|
In
This Issue:
· Amgen
v. Sandoz:
Federal Circuit’s December Ruling is Second Big Win for Biosimilar Applicants
· Merck’s Invanz®
Patent Claims Held
Obvious Despite Commercial Success, Copying
· New USPTO Director Nomination Approved
by Senate Judiciary Committee
Contact Us:
Walter
Schlapkohl, Ph.D., Esq.
wschlapkohl@gbpatent.com
703-716-1191 (phone)
703-716-1180 (fax)
|
BPCIA
Supersedes State Law – Federal Circuit Rules
On December
14, 2017, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit)
ruled in Amgen Inc. v. Sandoz Inc.
(2015-1499) that the Biologics Price Competition and Innovation Act (BPCIA),
which provides a regulatory and legal framework for the approval of
biosimilars, supersedes state law claims.
The ruling was the second victory for Sandoz in this case and a big
win for biosimilar applicants in general who may now proceed to opt out of
the BPCIA’s “patent dance” without fear of facing state law claims.
As we
previously reported, Amgen sued Sandoz for patent infringement after Sandoz
refused to provide Amgen with information regarding the manufacturing
information for its biosimilar Zarxio® (filgrastim-sndz). As
part of this suit, Amgen also claimed that Sandoz’s refusal to provide
information regarding its biosimilar and participate in the patent dance
constituted “unlawful” conduct that violated California’s unfair competition
law.
In the
first big win for biosimilar applicants, the Supreme Court held in June 2016 that
courts could not require a biosimilar applicant to engage in the “patent
dance.” The Supreme Court also held
that biosimilar applicants may provide notice of commercial marketing to a
reference product sponsor at any time before FDA’s decision to license the
biosimilar. However, with regard to the state law claims, the Supreme Court
remanded the case to the Federal Circuit with instructions to determine
whether California law would treat non-compliance with the BPCIA as
unlawful. If so, the Supreme Court
further instructed the Federal Circuit to address whether the BPCIA preempts
any additional remedy under state law.
The
Federal Circuit chose to address the preemption question first finding that Amgen’s
state law claims were preempted,
i.e., the BPCIA’s complexity and carefully calibrated scheme for preparing to
adjudicate and then adjudicating biosimilar patent infringement claims left
no room for state-law claims to exist in this “field.” The Federal Circuit also held that the
state law claims conflicted with the BPCIA such that these claims could not
proceed.
The December
ruling regarding state law claims bolsters what the Supreme Court held
earlier this year: i.e., that biosimilar applicants may opt out of the “patent
dance” without facing legal liability other than those expressly set forth in
the BPCIA itself.
Merck’s Invanz® Patent Invalid As Obvious Despite Evidence of Commercial Success and
Copying
In a split ruling on October 26, 2017, the Federal Circuit
held that claims 21-34 of Merck Sharp & Dohme Corp.’s U.S. Patent No.
6,486,150, which covers a process for preparing a stable formulation of
ertapenem (Invanz®), are invalid as obvious over
the prior art.
In May 2014, Hospira informed Merck that it had filed an abbreviated
new drug application (ANDA) seeking approval of a generic version of Merck’s Invanz® antibiotic.
Merck then sued Hospira for infringement of two patents, the first
directed to the antibiotic and the second directed to a process of preparing
a stable formulation of the antibiotic. However, only the ‘150 patent, i.e.,
the process patent, was at-issue in the appeal.
At trial, the U.S. District Court for the District of
Delaware agreed with Hospira that the contested claims of the ‘150 patent were
obvious. As part of its analysis, the District
Court reviewed objective evidence of commercial success and copying proffered
by Merck, and found that while evidence of both commercial success and
copying had been proffered, the evidence did not overcome the “strong prima
facie case of obviousness” made by Hospira.
On appeal, the Federal Circuit affirmed in a split
decision. Although the Federal Circuit
believed that more weight should have been given to the evidence of commercial
success, the majority found that the District Court did not err in concluding
that the evidence of commercial success did not overcome the evidence of
obviousness. With regard to copying, the Federal
Circuit was also not persuaded that Hospira’s attempts at five alternative
formulations to avoid the patented process were sufficient to overcome “the
weight of the competing evidence of obviousness of the claimed process.”
In this regard, the majority (Judges Lourie and Hughes) affirmed
the two-step approach of first deciding whether a prima facie case of obviousness has been made and then deciding
whether the objective considerations are sufficient to rebut the prima facie case.
Judge Newman dissented, noting the need to remedy the
court’s “inconsistent treatment of the procedures and burdens in applying the
evidentiary factors of obviousness” and bring them in line with the precedent
established in Graham v. John Deere Co.,
383 U.S. 1 (1966). According to the
dissent, the four Graham factors, i.e., (1) the scope and content of the
prior art; (2) the differences between the claimed invention and the prior
art; (3) the level of ordinary skill in the field of the invention; and (4)
objective (“secondary”) considerations such as commercial success, failure of
others, and long-felt need, are all to be considered as part of the obviousness
analysis. Judge Newman opined that the
both the District Court and majority improperly consigned the fourth factor
regarding objective considerations to “rebuttal against the other three
factors.”
Patent Office Director Approved by Senate Judiciary
Committee
In a unanimous voice vote, Andrei Iancu’s
nomination to lead the USPTO was approved by the Senate Judiciary Committee
on December 14, 2017.
Mr. Iancu, an intellectual
property litigation attorney, is the managing partner at Irrell
& Manella LLP.
The Judiciary Committee’s approval is an
important step and sets the stage for Mr. Iancu’s
likely confirmation by the full Senate in early 2018.
Mr. Iancu told the Senate Judiciary
Committee that looking at inter partes review (IPR) and post-grant review (PGR) proceedings
would be among his top priorities if confirmed. Mr. Inancu also
indicated that he would, if confirmed, make it a priority to issue further
guidance on Section 101 patent eligibility if such guidance seemed proper.
Currently, Joseph Matal is
performing the functions and duties of the Under Secretary of Commerce for
Intellectual Property and Director of the United States Patent and Trademark
Office.
|
