Intellectual Property Rights for Biotechnology

The development of the genetic resources of biodiversity is known as

biotechnology. Broadly defined, biotechnology includes any technique that uses
living organisms or parts of organisms to make or modify products, to improve
plants or animals, or to develop microorganisms for specific uses (Congress of
the United States, Office of Technology Assessment, 1990). Mankind has used
forms of biotechnology since the dawn of civilization. However, it has been the
recent development of new biological techniques (e.g., recombinant DNA, cell
fusion, and monoclonal antibody technology) which has raised fundamental
social and moral questions and created problems in intellectual property rights.

Intellectual property protection for biotechnology is currently in a state of flux.

Whilst it used to be the case that living organisms were largely excluded from
protection, attitudes are now changing and increasingly biotechnology is
receiving some form of protection. These changes have largely taken place in
the USA and other industrialized countries, but as other countries wish to
compete in the new biotechnological markets, they are likely to change their
national laws in order to protect and encourage investment in biotechnology.

Intellectual property protection currently available

There are currently two main systems of protection for biotechnology: rights in
plant varieties, and patents. Both systems provide exclusive, time-limited rights
of exploitation and are described in more detail below.
Keeping biotechnology 'secret' can also is a valuable form of protection.
National treatment of trade secrets is diverse, and all attempts to harmonize
trade secret laws in Europe, for example, have failed. Most jurisdictions do
provide some form of protection against those who steal or use others' trade
secrets unfairly. However, the problem with this form of protection is that the
secret generally becomes public once the biotechnology is used commercially
and thus the protection is lost.
It is conceivable that the law of copyright could afford some protection for
biotechnology. Lines of genetic code are analogous to some extent with
computer program code, which has now been incorporated into the copyright
systems of most industrialised countries. However, this route to protection is
fraught with practical and conceptual difficulties and is generally thought to be
unsuitable. There is as yet no recorded case of biotechnologists claiming
copyright in their inventions.
Trademarks are also unlikely to be of much use in protecting biotechnology,
though they may of course prove important later in regard to marketing
products, processes or services. An attempt to register the name of a plantor an
animal as a trade mark is unlikely to be successful as public policy would
prevent it (in England, registrations for names of varieties of roses have been
removed from the Trade Mark Register for lack of distinctiveness and because
of the likelihood of confusion).

Rights in plant varieties

Prior to the mid-1960s only a few countries (e.g., Germany, USA) gave any
intellectual property protection to plant varieties. Because of pressure from their
plant breeding industries, 10 western European countries entered into a
diplomatic process in the early-1960s which eventually culminated in the
formation of an International Union for the Protection of New Varieties of
plants (UPOV) and the signing of a Convention (the UPOV Convention 1961).
Since that time a number of other countries have become parties to the UPOV
Convention.
The UPOV Convention requires that each member country must adopt national
legislation to give at least 24 genera or species protection, in accordance with
the provisions of the convention, within eight years of signing. A plant variety
is protectable ("a protectable variety") under the UPOV system if it is distinct,
uniform, stable (DUS) and satisfies a novelty requirement. Novelty and
distinctiveness equate broadly to novelty under patent law, but are more
leniently applied in comparison to the patent rule. Satisfaction of the DUS
criteria is conducted by the national authority responsible, usually by growing
the variety over at least two seasons. There is also an important requirement that
the variety be maintained throughout the duration of protection. A country may
apply the system to all genera or species, but there is no obligation to do so and
thus the system has been extended only gradually. In addition, the UPOV
Convention allows national legislation to discriminate against foreigners
(including nationals of a UPOV Convention country) under the principle of
reciprocity. Thus amongst the UPOV members there is still some disparity in
protection.
Duration of protection depends on national legislation and on the plant species
to which the variety belongs, but is generally for 20-30 years. Grant of plant
variety rights confers certain exclusive rights on the holder, including the
exclusive right to sell the reproductive material (e.g. seed, cuttings, whole
plants) of the protected variety. However the rights do not extend to
consumption material (e.g. fruit, wheat seed grown for milling flour).
Essentially the exclusive rights define what others may or may not do in relation
to the protected varieties.
Plant breeders were for some time dissatisfied with the protection provided by
the UPOV system. This eventually resulted in a major diplomatic conference in
March 1991, at which the UPOV Convention was substantially revised. The
new 1991 text will provide far greater protection than is afforded at present,
most notably by requiring that all member countries apply the convention to all
genera and species, by extending the exclusive rights to include harvested
material (e.g., fruit, wheat grown for milling into flour) and, most
controversially, by allowing enforcement against farm-saved seed (where a
farmer produces further seed of the protected variety from the previous year's
crop).

Patents for biotechnology

Whilst the majority of countries provide some form of patent protection, only a
few provide patent protection forbiotechnology (these include: Australia,
Bulgaria, Canada, Czechoslovakia, Hungary, Romania, Japan, the Soviet Union
and the parties to the European Patent Convention). The reasons for this may
differ, but generally it has been because biotechnology has been thought
inappropriate for patent protection, either because the system was originally
designed for mechanical inventions, or for technical or practical reasons, or for
one or more ethical, religious or social concerns. In all the National Patent
Offices where patents are granted for biotechnology there is a considerable
backlog of pending applications. Even in those countries where patent
protection is provided, the type and extent of that protection is different in
nearly every national system.
It has largely been the USA which has broken new ground in providing the
possibility of patent protection for "anything under the sun that is made by
man". Patents have been granted for plants since 1930 in the USA, under The
Plant Patent Act. However, prior to 1980, the US Patent Office would not grant
utility patents (separate from The Plant Patent Act) living matter because it
deemed products of nature not to be within the terms of the utility patent
statute.Elsewhere, the treatment of applications for patents for living matter is
far from certain. Whilst patents are granted in many countries for plants and
microorganisms, it has been the issue of patents for animals which has been
most controversial.

