problems raised by biotechnological inventions for patent scope interpretation.
5 April 2002, All Rights Reserved.
field of Biotechnology is rapidly advancing. Ever since the report of the
first successful cloning of a sheep named Dolly in early 1997, advances in
genetic engineering have gained attention globally. Virtually no day
passes without reference to new developments in biotechnology, and most
have legal implications. A few are studded with ethical controversies.
research and development involves a great deal of time and money. Parties
investing in such research are looking to protect their investment.
As a result of this, the patent process has become important in the
field of Biotechnology.
the purposes of this paper, the structure of contents is in three
and justifications of patenting biotechnological inventions.
the scope of patent to be granted and looking at the patentable
subject matter in the biotechnology industry.
debate on human cloning and conclusion.
the words of J. Curry, who gives a very wide definition to the term
‘Biotechnology’, it refers “to any technique that uses living
organisms (or parts of organisms) to make or modify products, to improve
plants or animals, or to develop micro organisms for specific uses.”
can be seen as encompassing all technologies involving the processing of
biological materials. Biotechnological inventions have already had a major
impact on a number of industries, including medical research, agriculture,
animal production and health, dairy, beverages, food, and waste
processing. The potential applications of biotechnology are very wide and
new applications of biotechnological inventions are constantly being
developed. It is likely that in future, use of biotechnological
innovations will be increasingly important to many sectors of industry in
maintaining international competitiveness.
in Patenting Biotechnological inventions
question forming part of this section is whether or not it is appropriate
to issue patents for biotechnological inventions. Many arguments have been
raised against patenting of biotechnological inventions. In some cases,
these arguments are valid and are of real concern. However, in other
cases, they may stem from a general misunderstanding of biotechnology and
its potential applications, of the patent system and its limitations, and
of other forms of legislation that control the use of this technology.
us evaluate some concerns here: -
– The genetic alteration of life is an emotional subject and there
is no doubt that the debate on whether it is appropriate or not will
continue and evolve with the developments in biotechnology. This will
be the case whether such inventions are patented or not as further
experimentation and advances in this area will not be prevented merely
by prohibiting patents of life forms and genetic material. However, by
allowing patents for such inventions, it may be considered as an
encouragement and thus facilitate further research, development and
use in this area.
and commercialization of life – Allowing patents for these
types of inventions leads to the ownership and commercialization of
life, and reduces life forms to ‘products of manufacture’. This
seems somewhat misguided. The human race has claimed ownership of and
has been exploiting nature, including life forms, to a commercial end
for centuries. Further, now we can obtain genetically superior species
of plants and animals; albeit via breeding programmes. The only
difference between these past practices and the use of the current
technology is that biotechnology makes it easier, and potentially more
economical, for us to select desirable genetic traits.
of country’s resources – There is widespread concern that
granting patents for life forms and genetic material may encourage
multinational companies to exploit the natural resources of a country
without the authority and acknowledgement of, or reward to the
country. However, the provisions of the Convention on Biological
Diversity (the Rio Convention) of 1992, which as of 15.01.1999, 175
countries have ratified, gives signatory states the right to exploit
their resources by establishing laws which prevent overseas companies
from doing so.
concern – Allowing patents for certain life forms and genetic
material may be insensitive to the beliefs of indigenous populations and
may exploit their knowledge. These issues are real and must be addressed.
us evaluate some more factors which justify patentability of
biotechnological inventions: -
contributes to life saving medical treatments. Advances in
biotechnology have enabled the development and increasing availability
of life saving medication and contributed towards the eradication of
may increase human welfare. Biotechnological inventions have the
potential to provide increased and more reliable food harvests for the
world's population, and to provide alternative means of producing
goods that will use fewer resources. E.g.
may have positive environmental effects. Biotechnological advances
may result in production processes and products that are less
polluting and use less resources. There is also the potential to clean
up existing pollution and to improve waste management through
biotechnological processes. E.g. US $ 100 billion worth of crops are
destroyed annually by soil-dwelling nematodes damaging crop plants.
Chemical nematicides are the only option for crop protection, but
these are among the most toxic and environmentally damaging pesticides
that are in widespread use.
Biotechnological inventions serve as an alternative to this.
