It’s Been One of “Those Weeks” in Hatch-Waxman World: Another Two Lawsuits and Two Court Decisions

By Kurt R. Karst –      

There’s no rest for the weary!  There certainly hasn’t been much rest for FDA’s litigation team this past week . . . . and it’s not getting any better.  The week started off quiet (though clearly anxiety was in the air), as folks awaited FDA’s decision on whether or not to approve generic versions of Otsuka Pharmaceutical Co.’s  blockbuster drug ABILIFY (aripiprazole) with labeling that omits certain information protected by orphan drug exclusivity.  But that was the end of the quiet.

Late Monday, the first lawsuit dropped.  Spectrum Pharmaceuticals, Inc. (“Spectrum”) filed a Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction challenging FDA’s February 24, 2015 denial of a Citizen Petition (Docket No. FDA-2014-P-1649) and March 9, 2015 approval of an ANDA for a a generic version of FUSILEV (levoleucovorin) for Injection with labeling that omits certain information protected by orphan drug exclusivity. 

On Tuesday, FDA handed down its Aripiprazole Letter Decision and announced (around 1:30 PM) that the Agency had approved ANDAs.  That reignited a legal battle that had been brewing for the past month (see our previous post here), as well as Otsuka’s Motion for Temporary Restraining Order and/or Preliminary Injunction.  Later that afternoon, the parties convened in the U.S. District Court for the District of Maryland before Judge George J. Hazel, who indicated he would rule promptly on Otsuka’s Motion for Temporary Restraining Order and/or Preliminary Injunction.

On Wednesday morning, the U.S. District Court for the District of Columbia heard Oral Argument on Spectrum’s challenge to generic FUSILEV approval.  Judge Royce C. Lamberth quickly denied Spectrum’s request for a Temporary Restraining Order, and scheduled a Preliminary Injunction Hearing for May 18, 2015.  On Wednesday evening, Judge Hazel denied Otsuka’s Motion for Temporary Restraining Order and/or Preliminary Injunction. 

We were hopeful that Thursday would be a day of rest.  Fat chance!  The “rule of three” came into play. . . .

On Thursday morning, we learned that late on Wednesday, Boehringer Ingelheim Pharma GmbH & Co. KG and Boehringer Ingelheim Pharmaceuticals, Inc. (collectively “Boehringer”) filed a Complaint in the U.S. District Court for the District of Columbia alleging that FDA and the U.S. Patent and Trademark Office (“PTO”) shorted by about two months a Patent Term Extension (“PTE”) for a patent – U.S. Patent No. 6,087,380 (“the ‘380 patent) – covering Boehringer’s PRADAXA (dabigatran etexilate) Capsules approved under NDA 022512. 

In February 2015, we posted on FDA’s PTE regulatory review period decision.  In short, as explaind in the operative Federal Register notice:

[Boehringer] claims December 15, 2009, as the date the new drug application (NDA) for PRADAXA (NDA 22–512) was initially submitted.  However, FDA records indicate that NDA 22–512, received December 15, 2009, was incomplete.  FDA refused to file this application and notified the applicant of this fact by letter dated February 12, 2010.  The completed NDA was then submitted on April 19, 2010, which is considered to be the NDA initially submitted date.

Boehringer alleges in its Complaint that FDA violated the Administrative Procedure Act when the Agency unlawfully relied on the NDA “filing” standard instead of an “initially submitted” standard in the Agency’s calculation of PTE for the ‘380 patent.  Specifically, Boehringer says that:

The PTE statute unambiguously states that the approval phase begins when a marketing application is “initially submitted” to FDA. An application is “initially submitted” when it “contains sufficient information to allow FDA to commence review.”  21 C.F.R. § 60.22(f).  The PRADAXA® application was “initially submitted” to FDA no later than December 15, 2009, when BIPI submitted the final elements of the application.  At this point, all of the required elements of the PRADAXA® application were submitted, and the application contained sufficient information for FDA to commence review.  FDA was actively reviewing the application, and it continued to do so thereafter, even after FDA issued the RTF Letter.

In addition, Boehringer alleges that FDA’s action cannot be squared with past Agency practice, saying that “[t]he agency previously has explained that once review has commenced, the approval phase is triggered; FDA cannot thereafter revert back to the testing phase.”   Boehringer cites a 1985 notice (50 Fed. Reg. 19,809 (May 10, 1985)) providing FDA’s PTE regulatory review determination for Tonocard Tablets to support that contention. 

What will next week bring (or Friday, May 1st for that matter)?  Who knows, but it will be difficult to top this week.