A concise blood boiling presentation on patenting life and legal protection of biotechnological inventions

1. PATENTING LIFE (?!!) &
LEGAL PROTECTION OF
BIOTECHNOLOGICAL INVENTIONS
SUSAN ANN JAYAN
II M.Sc., BIOTECHNOLOGY
BHARATHIAR UNIVERSITY
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2. PATENTING LIFE
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3. What is a Patent?
• Patents are government guarantees that provide
an inventor with exclusive rights to use, sell or
manufacture an invention for a set period of
time
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4. • There are actually three different kinds of
patents under U.S. law
▫ Utility patent
 a new and inventive useful object
▫ Design Patent
 new and inventive ornamental designs for articles of
manufacture
▫ Plant Patent
 new and inventive plant varieties
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5. What is „Patenting life‟?
• Patenting of plants, animals and individual parts
of DNA
• Patenting allows industry to take control of and
exploit organisms and genetic material as
exclusive private property that can be sold to or
withheld from farmers, breeders, scientists
and doctors
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6. Why Patent?
• Patents were historically developed to insure that
inventors could share in the financial returns and
benefits deriving from the use of their inventions.
With the development of the modern corporation,
patent rights were always assigned to the company
rather than an individual.
• This gives the patent holder a form of monopoly
control for 20 years from the filing of the patent,
and creates a legal means of limiting competition.
Private investors generally regard such monopolies
as favorable to their interests, so in many industries
patents aid in the development of new products.
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7. What can be patented?
• In order to patent an object, the inventor has to
prove that
▫ it has never been made before,
▫ involves a �non-obvious� inventive step,
▫ and that it serves some useful purpose
• Patents are to be granted only on human inventions,
not on discoveries.
• Existing living organisms, like plants and animals
as well as their genes, are of course no-one's
invention and should therefore, by definition, never
be patented and put under private control.
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8. BUT IN 1980…
• In the landmark case of Diamond v Chakrabarty,
the US Supreme Court ruled that a living
organism, a bacterium that could digest oil,
could be patented. Chief Justice Warren Burger
declared that the "relevant distinction is not
between animate and inanimate things but
whether living products could be seen as human-
made inventions".
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9. EVER SINCE…
• This heralded a new era in which living
organisms could be patented, and paved the way
for the enclosure of the biological commons
• Once a shared heritage, the gene pool of plants,
animals and humans was now a commodity
waiting to be bought and sold
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10. Impact on companies
• A few months later, on October 14th, a recently
formed biotech company called Genentech offered a
million shares of stock to the market at $35 per
share. After just 20 minutes, the shares were being
sold at $89. By the end of the day, the company had
raised $36 million. Genentech had not yet
introduced a single product onto the market.
• In the words of Jeremy Rifkin, president of the
Foundation on Economic Trends, genes had been
identified as the "raw resource for future economic
activity". For those with the necessary technology
and capital, the race to patent life had begun.
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11. The Implication
• A patent, which usually lasts for 17-20 years,
gives the patent holder exclusive rights to exploit
an invention for commerical gain. What this
means in the case of genetically engineered
crops, for example, is that farmers have to pay a
license fee and royalties for the use of GE seed
and all seed produced from the plants for
duration of the patent.
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12. The Plant Patent Act (PPA) of 1930,
USA
• A plant patent gives its owner the “the right to
exclude others from asexually reproducing the plant,
and from using, offering for sale, or selling the plant
so reproduced, or any of its parts, throughout the
United States, or from importing the plant so
reproduced, or any parts thereof, into the United
States.”
• In short, a plant patent covers a single new plant
and its asexually reproduced offspring.
• The courts have construed the word “plant” in the
PPA to have its common meaning, rather than a
strict scientific meaning. Thus, for example, the
courts decided that bacteria are not eligible for plant
patent protection under § 161
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13. “Biocolonialism” ?!
• The open exchange of seeds and plant material over
the centuries has given the U.S. and Europe potatoes
and tomatoes from Latin America, soybeans from
China, and wheat, rye and barley from the Middle
East, to name but a few. The developing world has
never received compensation or recognition for these
intellectual and technological contributions.
• Patenting plant life will intensify the inequality
between the developing and industrialized nations.
• While centuries of innovation by indigenous farmers
have created most of the food crops grown today, the
tinkering by agribusiness entitles them to claim a
plant as their own invention, and receive all profits
from its use.
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14. INDIA (Azadirachtin) Vs W. R. GRACE
(US Company)
• It was possible that Indian citizens would have
been required to pay royalties on the products
produced from the Neem, since a patent had
been granted to the U.S. company W.R. Grace on
a compound in the tree (azadirachtin) for the
production of a biopesticide. In 1993, over five
hundred thousand South Indian farmers rallied
to protest foreign patents on plants such as the
neem, and launched a nation-wide resistance
movement.
• The patent was revoked later
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15. Animal Patenting
• In 1987 a Harvard biologist was granted the first patent
for an animal. The �oncomouse� was genetically
engineered to predispose it, and all its offspring, to
develop cancer, so they can be used for research. The
patent on the oncomouse, which is licensed to DuPont
(the corporation that financed the research), extends to
any other animal genetically engineered to contain genes
that cause cancer.
• By 1997, over forty animals had been patented, including
turkeys, nematodes, mice and rabbits. Hundreds of other
patents are currently awaiting approval, including
patents on pigs, cows, fish, sheep and monkeys.
