In the most recent lawsuit involving the Biologics Price
Competition and Innovation Act ("BPCIA"), Amgen filed a
complaint on March 4, 2016, seeking a declaration that Sandoz has
failed to participate in the BPCIA's information-exchange
provisions and an order compelling Sandoz to do so. Notably, the
complaint does not include a claim for patent infringement based on
Sandoz's application for FDA approval to market a biosimilar
version of the drug product Neulasta®. Rather, the complaint is
self-described as "an action to enforce the
patent-dispute-resolution provisions of the BPCIA." This is a
departure from Amgen's February 26, 2016 complaint against
Sandoz (concerning the immunosuppressant Enbrel®), in which
Amgen alleged similar behavior by Sandoz but brought only claims
for patent infringement.
The BPCIA established a unique and elaborate process for
information exchange between the biosimilar applicant and the
reference product sponsor ("RPS") to resolve patent
disputes. The Federal Circuit summarized the process, which has
become known as the "patent dance," as follows:
Under that process, codified at 42 U.S.C. § 262(l), the biosimilar applicant grants the RPS confidential access to its aBLA [abbreviated Biologics License Application] and the manufacturing information regarding the biosimilar product no later than 20 days after the FDA accepts its application for review. Id. § 262(l)(1)-(2). The parties then exchange lists of patents for which they believe a claim of patent infringement could reasonably be asserted by the RPS, as well as their respective positions on infringement, validity, and enforceability of those patents. Id. § 262(l)(3). Following that exchange, which could take up to six months, the parties negotiate to formulate a list of patents ("listed patents") that would be the subject of an immediate infringement action, id. § 262(l)(4)-(5), and the RPS then sues the biosimilar applicant within 30 days, id. § 262(l)(6). That information exchange and negotiation thus contemplates an immediate infringement action brought by the RPS based only on listed patents.
Amgen Inc. v. Sandoz Inc. In Amgen, the Federal Circuit held that a biosimilar
applicant (Sandoz in that case as well) did not violate the BPCIA
by failing to disclose its application and manufacturing
information as set forth in
§ 262(l)(1)-(2).
The newly filed Amgen complaint raises two related but separate
issues: (i) whether a biosimilar applicant must participate in the
patent selection procedures set forth in
§ 262(l)(4)-(5) after providing the RPS with its
application and manufacturing information, as well as its
contentions as to invalidity, unenforceability, and
noninfringement, and (ii) whether an applicant's decision not
to participate compels the RPS to file a patent infringement
lawsuit under § 262(l)(6) prior to the
negotiation and exchange of patent lists as set forth under
§ 262(l)(4) and, if necessary,
§ 262(l)(5).
Specifically, Amgen has alleged that Sandoz filed an aBLA with the
FDA "in order to obtain approval to commercially manufacture,
use, offer to sell, and sell, and import into the United States the
Sandoz Pegfilgrastim Product, a biosimilar version of
Plaintiffs' NEULASTA® (pegfilgrastim) product."
According to Amgen, "NEULASTA® is indicated to decrease
the incidence of infection in patients receiving myelosuppressive
anti-cancer drugs."
As it did in its Enbrel® complaint, Amgen asserts that Sandoz
engaged in the initial stages of the "patent dance" by
providing Amgen access to documents Sandoz "represented to
constitute its aBLA and information relating to the manufacturing
process for the Sandoz Pegfilgrastim Product." In response,
and pursuant to § 262(l)(3)(A), Amgen provided
Sandoz with a list of two patents (U.S. Patent Nos. 8,940,878 and
5,824,784) "for which it believed a claim of patent
infringement could reasonably be asserted against the Sandoz
Pegfilgrastim Product." In response, Sandoz provided
"contentions that the '878 and '784 patents are
invalid, unenforceable, or will not be infringed by the commercial
marketing of the biological product that is the subject of the
Sandoz aBLA."
Sandoz, however, "also stated that it no longer wished to
follow the strictures of the BPCIA because it effectively had
Plaintiffs' positions pursuant to 42 U.S.C.
§ 262(l)(3)(C)" and that it "was
'waiving' its right to receive Plaintiffs' statement
pursuant to 42 U.S.C. § 262(l)(3)(C), and
declared that negotiations pursuant to 42 U.S.C.
§ 262(l)(4) and (5) [regarding the identity of
patents that would be subject to a patent infringement suit] were
unnecessary." Amgen further alleges that Sandoz "then
insisted that Plaintiffs file an action for patent infringement
pursuant to 42 U.S.C. § 262(l)(6) within 30
days, i.e., by March 4, 2016," and if Plaintiffs did not do
so, then "the penalty for an untimely suit—that the
'sole and exclusive remedy' for any infringement be limited
to a 'reasonable royalty'—applies."
Accordingly, Amgen is seeking a declaration that Sandoz is required
to comply with § 262(l)(4) and (5), that
Sandoz's failure to comply with those provisions "means
there can be no 'immediate patent infringement action'
under 42 U.S.C. § 262(l)(6)," and that
Amgen's "not filing a patent infringement action by March
4, 2016" does not deprive it "of the remedies for
infringement available under 35 U.S.C. § 271(e)(4),
including lost profits damages and injunctive relief." Amgen
did not assert an alternative claim for patent
infringement.
This case highlights yet another dispute between an RPS and a
biosimilar applicant as they navigate through the uncharted waters
of the BPCIA's patent dance. In attempting to forego
Amgen's contentions regarding infringement, validity, and
enforceability under § 262(l)(3) and the
subsequent negotiation over the list of patents to be litigated,
Sandoz is attempting to accelerate the time by which Amgen must
file a patent infringement action by as much as 80 days or more,
which is significant given reports that Neulasta® generates
more than $4 billion in annual revenues.
The current district court case is pending in the Newark division
in the District of New Jersey (Civil Action No. 16-cv-01276) and
has been assigned to Judge Stanley R. Chesler and Magistrate Judge
Cathy L. Waldor. Judge Chesler 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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