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USPTO releases new guidelines for
determining patent eligibility of
nature-based inventions
RELATED INDUSTRIES
11 MARCH, 2015
Pharmaceuticals & Chemistry
By Gavin Recchia and Tania Uren
Over the past several years the United States Supreme Court has handed down
numerous decisions related to patent subject matter eligibility, i.e. whether
certain subject matter should be eligible for patent protection. These decisions
appear, at least in part, to have been made in response to a growing concern
that patents were "tying up" laws of nature and natural phenomena and
preventing others from using or applying them. These decisions have had a
significant impact on what types of claims may be granted patent protection by
the USPTO. In particular, the patent eligibility of diagnostic methods,
personalized medicine, and chemical or biological products, which were once
routinely the subject of patents, have come under intense scrutiny.
In the wake of the recent Supreme Court decisions and the resultant uncertainty
over patentability on the part of patent examiners, applicants and attorneys
alike, the United States Patent and Trademarks Office (USPTO) has released
updated guidelines for determining subject matter eligibility, with associated
training examples. The guidelines are particularly relevant to claims directed to
nature-based inventions (e.g. biotech, chemical, pharmaceutical and diagnostic
inventions) as well as computer-implemented inventions (e.g. software, business
methods, etc.). We focus here on the guidelines as they relate to nature-based
inventions.
Is the claim directed to a law of nature or natural
phenomenon?
Under United States law, natural phenomena and laws of nature have long been
held to be unpatentable. A claim is considered to be directed to a natural
phenomenon or law of nature if it recites a nature-based product, such as DNA, a
protein or a chemical, that does not have markedly different characteristics
compared to that which occurs in nature, or if it recites a naturally-occurring
principle.
Streamlined eligibility analysis, including for methods of
treatment
The USPTO guidelines make it clear that claims reciting a natural phenomenon or
law of nature should still be considered patent-eligible if it is apparent that the
claims do not seek to “tie up” the natural phenomenon or law of nature. For
example, an artificial hip prosthesis coated with a naturally-occurring mineral is
Chemical Engineering & Materials
Science
not an attempt to "tie-up" the mineral and is not directed to a natural
phenomenon or law of nature even though it recites one. Using this analysis the
USPTO has indicated that, generally speaking, methods of treatment will be
patent-eligible because they are typically directed to the process of practically
applying a nature-based product and do not seek to "tie-up" the nature-based
product itself.
Does the claim amount to more that a law of nature or
natural phenomenon?
If the claim is directed to a law of nature or natural phenomenon, then it will still
satisfy the patent-eligibility requirement if it contains additional elements or a
combination of elements that result in the claim as a whole amounting to
significantly more than the law or natural phenomenon itself. Examples of
limitations that can satisfy this "significantly more" test include those that recite
something other than what is well-understood, routine and conventional in the
field, or that add an unconventional step that confines the claim to a particular
useful application. Conversely, appending well-understood, routine and
conventional activities previously known in the field, or adding an activity that is
not central to the purpose of the invention (e.g. adding a data gathering step to
a method when all applications of the method would require such a step and it
would not impose a further meaningful limit to the claim), is not sufficient to
make a claim amount to significantly more than a law of nature or natural
phenomenon.
"Markedly different" nature-based products
To determine whether a nature-based product is markedly different from its
naturally-occurring counterpart, the following characteristics are taken into
consideration:
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biological or pharmacological functions or activities;
chemical and physical properties;
phenotype, including functional and structural characteristics; and
structure and form, whether chemical, genetic or physical.
The USPTO has indicated that the following differences are sufficient to satisfy
the "markedly different" test:
Proteins and nucleic acids
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single or multiple amino acid or nucleotide differences, regardless of whether it
results in a functional change.
heterologous nucleic acids or amino acids, or labels.
changes in glycosylation as a result of recombinant expression.
changes in crystal structure.
Chemicals
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different structures, such as one or more different chemical groups, even if the
change in structure does not result in a functional change.
changes in solubility, such as by formulation with a solubilizing agent.
Antibodies
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antibodies are patentable provided the antibody does not exist in nature, and
the onus is on the USPTO to demonstrate such an existence.
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chimeric, humanized and other variant forms of antibodies.
Cells
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phenotypic differences arising from human manipulation, such as genetic
engineering or culture methods.
Bacteria
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mixtures of bacterial species that display different biological or functional
characteristics as a mixture compared to as individual species.
as with antibodies, the onus is on the USPTO to demonstrate the existence of a
particular mixture of bacteria – the mere possibility that it might exist in nature
is not sufficient for a rejection.
Naturally-occurring principles and patentability of diagnostic
methods
As recently decided by the Supreme Court in Mayo v Prometheus, correlations
based on the metabolism of a compound by the body are deemed
naturally-occurring principles. Relying on this decision, the USPTO has since
routinely concluded that the correlation between the presence or level of a
protein or nucleic acid in the body and a disease state is also a
naturally-occurring principle. As a result, diagnostic methods and personalized
medicine methods are now generally considered by the USPTO to be directed to
natural phenomena or laws of nature and are hence patent-ineligible.
Unfortunately, the USPTO guidelines do not provide any further guidance by way
of commentary or training examples on what might make a diagnostic method
claim amount to "significantly more" than the naturally-occurring principle upon
which it relies. Based on our recent experience, unless the method includes the
use of a new diagnostic reagent or assay, generally speaking the USPTO
considers most additional steps in a broad diagnostic method to be
well-understood, routine or conventional, and the method is rejected as being
directed to patent-ineligible subject matter.
Where to from here?
While forming the basis on which US patent examiners will assess the question
of patent eligible subject matter, one should bear in mind that the new USPTO
guidelines are not legally binding and may be modified or changed as new
judicial decisions are handed down. In addition, any final adverse decision by
the USPTO can be appealed. This area of law is rapidly changing and it not yet
clear how broadly the US Courts will apply the recent decisions in Mayo v
Prometheus and others.
Despite the somewhat negative treatment that claims to diagnostic methods or
natural products are currently receiving at the USPTO, applicants working in
these areas should not assume that their inventions are no longer patentable.
The complexity of the law and, in some cases, lack of clear guidance from the
Courts and USPTO means that such inventions should be assessed on a
case-by-case basis. Certain strategies can also be adopted to increase the
likelihood that claims can be crafted satisfying the patent-eligibility requirements
and affording commercially relevant protection. We would encourage clients to
discuss these with us.
Filed Under: IP ARTICLES IP UPDATE PRACTICE UPDATES PATENTS