Awesome Baby; We Love This Game! An Update on Pending Hatch-Waxman and BPCIA Litigation

By Kurt R. Karst –      

Some days we feel like the “Dickie V” (Dick Vitale) of the Hatch-Waxman and Biosimilars worlds – enthusiastically calling play-by-play on litigation and other FDA happenings, just like the Basketball Hall of Fame broadcaster does for college basketball games.  (And while we’re on that topic, this blogger can’t help but express his disappointment in Wisconsin’s loss to Duke in the championship game – Go Badgers!)  But even Dickie V needs a break from the detailed play-by-play once in a while.  And today is our break.  Instead of putting out one of our typically detailed posts, we’re just going to give our readers brief updates on a couple of cases we’ve been following and that we’ve previously detailed.  After all, like Dickie V, who is now 75 years old, we too at the FDA Law Blog are getting old, having just celebrated our 8th anniversary.

First off is Otsuka Pharmaceutical Co., Ltd.’s (“Otsuka”) two-count Complaint and Motion for Summary Judgment filed against FDA in the U.S. District Court for the District of Maryland concerning ABILIFY (aripiprazole).  As we previously reported, Otsuka alleges in Count I that FDA impermissibly broadened a recent supplemental approval for ABILIFY to include treatment of all patients with Tourette’s disorder, instead of treatment of pediatric patients with Tourette’s Disorder.  In Count II, Otsuka alleges that FDA is precluded from approving generic versions of ABILIFY on April 20, 2015 (when a period of pediatric exclusivity associated with U.S. Patent No. 5,006,528 expires) based on FDC Act § 505A(o) (concerning the inclusions and omission of protected pediatric information in generic drug labeling) and the fact that the labeling of ABILIFY is “loaded with pediatric information.” 

In a Motion to Dismiss filed earlier this week, FDA argues that Otsuka’s case is unripe, that the company lacks standing, and that there hasn’t been any final agency action to challenge in the first place.  According to FDA:

FDA has made no determination with respect to the issues raised in Otsuka’s January 21, 2015 letter and, to the extent it ultimately finds it necessary to decide these issues, would only do so if, and when, it approves any generic versions of Abilify.  In order to make any generic Abilify approval decisions, however, the agency may also need to consider other potentially important parts of the regulatory scheme, which Otsuka’s letter does not take into account.  These may include the scope of the permissible difference to the same labeling requirement in the statute (see 21 U.S.C. § 355(j)(2)(A)(v)), regulations (see 21 C.F.R. § 314.94(a)(8)(iv)), and applicable case law, as well as the effect of 21 U.S.C. § 355A(o) on labeling that is protected by both Hatch-Waxman and orphan exclusivity.  FDA may also deem it important to consider arguments potentially raised by generic drug sponsors.

In addition, even when FDA has tentatively approved an ANDA,any number of events may nevertheless prevent or delay final approval (e.g., a pre-approval inspection that reveals manufacturing deficiencies or a change in standards governing impurity are just two examples).  FDA will consider all relevant factors, in making any future decisions on these matters.  However, FDA will make these final determinations at the time that it approves any generic versions of Abilify (and not before).

FDA also makes some hay out of a recent Otsuka Motion to Compel Supplementation of the Administrative Record, saying that the company is attempting to change the action challenged in Count I.  (Later in the day on April 8th, the District Court issued a Memorandum Opinion granting Otsuka's motion.)

Intervenor-Defendants Apotex Inc. and Apotex Corporation, and Teva Pharmaceuticals USA, Inc. take a tack similar to FDA in their combined Motion to Dismiss, but they also address the substantive legal issues raised by Otsuka:

[T]he ultimate question Otsuka’s motion poses is whether FDA has authority to approve ANDAs that carve out the orphan indication for Tourette’s disorder (whether or not the indication includes any reference to a pediatric population).  FDA’s authority to do so is clear. Otsuka’s motion rests on a myopic view of FDA’s authority to approve ANDAs that carve out portions of brand-name drug labeling—a view that is belied by the FDCA as a whole, the Orphan Drug Act, agency regulations entitled to deference, and clear Fourth Circuit authority.  Otsuka’s claims must fail because FDA has authority to approve ANDAs carving out a Tourette’s disorder indication, and that authority is not abrogated or constrained by Section 505A(o).

Other Intervenors-Defendants, Alembic Pharmaceuticals Limited, Alembic Limited, Alembic Global Holdings SA and Alembic Pharmaceuticals, Inc., filed a brief Memorandum opposing Otsuka’s Motion for Summary Judgment.

Second up today is an update on Amgen Inc.’s (“Amgen”) appeal to the U.S. Court of Appeals for the Federal Circuit (Case No. 2015-1499) of a March 2015 decision from the U.S. District Court for the Northern District of California concerning Sandoz Inc.’s  (“Sandoz”) biosimilar version of Amgen’s NEUPOGEN (filgrastim) and the applicability and interpretation of various provisions of the the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).  As we previously reported, the District Court denied Amgen’s Motion for a Preliminary Injunction (as well as an earlier filed Motion for Judgment on the Pleadings or, in the Alternative, Motion for Partial Summary Judgment) and ruled, among other things, that the BPCIA’s “patent dance” procedures are not mandatory for Section 351(k) biosimilar applicants, and that the statutory 180-day notice of first commercial marketing can come well before biosimilar licensure. 

Amgen asked the Federal Circuit for and was granted an expedited briefing schedule, with briefing to be completed by the end of April 2015.  Amgen lays out the company’s arguments in its Opening Brief filed last week, and asks the Federal Circuit to address four issues:

1. Whether the district court erred in holding that, under the [BPCIA], Sandoz . . .may elect not to comply with the requirement that it “shall provide” to Amgen, the reference product sponsor (or, “RPS”), a copy of its biologics license application (“BLA”) and information describing “the process or processes used to manufacture the biological product that is the subject of such application.” 42 U.S.C. § 262(l)(2)(A).

2. Whether the district court erred in holding that Sandoz may comply with the requirement that the Applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k)” by giving notice before the biological product becomes “licensed.” 42 U.S.C. § 262(l)(8)(A).

3. Whether the district court erred in holding that where Sandoz refused to provide its BLA and manufacturing information and provided untimely notice of commercial marketing, Amgen cannot compel Sandoz’s compliance and its sole remedy is a declaratory judgment on patent issues under 42 U.S.C. § 262(l)(9).

4. Whether the district court erred in denying Amgen’s motion for a preliminary injunction based on an erroneous interpretation of the BPCIA and an erroneous finding of no irreparable harm.

Another case raising similar issues is brewing in the U.S. District Court for the District of Massachusetts.  In that case, Janssen Biotech, Inc. (“Janssen”) is challenging Celltrion, Inc.’s and Hospira, Inc.’s biosimilar version of Janssen’s REMICADE (infliximab).  On April 8, 2015, Janssen filed a Motion for Partial Summary Judgment and a Preliminary and Permanent Injunction.