PATENT AND BIOTECH

History and Evolution of

Biotech Patents
- (1700s-1978)
[IUCIPRS]

Submitted By

Sweatha P.R
Table of Contents
History and evolution of Biotech Patents.......................2
Timeline of Patent claims and cases..............................2
Yeast..............................................................................2
Fibre..............................................................................3
Plant Patents Act 1930..................................................4
Purified Adrenaline........................................................4
Coated Oranges............................................................6
Product of Nature Doctrine............................................6
Tungsten........................................................................7
Mixed cultures of root nodule bacteria..........................7
DNA...............................................................................8
Purified Prostaglandins PGE and PGF.............................8
Anibiotic Daunorubicin..................................................8
Pure Version of Streptomyces Vellosus..........................9
Conclusion.....................................................................9
History and evolution of Biotech Patents
The Patent Act of 1790 was the first federal patent statute of the United States. Even
before this the Constitution of the United States adopted in 1787 had a provision for
protecting intellectual properties. Patenting of living organisms or biotechnology was not
within its purview then.
Biotechnology has been defined as follows Biotechnology concerns the application
of cellular and molecular biology to make or modify products or processes. It includes
scientific and industrial disciplines focused on understanding and manipulating living or
biologically-active material at the molecular level, often involving DNA techniques and the
analysis of genetic information. 1
The 1970s were the first time when scientists came forward to obtain patent methods
on their biotechnological inventions .But until 1980s patents for whole living organisms were
not given. It was in the case of Diamond v Chakrabarty where the Supreme Court upheld the
first patent on a newly created living organism and bacterium with capabilities to digest crude
oil and hence found use in treating oil spills. The court has played an important role in laying
the foundation for the evolution of biotechnology through their liberal approach.

Timeline of Patent claims and cases

The developmental stages of the biotech patents can only be analysed by looking into
the case laws and the claims that arose during the period.

Yeast

The first patent for a living process was given in the US to Louis Pasteur for Yeast 2
that is free from organic germs of disease in the year 1978.
Invention: He invented an improvement in the manufacture and preservation of Beer and in
the treatment of yeast and wort together with apparatus for the same.
Use: The object of this invention is to eliminate and prevent the multiplication of these
organisms by the following means.

1
http://www.wipo.int/patents/en/topics/biotechnology.html
2
Patent US141072
The process he used was by causing impure yeast and to act on a solution of sugar candy in
pure water, when the fermentation is terminated , the fermented liquid is decanted and fresh
quantity of sugared water on the top of the yeast deposit. This is repeated thrice and the yeast
is then transferred to a porcelain dish after which it is dipped in boiling water. This yeast is
then put in recently boiled beer wort and subsequently diluted and covered with a glass plate.
All kinds of beer manufactured by this process may be preserved without the aid of ice, and
may be made in hot as well as cold climates. A very small quantity of yeast will be sufficient
to ferment it.
Claims :
1. The method of obtaining pure yeast by eliminating the organic germs of disease from
brewers yeast, in the manner described.
2. Yeast, free from organic germs of disease, as an article of manufacture.
3. The vessel, having neck A B, rubber-tube and glass plug as and for the purpose
described.
4. The apparatus, consisting essentially of covered vessel having water-trough around
the top, rubber tube metal pipe a, tube top and bottom gutters, and pipes together with
suitable thermometer, outlets, and inlets, substantially as set forth.
Here the court applied its mind and granted a patent for the pure form of yeast which was
something very useful as it was free from germs, it was the first of its kind.

Fibre
The next case that came up before the court was Ex Parte Latimer3 in 1989.The
patent claims were filed for fibre found in the needle of the Pinus Astralis. The applicant had
filed two application, one for the process by which the fiber in question is take from the
needles of the Pinus Australis, the other for the product itself. His claim for the product was
rejected as the fibre was produced by a natural process and existed naturally and only the
process for taking it out could be patented. If patent is granted for the fibre the result would
be that one person would get the exclusive right to use the fiber and it may also lead to
successive patents being obtained upon the trees of the forest and the plants of the earth
which would be unreasonable and impossible.
The examiner also opined that the Fibre thus obtained was more stronger and more durable
and can be produced at much lesser rate and is unquestionably valuable. He stated that if the

3
http://www.law.nyu.edu/sites/default/files/ECM_PRO_071307.pdf
applicants process had another final step by which the fiber thus withdrawn or separated
from the leaf or needle in its natural state were changed by curing or giving it some new
quality or function which it does not possess in its natural condition as fibre, the invention
would probably cover a product.
Through this case a general principle was set that the plants were natural products and were
not subjected to patent protection. It was also rejected as it was not possible to describe
plants in a written form as new plants differ from old in colour and perfume that cannot be
described in a written form, which meant that plans could not satisfy the written description
requirement under section 112 of the United States Patent Statute.
The court made a well thought out decision in terms of this case as allowing of such a patents
would have led to more and more cases of such nature with people trying to get patent rights
on the different products of nature. The courts thoughtful decision prevented such a
sceneario.

