Patenting of Products of Nature
The Decline and Fall of the
Prohibition on Patenting Products of
Nature
The Original Scope of
Patentable Subject Matter
• The first category of patentable subject matter
was machines.
• With the advent of the industrial age,
processes of machinery, automation, and
other manufacturing processes became the
second category of patentable subject matter.
• However, in the middle 19th century, the coal
tar industry in Germany gave rise to evolution
and development of organic chemistry.
The Coal Tar Industry
• The discovery by chemists that organic
chemistry offered a new world of products
marked the beginning of a new epoch in
industrialization, and to a large extent, on
patent law.
• From the coal tar industry, synthetic medicinal
agents, artificial perfumes, sweetening
materials, anti-toxins, and photographic
developers were made.
• These new products helped redefine the
scope of patentable subject matter.
The Pharmaceutical
Industry
• The pharmaceutical industry is indeed a
subsidiary of the coal tar industry.
• The manufacture of synthetic medicinal
preparations was equally an offshoot of the
coal tar industry.
• The most important development, at least
within the context of patent law, is the
extraction and purification of the active
components of plant-based drugs. Plantbased alkaloid substances such as morphine,
codeine, quinine, and cocaine, opened the
doors for a wider patent scope.
Chemical Compounds &
Patents
• The application of synthetic chemistry to drug
discovery began to bear fruit from the late 19th
century. The dyestuff firms were at the
forefront.
• Bayer became the world’s first pharmaceutical
company, when in 1888, it placed on the an
anti-pyretic drug that is sold as Phenactin.
• Bayer also put on the market a naturallyderived substance, acetylsalicylic acid under
the name “aspirin.” By 1909, drug companies
were obtaining patents on naturally-derived
substances.
Expanding the Scope of
Patentable Subject Matter
• The patenting of substances derived from
nature or their synthetic compounds raises the
question of whether such products fall within
the scope of permissible subject matter.
• This question has assumed greater cogency
because historically, patent law has always
purported to outlaw the granting of patents to
discoveries pertaining to natural things.
• Proteins and DNA sequences are naturallyoccurring polymers. As such, they are better
described as discoveries rather than
inventions.
The Case Law
• Virtually all the apex courts of most patent
granting states of the world have consistently
declared that products of nature are not
patentable subject matter.
• However, in the past 25 years, a second line
of cases have distinguished “purified” from
“impurified” forms of these products. In this
binary world, the general rule is that the
former is patentable while the latter is not.
Arguments for Patents on
Purified Natural Substances
• The purification process of many
substances is often laborious and
expensive. For example, the human
growth hormone is harvested from
cadaverous tissues. The tissue is not
plentiful and there is the extant danger
of transmitting diseases.
• However, arguments of labour and cost
hardly justify the trashing of a wellestablished rule of patent law.
Arguments Against Patents
on Products of Nature
• It is a remarkable apostasy in patent law that
products of nature are patented at all.
• First, products of nature, as already noted are
discoveries of what already exists in nature.
• Second, it is difficult to argue that a natural
compound is indeed a new thing. In other
words, on a strict construction of the test of
novelty, it is difficult to associate natural
products with novelty.
• Third, patents on products of nature are
inconsistent with a long line of decided cases.
Early Judicial Position on
Products of Nature
• In Leroy v. Tatham, the US Supreme Court
rejected a patent application on purified lead.
• In American Fruit Growers v. Brogdex, the US
Supreme Court held that an “orange carrying
borax in an amount that is very small but
sufficient to render the fruit resistant to decay”
remained an orange, and was therefore not
patentable.
• In Funk Brothers, the same court declared
that “patents cannot issue for the discovery of
the phenomena of nature.”
Purified Tungsten
• In GE Co. v. DeForest Radio Co., William
Coolidge, who had assigned his patent to GE,
had developed a process of converting
impure tungsten to a highly pure version. In
the suit for infringement, the issue turned on
whether the patent itself was valid. According
to the court, “if it [tungsten] is a natural thing
then clearly, even if Coolidge was the first to
uncover it and bring it into view, he cannot
have a patent for it because a patent cannot
be awarded for a discovery or for a product of
nature or for a chemical element….”
Purified Tungsten
• …’naturally we inquire who created tungsten.
Coolidge? No. It existed in nature and
doubtless has existed there for centuries. That
fact that no one before Coolidge found it there
does not negative its origin or existence. What
the patentee produced by his process was
natural tungsten in substantially pure form.
What he discovered were natural qualities of
pure tungsten. Manifestly he did not create
pure tungsten, nor did he create its
characteristics. They were created by nature.”
Purified Natural Compounds
• Interestingly, notwithstanding these long line
of cases, the United States and elsewhere
have not been consistent in their approach to
all natural products, especially biomolecules.
• While they have shown some high degree of
firmness and consistency in their rejection of
patents on metallic elements, a completely
different, indeed contradictory approach has
been exhibited in respect of chemical
compounds derived from nature.
The Aspirin Patent
• The first major breach on the rule against the
patentability of biomolecules is Kuehmsted v.
Farbenfabriken. The issue here was whether
purified acetyl salicylic acid (aspirin) could be
patented. Writing for the court, Judge
Grosscup reasoned that “where the one is
therapeutically available and the others were
therapeutically unavailable, patentability will
follow.”
Ratio of the Aspirin Case
• The plurality of the court held that a
compound purified from a mixture was
patentable, even if that compound was
previously known to exist as part of a mixture,
as long as the purified compound was useful
in a manner that the original mixture was not.
• It was on the basis of this ratio decidendi that
Judge Learned Hand validated the patent on
adrenalin in Parke-Davis v. Mulford.
