Major issues in the Thai
patent system
Jakkrit
Kuanpoth
III. PATENTABLE SUBJECT-MATTERS
As
with many countries, both developed and developing, Thailand has a diseriminative
policy against several types of inventions. The law does not recognise
some subject-matters as patentable inventions. This section is divided
into three parts, dealing with the protection of pharmaceuticals, medical
treatment, and biotechnological inventions.
A. Protection for
pharmaceuticals
The
old and new provisions follow most other countries legislations by explicitly
excluding a scientific or mathematical rule or theory, a computer program,
an invention which is contrary to public policy or morality, or public
health or welfare.
Before
amendment, Thailand's Patent Act excluded from patentability food, beverages,
agricultural, machinery, pharmaceutical products and ingredients. The
exclusion of food, beverages, and pharmaceuticals in Thailand was based
on social and economic grounds. It was the view that these inventions
are vital for the public, as they are basic requirements for all humans.
This was similar to the reason for not protecting agricultural machinery,
which is essential for the majority of Thai population whose incomes largely
depend on agriculture. In order to ensure that scarcity of the goods would
not arise and led to high prices, the old provision explicitly refused
patent protection to these essential subjects.
The
exclusion of these inventions under the old s.9 of the Thai patent law
was neither original nor unique. This exclusionary provision was copied
from the laws of some developed countries. When their industrialisation
was still at an early stage, the patent laws of most of today's developed
countries also contained a similar exclusion list, which included not
only pharmaceutical but also food products, chemicals and biotechnology.
Basically,
the patenting policy of all countries depends on the level of development
of indigenous industry in a particular field. It may be recalled that
many advanced industrial countries first developed their industrialisation
from protected local markets. In the early stage of industrial development,
it would be impossible for a new indigenous industry to compete with foreign
multinational corporations. Providing a high degree of protection will
open the national market for foreign firms. Large enterprises can use
their superior R&D and, through patent protection, conquer the market.
The dominant position of foreign firms might impede the growth and the
initial development of such a new local industry. This is the reason why
pharmaceutical inventions are still excluded from patentability under
some developed countries patent laws, and they were only introduced in
the united Kingdom in 1949 and within the last twenty-five years in Italy,
Germany, the Netherlands, Switzerland and Japan. As pointed out by OECD,42
"one
of the major reasons for introduction of full patent protection by Japan
in 1975 derived from a recognition of the fact that the level of development
reached by their firms at that time required that this monopoly be granted
so as to permit them to launch into R&D and innovation in a major way."
While
pressure is being exerted on developing contries to offer equivalent protection
level (as in advanced countries) to product and process patent, it is
ironic that the momentum of the current debate in home-states of transnational
pharmaceutical companies is in the direction of whether or not general
formulas in chemicals should be protected. In other words, should chemical-pharmaceutical
product-patent be regarded as granting patent-holders an absolute scope
of protection? Or should general formulas be relied upon in determining
the scope and validity of patent?43 The
developing countries are not granted the option to determine what chemical
aspects of pharmaceuticals to protect, or what processes of manufacture
should be excluded.
Although
the old s.9 affected all products or substances relating to these inventions,
a process for their manufacture, as well as a method for their use, was
not left out of protection. The inventors were still afforded a certain
degree of protection. They were able to exclude others from utilising
a patented process, and to prohibit competitors from exploiting the final
products of such a process for business purposes.
When
the new Thai patent law was introduced, it extended protection to food,
beverages, agricultural machinery, and pharmaceutical products. This extension
of patent protection means that an inventor of these technologies can
enjoy absolute protection if he is a person who comes up with a new invention,
and the first to file a patent application.
B. Protection for
medical treatment
As
regards an invention relating to medical treatment, the old s.9 did not
den the patentability of this invention. The amended s.9(4), on the other
hand, expressly refuses the granting of patents for methods for treatment
of the human or animal body by surgery or theraby and diagnostic methods
practised on the human or animal body.
The
intention underlying s.9(4) of the Patent Act is to ensure that monopolisation
will not inhibit the free flow of knowledge in this area.44 Patent protection would "operate as a restraint rather than a stimulus
to research, investigation and the creation of ultimately useful, practical and valuable innovation."45 Phillips and Firth quite rightly states that, "the protection of life
and health are universally recognised objectives which transcend the sordid
realm of proprietary rights."46
It
is clear that the exclusion of this subject-matter is based on the ground
of ethical and social policy, in order to safeguard well-being of the
public. Although the methods of treatment are not considered being patentable,
the new law does not prohibit patenting a substance or composition used
in the method for treatment of human and animal body. Like the position
in many other payent systems, the legal status of pharmaceutical products
and medical methods under Thailand's present patent law is unequal.
