Legal Issues of Biotechnology Patents

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Oct 22, 2013 (3 years and 7 months ago)

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Legal Issues of Biotechnology Patents
V.K. Unni
Lecturer
NALSAR University, Hyderabad
www.nalsarlawuniv.org
E-mail: unni@nalsarlawuniv.org
Basics of Biotech
The science of genetics has its roots in the botanical
gardens of the Austrian monk Gregor Mendel, who
observed that certain traits, such as the shape of peas,
were predetermined by a distinct entity called genes
The biochemical structures and functions of genes
were not fully explained for a long time, almost a
century it was unknown
In 1953, Francis Crick, James Watson, Maurice
Wilkins and Rosalind Franklin determined the three
dimensional structure of DNA through X-ray
diffraction.
Basics contd
In 1972 the era of biotechnology came of age, when
the first successful molecular cloning experiment
was reported.
By demonstrating that a gene could be transferred
from one DNA molecule to another through
biochemical manipulations in a test tube,
Thus the door to understanding the molecular basis
of life, and to a multi-billion dollar industry, was
knocked wide open.
Genes-Basics
Human body is made up of approximately 10 trillion cells
DNA is found in the nucleus of every cell and is the basic
genetic material
DNA instructs the cell how to make proteins
Just as a story book contains stories, DNA contains genes
In every human cell the DNA is tightly wrapped into 46 (23
pairs) structures called chromosomes, 23 we inherit from
father and 23 from mother
Chromosome to be simple is a long piece of DNA
Genetic Engg. / Recombinant DNA Tech/ DNA
Cloning
Here a DNA fragment containing a particular gene
(e.g. insulin) is isolated and united with a cloning
vector
This recombined DNA is introduced into the host
cell, normally a bacterium to produce insulin
This bacterium can be grown in large quantities to
extract insulin
Reproductive Cloning
In this type of cloning , genetic material (DNA) from the
person who has to be cloned is taken
Secondly an unfertilized egg is taken from a female, and
its genetic material (DNA) is removed
Thirdly the genetic material of the person to be cloned is
placed into the egg and this reconstructed egg is treated
with a process which results in cell division
This creates an embryo which is an exact copy of the
person to be cloned and it is transferred to the uterus of a
female which gives birth by natural process
Therapeutic / Stem Cell Cloning
Here the aim is not to clone human beings or animals, but
this is aimed at creating stem-cells
Stem-cells can be used to create any type of specialised
cell in the human body , like liver cells, heart cells etc
Stem-cells are extracted from the embryo after 5 days
from the date of fertilization of egg
Using stem cells organs may be cloned
This will provide great relief incases of organ rejection
which is very common in transplantations
Basics of Patents
»Laws of almost all countries rewards inventors
for their innovation by granting a temporary
monopoly on their inventions in exchange for
making their findings public
»To receive patent protection, however, an
invention must:
(1) qualify as patentable subject matter;
(2) be novel;
(3) have utility; and
(4) be inventive (non-obvious)
Gene Patenting
Patents in genes and genetic fragments fall under the category of
general patents (utility patents in USA), which covers such items as
"machines, industrial processes, compositions of matter, and
manufactured articles.
Regardless of which category an invention falls into, it must bea
"new and useful process, machine, manufacture, or composition of
matter, or any new and useful improvement thereof" in order to be
considered patentable subject matter
This general doctrine is limited by the fact that products of nature
cannot qualify as patentable
Case Laws
In Funk Brothers Seed Co. v.Kalo InoculantCo.
333 U.S. 127 (1948).
The patent involved a process for inoculating plants with
strains of naturally occurring bacteria
The U.S. Supreme Court stated, "Patents cannot issue for
the discovery of phenomena of nature," and "these 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
Diamond v. Chakrabarty
But in Diamond v. Chakrabarty, 447 U.S. 303 (1980), the US
Supreme Court extended patent law to cover living things.
Diamond involved a patent application that claimed rights ina strain
of bacteria that was genetically engineered to break down crude oil.