International treaties
There are three international intellectual property treaties which are of particular
importance for the protection of biotechnology:
 the Paris Convention for the Protection of Industrial Property (the Paris
Convention);
 the Budapest Treaty on the International Recognition of the Deposit of
Microorganisms for the Purposes of Patent Procedure (the Deposit
Treaty);
 the Patent Cooperation Treaty (PCT)

The Paris Convention was originally signed in 1883 by just 11 countries, but
now the majority of countries who have any form of intellectual property law
are parties to it. The keystone to the convention is the principle of national
treatment: an applicant from one convention country shall have the same rights
in a second convention country as a national of that second country. The
convention covers patents and defines them so broadly that it permits
application to any of the forms of industrial patents granted under the laws of
the convention countries.

The Deposit Treaty, as the full title suggests, is concerned with the deposit of
examples of microorganisms for the purposes of patent applications.
Applications for patents for biotechnology often face considerable difficulties in
describing the nature of the invention sufficiently. The Deposit Treaty is a
vehicle for solving these problems, primarily through the setting up of a series
of International Depository Authorities (IDA) and through the recognition by all
member countries of a deposit in a single IDA.

The PCT simplifies the process of filing patent applications simultaneously in a

number of countries. Under the PCT a single application may be filed in one of
the official receiving offices, designating any number of PCT member
countries, which can eventually result in a national patent being granted in each
of the designated states. A prior-art search is performed by the receiving office
and a report sent to the applicant. The application and report are published and
the application will then move on either to an international preliminary
examination followed by national examination or alternatively straight to the
national examination stage. Unfortunately, the eventual outcome is not a 'world
patent' and there is no harmonization patent law under the PCT apart from the
procedural aspects.

In order to comply with the TRIPs (Trade Related Intellectual Property Rights)
and CBD (convention on Biological Diversity) India has passed Indian Patent
(Second Amendment) Act, 2002 and the Biological Diversity Bill, 2002
respectively. According to this Amendment Act, 2002 the duration of the term
of patent has been extended to 20 years for all product and process patents. Now
microorganisms will be patentable subject in India.

Case study: the Iguana Management Programme

The Green Iguana Iguana iguana of Latin America is a highly prized source of
meat and eggs. Green Iguanas are arboreal herbivores which can grow up to 2m
in length and can weigh as much as 6kg (about 82% of the lizard is edible).
They need about half as much food as a chicken or rabbit to produce the same
amount of meat. The species is now widely threatened because of excess
hunting and habitat destruction.
Research into the reproductive behavior of the Green Iguana was begun in 1983
and resulted in development of new management techniques for ranching. A
'genetic brood stock' of adult iguanas which are larger, faster growing and more
productive has been developed. The research has largely been the work of the
Pro Iguana Verde Foundation (formed by Dagmar Werner in 1985). The
Foundation's programme for training and advice on Iguana ranching is called
the Iguana Management Programme (IMP). The IMP is based in Costa Rica but
it is intended to implement it throughout Latin America and possibly elsewhere.
The primary purpose of the IMP is to conserve living natural resources; its basic
premise is that if farmers can raise iguanas as a food crop, the status of the wild
species will be improved and forest clearance might be reduced. Farmers
adopting iguana ranching would have to protect or re-establish areas of forest to
provide food for stock. Research indicates that meat production per hectare by
iguanas is approximately three times higher than by cattle. Income can be
derived from selling iguanas and their products (meat, eggs, leather) and
products from the forest.
The new technology and expertise which have been incorporated into an iguana
ranching model are being applied for an industrial purpose (i.e. agriculture) and
are of commercial value; they thus fall within the area of intellectual property
law as applied to biotechnology. The biotechnological components of the
ranching model are the genetic brood stock (the Fundacion has 'bioengineered'
an improved stock of Green Iguanas) and the husbandry procedures (egg laying
and incubation, nutrition, disease control, release and harvesting). These are
forms of 'original or traditional biotechnology', as opposed to 'new
biotechnology' which is largely laboratory based and dependent upon human
manipulation of genetic material.
Intellectual property rights provide the means for compensating the Fundacion
for its efforts. The technologies involved in the IMP are vulnerable to piracy.
Much of the work of the Fundacion is contained in the genetic make-up of the
Genetic Brood Stock. Once these Iguanas are transferred or sold the Fundacion
loses its direct control over the animals. In addition, the success of the Iguana
ranching model is dependent on the expertise to use the technologies efficiently;
this is information which took years to develop but which can be pirated very
easily once a license is purchased. The Fundacion needs to be able to
disseminate its innovations and expertise in the security of knowing that it
cannot be re-sold by pirates and that there will be no reduction of the licensing
potential. Only internationally recognized intellectual property law can provide
these types of protection.
Because of the uncertainties of the world's intellectual laws with regard to
biotechnology the availability of protection for the most important components
of the IMP is questionable. At present there is widespread discrimination
against the application of intellectual property rights to natural genetic materials
and in favour of human-modified genetic materials. This provides no incentives
for exploitation of useful genetic materials in the natural environment, even
though in developing countries natural resources are obvious subjects for
investment. However, one important way to limit conversion of natural
resources is to ensure that fair value is paid for current uses of the existing
resource base. Intellectual property rights could be a means of influencing
developing countries to maintain and develop diverse resources in return for the
value that these resources render to the world community.
Reference
www.ciesin.org/docs/008-265/008-265i.html