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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.