FDA Law Blog: No Beginning and No End: A Moment of Zen in the Patent Term Extension World

FDA Law Blog: No Beginning and No End: A Moment of Zen in the Patent Term Extension World

No Beginning and No End: A Moment of Zen in the Patent Term Extension World

Posted: 07 Apr 2015 08:48 AM PDT

By Kurt R. Karst –     

It’s not all that often that we see the Patent and Trademark Office (“PTO”) dismiss or deny a request to extend the term of a patent covering a medical device, though such actions on a Patent Term Extension (“PTE”) request do come up from time to time (see our previous posts here and here).  The PTO’s recent dismissal of a PTE request for U.S. Patent No. 5,762,599 (“the ‘599 patent”) filed by Vesiflo Inc. (“Vesiflo”) and covering the company’s inFlow Intraurethral Valve-Pump and Activator (“inFlow”) device for a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder presents an interesting moment of zen in the PTE world.

The inFlow device was reviewed by FDA through the de novo classification process and is the subject of an October 14, 2014Classification Order, which FDA announced on the same day.  The de novo process, formally known as Evaluation of Automatic Class III Designation, is established by FDC Act § 513(f)(2).  It was added to the statute by the 1997 FDA Modernization Act (“FDAMA”), as modified by the 2012 FDA Safety and Innovation Act (“FDASIA”), to address novel medical devices that lack a predicate device but pose only a low-to-moderate risk, making them ill-suited to the PMA process under FDC Act § 515 (see our previous post here).  Vesiflo utilized the de novo process after a long history of being shut out of other marketing routes for its inFlow device.  As stated by Vesiflo in its PTE application:

[T]he applicant sought FDA approval for over 17 years prior to the De Novo Petition (DEN130044) being granted on October 14, 2014.  Throughout the process, the FDA maintained its stance that the InFlow™ device required § 515 approval and was a class III device.  The initial IDE (G970029) was performed from 1997 to 2000 in accordance with § 515 for a class III device.  The applicant subsequently prepared for submission and attempted to file pre-PMAs under § 515 in 2002 and 2011, an application under § 513(g) in 2005, and an application under § 510(k) in 2006, but the FDA, based on the actions of the Urology Branch Chief Janine Morris, refused to accept of any of the applications.  It was not until 2013 that the FDA changed its stance, when it down-classified the InFlow™ to class II based on its re-examiniation of the safety data from the pivotal (IDE) trial and agreed to accept a submission under §513(g), rather than under § 515 as it had been treated for the prior seventeen years.  Ultimately, DEN 130044 was filed and approved based on the same data from G970029 that was originally submitted in 2002.

Shortly after FDA handed down the October 14, 2014 Classification Order, Vesiflo requested a PTE for the ‘599 patent.  But just a few months later, on March 4, 2015, the PTO dismissed the request, concluding that the ‘599 patent is ineligible for a PTE.

Under the PTE statute at 35 U.S.C. § 156, the owner of record of a patent (or its agent) must submit a PTE request to the PTO “within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use.”  For a medical device, the “regulatory review period” is defined at 35 U.S.C. § 156(g)(3)(B) to be the sum of:

(i) the period beginning on the date a clinical investigation on humans involving the device was begun and ending on the date an application was initially submitted with respect to the device under section 515, and

(ii) the period beginning on the date an application was initially submitted with respect to the device under section 515 and ending on the date such application was approved under such Act or the period beginning on the date a notice of completion of a product development protocol was initially submitted under section 515(f)(5) and ending on the date the protocol was declared completed under section 515(f)(6).

Thus, the definition of “regulatory review period” for a medical device requires that an application for a medical device be submitted under FDC Act § 515 – i.e., a PMA – and also that the PMA be approved.  And that’s where Vesiflo’s troubles began and ended.  According to the PTO’s dismissal decision:

Since no application under section 515 of the FFDCA was filed with FDA, the time period in § 156(g)(3)(B)(i) has not ended.  Turning to the § 156(g)(3)(B)(ii) period, since no application was filed under either 515 or 515(f)(5), the regulatory review specified in § 156(g)(3)(B)(ii) did not begin nor did it end.  Instead, an order under 513(f)(2) of the FFDCA for applicant’s medical device was issued October 14, 2014.  This means that the triggering event in §156(d)(1) has not occurred since the product was not reviewed under “the provision of law”—section 515 of the FFDCA —under which the applicable “regulatory review period” occurred —the regulatory review period as defined in 35 U.S.C. 156(g)(3)(B)(i) and (ii).

Vesiflo’s ineligibility for a PTE also doomed the company’s hopes for an interim PTE, requested pursuant to 35 U.S.C. § 156(e)(2), on the ‘599 patent.  Citing legislative history and the Federal Circuit’s decision in Somerset Pharmaceuticals, Inc. v. Dudas, 500 F.3d 1344 (Fed. Cir. 2007), the PTO concluded that an interim extension cannot be granted if a patent is not eligible for extension under 35 U.S.C. § 156(a).