experience in intellectual property matters, including patent
prosecution and litigation, invalidity and non-infringement opinions,
licensing of patents and computer technology, as well as trademark
and copyright protection. He has been the author of a blog dedicated
to patent law issues and strategies called Inventive Step since 2008,
which can be found at http://inventivestep.net.
4501 Highwoods Parkway
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Glen Allen, Virginia 23060
804.346.0600 Phone
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www.goodmanallen.com
patented? To meet the patentability
requirements of the Patent Act, an
invention must be useful, novel and
non-obvious. The invention must be
described in sufficient detail to permit
one of ordinary skill in the art to
make and use the invention. Are there
any other limitations on what can be
patented? Should there be? A recent
Supreme Court opinion says yes, limiting
the types of inventions that may be
patented, particularly in the field of
biotechnology.
patent is set forth in 35 U.S.C. § 101:
new and useful process, machine,
manufacture, or composition of mat-
ter, or any new and useful improve-
ment thereof, may obtain a patent
therefore, subject to the conditions
and requirements of this title.
Chakrabarty, the Supreme Court decided
patented. The inventor had developed
a bacterium capable of breaking down
crude oil that could be used in cleaning
up oil spills. The United States Patent
and Trademark Office (PTO) rejected his
patent application on the basis that living
things are not patentable subject matter.
The Supreme Court reversed, holding
that the bacterium was not naturally
occurring and qualified as patentable
subject matter as a "manufacture" or
"composition of matter" under the § 101.
The Court cautioned that limitations
should not be read into the statute that
Congress has not expressed.
In what is now considered the high
point of the permissiveness of patentable
subject matter, the Court quoted the leg-
islative history of § 101 that patentable
subject matter includes "anything under
the sun made by man."
Chakrabarty is widely viewed as
the case that spurred the nascent field
of biotechnology. The PTO took the
Supreme Court's injunction literally
and began issuing patents on isolated
Isolating DNA sequences has permitted
biotechnology companies to develop
tests for genetic diseases and to create
research tools to permit us to learn
more about the human body and how to
treat various diseases. These inventions
are leading to personalized medicine,
including customized medical decisions,
practices and products tailored for
individual patients.
While patents may have been the
incentive to spur on these advances in
biotechnology and medicine, patents
also permit their owners to exclude
use of the claimed technology for the
term of the patent. This has raised the
debate on access to these new medical
breakthroughs.
More than 30 years later, the
Supreme Court has waded into the field
once more and decided that isolated
DNA is a product of nature and is
therefore not eligible to be patented.
Pathology v. Myriad Genetics
humans and other organisms. Each gene
is encoded as DNA that occurs within
the organism. Scientists can extract and
isolate DNA from the genes for research,
as mentioned above. Through manipula-
tion, they can develop synthetic DNA in
Biotechnology Can be Patented