Regarding
rationalisation in this difference, Baibridge has argued that the medical
practitioner is in a position where he is expected to pass on his knowledge
to others and will not expect financial recompense for his idea. In the
contrast, the drug company is operating in a competitive industry and
needs a patent to recoup its R&D investment.47
This
view, however, does not consider the fact that the monopoly position of
the pharmaceutical industry might preclude the free exchange of information
and ideas in this area, and the lack of price competition may lead to
high prices for pharmaceutical products, considered basic health care
requirements. It also ignores the fact that ethics and morality should
play an important role in every sector of medicine, not only among professionals,
but also among manufacturers and distributors of life-saving drugs.
There
can be no doubt that the law now prohibits the patenting of medical methods,
but not medical products. Two sets of questions in this regard, However,
may be raised. Since the law strongly denies the grant of patent to medical
treatment on public interest basis, the first would be what justification
there is for state-enforced monopoly rights of medical substances, which
also directly affect the human health care, by making them a means of
profiteering. The second question is whether the right to recompense for
R&D and creative efforts can be adequately provided for by the patent
system. If it is so, how such compensation can be accurately calculates?
This question seems to be uneasy, particularly when one considers the
complex multi-pricing system of the pharmaceutical industry, namely transfer
pricing, consumer subsidy, marketing and promotion costs added, etc.
C. Protection for
biotechnological inventions
Under
the old s.9(3), no patent would be granted to any variety of animal or
plant, or any essentially biological process for the production of animals
or plants. The exclusion was based on two grounds. First, animals and
plants, like agricultural machinery, are important for Thai farmers. Patent
protection on animals and plants would inhibit farmers from earning a
living. Secondly, the special features of plants and animals would create
a technical difficulty in the administration of animal and plant patents.48
After
the 1992 amendment, the following biotechnological inventions are excluded
from patentability ; (I) micro-organisms existing in nature ; (ii) any
variety of animal or plant ; and (iii) any substance extracted from animals
or plants.49
The
old provision did not mention micro-organisms. It was not clear whether
micro-organisms were to be included in the term animal or plant varieties
for the purpose or the old s.9(3).50 The
amended s.9(1) has eliminated this uncertainty by recognising micro-organisms
as a patentable subject-matter. It only prohibits the patenting of micro-
organisms, when they are the subject of biologically pure cultures existing
in nature. It is, however, still unclear what naturally occurring micro-organisms
will mean in practice.
When
the claimed micro-organisms is a product of technical processes involving
human intervention, it may not be excluded from protection. This includes
micro-organisms themselves created or isolated by selection or mutation
effects, microbiological processes such as methods of preparing or using
micro-organisms, and the product obtained by the microbiological processes,
e.g.yeast, vinegar, alcohol, enzymes, antibiotics, etc. But when the product
of the microbiological processes is a plant or animal variety, it may
be unpatentable, as prohibited by the amended s.9(1).
Like
the old s.9, the present law does not recognise plant and animal varieties
as patentable subject-matters. All substances extracted from animals or
plants, such as cultures of cells of plants or animals or plants, such
as cultures of cells of plants or animals, are also excluded from patentability.
It is, However, uncertain whether this provision refers to substances
that are part of animals or plants per se (e.g. an animal gene), or it
also includes cortain products obtained from animals and plants (e.g.
steroids, enzymes, vaccines, etc).
As
in the legislations of EPC countries, Thailand's law does not provide
a legal definition of the term "any variety of animal or plant". Due to
the lack of the case law, there is no boundary between what is and what
is not patentable in these kinds of inventions. It is doubtful whether
the Patent Act rejects from patentability all animals and plants, or,
as in the European Patent Office (EOP), only a particular type of animals
and plants.51
As
to plant varieties, the intellectual property regime in Thailand is different
from that in some developed countries, The reason for the exclusion of
plant varieties from patentability in those countries is to avoid double
protection because plant varieties may be protected by plant breeders'
rights adopted under the International Convention for the Protection of
New Varieties of Plants (UPOV).52In Thailand,
no sui generisprotection has been established to deal with plant inventions.
The lack of the "plant breeders' rights" and the uncertainty in the Patent
Act mean that plant varieties may not be protectable by any form of intellectual
peoperty law.
In
the revised provision, there is no explicit exclusion for essentially
biological process. This means that patent protection is extended to biological
processes for the production of animals or plants. According to the new
s.9, it is most likely that patent protection is now applicable to all
kinds of biological process, regardless of whether they involve micro-organisms,
or are nonbiological or biological, While the protection of biological
processes in countries with highly developed patent systems like the EPC
members has been inconclusive, it is rather ironic that the scope of protection
under Thailand's law has gone further by allowing all types of biological
processes to be patentable.
When
someone invents a new biological process for the production on an animal
or a plant, the new process can be claimed for a patent. Although patenting
does not apply to animal or plant varieties, the exclusive rights under
the biological process patent can be extended to such animals or plants.