Plant Patents Act 1930

The Plant Patents Act of 1930 made it possible to patent new varieties of plants, excluding
sexual and tuber-propagated plants. It provided for a protection for a term of 20 years from
the filing of the application.
The act removed the written description hurdle by relaxing the written description
requirement by stating that reasonable restriction is enough to grant patents.
The act also made it possible to provide patent protection to the work of a plant
breeder in aid of nature.
Extended patent protection to certain asexually reproduced plants, such as
reproduction of plants by grafting and budding.

Purified Adrenaline

The discoveries in physiology and pharmacology resulted in the research into

adrenalin4. In 1894, Physician George oliver and psychologists Edward Schafer of University
college of London, reported the blood pressure raising effects obtained from an extract of
animal adrenal glands. This was found to be useful for surgical purposes and immediate
research was launched to find out the active principle (substance) in 1987 pharmacologist
4
http://www.pubpat.org/assets/files/brca/mats/Parke-Davis,%20189%20Fed%2095%20(1911).pdf
John Hopkinson produced a crystalline substance which he considered to be the active
substance in discovery made by Oliver and Schafer, but it was in impure form. Similar
discoveries were made by other scientists albeit in impure form which made it prone to rapid
decomposition and dangerous to administer by injection.
Subsequently John Takamine of Parke Davis &Co succeeded in isolating the first ostensibly
pure hormone and called it adrenaline5. The patent for the invention was filed in 1900.
Original application :
Takamines original application included seven process claims and two product claims. one of
the product claims was for the product adrenalin for the active principle in white, solid.
Crystalline form and the other was for a salt of the active principle.
This claim was however rejected by the Patent office examiner citing it as a Product of
nature merely isolated by the applicant and was not a patentable subject matter under the
statute.
An amended application was filed a year later showing that Takamines active principle had
never existed as a white crystalline substance and its complete transformation rendered it to
be New. But this claim was also rejected with the response that the transformation as really
no more than a separation, the active principle here did not exist free from impurities in
nature but it did exist and hence is not patentable.

Takamine submitted a new patent application containing sixteen product claims by reframing
what he claimed and how he claimed it. They described the active principle of the gland as
a substance having the herein described characteristics and reactions of the adrenal glands.
The claims were framed to identify the substance based on appearance, solubility, melting
point etc and more stress was given on the purity and function which the natural substance
did not possess in its natural condition. The claims also by specified the product in a stable
and concentrated form which is free from inert constituents which do not deteriorate and
decompose on keeping. The patent was subsequently granted in 1903.

The difference in the Latimer claim and adrenalin claim is that Latimer claimed a fiber which
was just withdrawn or abstracted from its natural setting and in no way affected, changed or
altered from its natural condition, whereas Takamines active ingredient possessed new
qualities or functions which the substance does not possess in its actual condition thus
making it new.
5
US Patent No 730176
It shows a situation wherein the drafting of patent claim could make a difference. It is so
because the intitial applications were rejected by the examiner rejected it the first two times
and it was only after the second re drafting of the claims the application was finally accepted
and patent was granted to the applicant.

Coated Oranges
In the case of American Fruit Growers, Inc. v. Brogdex Co 6a patent was claimed for a
new and improved process of preparing fresh fruit for market by applying a solution of borax
making it resistant to decay cause by blue mold. The court while giving its judgement
interpreted the term manufacture Under section 101 of the Patent statute to mean the
product of articles for use from raw or prepared materials by giving to these materials new
forms, qualities, properties, or combinations whether by manual labour or by machinery. The
claim was rejected as invalid as the process was anticipated and the product is not within the
patent law. The court in the light of its interpretation held that the claimed oranges were not
attributed considerably new qualities, properties, or a combination of these in order to be
considered as a manufacture.

But this also raises another question as to whether the inventor could obtain a patent if the
claimed oranges were considerably modified to possess new qualities or properties?