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16. • Tracey the sheep has had human genes introduced
into her mammary glands so that she produces a
human blood-clotting agent called alpha-1-
antitrypsin in her milk. The patent is held by
Pharmaceutical Proteins Ltd. (PPL). Their
spokesperson described sheep like Tracey as "furry
little factories walking around in fields." Tracey's
success was said to provide "a strong impetus to the
further exploitation of transgenic sheep as
bioreactors for the production of large amounts of
pharmacologically active proteins"
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17. Human Gene Patenting
• It is difficult to estimate how many human genes
have been patented, but one company estimates
that the U.S. Patent and Trademark Office has
issued more than 1,250 patents on human gene
sequences (?!!)
• In 1991, the European Patent Office granted a
patent on a human gene for the first time,
defending its position to the European
Parliament by arguing that �DNA is not life�
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18. A weird example..
• A Massachusetts corporation called Athena
Diagnostics, wrote to laboratories informing them of
its "exclusive rights to certain tests in the diagnosis
of late-onset Alzheimer�s disease. These tests are
covered under US patent number 5,508,167, a copy
of which is enclosed." Athena went on to say that it
would be pleased to perform the tests for the
published price of $195 per specimen. That is more
than twice the price previously being charged by
some university medical laboratories, and way
beyond the means of some of the researchers
operating on government grants, who examine
hundreds of samples in the search for new
mutations and possible therapies.
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19. Another example..
• In 1976, a leukemia patient named John Moore had
surgery at the University of California to remove his
cancerous spleen. The University was later granted a
patent for a cell line called “Mo,” removed from the
spleen, which could be used for producing valuable
proteins. The long term commercial value of the cell
line was estimated at over one billion dollars. Mr.
Moore demanded the return of the cells and control
over his body parts, but the California Supreme
Court decided that he was not entitled to any rights
to his own cells after they had been removed from
his body.
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20. The broad species patent
• It is extraordinary that a company can make a single genetic
alteration to a plant, and claim private ownership to it as their
invention, when the very plants that are being engineered
result from thousands of years of careful selection and
breeding by farmers around the world.
▫ In 1994, the company Agracetus was awarded a European patent
which covered all genetically engineered soybeans. Rival
companies, including Monsanto, were outraged and immediately
challenged the patent, saying that it would result in just one
company having an effective monopoly over all GE soybeans.
Monsanto argued that "the alleged invention lacks an inventive
step" and was "not ... novel". In the end the solution for
Monsanto was to buy Agracetus, together with the patent, and
drop the complaint. As well as the patent on soya, Monsanto now
holds a patent in both Europe and the US on all genetically
engineered cotton (?!)
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21. TRIPS (Trade Related Aspects of
Intellectual Property Rights)
• TRIPS was the brainchild of a coalition of corporations
who called themselves the Intellectual Property
Committee. It was vigorously opposed by the resource-
rich countries of the Third World because it legitimises
biopiracy, enshrines it in international law and
undermines community rights.
• Monsanto's James Enyart describes how this happened:
"Industry identified a major problem for international
trade. It crafted a solution, reduced it to a concrete
proposal, and sold it to our own and other
governments�The industries and traders of world
commerce have played simultaneously the role of
patients, the diagnosticians, and the prescribing
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22. TRIPS does not require biotech companies to
ask for prior consent before accessing biological
resources, nor does it demand that patent
holders share their benefits with the people or
lands from which the genes originate. Under the
agreement, countries are obliged to bring their
patent laws into line with the industrialised
nations by extending them to include living
organisms or by setting up equivalent systems of
intellectual property rights.
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23. LEGAL PROTECTION
OF
BIOTECHNOLOGICAL
INVENTIONS
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24. In Europe… the Directive 98/44/EC
Clear and effective legal protection in the field of
biotechnology is essential for both techno-scientific
research and economic development. That is the purpose
of this Directive which also specifically bans human
cloning and any modifications to germ line genetic identity.
The ethical aspects are handled by an independent
committee which has been given the task of advising the
European Commission on these matters.
Inventions which are new, involve an inventive step and
are susceptible of industrial application
are patentable even if they concern a product consisting
of or containing biological material
Biological material which is isolated from its natural
environment or produced by means of a technical process
may also be the subject of an invention.
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25. The objective of the Directive is to clarify the
distinction between what is patentable and what
is not. It particularly seeks to confirm that the
human body at the various stages of its
formation and development, and processes for
cloning human beings and for modifying the
germ-line genetic identity of human beings, may
not be regarded as patentable inventions.
In order to protect biotechnological inventions,
Member States must ensure that their national
patent laws conform to the provisions of the
Directive.
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26. The following are not patentable:
plant and animal varieties;
essentially biological processes for the production of plants or
animals, such as crossing or selection. This exclusion from
patentability does not, however, affect the patentability of inventions
which concern a microbiological process ;
the human body and the simple discovery of one of its elements,
including the sequence or partial sequence of a gene.
However, an element isolated from the human body or produced by
means of a technical process, including the sequence or partial
sequence of a gene, may constitute a patentable invention.
The following inventions include those that are
unpatentable where their exploitation would be contrary to public
policy or morality:
processes for cloning human beings;
processes for modifying the germ-line genetic identity of human beings;
uses of human embryos for industrial or commercial purposes;
processes for modifying the genetic identity of animals which are likely to
cause them suffering without any substantial medical benefit to man or
animal, and also animals resulting from such processes.
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27. REFERENCES
• Patent Law: How Patents Grew Over Time To
Include Living Organisms-1,2 and 3. By Joe
Miller
• http://archive.greenpeace.org/geneng/reports/
pat/intrpat.htm
• http://www.actionbioscience.org/genomic/crg.h
tml
• http://www.innovaccess.eu/documents/protecti
onBiotechnological_0000001089_00.xml.html
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