Under
the amended s.36(2), the law confers monopoly rights on the holder of
a process patent to exploit not only the patented process but also the
products obtained from that process. Because of this strenght, on can
expect that the biotechnology industry will be encouraged to use the process
patent to turn this scientific technology into marketable products. With
the expansion of patent law and the domination of foreign bioengineering
companies in Thailand, the Thai economy may have to bear negative consequences
resulting from the patentability of biotechnological processes.
For
example, when a patent is granted to a laboratory technique relating to
the genetic engineering for the production of a new species of rice, the
process patent holder has the following rights. First, he can prevent
others from utilising such a method. Other researchers, in both public
institutions and private sectors, are thus barred from developing an adaptive
invention based on the patented process. Second, he will have monopoly
rights to manufacture, use, sell, offer for sale, or have in the possession
for sale rice produced from the newly invented process. Third, he is the
only person to be able to import the rice into Thailand. No one else can
import the rice even for propagation or personal consumption. This, in
effect, means that the supply of the product in the country is controlled
by one distributor. Fourth, if the patentee alleges that someone has infringed
his legal right, the alleged person is presumed quilty unless he can prove
otherwise. This assumption serves to strengthen the legal and commercial
position of the patent holder, since no competitor will challenge his
legal rights by learning the operation of the patented invention (so-called
"reverse engineering"). Fifth, the farmers do not have a right to grow
the new variety of rice without permission of the patentee. Unlike the
"plant breeders rights", when a farmer grows the new rice after having
paid royalties, he cannot save the seeds for replanting in the next season.
This means that the monopoly rights would cause an adverse effect on the
incomes of Thai farmers.
The
introduction of the process patent for biological inventions may undermine
agriculture and food industries, which are of extraordinary importance
for the Thai economy. Patent law protects the public interest by excluding
from patentability plant and animal varieties per se. A fundamental question
is : why biological processes are regarded as a patentable subject-matter?
When patents are granted to biological processes, can the exclusionary
provision under s.9(1) achieve its aim in protecting public interest from
the monopoly rights of the patent owner?
Apart
from its socio-economic impact, another problem in extending patent protection
to biotechnological inventions concerns legal and technical difficulties
in the administration of micro-organism and biological process patents.
How will the Thai government officials search the prior art of micro-organism
and biological method claims? How will the inventive step of the biological
inventions be examined? Moreover, since Thailand is not a party to the
Budapest Treaty and cannot utilise the international depository system,
how can a biotechnological invention be described adequately so as to
fulfil the requirements of disclosure? And what conditions should there
be for the deposit and release of micro- organisms? What regulations should
be adopted to deal with possible hazards resulted from the release of
micro-organisms into the environment? These practical problems are to
be taken into consideration if Thailand intends to promote industrial
development in the field of biotechnology, and to avoid negative effects
resulting from patenting biotechnological inventions.
Part
5
42
The Pharmaceutical Industry: Trade Related Issues, OECD, Paris, 1985,
p.40.
43 For further discussion see Marisco, p., The Chemical-Pharmaceutical-Product
Patent, 11 EIPR [1990], p.397
44 Unpublished Parliamentary Document, Circulated before
the Debate of the Patent Law Amendment, No. PL.0003/N48, 6 November 1991,
p.8(in Thai).
45 black,Trever, Intellectual Property in Industry, Butterworths.
London and Edinburgh, 1989. p.13. The similar reason is expressed by Phillips
and Firth, op.cit., at p.51; and see also the decision of the EPO Board
of Appeal T116/85, WELLCOME/Pigs I, OJ EPO (1989), 13.
46 Ibid.
47 Bainbridge, D.I., Intellectual Property, Pitman Publishing,
London, 1992 p.271.
48 Phaungrach, op.cit, at pp.36-37
49 Patent Act B.E.2522, amended by Patent Act B.E. 2535
s.9(1).
50 Phaungrach. Op.cit, at p.37
51 For discussions on patent protection for biotechnological
inventions in the EPO see Straus. J., The Development and Status of European
Law, in Lesser, W. (ed.), Animal Patent: The Legalm, Economic and Social
Issues, Macmillan, London, 1989; and Teschemacher, R., Patenting Subject
Matter under the European patent Convention (EPC) in the Field of Biotechnology,
in WIPO and Cornell University, Symposium on the Protection of Biotechnological
Inventions, New York, 4-5 June 1987. See also the EPO Technical Board
of Appeal in T19/90, Harvard/Onco-mouse, OJ EPO (1990), 476, which held
that "the exception to patentability under Art.53(b) EPC applies to certain
categories of animals but not to animals as such."
52 See Greengrass, B., The 1991 Act of the UPOV Convention,
12 EIPR [1991], pp.466-472; and WIPO and Cornell University, Ibid. |