Product of Nature Doctrine

On numerous occasions Patents on living things were rejected by courts and patent
offices on the basis of the fact that living things are products of nature. The philosophy being
one cannot patent a product that occurs in nature in essentially the same form, it belongs to
all beyond the monopoly of anybody.
Exparte latimer is the first case where the court cited this doctrine to reject a patent claim on
fiber obtained from pinus leaves. The court laid out the following essentials.
1. A product whose physical characteristics are indistinguishable from those of its
naturally occurring counterpart does not constitute patentable subject matter.
2. It may be said that such a product is unpatentable because it lacks novelty.

6
https://supreme.justia.com/cases/federal/us/283/1/case.html
 3. Neither the novelty of a process used to produce a product of nature, nor the
unprecedented status of its discovery, can cure the inherent unpatentability of the
product.
4. The utility and consequent values of the product are irrelevant to its status as
patentable subject matter.

Tungsten
The same reasoning was applied by the court in the case of General Electric Co. V
De Forest Radio Co7. The case involved the development of Tungsten wire, which was
considered a major advance in the history of the electric bulb. Ge sued De Forest and others
for infringement of a patent claiming substantially pure tungsten having ductility and high
tensile strength, tungsten wire and the processes for making the claimed products. The district
court found the claims invalid and dismissed the complaint. Third circuit concluded that
Coolidge took tungsten as it existed or as it is found in the earth and by his process
converted it into pure tungsten and also discovered some properties which are different from
among the natural tungsten such as ductility, high tensile strength whereas natural tungsten
was brittle . But in essence what he produced by his process was tungsten in substantially
pure form, what he discovered were natural qualities of tungsten which were created by
nature and rejected the claim.
On the argument that Coolidges tungsten did differ from the natural tungsten found in nature
the court said that Tungsten is an element all of its properties are natural by definition.

Mixed cultures of root nodule bacteria

The Funk Brothers Seed Co. v. Kalo Inoculant Co 8 is another case wherein the
court applied this principle. The funk case involved a patent issued to an inventor bond who
discovered a mixed culture of rhizobia capable of inoculating the seeds of plants belonging to
several cross-inoculation groups. He obtained a patent on the multi-species inoculants but on
an infringement suit by his assignee the district court held the patent invalid for want of
invention The seventh circuit court reversed the decision but the supreme court reversed
invalidating Bonds patents and stated the following Bond does not create a state of
7
http://law.justia.com/cases/federal/appellate-courts/F2/28/641/1502452/
8
https://supreme.justia.com/cases/federal/us/333/127/case.html
inhibition or non inhibition in the bacteria. Their qualities are the work of nature and those
cannot be patentable. They are manifestations of laws of nature , free to all men and reserved
exclusively to none.
It appears from this that when the claimed subject matter lies within the natural realm, no
amount of novelty or utility in its discovery can render it patentable. Bond failed here as he
dint not take an inventive step beyond the prior art. His application was not materially
distinguishable from the work of nature.
The court in this case has clearly applied a higher standard of patentability and thereby
rejected the patent. The court here appeared to have erred in understanding the utility of the
inoculums and the advancements it provides. In fact many scientists had conducted
researches on finding out such inoculums and had failed. The court even mentioned it as a
mere advancement in the packaging
In Shell Development Co V Watson9 the expression composition of matter was
interpreted to include compositions of two or more substances and all composite articles
whether they be the results of chemical union or mechanical mixture. By this interpretation it
is also possible to bring biotechnological inventions within the meaning of composition of
matter. The patent law was also liberalized and amended in the year 1952 where any new
and useful process was added to section 101.

DNA
DNA was discovered by Crick and Watson in 1953 and it laid the foundation for modern
biotechnology. The scope of biotechnology widened even upto the potential of manipulating
and producing innovative living beings. But the 1960s did not see any inventions in
biotechnology.

Purified Prostaglandins PGE and PGF

In the case of Re Bergstrom10 the claimants had isolated two distinct chemical
compounds in essentially pure crystalline form from crude materials such as von euler
prostraglandin (human prostrate glands.. The compounds are known as PGE and PGF. This
case has been widely cited to support gene patenting. The court of customs and patent appeals
ruled that the purified hormones were not natural substances. The court held that purified

9
https://casetext.com/case/shell-development-co-v-watson
10
https://casetext.com/case/application-of-bergstrom
prostaglandins PGE2 and PGF were not anticipated and concluded that the subject matter
claimed by the applicant is new.
Here in this case the purified form is what makes the product different from what was already
existing in nature and the court interpreted that purified version of the compounds were not
obvious or anticipated and hence patent was granted with sufficient reasoning.

