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Greenblum & Bernstein, P.L.C. PHARMA/BIOTECH NEWSLETTER Recent News in Intellectual Property |
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July 2017 |
In
This Issue: · Sandoz v. Amgen: Supreme Court Weighs in on Patent Dance and Commercial
Marketing Notice Requirements · Interference Decision in favor of
Gilead Affirmed at the Court of Appeals for the Federal Circuit · NIH Enforcement of Bayh-Dole
Requirements on the Rise? Contact Us: Walter
Schlapkohl, Ph.D., Esq. wschlapkohl@gbpatent.com 703-716-1191 (phone) 703-716-1180 (fax) |
U.S. Supreme Weighs in on BPCIA – Decision Seen as Favorable to Biosimilar ApplicantsIn
Sandoz, Inc. v. Amgen, Inc. et al., 137 S. Ct. 1664 (2017),
the Supreme Court recently tangoed with a case involving, among other things,
injunctive relief arising from what is known as “the patent dance” of the
Biologics Price Competition and Innovation Act (BPCIA). The Court also decided that the biosimilar
applicant can determine when the music starts playing insofar as the
biosimilar applicant may notify the reference product sponsor of its intent
to commercialize the biologic before
obtaining a license from FDA.[1]
Sandoz
sought approval to market Zarxio, a filgrastim biosimilar of Amgen’s approved
Neupogen. One day after FDA accepted
the application for review, Sandoz notified Amgen that it had submitted an
application. At that time, Sandoz also
notified Amgen that it would begin commercializing Zarxio immediately upon
receiving FDA approval. When it came
time for Sandoz to disclose to Amgen additional information required for the
first phase of litigation, such as a copy of the FDA application and the
manufacturing information for making the biosimilar[2],
Sandoz said it would not do so. Sandoz
instead stated its position that Amgen could sue for infringement
immediately.[3]
In
response, Amgen sued Sandoz for patent infringement. Amgen also claimed that Sandoz engaged in
“unlawful” conduct that violated California’s unfair competition law.
When
the case arrived at the Supreme Court, three legal issues remained: 1)
whether courts could issue an injunction to force the parties to exchange
information as part of the patent dance, 2) whether notice of
commercialization could only be provided after FDA licensed the biosimilar,
and 3) whether the claim under California’s unfair competition law should
remain.
Holding
1: Preliminary Injunctions for Failing to Engage in the Patent Dance Are Not
Permitted.
The
Supreme Court held that courts could not require a biosimilar applicant to
engage in the patent dance. Rather, if
the applicant refused to voluntarily participate, the only remedies available
to courts were the declaratory judgments and declarations of infringement,
validity, and enforceability identified in the statute.
Holding
2: Biosimilar Applicants Can Notify Sponsors of Commercialization Before
Receiving a License.
The
Court held that a biosimilar applicant may provide notice of commercial
marketing to the reference product sponsor at any time before FDA’s decision
to license the biosimilar. The Supreme
Court’s holding in this regard means that biosimilar applicants need not wait
for FDA approval of the biosimilar before forcing litigation of all the patents
the sponsor could assert.
Holding
3: Claims under California’s unfair competition law will need to be resolved
by lower courts.
Amgen
alleged that Sandoz engaged in “unlawful” conduct when: 1) it failed to
provide its application and manufacturing information, and 2) provided notice
of commercial marketing before, rather than after, FDA licensed the
biosimilar. Regarding the first
claim, the Supreme Court remanded the case for further proceedings. However, because the Supreme Court held
that notice could be provided before FDA approval, the second claim under
California’s unfair competition act should likely be dismissed by lower
courts.[4]
--By
Christopher L. Wright Federal Circuit Affirms PTAB’s Judgment of Priority to Gilead in Interference with IdenixOn
June 21, 2017, the U.S. Court of Appeals for the Federal Circuit (“Federal
Circuit”) affirmed the Patent Trial and Appeal Board’s (PTAB) judgment of
priority to Gilead Pharmasset LLC (“Gilead”) in an interference declared
between an issued patent owned by Merck & Co.’s Idenix Pharmaceutical
Inc. (“Idenix”) and a pending application owned by Gilead (Storer v. Clark, 860 F.3d 1340
(Fed. Cir. 2017). The
subject matter of the count of the interference was a method of treating a
host infected with a hepatitis C virus, comprising administering an effective
amount of a compound selected from a genus of nucleosides, and an embodiment
of the count required a 2’-fluoro(“down”) 2’-methyl nucleoside. To
establish priority, Idenix relied on the disclosure of the provisional
application from which priority was claimed for conception and constructive
reduction to practice. After an analysis
of the eight Wands factors, the
PTAB found that at the time of filing the provisional application, a person
skilled in the art would not have arrived at the claimed invention without
undue experimentation. The PTAB thus held that Idenix’s provisional application
was not enabling for the count of the interference, and entered judgment
granting priority to Gilead. Idenix appealed the judgment. The Federal Circuit concluded that
substantial evidence supported the PTAB’s findings that the synthetic schemes
in Idenix’s provisional application do not teach or suggest conversion of any
precursor into the 2’F(down) structure, and that the Matsuda synthesis of a
corresponding 2’-methyl(down), 2’-hydroxyl(up) structure (known in the prior
art but not disclosed in the provisional application) would not have enabled
a person of ordinary skill in the art to produce the target compounds without
undue experimentation. The
record before the PTAB showed sufficient variability and unpredictability to
support the PTAB’s conclusion that Idenix’s provisional application did not
enable the interference subject matter. Consequently, the Federal Circuit
affirmed the PTAB’s decision. --By Jeff Bousquet Signals That NIH Enforcement of Bayh-Dole Act Reporting Requirements May IncreaseThe
Bayh-Dole Act of 1980 significantly changed the landscape for institutions
receiving federal funding from agencies such as the National Institute of
Health (NIH). Prior to the Bayh-Dole
Act, inventors receiving federal research funding were required to assign
inventions made with such funding to the government. The Bayh-Dole Act allowed small businesses
and non-profit organizations such as universities the ability to keep
inventions made with federal funding. In
exchange the inventor and the organization must comply with a certain
reporting requirements. For
example, institutions that elect to retain ownership of their inventions must
inform the funding agency of an invention within two months of disclosing it
in writing in house. Institutions that
retain title to the invention must also file for patent protection within one
year of electing title. (The NIH makes
exceptions in this regard for research tools including proteins, cell lines,
etc.) Institutions must also make
reasonable efforts to obtain a license for the invented product from small
businesses and provide annual reports on the utilization of the invention,
including date of first commercial sale or use and royalties received. Finally, all “substantial manufacturing”
must be performed in the United States. The
NIH’s director of inventions and technology recently indicated that non-compliance
with the Bayh-Dole requirements are getting more attention from the agencies
that award federal research grants.[5] Institutions failing to comply with the
above requirements should watch out:
the NIH has the option to halt funding to the entire institution for
non-compliance. Potential
modifications to the Bayh-Dole scheme have also been discussed as part of the
new White House administration, including revisions to allow the government
to receive some return on investment from its funding support for biomedical
research. --By
Walter Schlapkohl |
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[1] 137 S. Ct. 1664, 1676 (2017).
[2] 42 U.S.C. §262(l)(2)(A).
[3] Under 42 U.S.C. §262(l)(9)(C).
[4] 137 S. Ct. 1664, 1678 (2017).
[5] Patent, Trademark & Copyright Journal, vol. 94, no. 2314, p. 389, June 2017 citing Ann M. Hammersla’s comments at the Health Care Compliance Association’s research compliance conference in Baltimore on June 5, 2017.