions for U.S. Patent Nos. 5,260,273 and 5,789,381.  According to the PTO:

Based on the language of the statute, as a whole, and the plain meaning of “a patent,” the statute only contemplated that a single patent is entitled to have the term extended for the same (single) regulatory review period. Similarly, the explicit language of section 156(d)(5)(C) makes clear that interim extension is applicable only for “a patent,” stating, “[t]he owner of record of a patent, or its agent, for which an interim extension has been granted under subparagraph (b), may apply for not more than 4 subsequent interim extensions under this paragraph . . . .”

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.

Because TECFIDERA is an approved drug, the PTO’s March 27, 2018 interim PTEs were granted pursuant to 35 U.S.C. § 156(e)(2), not 35 U.S.C. § 156(d)(5). Nevertheless, 35 U.S.C. § 156(e)(2) uses similar “a patent” language when compared to 35 U.S.C. § 156(d)(5).  Specifically, 35 U.S.C. § 156(e)(2) states:

If the term of a patent for which an application has been submitted under subsection (d)(1) would expire before a certificate of extension is issued or denied under paragraph (1) respecting the application, the Director shall extend, until such determination is made, the term of the patent for periods of up to one year if he determines that the patent is eligible for extension.
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.

First, the TECFIDERA interim PTEs are not precedent-setting.  The PTO has previously granted multiple interim PTEs under 35 U.S.C. § 156(e)(2) on several occasions.  These cases include:

  • Interim PTEs granted in February 2016 for U.S. Patent Nos. 7,820,193 and 5,616,608, for ZILVER (PTX drug eluting peripheral stent);
  • Interim PTEs granted in May 2016 and June 2017 for U.S. Patent Nos. 6,180,371, 6,458,563, and 7,560,107 for OBIZUR (Antihemophilic Factor (Recombinant) Porcine Sequence);
  • Interim PTEs granted in February 2017 for U.S. Patent Nos. 6,299,900, 6,818,226, and 6,916,486 for RECUVYRA (fentanyl); and
  • 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 request for interim extension of the ‘326 patent, perhaps referring opaquely to the PTO’s prior SURFAXIN interim PTE decision, states:

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 PTO did not issue a decision documenting the Office’s reason for granting an interim PTE to the ‘326 patent, but the fact that the PTO granted the interim extension in the first place indicates that the Office agreed with the Foundation’s rationale. And the rationale carries over to instances in which multiple interim PTEs are requested under 35 U.S.C. § 156(e)(2).

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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