As biosimilar litigation between Amgen, the maker of
Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM
(etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District
of New Jersey, Sandoz is seeking to stave off Amgen’s infringement claims for
three of the patents in suit by pointing to its recent amendment to the Erelzi
label, which “carves out” certain treatment indications listed on the Enbrel
reference label and, Sandoz argues, moots any claim that Erelzi infringes
Amgen’s patents covering the use of etanercept to treat those conditions.
The active ingredient in Enbrel, etanercept, is a
fusion protein consisting of a portion of the tumor necrosis factor receptor
(TNFR) linked to an Fc (a portion of an antibody) that binds to TNF molecules
and inhibits their binding to cell-surface TNF receptors. In doing so,
etanercept helps regulate immune responses and inflammation in the body. FDA
approved Enbrel for the treatment of five autoimmune and inflammatory
disorders: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,
psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
In September 2015, Sandoz filed an abbreviated
Biologics License Application (“aBLA”) seeking authorization from FDA to market
Erelzi, an Enbrel biosimilar. At the time, Sandoz sought approval for all of
the indications included in the reference product label. In August 2016, FDA
approved the biosimilar Erelzi for all five indications. Sandoz has not yet
launched Erelzi, however, due to the ongoing patent litigation with Amgen.
In February 2016, while Erelzi’s approval had been
pending, Amgen sued Sandoz under the BPCIA, claiming that Sandoz’s aBLA
infringed five patents covering Enbrel, its manufacture, and certain
therapeutic uses of etanercept. But in the middle of the litigation, Sandoz
returned to FDA to seek approval for an amended biosimilar label carving out
indications for the treatment of psoriatic conditions—methods covered by three
of the patents asserted by Sandoz. FDA approved the request in January 2018.
Meanwhile, in December 2017, Amgen moved for
summary judgment on
infringement of one of its psoriasis patents on the basis of Sandoz’s original
biosimilar label, and Sandoz responded by arguing that the label carve-out mooted Amgen’s
infringement claim. In a letter to Judge Cecchi following FDA’s approval of the
amended label, Sandoz argued that the amendment “effectively eliminates”
Amgen’s psoriasis patents from the case and thus moots Amgen’s pending summary
judgment motion. According to Sandoz, Amgen’s summary judgment motion “relies
exclusively on allegations of infringement on a Sandoz label—a label Sandoz has
not been seeking to use since July 2017 and is indeed no longer able to use for
launch as it is not the approved label for Sandoz’s product.” Therefore, Sandoz
continued, “there is no longer a live controversy surrounding [Erelzi’s]
pre-amendment label.”
In a letter
response filed the
same day, Amgen referred the court to arguments made in its summary
judgment reply brief, which, according to Amgen, “squarely and
systematically refute[]” Sandoz’s position that a label carve-out moots Amgen’s
claims. Although Amgen’s summary judgment reply brief is heavily redacted, the
gist of the argument appears to be that Sandoz has already committed an act of
infringement under Section 271(e)(2)(C) by filing its aBLA, which “cannot be
retroactively undone” by later carving out indications from the label. Amgen
also appears to suggest that Sandoz’s biosimilar may in fact be prescribed as a
psoriasis treatment notwithstanding the label carve-out, latching onto FDA’s
statement that there was “scientific justification for extrapolating
conclusions of biosimilarity to additional indications that had not been
studied.” According to Amgen, FDA “published to the physician and patient
community” its conclusion that Sandoz’s product was biosimilar to Enbrel and
could be used to treat the same indications.
In late-April, Sandoz filed a supplemental
brief in
opposition to Amgen’s summary judgment motion, in which Sandoz reiterated the
argument that its label carve-out “render[s] infringement of the Asserted Claim
an impossibility.” Sandoz argues that Amgen is not permitted to sell a product
with the pre-amendment label, and thus there is no reasonable expectation that
infringement under § 271(a), (b), or (c) will occur. Sandoz further refutes as
a hypothetical “what-if” Amgen’s argument that the biosimilar maker could ask
FDA to re-approve the old label.
Amgen’s summary judgment motion remains pending as the
parties inch closer to trial, now scheduled to begin in September 2018.
Although the motion only involves one of the claimed patents, Sandoz has made
clear that the reasons supporting denial of the motion also support
noninfringement of each of the three psoriasis patents. Judge Cecchi’s decision
on the role of label carve-outs would be a first, and may have important
implications for innovators and biosimilar makes alike in biosimilar
litigation. In particular, the decision will address the role of carve-outs in
cases involving alleged infringement of innovators’ method of treatment
patents.
The case is captioned Immunex Corp.
et al. v. Sandoz Inc. et al., No. 16-cv-1118(CCC)(MF) (D.N.J.).
Blog Biologics, Patterson Belknap Webb & Tyler LLP
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