THE SINGAPORE PATENTS ACT 1994: WHITHER BIOTECHNOLOGY AND PATENT LAW?

• Date: 01 December 1995
• Author: STANLEY LAI
• Published date: 01 December 1995
• Citation: (1995) 7 SAcLJ 396

In the sphere of patents, the area of law surrounding the patenting of living organisms, middle to higher life forms, plant and animal varieties has always been shrouded in controversy and diverse opinion.

The Singapore Patents Act 1994 (the “Singapore Act”) and the Patent Rules 1995, both of which came into force on 23 February 1995, has sought to introduce a completely new system of patent administration into the law of Singapore. Most radically, the Registry of Patents is conferred the power to process applications and make grants locally.

Therefore it is not inconceivable that in the not-too-distant future, the Singapore Patent Office may very well be faced with applications for the registrations of various biotechnological inventions as patents — opportunities to get completely immersed in the omnipresent debate about, inter alia, whether life forms and genetically modified organisms may even be declared to exist as patentable inventions.

This article attempts to draw attention to the relevant provisions of the Singapore Act, in comparison with provisions of the UK Patents Act 1977 (the “UK Patents Act”), the European Patent Convention (“EPC”) as well as case-law/legislative developments. The larger question is then discussed; whether the ecological/moral debate surrounding the patenting of genetically modified organisms and the like, should fall within a patents regime.

The Singapore Act

The scheme of the Singapore Act in conferring patent protection lies in what is a “patentable invention”. In defining “patentable inventions” for the purposes of the Singapore Act, the legislature has adopted both an inclusionary as well as an exclusionary approach. The former is reflected in section 13(1), which states that a “patentable invention” is one that satisfies the conditions of novelty, inventive step and industrial application1. The latter, is reflected in section 13(2), which states that the following are not inventions for the purposes of the Act:

1. “(a) a discovery, scientific theory or mathematical method;

2. (b) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever;

1. (c) a scheme, rule or method for performing a mental act, playing a game or doing business; or a program for a computer; or

2. (d) the presentation of information.”2

It is however observed that the Singapore Act is virtually silent on the protection of living organisms, their derivatives and grades.

As observed by some quarters, the criteria for patentability of biotechnological inventions now appears to be set out in section 13(1) of the Singapore Patents Act3. Two other sections deserve mention. Section 13(3) which excludes inventions that “would generally be expected to encourage offensive, immoral or antisocial behaviour”; and section 13(5), which states that the provisions of section 13(2) may be varied by gazetted order, for the purposes of conformity with developments in science and technology.

Section 1(3)(b) Patents Act 1977 (UK)/Article 53(b) European Patent Convention

In the UK Act, section 1(3)(b) states that a patent will not be granted:

“for any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a microbiological process or the product of such a process.”

This section is in pari materia with Art 53(b) EPC. It is noted that the section does not extend to microbiological processes for the production of animals or plants or the products of such processes, eg. brewer’s yeast4. In American Cyanimid Co. (Dann’s) Paten5, a method of producing antibiotics using microorganisms was held to be patentable.

The Singapore legislature has decided to omit this section from the new Act. At the Select Committee stage, two representations were made on the subject of plant, animal varieties, calling for the inclusion of section 1(3) UK Act (reproduced above). The Select Committee recommended no changes to the existing provisions of the (then) Bill6.

In the UK, plant varieties are protected under the Plant Varieties and Seeds Act 19647 (“PVSA”). Under the PVSA, proprietary rights are granted to the breeders or discoverers of distinctive, uniform and stable plant varieties for a period not exceeding 30 years8. These rights are monopolistic in nature and are conferred for the production and sale (or the offer for the sale of) reproductive material of any plant variety9. The scheme is administered by the Plant Variety Rights Office under the Controller of Plant Variety Rights.

The Select Committee considered that, in the absence of Plant Varieties legislation, there was no need to include an equivalent of section 1(3)(b) (UK Act) into the new Patents Act. The Committee thought it desirable to encourage the development of new plant varieties — since the allowance of patent protection for plant varieties would serve as a launch pad for the products and by-products of horticultural research.