– Broad vs. Narrow Patent scope
Schumpeter raised an issue of whether a highly concentrated industry or a
structurally more competitive one is best for technical change. Since
then, this question has been a prime topic for research and controversy
it is worth mentioning the analysis of two authors – Edmund Kitch and
Robert Merges & Richard Nelson, in assessing the appropriate patent
– Prospect theory
author is associated with designing a patent system that allows the
inventor of the technology to have a broad patent scope initially to
enable the pioneering inventor to plan, undertake or coordinate future
developments. Kitch proposes this theory keeping in mind the waste and
inefficiency associated with rivalrous development of technology.
further says that patents are granted after invention but before
commercialization and this has two advantages:
it allows “breathing room” for the inventor to invest in
development without fear of another firm pre-empting the work.
it allows the inventor to coordinate activities with those of
potential imitators to reduce inefficient duplication of inventive effort.
prefers a single-firm dominance in respect of a technological prospect. He
emphasizes that a firm can develop the prospect by itself. And in respect
of the different parts of the prospect, the firm can engage in carefully
controlled licensing agreements.
Kitch’s hypothesis stresses that granting broad patents is likely to
make subsequent invention and development more orderly and productive.
us evaluate an example where broad patent was granted:
was granted to Dr. Phillip Leder and Dr. Timothy Stewart of the Harvard
Medical School for their successful work involving transgenic mice. They
isolated a gene that is associated with cancer in mammals and then
injected the same into a fertilized mouse egg, which yielded transgenic
mice that are extremely sensitive to carcinogens.
Leder and Stewart claimed not only the technique they had used, or the
particular transgenic mice variety they had created, but also on all
“non-human transgenic animals” produced by their technique. A significant question arising here is that whether
substantial steps are required to get the same results in higher order
mammals like dog or whether a transgenic cat produced using a different
technique would fall outside the scope of infringement?
and Nelson approach
authors propound a theory entirely different from Kitch and is based on
the existence of competition in the industry. Following points are worth
noting in their favour:-
Past experiences have shown that when a firm had control over a
broad technology, it became relaxed until faced with outside threat.
Once a firm develops and becomes competent in one part of a
‘prospect’, it may be very hard for it to give much attention to other
parts, even though the competitors feel tremendous scope there.
The characteristic of ‘prospect’ for technological development
is that no one knows for sure what is out there. Different parties are
bound to see the prospects differently. The only way to find out what
works and what does not is to let a variety of minds try.
The licensing agreement criteria suggested by Kitch is impractical
as per these authors. Substantial literature documents the steep
transaction costs of technology licensing, and there is indirect evidence
that these costs increase when major innovations are transferred.
and Nelson acknowledge the fact that rivalry does lead to waste. But it
argues the converse that there are major social dangers of letting the
advance of a technology to be under the control of one or a few
organizations. They also argue that granting limited patents would be more
consistent with the enablement doctrine, which allows the inventor only
what he has actually invented as spelled out in the specification.
claim on particular product is clearly broader than one simply on a
particular way of making that product. Thus, Merges and Nelson recommend
that the product versus process issue in biotechnological inventions is an
interesting variation on the patent scope issue. E.g. a product produced
by Genentech using recombinant DNA technique was found to infringe a
patent covering an old product, even though the recombinant version of the
product was much simpler and cheaper to prepare.
Patent Scope and Biotechnology
inventions are concerned with processes occurring in living matter
including animals, plants or microorganisms, the products so obtained and
their industrial application. The field of their application is broad and
covers, for example, the use of fungi in the bakery, wine and antibiotic
industries, bacteria for the manufacture of vaccines, plant extracts and
the like. Classical biotechnology was concerned with natural occurring
biological processes and products and their improvement. This situation
posed serious problems concerning patentability:
of living matter that reproduces itself, that is, patentability of
plants, animals and microorganisms.
of chemical substances produced by living matter.
of microorganisms extracted from natural sources.
problems in patentability have arisen:
Does the identification and separation by conventional methods of
genes which code for well-known compounds represent a discovery or an
invention? A classical example in this area is insulin, a protein that has
been known for some time and is produced by a specific gene in the animal
body. The structure of this gene was not known until recently.
Are claims directed to genetically-engineered known compounds
acceptable? For example, should a claim directed to "genetically
engineered insulin" be allowed, notwithstanding that the inventor
discovered only one of the many gene manipulation methods, or should the
claim be limited to a product by process?
Are functional claims often so broadly worded that they may prevent
further research in a specific field for fear of infringement suits,
acceptable of should the claims be limited to the actual description in
prerequisites to render a biotechnological invention patentable may
generally be described as:
Novelty – The invention has to be new. This ensures that
the granting of a patent will not provide a monopoly right to a party for
something that was already known. Another unique thing about this
qualification is that it differs between countries. Throughout the world,
one of the following three main systems are adopted by different countries
for assessing novelty:
Local Novelty – an
invention must neither be publicly used nor published in the particular
country in which the applicant seeks patent granting.
Relative Novelty – an
invention must neither be published in any country in the world nor used
publicly in the particular country in which the applicant seeks a patent.
Absolute Novelty –
Prior to the filing of application, the invention must not have been
published or publicly used in any country.
