Courtroom Drama Over NEUPOGEN Biosimilar Spills Over to FDA With the First Petition Accompanied by a 505(q) Certification

November 5, 2014

By Kurt R. Karst –      

Last week when this blogger reported on the lawsuit filed by Amgen, Inc. (“Amgen”) in the U.S. District Court for the Northern District of California alleging that Sandoz Inc. (“Sandoz”), in its efforts to obtain approval of a Section 351(k) application for a biosimilar version of NEUPOGEN (filgrastim), unlawfully refused to follow the patent resolution procedures outlined in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), I had it in the back of my mind that something more might be in the works.  A citizen petition perhaps?  As it turns out, that thought was prescient. 

In an October 29, 2014 Citizen Petition (Docket No. FDA-2014-P-1771), Amgen asks FDA to adopt policies and procedures to require biosimilar applicants – before their applications are accepted for review by FDA – to certify to the Agency that they will comply with PHS Act § 351(l)(2)(A) (42 U.S.C. § 262(l)(2)(A)) by providing the reference product sponsor with a copy of the 351(k) application “and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application” within 20 days after FDA informs the biosimilar applicant that its 351(k) application has been accepted for review.  “This certification should be required for all biosimilar applications that have not been accepted for review by the FDA,” says Amgen. 

According to Amgen, what’s at stake here goes way beyond delays in the initiation of patent infringement litigation – it’s the entire fabric of the BPCIA that is is in jeopardy, including biosimilar exclusivity:

Non-compliance with subsection (l)(2)(A) vitiates the entire scheme that Congress created.  If the biosimilar applicant does not disclose the biosimilar application and manufacturing information, the reference product sponsor may not know that an application referencing its product has been submitted.  Even if the reference product sponsor learns of this filing from other sources (e.g., the press), its ability to identify relevant patents is undermined as it may not have the information describing the biosimilar product and its manufacture necessary for meaningful judicial resolution and that should have been exchanged under subsections (l)(2) through (l)(5).  This, in turn, prevents or delays the initiation of court proceedings to enforce infringed patents.  A patent infringement action commenced by means other than as set out in subsections (l)(2) through (l)(6) also may call into question the biosimilar applicant’s obligation to notify FDA, and public notice via the Federal Register may not result. 

The timely initiation of patent litigation under (l)(6) also affects the Agency’s administration of other portions of BPCIA. Pursuant to subsection (k)(6), the sponsor of the first biosimilar product to be designated an “interchangeable” biosimilar product earns a period of exclusivity that will expire on the earliest of five defined dates . . . .  This exclusivity is implemented by the Secretary withholding designation of another biosimilar product as being “interchangeable” until the expiration of the first of these five periods to occur.

Delays in compliance with subsection (l)(2)(A) will delay commencement of, or possibly even eliminate, litigation under subsection (l)(6).  That, in turn, delays the expiration of the periods specified in subsection (k)(6)(B), rendering those potential expiration dates inapplicable.  That result would frustrate a clearly stated Congressional intent. 

Moreover, writes Amgen, a decision by FDA to stand on the sidelines makes the Agency culpable:

By not implementing measures to ensure timely compliance with the subsection (l)(2)(A) disclosures, FDA is contributing to that uncertainty to the detriment of the legitimate interests of reference product sponsors, subsequent biosimilar applicants who may wish to seek an interchangeability designation, and the public.

The remedy Amgen seeks – a certification of compliance with PHS Act § 351(l)(2)(A) – is well within the Agency’s authority, according to the company.  “FDA has the power to remind parties of existing statutory duties without going through any particular level of formality,” writes Amgen.  “Similarly, FDA has broad authority to determine the manner in which parties present themselves or their viewpoints to the agency.  Thus, either as a matter of interpretative or procedural authority, FDA has the power to require that biosimilar applicants certify compliance with subsection (l)(2)(A).”

Whatever the merits of Amgen’s Citizen Petition, we are eager to find out what FDA thinks.  But it may be some time until the Agency responds to Amgen.  Although the petition includes a certification pursuant to FDC Act § 505(q), we question whether or not FDA will deem Amgen’s petition a “505(q) petition” subject to the statutory 150-day response deadline. 

Briefly, under the version of FDC Act § 505(q) in effect since 2012, FDA cannot delay approval of a pending ANDA, 505(b)(2) application, or 351(k) biosimilar application as the result of a result of a citizen petition submitted to the Agency pursuant to 21 C.F.R. § 10.30 (citizen petition) or § 10.35 (petition for stay of action), unless FDA “determines, upon reviewing the petition, that a delay is necessary to protect the public health.”  (See our previous post here for additional background on FDC Act § 505(q).)  Amgen’s petition, however, does not seem to apply to Sandoz’s 351(k) application.  As noted above, Amgen’s “ask” of FDA is for a certification of compliance with PHS Act § 351(l)(2)(A), but only for “biosimilar applications that have not been accepted for review by the FDA” (emphasis added).  Sandoz’s 351(k) application does not fit the bill because the application was already accepted by FDA.  Unless there is another 351(k) application pending at FDA that could be affected by Amgen’s petition, the Agency might simply put the petition on a backburner and respond at a later date.