In the latest lawsuit under the Biologics Price Competition and
Innovation Act ("BPCIA"), Immunex, Amgen, and Hoffman-La
Roche filed a complaint on February 26, 2016, based on Sandoz's
application for FDA approval to market a biosimilar version of the
drug product Enbrel® (etanercept). The complaint alleges that
Sandoz's proposed biosimilar will infringe five patents.
According to The Wall Street Journal, U.S. sales of
Enbrel® were $5.1 billion in 2015, so the stakes in this case
are high.
Enacted in 2010, the BPCIA established "an abbreviated pathway
for regulatory approval of follow-on biological products that are
highly similar" to a previously approved biologic product.
This process allows a biosimilar or interchangeable product to be
approved using clinical data that was produced and obtained by the
sponsor of the approved reference product ("reference product
sponsor" or "RPS"). In exchange, the RPS is granted
12 years of regulatory exclusivity and "the right to file
infringement suits based on a biosimilar application prior to FDA
approval and prior to marketing of the biological
product.''
Under what has come to be known as the BPCIA's "patent
dance," an abbreviated Biologics License Application
("aBLA") filer provides the RPS with a copy of the aBLA
and information about the product's manufacturing. The parties
next exchange lists of patents they believe may be infringed by the
biosimilar product. The RPS then has 30 days within which to file a
patent infringement action on the listed patents.
In this latest case, Immunex, Amgen, and Hoffman-La Roche own or
license five patents directed to etanercept, the active ingredient
of Enbrel®. As explained in the complaint, tumor necrosis
factor ("TNF") is a cell signaling protein that is
involved in various biological effects, and overproduction of TNF
in the body is implicated in various autoimmune diseases and other
inflammatory disorders. Etanercept is a "non-naturally
occurring fusion protein" that was "genetically
engineered to fuse the extracellular region of the human p75
version of the TNF receptor with a portion of a human
immunoglobulin heavy chain (i.e., a portion of a human
antibody)." Etanercept "binds to and inhibits TNF from
binding to a TNF receptor" and "can reduce certain
inflammatory responses implicated in certain disorders." The
FDA has approved Enbrel® for treatment of "rheumatoid
arthritis, polyarticular juvenile idiopathic arthritis, psoriatic
arthritis, ankylosing spondylitis, and plaque psoriasis." The
five asserted patents are alleged to cover etanercept, its method
of manufacture, certain materials used in its manufacture, and
certain therapeutic uses of etanercept.
Procedurally, the FDA accepted Sandoz's aBLA for etanercept on
September 29, 2015, but has not yet approved the application. The
plaintiffs allege that: (i) Sandoz's filing of the aBLA was an
act of infringement under 35 U.S.C. §271(e)(2)(C) as provided
under the BPCIA; and (ii) if the FDA eventually approves the aBLA,
Sandoz's commercial marketing of the proposed biosimilar will
constitute infringement under §§271(a), (b), or
(g).
The complaint describes the kind of pre-filing procedural
skirmishes that have been common in BPCIA disputes, and it raises
the question of whether parties must carry out all phases of the
"patent dance" where there is early agreement as to which
patents are relevant to an infringement lawsuit. The complaint
alleges that, shortly after its aBLA was accepted by the FDA,
Sandoz provided Immunex with access to its aBLA and manufacturing
information, albeit with additional confidentiality designations
and in a manner difficult to access. In response, Immunex provided,
under 42 U.S.C. §262(3)(A), "a list of patents for which
a claim of infringement could be reasonably asserted based on
[Sandoz's] etanercept product." Sandoz agreed to
Immunex's patent list and provided contentions under §
262(l)(3)(B).
At this point, plaintiffs allege, Sandoz refused to participate in
the patent resolution negotiation portion of the "patent
dance" set forth in § 262(l)(4), and by extension §
262(l)(5), which provides a procedure for failed negotiations under
§ 262(l)(4). The plaintiffs state that Sandoz's alleged
refusal to negotiate the (seemingly agreed) patent list
"extinguish[ed] Immunex's ability to consider and respond
to Sandoz regarding the patents that Immunex had properly
identified." Accordingly, the plaintiffs contend, under §
262(l)(9), that the plaintiffs are entitled to bring a declaratory
judgment action relating to Sandoz's aBLA, but Sandoz is
precluded from doing so.
Of interest, Sandoz earlier filed a declaratory judgment action
seeking to invalidate two of the five patents asserted in this
case. Sandoz had filed that action before submitting its biosimilar
application to the FDA. The district court dismissed Sandoz's
declaratory judgment claim as premature before the filing of any
aBLA with the FDA, and the Federal Circuit affirmed,
"concluding that Sandoz did not allege an injury of such
immediacy and reality to create subject matter
jurisdiction."
Also, interestingly, one of the asserted patents in this case is
the subject of a pending petition for inter partes review
("IPR") filed by Kyle Bass, Erich Spangenberg, and the
Coalition for Affordable Drugs. The parties have completed their
initial submissions in that IPR, and the Patent Trial and Appeal
Board is expected to issue a decision whether or not to institute
the IPR shortly.
The current district court case is pending in the Newark division
in the District of New Jersey (Civil Action No. 16-cv-01118) and
has been assigned to Judge Claire C. Cecchi and Magistrate Judge
James B. Clark. Judge Cecchi is one of the designated Patent Pilot
Program judges in the District of New Jersey. Congress established
the Patent Pilot Program in 2011 to "encourage enhancement of
expertise" in patent cases among district judges. The program
directs patent cases to specific judges who volunteer to become
"pilot judges."
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