• However, it is difficult to reationalize ParkeDavis within the ratio of Kuehmsted.
Aspirin v. Adrenalin
• Aspirin is an artificial compound.
Adrenalin is extracted from adrenal
glands, a product of nature.
• Interestingly, Judge Learned Hand
distinguished aspirin from adrenalin, on
the basis that adrenalin was a purified
extract of adrenal glands. In his words,
the difference was not one of degree
but in kind.
Judge Learned Hand’s
Formulation
• “But even if it were merely an extracted
product without change, there is no rule that
such products are not patentable. Takamine
was the first to make it available for any use
by removing it from the other gland-tissue in
which it was found, and while it is of course
possible logically to call this a purification of
the principle, it became for every practical
purpose a new thing commercially and
therapeutically.’
Patents on Purified Natural
Compounds
• Patents on purified natural compounds
are more or less routinely granted.
• In Olin Mathieson, patents on purified
vitamin b12 were upheld. Strictly
speaking, vitamin b12 is not an
invention.
Merck v. Olin Mathieson
• Vitamin b12 is produced by a large number of
microorganisms, and as such, it is a product
of nature. The reasoning of the court is to the
effect that something can still be new even
though it is a product of nature.
• Surprisingly, the court’s reasoning begins with
the premise that all things are derived from
nature, and therefore all inventions can be
viewed as products of nature!
• More importantly, the court reasoned that
Vitamin b12 does not exist in its pure state in
nature.
Vitamin b12 v. Tungsten
• If the reasoning of the court in Olin Mathieson
is correct, then GE was wrongly decided.
• It seems that the court in b12 case was
unduly influenced by the fact that scientists
had for decades searched for the elusive
factor used to treat pernicious anemia, which
had been known only to exist in minute
quantities in beef liver. Thus, the discovery
that microorganisms produced this factor in
relatively large quantities which could be
readily purified was a significant milestone in
medicine. But, why the difference in tungsten?
In Re Bergstrom
• The reasoning of the court in Olin Mathieson
was was followed in In re Bergstrom where
the ptf contested the Patent Board of Appeals’
rejection of patents for two purified
prostaglandins. The two compounds were
purified from sheep prostate glands and
deemed products of nature. The court
reasoned that pure materials necessarily differ
from less pure or impure materials and are
hence, new and patentable.
Patents on Purified Natural
Compounds
• The University of Wisconsin received U.S
patents for a protein isolated from the
Gabonese berry Pentadiplandra brazzeeana.
This berry has been known and used by
peoples in Gabon for millennia for its
incredibly sweet taste. The protein, a natural
substance is 2,000 times sweeter than sugar
and does not lose its sweetness when heated.
• US Patent #5,900,240 was granted to Cromak
Research Inc on the anti-diabetic properties of
Jamun, a plant known to Indian Ayurvedics for
that purpose for millennia.
Patents on Purified Natural
Substances
• U.S Patent 5,929,124 was granted to 2
Swiss scientists for the purified extract
from the Zimbabwean tree Swartzia
madagascariensis for the treatment of
Athlete’s foot, thrush, and some
hitherto incurable eye infections.
• This is not limited to the US. The
German Supreme Court upheld a
similar patent in Menthonthiole case.
Explaining the Demise
• There is little question that the product of
nature exclusion is dead in patent law. Two
theories may be advanced in explanation.
• The first is the theory that a purified product
differs in form from that in the natural state.
This theory, as Michael Davis has argued
centers on a literal reading of the test of
novelty and appears to make no distinction
between natural and artificial products.
• This theory has its origins in Parke-Davis, and
was applied in re Bergstrom & Olin
Mathieson.
The First Theory
• In sum, applying the first theory, courts have
declared that biochemicals become new
things during or following their isolation from
their natural environment.
• The problem with this approach, as pointed
out by Thomas Kiley, is that “there is nothing
in the patent statute that says old substances
become “new” when first offered in purified
and isolated form. This is law that judges have
engrafted on the statute.” It is a legal fiction
foisted upon patent law by judges.
Debunking the First Theory
• It must be borne in mind that biochemistry is
premised upon the assumption that individual
compounds would behave in the same way
both inside and outside of a living organism.
Generally speaking, this assumption has
proven to be correct.
• On this assumption, biochemists isolate
natural products for use as medicine. Vitamins
found in nature behave the same way in the
human body as their purified and isolated
versions. Thus, the distinction foisted on
purified natural products is solely one of utility,
not of kind.
Debunking the First Theory
• When judges are confronted with the
natural product exception, the test of
novelty is often confused with the
former.
• Yet, it must be borne in mind that
novelty, obviousness, and utility are all
distinct from the criterion of statutory
subject matter. Landmark decisions
such as Diamond v. Chakrabarty
reiterate this point.
The Second Theory
• The second theory is based on a
slippery slope argument; that is, that all
inventions are products of nature.
• This is a mischievous and spurious
argument.
• A clear line can be drawn between
products of nature and artificial
inventions. Natural products pertain to
substances which exist in nature but
not artificial substances.
State of the Law
• Leaving aside the controversy surrounding
the patenting of natural products, the law
seems settled that natural products can
become patentable upon purification of
isolation.
• It is this new doctrine that purports to justify
the granting of patents on purified proteins,
purified DNA transcripts.
• What is disturbing however is the dilution of
the requirement for utility in those patent
grants.
Summary
• Patentees of products of nature receive
rights for products they neither
designed nor improved. They simply
receive limited monopolies for
converting natural products to a form
that is more practical for human use.