OBTAINING PATENTS FOR MANUFACTURED PRODUCTS
A manufactured product which differs from one that is
naturally occurring only because it is artificially made is not
novel and thus is not patentable. However, the process by which it
is manufactured may be novel and unobvious, and therefore
patentable.
A Supreme Court case addressing whether a synthetic
product is patentable is Funk Bros. Co. v. Kalo Co.. The claimed
invention was directed to a naturally occurring strain of bacteria
which enabled different species of leguminous plants like clover
and alfalfa to take nitrogen from the air and fix it to the roots
of the plants. No species of bacteria acquired a different use.
The Supreme Court held that:
A different result is achieved in the case of genetically
altered bacteria where the end product is a bacterium that
possesses properties unknown to any other living organism. The
bacterium itself would be patentable because it is unique and
novel. However, any product produced by the metabolic activity of
the bacterium would only be patentable if it too were unique, novel
and unobvious. The case establishing the patentability of a
human-made, genetically engineered bacterium is Diamond v.
Chakrabarty. In 1972, Chakrabarty, a microbiologist working for
General Electric, asserted claims for the invention of a bacterium
that was capable of breaking down multiple components of crude oil.
This property was not possessed by any bacterium known to exist in
nature. The significant value of the invention was in the
treatment of crude oil spills. This case was distinguished from
Funk Bros. because "the patentee produced a new bacterium with
markedly different characteristics from any found in nature".
Is a replica of a naturally occurring substance which is
of higher purity patentable? This was addressed by the Court of
Customs and Patent Appeals in In re Merz.
The exception to the rule was addressed in Merck & Co. v.
Olin Mathieson Chemical Corp.. The court held that the product
claims to a bacterially produced vitamin B12 protein, although known
in nature, were patentable because the claims recited a specific
purity limitation. The claim stated:
In In re Bergstrom, an often-cited case, the claims
related to the prostaglandins PGE and PGF, natural substances
extracted from sources such as the human prostate gland. The
C.C.P.A. held that the pure prostaglandin substance is not
naturally occurring and that the applicant had not merely claimed
that which had previously existed in nature, albeit unknown.
"Whether the claimed pure materials are novel as compared with the
less pure materials of the reference," the Court stated:
While the U.S. Patent Office often rejects claims for a
recombinantly produced product which exists in a natural form, it
has become common practice to distinguish the recombinant product
from the natural product by stipulating that the new recombinant
product exists in a "purified or isolated" form.
Claims to recombinantly produced proteins or DNA
sequences have been allowed relying on the levels of purity as the
distinguishing feature of the claim. In U.S. Patent Number
4,703,008, the Amgen EPO patent, there is a claim to:
A Court has stated that this claim was not to the DNA
sequence encoding human EPO because that is a "nonpatentable
naturally occurring phenomenon 'free to all men and reserved
exclusively to no-one'" It was the "purified and isolated" DNA
sequence encoding EPO.
"There is no dispute over the patentability of a Factor
VIII:C preparation. Although Factor VIII:C molecules
occur in nature, a purified and concentrated preparation
of Factor VIII:C as claimed in the patent constitutes a
new form or combination not existing in nature, and hence
is patentable under 35 U.S.C. 101.
(ii) Claims to a Recombinant Product
This is a new development in patents directed to
recombinant products. This means that claims are not allowable
merely to recombinantly produced products simply because they are
produced by recombinant DNA techniques. Increased purity of
biological activity or other property not found in the natural,
known product or other properties will need to be shown to overcome
an unobviousness rejection.
Thus, the current standard in the United States is that
a recombinant product will be patentable if it is in a more highly
purified or isolated form than the product can be found in nature.
If the purified and isolated natural product is previously known,
some other evidence of novelty and nonobviousness is required.
OF NATURALLY OCCURRING SUBSTANCES
by
Sheldon Mak Rose & Anderson
Many of the products which are produced by biotechnology,
such as recombinant DNA technology, are products which also occur
naturally. Obtaining patent protection for such products which
exist in nature is difficult because the products may not be novel,
and therefore the invention may not meet the novelty requirements
for patentability.
"The qualities of bacteria, like the heat of the sun,
electricity, or the qualities of metals, are part of the
storehouse of knowledge of all men. They are
manifestations of laws of nature, free to all men and
reserved exclusively to none. He who discovers a
hitherto unknown phenomenon of nature has no claim to a
monopoly of it which the law recognizes. If there is to
be invention from such a discovery, it must come from the
application of the law of nature to a new and useful
end."
"While appellant may be entitled to a patent on a method
for purifying an ultramarine either artificial or
natural, he is not entitled to a patent on the article
which after being produced has a greater degree of purity
than the product produced by former methods. This
general rule is a well-settled one, but like all other
rules it has an exception. The exception is that if the
process produces an article of such purity that it
differs not only in degree but in kind it may be
patentable."
"A vitamin B12 active composition comprising recovered
elaboration products of the fermentation of a vitamin B12
activity producing strain of Fungi selected from the
class consisting of Schizomycetes, Torula, and
Eremothecium, the L.L.D. activity of said composition
being at least 440 L.L.D. units per milligram and less
than 11 million L.L.D. units per milligram."
"...pure materials necessarily differ from less pure or
impure materials and, if the latter are the only ones
existing and available as a standard of reference, as
seems to be the situation here, the "pure" materials are
"new" with respect to them."
Similarly, in In re Bergy, the C.C.P.A. held that a
biologically pure culture of the Streptomyces microorganism was not
a "product of nature". It was therefore patentable over the
microorganism as it existed in nature.
A purified and isolated DNA sequence consisting
essentially of a DNA sequence encoding human
erythropoietin.
Rejections based on the DNA sequence being a "product of nature"
were overcome by the addition of the words "purified and isolated"
to the claim.
Also, in Scripps v. Genentech, it was stated:
In Ex Parte Gray the Patent Board of Appeals rejected
a claim to recombinantly produced nerve growth factor identified by
the particular amino acid sequence and being free from other
proteins of human origin. The prior art disclosed the material
isolated from human placental tissue. The difference between the
claimed material and the prior art was primarily that the claimed
material was produced by recombinant technology. The Board,
however, stated that the applicant needed to establish unexpected
properties for the claimed recombinant product over the prior art.
The mere presence of a single methionyl moiety on the recombinant
protein not present on the natural protein would not in itself
render the claim patentable.