As regards animal varieties (non-human species) the general justification for the patenting of new life forms is the incentive to invest and innovate. The Committee was of the view that the Patents Act should serve the biotechnology industry as an instrument providing both incentive and reward. The Committee, in their report, also placed great emphasis on the “fall back” provision of what is now section 13(5) of the Singapore Act, which empowers the Minister by an order that is published in the Gazette, to vary the provisions in section 13(2), so as to be in conformity with developments in science and technology10.

The position taken by the Select Committee is perhaps justifiable, for one other reason. One of the more difficult distinctions, as recognised by the UK experience with section 1(3)(b) has been the differentiation between biological and micro-biological processes11. At micro-biological level, patents have been obtained for single genes, vectors, plasmids and other sub-cellular items. Even human genes have been patented; for example, in early 1993, the University of Michigan and the Toronto hospital for Sick children took out a joint patent on the human gene responsible for cystic fibrosis12. It is

only the latter which may qualify for patent protection as long as all the other requirements are satisfied. Micro-organisms can be considered to be very small independent units of living material invisible to the naked eye, and the degree of human intervention that is involved in genetically altering or producing micro-organisms justifies the patentability of a given micro-biological invention. The European Patent Office (“EPO”) has published guidelines stipulating that processes which either use or operate upon a micro-organism, or result in a micro-organism, should be considered micro-biological and therefore eligible for patent protection.

Notwithstanding the above, it is also apparent that the definition of “animal varieties” has undergone the challenges of varied meanings, most notably when applied to genetically modified organisms.

Animal Varieties — The Harvard Oncomouse

The United States has traditionally been noted for encouraging the patenting of genetically engineered animals and other genetic material13. The “Harvard Oncomouse” (a famed genetically engineered rat endowed with activated oncogenes) is such an example. By contrast, in the European sphere, Art 53(b) EPC has resulted in a more conservative approach towards the patenting of such inventions14.

In a dramatic shift of worlds, the Board of Appeal in the EPO nevertheless granted a patent in respect of a genetically engineered mouse15.

At first instance the Examining Division took the view that the “animal varieties” exclusion in Art 53(b) EPC concerned not only groups of animals, but also animals in general and rejected the onco-mouse application16. This decision was overturned by the Board of Appeal, which emphasised that the exceptions to patentability should be strictly construed so that “animal varieties” should be given a narrow meaning. The Board declined to cast further light on what this meaning was precisely, noting only that the wording of Article 53(b) EPC differed in each of the Official Texts of the EPC (English, German, French). The matter was transferred back to the Examining Division for reconsideration.

On re-examination17, the Examining Division considered the three texts of the EPC and held that whereas the German translation of “animal varieties”

meant “species”, the English and French translations referred to “a subunit of a species”. It reached the view that the claim in Oncomouse was for neither a species nor a sub-unit thereof, but for a “taxonomic classification unit much higher than a species” — ie. rodents and mammals, and was thus outside the scope of Art 53(b).

It does seem peculiar to characterise the claim, which was for rodents into which the onco-gene had been introduced, as being concerned with mammals or rodents rather than sub-categories thereof. Such a claim could equally be characterised as a category of animals lower than a species. One commentator has remarked that it seems odd that a claim to a larger category or genetically-modified animals is more likely to succeed than a claim to a smaller category18. It is clear that Art 53(b) has been limited in no uncertain terms19.

Plant Varieties — Greenpeace (1993)

Turning over to “plant varieties”, a case to consider is Greenpeace v Plant Genetic Systems NV20. The Opposition Division of the European Patent Office heard objections regarding claims which were directed to plants, plant cells and seeds which possessed a foreign gene encoding resistant to glutamine synthetase inhibitors (ie. herbicide resistant plants). Two primary objections were raised under Art 53(b) EPC:

1. (a) the patenting of plants per se is excluded under Art 53(b) EPC upon a proper reading of that article (constituting “plant varieties”).

2. (b) the present plant cells...