On July 27, the Federal Circuit in Integra LifeSciences
v. Merck ruled on the Supreme Court's broad
interpretation of the patent infringement exemption
set forth in 35 U.S.C. § 271(e)(1), for "uses reasonably
related to the development and submission of
information" to the Food and Drug Administration
(FDA). The Federal Circuit reversed the district court's
judgment of infringement, finding that all of the uses
at issue qualified under the safe harbor provision of
35 U.S.C. § 271(e)(1) because they were "reasonably
related to research that, if successful, would be
appropriate to include in a submission to the FDA,"
even though not all of the experiments ultimately
resulted in information submitted to the FDA.
Integra LifeSciences owns patents related to the
peptide sequence of amino acids arginine (R), glycine
(G) and aspartic acid (D), known as the "RGD peptide."
Scripps Research Institute found RGD peptides to be
effective in inhibiting angiogenesis – the development
of blood vessels – which is a factor in some serious
diseases, such as solid tumor cancers, diabetic
retinopathy and rheumatoid arthritis. As a result,
Scripps entered into a collaborative agreement with
Merck to develop a drug based on these findings, and
specifically to evaluate the "efficacy, pharmacology,
pharmacokinetics, and mechanism of action" of
several RGD peptides toward the goal of obtaining
permission to conduct clinical trials through an
Investigational New Drug (IND) application to the FDA.
Integra claimed that the early experiments conducted
by Scripps, as well as the subsequent studies
conducted jointly by Merck and Scripps, infringed
Integra's patents on RGD peptides. Merck and Scripps
argued that their experiments fell under the safe
harbor provision set forth at 35 U.S.C. § 271(e)(1), which exempts from infringement uses of patented
inventions that are "reasonably related" to obtaining
information for submission to the FDA.
The relevant portion of the safe harbor provision
states: "It shall not be an act of infringement to make,
use, offer to sell, or sell within the United States or
import into the United States a patented invention...
solely for uses reasonably related to the development
and submission of information under a Federal law
which regulates the manufacture, use, or sale of
drugs or veterinary biological products." 35 U.S.C. §
The majority opinion noted that the FDA exemption is
not applicable to "basic scientific research unrelated
to development of a particular drug." However, since
all of the experiments at issue were conducted "after
discovery of the anti-angiogenesis property of the
experimental RGD peptide," they did not fall under the
ambit of "basic scientific research."
The majority opinion further explained that whether
the uses in question are "reasonably related to the
development of information for submission to the
FDA" is established at the time of the experiment,
and "does not depend on the success or failure of
the experimentation or actual submission of the
experimental results." Therefore the Court held that
the entire series of experiments qualified for the
FDA exemption because all were conducted for "the
purposes of determining the optimum candidate
angiogenesis inhibitor" for commercial development,
even though only one particular RGD peptide, EMD
121974, was selected as the candidate for the IND
application. The court further found that the FDA exemption is not restricted to studies that follow
the FDA's Good Laboratory Practices regulations for
clinical studies, and rejected Integra's proposal to
exclude from the FDA exemption any experiments that
were "entirely routine."
In dissent, Judge Rader argued that the majority
opinion expands the exemption even beyond the
Supreme Court's already broad interpretation. He
notes that two of the patents-in-suit are research
tool patents that have no application outside of the
laboratory, and criticizes the majority for failing to
distinguish the research tool patents from the others
(i.e., patents directed at the compounds themselves).
The majority opinion explained that it did not address
the research tool patents because Integra declined to
argue on appeal that Merck and Scripps used the RGD
peptides as research tools, and thus "the issue is not
Judge Rader asserts that patents for research tools
are "beyond the scope of the 'patented compounds'
that the Supreme Court placed within the statutory
exemption," citing legislative history discussing
the primary purpose of the statute to permit generic
manufacturers to establish the bioequivalence of a
generic substitute for FDA approval and the intended
"de minimus" impact on the rights of patent holders.
The Supreme Court's June 13, 2005, decision in Merck
v. Integra LifeSciences, 545 U.S. 193 (2005), focused
on "patented compounds" because Integra did not
assert that Merck's and Scripps' experiments used the
RGD peptides as research tools. Although Judge Rader
looks to the Supreme Court's opinion for support, the
Supreme Court did not limit the exemption to patented
compounds, but rather explicitly declined to express
any view as to whether use of patented research
tools qualified for the exemption. Also, despite the
legislative history, the language of the statute does
not restrict the exemption to patented compounds or
otherwise exclude research tool patents.
Although the majority opinion declined to address
the issue of research tool patents specifically, its
holding that the FDA exemption includes any research
that "if successful, would be appropriate to include
in a submission to the FDA" arguably encompasses
research tool patents, and certainly will be cited by
future patent litigation defendants as such. As Judge
Rader points out, if research tool patents indeed
are subject to the FDA exemption, the value of such
patents will be greatly impacted.
For further information, please contact:
Michael J. Shuster, Ph.D., Partner, Intellectual Property Group, Co-Chair, Life Sciences Practice
Heather N. Mewes, Patent Litigation Partner
C. J. Alice Chuang, Patent Litigation Associate
©2007 Fenwick & West LLP. All Rights Reserved.
This update is intended by Fenwick & West LLP to
summarize recent developments in the law. It is not
intended, and should not be regarded, as legal advice.
Readers who have particular questions about these
issues should seek advice of counsel.