Anibiotic Daunorubicin

The claim in the InRe Mancy11 case was for a process for producing anibiotic
daunorubicin by aerobically cultivating the microorganism Streptomyces bifurcus. The
examiner rejected all the claims citing obviousness and held that It is not patentable to
produce the known antibiotic from either a different strain of the same species of
microorganism or a different species of the same genus unless something more is present that
merely the utilization of another source from the same field of sources of these products. The
board agreed with the examiner and cited that the choice of a different strain of the same
microorganisms is prima facie obvious.
The court also rejected the claims due to lack of novelty but Judge Rich stated that he
thinks it is in the public interest to include microorganisms within the terms manufacture and
composition of matter.
The court made a good interpretation of the product of nature doctrine and also
reflected on the lack of novelty from what was existing as the applicant had derived the same
product from a different species of the same microorganism which could have been obvious
to a person skilled in the art. The patent was rightfully rejected by the court. Pure Version of
Streptomyces Vellosus
In the case of Re bergy12 the applicant claimed a biologically pure version of the
microorganism streptomyces vellosus. The examiner rejected this claim stating that the
microorganism was a product of nature and does not comprise patentable subject matter
under section 101 of the US Patent Statute. The PTO Board of Appeals affirmed on the
argument that section 101 excluded the patenting of living organisms. The court of customs
and patent appeals reversed board. The court stated that the biologically pure culture which
was claimed by Bergy did not exist in nature and hence is not a product of nature. It is man

11
https://casetext.com/case/application-of-mancy
12
https://casetext.com/case/in-re-application-of-bergy-2
made and can only be made under controlled laboratory conditions. It also rejected the
Boards conclusion that living things are inherently unpatentable.
The Supreme Court vacated the judgment of the CCPA and remanded the Bergy case for
further proceeding. CCPA considered Bergy case and Chakrabarty case together and
reiterated that both inventions comprised statutory subject matter and also added that
whether an invention comprises statutory subject matter is a freestanding inquiry under
section 101 and has to be decided without reference to utility or non-obviousness. The
government appealed both cases to the Supreme Court and Bergy withdrew his application
and subsequently patent was granted to the living organism in the case of Chakrabarty.

The court also made an attempt to distinguish between the standards applied in the
Funk case and Chakrabarty case. According to the court Funk had just simply discovered a
natural possibility that a combination of certain root nodule bacteria did not effect mutually
inhibiting effect on each other. The court considered it as a mere discovery which was as
good as a packaging method.

But when it came to the case of diamond vs chakrabarty the court opined that it was
an invention, the applicant had made new bacteria with properties different from that of what
is found in naturally existing bacteria.

According to my understanding the court applied a higher standard of patentability for

the funk case and opted for a lower standard when it came to chakrabarty case. It opened the
flood gates for many such inventions and became a landmark decision wherein it was stated
that anything under the sun which was made by man would become patentable subject matter.
It made a huge impact on the biotechnology industry and also reflected the courts trend
towards an acceptance of a changed reasoning in order to pave way for inventoned in the
field of biotechnology.
Conclusion
The rapid growth in the field of science and the discovery of human genetic material
introduced an invaluable tool in the advancement of medicine. It enables beneficial medical
applications and other uses and hence has been commoditized through patent law. This has
created substantial difficulties in applying the requirements for a patent in the United States
The courts have made varied interpretations through the years by trying to make a
balance between keeping things in the public domain and also following a liberal approach to
accept the products resulting from the growth of biotechnology.
The courts have also added new dimensions to the product of nature doctrine through
its interpretations from Ex parte latimer to the Chakrabarty case. There have also been
situations wherein the lower courts have been confused regarding the essence of product of
nature doctrine. But through the readings one can understand the Supreme Court has
consistently adhered to the one approach. We can see a gradual growth from one to the other.
The chakrabarty decision opened the flood gate and is fundamental to the patent
landscape. The basic factor of the current patent regime is not in whether a thing is living but
whether the things are a product of nature or a product of human ingenuity. Just because
something is isolated purified and synthesized does not mean it does not come within
the product of nature. It needs a systematic evaluation of the different specific ways in which
the invention differs from the natural product.
But neither the courts nor USPTO have been able to provide a clear picture about the
patenting of living organisms. But it cannot be disputed that the courts have played an
important role in shaping up a settled patent system when it comes to biotechnology.
Biotechnology being a unique field where changes happen at a rapid pace, it throws
out newer problems for the courts to resolve. It is upon the court to set the standards and it
needs to be seen how they handle it as biotechnology inventions also involve public concern
and might also lead to detrimental effects on health on one side and also bring up rapid
advancements in science. Hopefully the distinction between inventions and discoveries will
be maintained.