Inventive Step – For patenting something, it must provide
some advancement or step forward in technology. An alleged invention is
said to lack an inventive step if it would be obvious to a person of
general skill in the art. The degree of thought and imagination required
to render an invention patentable will differ. However, in general, it is
only a small degree of imagination or a small step above what was known
previously, that shall constitute an inventive step.
Utility – Another requirement for a patent is that the
invention has industrial applicability, i.e. the invention must serve a
practical purpose and be capable of use in some kind of industry.
requirements to obtain a valid patent in case of biotechnology are:
Enabling Disclosure – The constraint for an enabling disclosure
is central to one of the main aims of the patent system; to promote
disclosure of information to the public. The specification filed with
the application for a patent must sufficiently describe the invention
along with the best method by which it may be performed in enough
details to allow a person of average skill in the relative field to
rework the invention with no further experimentation or invention. To
the extent it is to include a clear description of how to use an
invention, this requirement overlaps with the utility principle.
Deposit of Micro-organisms – This is essential to the need of
filing an enabling disclosure. This is necessary as it would be near
impossible to accurately describe in writing all the characteristics
of the micro-organisms. A sample can be deposited in a recognized
depository, e.g. American Type Culture Collection.
Case Study – NIH cDNA Patent
the period June 1991 and February 1993, National Institutes of Health (NIH)
filed three applications for allegedly novel human EST’s (expressed
sequence tags). The applications sought protection for alleged inventions
associated with the identification of approximately 6800 partial cDNA
sequences or EST’s. The EST’s appeared to have been isolated by
standard techniques used in the field of molecular genetics.
claimed protection for each basic EST’s, full genes containing the
EST’s, constructs containing the EST’s, panels of EST’s, antisense
probes relating to the identified EST’s.
us now evaluate this patent application in terms of the requirements
mentioned above: -
– even though there is no concrete information or evidence here, we
will assume that the EST’s were found to be novel in the form in
which they were isolated.
Step – During the examination of the application, following
objections were raised against claims directed to the method of
isolating the EST sequences of the applications:
methods used principles and strategies commonly applied in molecular
the methods were well-known was established in a number of
mere fact that the methods were used to isolate previously unknown
sequences was not considered to impart any degree of inventiveness
to the method.
Utility – Consideration was given of the techniques utilized to
put the EST’s to the use and which EST’s can be put to which uses. The
following points of arguments featured:
The NIH stated uses for the EST’s which were known in the field
of molecular genetics and precise techniques were previously available for
carrying out these uses. The NIH did not suggest that the techniques which
may be used to put the EST’s to use were any different from the
techniques already known in the field. Based on these facts, it seems that
the NIH had not invented any new technique for putting EST’s to use.
At the date of filing the patent specifications, none of the
EST’s had been fully characterized in respect of what they may code for
or where they mapped in the human genome. Thus, the uses suggested were
from the above, it was suggested that all the NIH appeared to have
achieved was a mere discovery of a vast number of sequences obtained using
Enabling Disclosure – NIH specifications were severely lacking,
as they did not disclose methods for putting any one of the identified
sequences to a specific use. As a result, skilled person would not have
been able to put the EST’s to use without first characterizing them and
identifying which of the many sequences were of interest for one of the
particular purposes alluded to in the specifications. This obviously would
involve a considerable amount of experimentation.
NIH discoveries appeared to lack any inventiveness, did not provide an
enabling disclosure and as a result did not establish that the EST’s had
any immediate practical use. Amidst surrounding controversy and adverse
examination reports from the US Patents and Trade Marks Office (PTO), the
NIH abandoned these patent applications in February 1994.
is Patentable in Biotechnology?
assessing the scope of Biotechnological inventions, we now turn to look at
what parts of Biotechnology are patentable: -
protection for a protein may be granted if, not been previously
characterized, has been isolated from a natural resource in pure form.
novel or known protein obtained via recombinant DNA technology may be
patentable. E.g. a hormone expressed from a recombinant vector.
A new strain of micro-organism produced artificially – this may
include a micro-organism transformed by a recombinant vector.
A micro-organism newly isolated in pure form from a natural source.
A novel product produced by a micro-organism is patentable – e.g.
If a product produced by the micro-organism is known, the process
of producing the product using the micro-organism may be patentable.
Novel techniques/processes for producing a particular product
(protein/clone) may be patentable.
A known process used to produce a novel product is generally not
if artificially produced.
RNA, Amino Acid Sequences?
isolated sequences generally will not be patentable if they have no
utility, i.e. they have no known use at the date of filing the
Newly isolated genes in pure form.
A gene to which alterations have been made.
A gene in recombinant form.
vectors created in the laboratory and used for cloning or expressing gene
sequences may be patentable.