The Patent Examiner and the Patent Office Board of Appeals denied
the patent application, but the Court of Customs and Patent Appeals
reversed this decision and the Supreme Court affirmed. The Supreme
Court held that living organisms fall within the realm of patentable
subject matter as long as they are "a non-naturally occurring
manufacture or composition of matter -a product of human
ingenuity.
Evolution of Law
Thus genes, which are naturally occurring, would
not qualify as patentable subject matter
The mere identification of a gene is no more than
the discovery of a naturally occurring object
Discovering a gene does not require the ingenuity
involved in genetically creating bacteria
But "purified and isolated" gene sequences are
different from those occurring in nature and are
patentable, Amgen, Inc. v. Chughai Pharmaceutical
Co., Ltd 927 F.2d 1200, 1206 (Fed. Cir. 1991)
Amgen, Inc. v. Chughai
•The Court in Amgen found that the ingenuity
involved in isolating the useful portions and
removing the extraneous portions of a gene
created a new composition of matter, a
composition that was sufficiently different from
its naturally occurring counterpart to warrant
patent protection
•Since a gene patent is really a patent on modified
portions of DNA that are created through genetic
engineering, granting such patents does seem
acceptable
Novelty
When it comes to novelty there is a strong argument that
non-naturally occurring organisms, which are clearly
original, easily satisfy the novelty requirement.These non-
naturally occurring organisms are the product of human
ingenuity.
With regard to genes, however, the analysis is not so
straightforward. The genetic material involved in human
gene patenting appears to be a product of nature.
How can these genes qualify as novel?
In their natural form, genes are not novel under any
standard;
But once isolated and purified, however, these genes
constitute creations that are easily distinguishable from
their natural counterparts and are, therefore, "new.
When scientists clone sequences, they isolate only the
protein-coding portions
Isolating and purifying the gene sequence creates the
requisite novelty necessary to satisfy patent law.
Inventiveness
Inventiveness or non-obviousness means that a person
reasonably skilled in a particular area (e.g., genetic
engineering), based on the knowledge in the area at the
time, would not have foreseen the development of the
invention in question.
This may prove problematic in gene patenting cases
because the discovery of new genes generally incorporates
well-established scientific techniques
Thus, the inventiveness / non-obviousness" of the specific
gene in question may be defeated simply because the
technique used to discover the gene has already been used
Inventiveness contd
In reDeuel, 51 F.3d 1552 (Fed. Cir. 1995).
The court solved the aforementioned problem by establishing that
non-obviousness could be established for a specific gene despite
the fact that the engineer isolated the gene through an already
existing technique.
a general motivation to search for some gene that exists does not
necessarily make obvious a specifically-defined gene that is
subsequently obtained as a result of that search.
Thus newly-identified genes can satisfy the non-obviousness
requirement despite the fact that the process used to isolate the
gene was obviously based on the knowledge in biotechnology at
the time
Utility
•Utility in patent law requires nothing more of an
innovation than to show usefulness.
•In cases in which the biotechnological material at issue
cures disease or is used as a pharmaceutical product,
it is easy to satisfy the utility standard
•But when genes or gene fragments are discovered,
their specific purpose or possible use is not self-
evident
•In such cases one must, in order to demonstrate
utility, it must be shown that the gene sequence can
"function as different types of markers, probes, and
primers for various genetic research."
Benefits
Gene patenting promotes advancements in medicine and
genetic engineering that justify the practice of granting
such patents
It is possible that in the near future animals will be
genetically engineered to produce insulin, growth
hormones, and drugs designed to treat heart attacks
and strokes
In the food and agriculture industries, genetic engineering
may lead to higher quality food for humans by creating
animals "that are "better able to resist disease
The present and possible future results of genetic
engineering will benefit the human race; therefore, we
need to assure the protection of genetic engineering so
that these advancements will continue
Arguments against Gene Patenting
Universal Heritage Argument
A preliminary question concerning the ethics of
gene patenting is whether it is "ethical to patent
segments of the human genome when these
segments are inherent to each individual's personal
identity and common to all humanity.
