4-Patents: U.S. court bars patent protection for certain gene fragments
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------------------------------- GENET-news -------------------------------
TITLE: Court bars patent protection for certain gene fragments
SOURCE: The Wisconsin Technology Network, USA, by Jonathan Fritz
DATE: 10 Oct 2005
------------------ archive: http://www.genet-info.org/ ------------------
Court bars patent protection for certain gene fragments
Decision raises the bar on proving usefulness of gene, protein related
The Court of Appeals for the Federal Circuit (CAFC) issued a patent-law
decision last month that inevitably will render hundreds of pending
patent applications worthless, and that will raise the bar for proving
gene and protein related inventions useful.
At issue was whether certain gene fragment sequences were useful. Most
notably whether the gene fragments have a specific and substantial use,
as required by U.S. patent law.
The CAFC ruled against the patent applicants in In re Fisher. <http://
www.fedcir.gov/opinions/04-1465.pdf> By maintaining the decision of the
United States Patent and Trademark Office (USPTO) <http://www.uspto.gov/>
Board of Patent Appeals and Interferences, the decision bars patent
protection for gene fragments that do not have a "specific and
substantial" utility. The ramifications of this decision were recognized
by some of the largest pharmaceutical and biotechnology companies who
submitted amicus curie, or friend of the court, briefs in support of the
Patent rights are designed to be quid pro quo. In exchange for sufficient
public disclosure of the invention in order to allow others to make and
use the invention, the federal government confers a monopoly for a
limited time to the inventor. There is a recognized societal benefit
received from knowledge shared by inventors.
There are statutory requirements aimed at ensuring that society receives
a benefit for this exchange. The patent statutes require a showing of
utility, nonobviousness, and novelty prior to granting a limited monopoly
for the claimed invention. The USPTO requires that an inventor provide at
least one credible disclosure with specific and substantial utility. In
the event that a patent is granted absent a specific and substantial
utility, the patent may be found invalid. In such a case, the inventor is
not providing a value to society, and therefore insufficient quid pro quo.
The utility requirement has traditionally been the least contentious
hurdle to overcome, but for gene fragment patent applications the
standard has now been heightened. Regardless of how the decision is
interpreted, there is now more predictability as to how the USPTO will
determine genetic and protein related inventions. Patent practitioners
and inventors are better informed as to what they must provide in order
to meet the utility requirement.
What technology was at issue in Fisher?
Two researchers at the Monsanto Company laboratories harvested and
purified DNA from the maize plant during its flowering phase, also known
as anthesis. Harvesting genetic data during this phase was designed to
provide the researchers with valuable information for use in finding what
genes were expressed and ultimately what proteins were present at a
particular time in the development of the maize plant. Though the
researchers were not intending to obtain this information directly
through their experiments, they were intending to use the gene fragments
they found as a tool in more efficiently obtaining the gene and protein data.
The invention involved DNA sequence fragments that did not specifically
encode for a protein and therefore did not entail an entire gene.
Nucleotides are the building blocks of DNA, which is nucleic acid.
Relatively long sequences of nucleotides make up genes, which when
expressed can cause various proteins to be present within a cell. The
Fisher patent application was directed to short nucleic acid sequences
thought to be gene fragments and specifically referred to as expressed
sequence tags (EST). <http://www.ncbi.nlm.nih.gov/About/primer/est.html>
ESTs are thought to be useful as tools for more efficiently identifying
previously unknown expressed genes and downstream proteins.
The patent application contained a single claim describing a set of five
ESTs that encodes a fragment or entire maize protein. Neither the genes
that encode the proteins nor the proteins themselves were claimed because
the researchers had not uncovered them at the time of filing the patent
application. Essentially, the ESTs were being claimed as a research tool
that could be used to obtain the genetic and protein information.
What is specific and substantial utility?
The Fisher decision is one of the first CAFC cases that applied the
specific and substantial utility standard to genetic technologies. USPTO
Guidelines for applying this standard were finalized in 2001. The
guidelines identify that in order to meet this standard, the patent
applicant must have a credible assertion "that the claimed invention is
useful for any particular practical purpose." The USPTO specifically
rules out "throw-away," "insubstantial" and "nonspecific" utilities,
including the "use of a complex invention as landfill."
Though the Fisher applicants identified a list of seven uses for the
claimed ESTs, the court reasoned that the identified uses were not
specific to the claimed ESTs, but could be applied to all ESTs. The CAFC
further identified that using ESTs as research tools was too
insubstantial to meet the standard. This was in part due to the fact that
the applicants did not know what genes, if any, contained the ESTs, nor
what proteins may be involved, and why they were important. The CAFC
reasoned that though the ESTs could be used for further genomic and
proteomic research, this was not enough to fulfill the utility
requirement. The CAFC disagreed with Fisher's analogy that the invention
was akin to a microscope, which is used for advancing scientific
How does this affect patents on genetic related technologies?
All pending patent applications that claim ESTs without identifying a use
beyond that of a research tool are likely never to be granted. It is
unlikely that this decision will be applied to all technologies and more
likely that it will be limited to genetic and related technologies.
However, it is safe to say that the Fisher decision will be considered
carefully when dealing with genomic or proteomic related inventions.
Equally as important in this case is the CAFC's underlying lack of desire
to grant patent protection for genetic research tools. Considering the
advances made in understanding genetics in recent years, this decision is
likely to play a significant role in how inventors approach patenting
their genetic inventions.
For those disagreeing with the CAFC's decision, it is important to note
that Fisher was a 2-1 decision containing a well-reasoned dissenting
opinion. In the next couple of months it will become apparent whether the
patent applicants intend to appeal the decision directly to the United
States Supreme Court.
Jonathan Fritz is an attorney with the law firm of Whyte Hirschboeck
Dudek S.C. <http://www.whdlaw.com/> He is a registered patent attorney
with a background in biotechnology, bioinformatics, and computer science.
His practice is focused upon intellectual property counseling,
information technology and IP litigation. He can be reached at
The opinions expressed herein or statements made in the above column are
solely those of the author, & do not necessarily reflect the views of The
Wisconsin Technology Network, LLC. (WTN). WTN, LLC accepts no legal
liability or responsibility for any claims made or opinions expressed herein.
European NGO Network on Genetic Engineering
Hartmut MEYER (Mr)
In den Steinäckern 13
D - 38116 Braunschweig
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