Plant or Animal?
present, there is much controversy over the patentability of plants and
many countries, it has generally been considered that an animal or plant
or a process for producing an animal or plant is not patentable. However,
views on this are changing and a number of patents have already been
granted. E.g. the Harvard Oncomouse.
varieties may be protected in most industrial countries by way of Plant
Variety Rights – also called Plant Patents.
these broad guidelines, across the globe, each country has taken a
different approach to biotech patent regulation. Let us evaluate the
stand adopted by some countries:
Australia’s approach to biotech patents is one of the most liberal. In 1976, the
Australian Patent Office (APO), in Rank Hovis McDougall Ltd.’s
Application, held that living organisms are patentable, implying that they
are inventable. The Australian Patent Act contains no express
prohibition against the patenting of life forms (aside from human beings).
The APO considers all living organisms excluding human beings as
potentially patentable subject matter.
US Patent Law has followed Australia’s liberal approach
towards biotech patents. The US Supreme Court decision in Diamond
vs. Chakraborty (1980) opened the way for inventions relating to genetic
engineering and living organisms, declaring them as inventable. The
United States Patent Office (USPTO) has since issued patents for over
6,000 genes, and about 1,000 of these relate to human genes.
However, in response to criticism that their gene patents are too liberal
in defining what is invented, the US recently issued “utility
guidelines” requiring stricter applicability standards.
contrast, Europe adopts a more cautious approach towards granting biotech
patents, which is addressed by the European
Union Directive on the Legal Protection of Biotechnological Inventions.
The Directives include a non-exclusive list of unpatentable processes, for
example, cloning, germ-line modifications, embryo processes, transgenic
27 of the TRIPS Agreement
provides that members may
exclude from patentability:
Inventions, the commercial exploitation of which is necessary to
protect ordre public or morality, including to protect human, animal or
plant life or health or to avoid serious prejudice to the environment:
Diagnostic, therapeutic and surgical methods for the treatment of
humans or animals.
Plants and animals other than micro-organisms, and essentially
biological processes for the production of plants or animals excluding
non-biological and microbiological processes.
biotechnology as a whole has been the subject of enormous claims. In many
ways, to talk about biotechnology in general is not helpful because we are
really talking about problems concerning human beings, problems concerning
plants, animals and environment. We have to decide to what extent we want
our society to encourage or discourage research and development in this
area. We have to look at the question of limits. Are there limits here, if
so, how do we discover them, how do we accept them and how do we enforce
the end, biotechnology should be treated as a great experiment. We really
don't know yet where it is going. We don't know what it will do for us or
to us. My own bias would be somewhere in the middle. If there are
benefits, we will get to them eventually.
Issue– Human Cloning
began cloning frogs in the 1950s. When a team from the Roslin Institute in
Edinburgh successfully cloned an adult mammal for the first time in 1996,
the possibility of human cloning came a step closer to reality. No one has
managed to clone a human being yet, but several groups have announced that
they plan to do so.
is it done?
the sheep was cloned by transferring the nucleus of a body cell into an
egg which had already had its nucleus removed. This is also known as
nuclear transfer. It is likely that an attempt to clone humans would be
based on the same method.
ban human cloning?
mainstream scientists are set against attempts at reproductive human
cloning, including Ian Wilmut, the British embryologist who led the team
which cloned Dolly the sheep, and Richard Gardner, who chaired a Royal
Society working group on human cloning. The most persuasive argument is
that the risks are far too great at present. It is feared that human
cloning would be cruel, because the process may result in a large number
of miscarriages and deformities before a human could be successfully
cloned. For instance, it took 272 attempts to create Dolly. Even then, the
child could not be guaranteed ongoing good health.
Prof Gardner put it: "Our experience with animals suggests that there
would be a very real danger of creating seriously handicapped individuals
if anybody tries to implant cloned human embryos into the womb."
religious groups, including some Roman Catholic and Muslim organizations,
also object to cloning. There are many ethical arguments for a ban,
including fears that cloning humans will lead to "designer
babies" with genetic traits selected by their parents, or a black
market for embryos, and the creation of a "genetic underclass".
break-through in cloning involved tricking a human egg into starting to
develop on its own, without benefit of a sperm. The idea is to use a
person’s own DNA to make an embryo or, in the case of a woman, her own
egg to make an embryo. Stem cells could then be extracted from these
embryos and used to grow whatever cells or tissues a person might need —
even whole organs for transplantation. This strategy would obviate the
rejection problems that haunt transplants today, as an embryo created from
the recipient’s own DNA would be the source of the replacement organs. Thus,
reiterating bringing this domain within the span of patenting
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5 April 2002, All Rights Reserved.