Many argue that it is inappropriate to grant a patent
on something that is, "part of our universal
heritage."
Arguments Against Gene Patents
The universal heritage theorists argue that genes are
the product of millions of years of evolution and
thus are the property of all of mankind, not any one
individual.
As a result, those who advance the universal
heritage theory claim that the information contained
within genetic material cannot become intellectual
property
Arguments against .. cont…d
Distributive Justice

The distributive justice argument claims that
the practice of gene patenting vests the
benefits of biotech research in a small number
of countries, while denying these benefits to
less-developed countries.
This discriminates developing countries
Arguments against .. cont…d
Religious Objections to Gene Patenting
•Those opposed to gene patenting on
religious grounds claim that genetic
engineering is tantamount to "playing
God“
•Such genetic manipulation enters an area
of life that God rules and that humans
should not enter.
Arguments against .. cont…d
Commodification of Genetic Material
Argument is based on the premise that patents in
biotechnology are essentially the issuance of
property rights in life.
Thus life is reduced to a commodity ie, life is no
different from a car or some other object.
Just as we are not allowed to sell our children or our
organs, proponents argue, we should not allow
others to sell and manipulate our genetic material
for profit
Other arguments against…
Genes are not "Inventions
•Because the discovery of genes does not require an
inventive effort, the PTO should not issue patents for
genes.
•Human genes have existed as long as the existence of
humanity; therefore, an inventor can never discover a
gene and claim that it is "novel."
•Finally, carrying patent law to its extreme, some argue
that anyone containing patented genes within his or
her body could be considered an infringer, because he
or she is "using" a patented gene merely by being
alive.
Legislature’s Non-intention
It was not the Legislature's Intent to Include
Genes as Patentable Subject Matter
•Another argument proffered by those opposed
to the patenting of genes is that Congress did
not intend to include genes as patentable
subject matter
No Inventive step Involved
•Sequencing DNA is so Routine that it is not
Inventive
•The argument is that because of recent
advances in the isolation, purification, and
sequencing of genes, it may take only a few
days to determine the sequence of a particular
gene. Therefore, the relative ease of
determining the sequence of a particular gene
should preclude patenting of the gene because
obtaining the sequence is obvious
Objection on Non Utility
A DNA Sequence by Itself has Little Utility
Some argue that "because a DNA sequence by
itself has little utility," genes should not receive
patents.
DNA sequence is just information that describes
the corresponding gene, and because a gene
consists of a DNA sequence, it therefore has little
practical utility and is not patentable under the
relevant law
Gene Patents Should Be Limited to
"Processes"
The final argument in this category relates to the
difference between patents on compositions and
patents on processes.
Patents on compositions are considered broader
than patents on processes because patents on
compositions can cover all processes that use the
composition.
Position in EU/ Canada
A genetically modified mouse was granted a patent by
the EPO in 1990.
(Harvard Onco-mouse case(T19/90), [1990] E. P.O.R. 501
But the Canadian Supreme Court rejected the claim for
genetically modified mouse by drawing a distinction
between higher and lower life forms (2002 SCC76)
Though lower life forms are patentable in Canada
higher life forms are not
EU Directive
Directive 98/44 was adopted by the Council and the European
Parliament to promote the development of biotechnological
inventions at EU level
Art 6 EU Directive states that
Inventions that would be contrary to order public or morality
shall be unpatentable
processes for cloning human beings;
processes for modifying the germ line genetic identity of human
beings,
uses of human embryos for industrial or commercial uses
Process of modifying genetic identity of animals which are likely
to cause them suffering without any substantial benefit to man or
animal
Indian Position
In India the debate is still a low key one
Sec. 3(j) of the Indian Patents Act states that plants
and animals in whole or in part thereof including
seeds, varieties and essentially biological process
for the production of plants and animals are
excluded
However after the 2002 amendment micro-
organisms can be patented provided they satisfy the
other requirements
NALSAR University, Hyderabad
Thanks a Ton
E-mail: unni@nalsarlawuniv.org