One question innovators frequently ask is "What is a
patentable invention?" This is an important question because
patents confer legal rights that enable the patent owner to prevent
others from making, using, selling, and offering for sale patented
inventions. Thus, patents can be used to prevent competitors from
copying a new or improved product or process. This article provides
a brief summary of the topic of patent eligibility.
The first patent law enacted in 1793 and authored by Thomas
Jefferson, described patentable subject matter as "any new and
useful art, machine, manufacture, or composition of matter, or any
new or useful improvement [thereof]." This same broad language
remains embedded in the law today, although in 1952, Congress
replaced the word "art" with "process" but
otherwise left Jefferson's language unchanged.
Other sections of the patent statute address the "new"
requirement in terms an invention's novelty and
non-obviousness. Putting those issues aside, an invention's
eligibility for patent is often never challenged by the U.S. Patent
and Trademark Office except in certain areas like process claims to
business methods. This is in large part due to statements by the
Supreme Court broadly construing the patent statute to cover
"anything under the sun that is made by man."
The courts, however, have recognized three categories of
discoveries that are unpatentable: (1) abstract ideas, (2) laws of
nature, and (3) natural phenomena. Practical applications or uses
of an idea, law of nature, or a natural phenomenon, however,
generally are patentable. Those practical applications are often
embodied in the categories of machines, manufactures and
compositions of matter.
Process claims appear to be the area in which patent eligibility
should be more carefully considered. A recent Supreme Court
decision illustrates this point and has now put another category of
discoveries under scrutiny—diagnostic methods.
In Mayo Collaborative Services v. Prometheus Laboratories, Inc.,
the Court reviewed the eligibility of patent claims to processes of
using thiopurine drugs to treat autoimmune diseases. When ingested,
the drugs produce metabolites in the bloodstream. Because patients
metabolize drugs differently, doctors found it difficult to
determine whether a particular patient's dose was too high
(resulting in toxic side effects) or too low (having no effect).
Researchers discovered that precise dosing regimens could be
correlated with the concentration of certain drug metabolites.
The U.S. Patent and Trademark Office granted claims to the
discovery in U.S. Patent No. 6,355,623. The claims covered
processes for "optimizing therapeutic efficacy" and
"reducing toxicity associated with treatment" by reciting
two steps: (a) administering a drug and (b) determining the level
of the drug or metabolite in a patient.
The Supreme Court unanimously found, however, that the claims
were ineligible for patent protection. In particular, it ruled that
the steps recited in the claimed processes involve "well
understood, routine, conventional activity" by scientists and
doctors that "effectively claim the underlying laws of nature
In light of the Supreme Court's most recent decision, patent
claims directed to processes may not be eligible for patent
protection, if the claims broadly cover a law of nature, natural
phenomenon, or naturally occurring relation or correlation. To be
eligible, the claim must cover something significantly more than
practicing the natural principle itself.
In summary, innovators can patent a wide variety of inventions
that fit within the broad categories of machines, manufactures, or
compositions of matter. Thoughtful consideration, however, of
claims to processes should be made to ensure that they do not cover
ideas and natural laws and phenomena.
Previously published in the Summer 2012 issue of the
Intermountain West Society of Cosmetic Chemists
This article is intended to provide information of general
interest to the public and is not intended to offer legal advice
about specific situations or problems. Brinks Hofer Gilson &
Lione does not intend to create an attorney-client relationship by
offering this information and review of the information shall not
be deemed to create such a relationship. You should consult a
lawyer if you have a legal matter requiring attention. For further
information, please contact a Brinks Hofer Gilson & Lione
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