SECTION:		ISSUES RELATED TO BIOTECHNOLOGY
TITLE:		Intellectual Property Rights
BY:		Julian Kinderlerer
LABEL:	IPR		UPDATED:	31 Dec 1997

Contact: IRRO Secretariat

CONTENTS

Introduction

The ownership of physical property is recognised everywhere as obvious. Even in societies where individuals are not able to own ‘property’ individually, group ownership is recognised. Intellectual property, on the other hand, is often not recognised as the equivalent of physical property. What are the differences, and why should we allow ownership of ‘ideas’? Intellectual property rights are rights granted by governments for certain products of intellectual effort and ingenuity.

The arguments made in favour of Intellectual Property Rights include

• encouraging and safeguarding intellectual and artistic creation
• disseminating new ideas and technologies quickly and widely
• promoting investment
• providing consumers with the results of creation and invention
• providing increased opportunities for the distribution of these effects across countries in a manner proportionate to national levels of economic aconomic and industrial development

There are many problems associated with the application of rights to intellectual property in Biotechnology. Many do not want to allow it at all, India for example, has fought hard to exclude most living systems, and their use therapeutically, from inclusion in any protective system and the patent system was based on protection of process rather than product. On the other hand ‘modern’ biotechnology costs money — lots of money. Those investing in it will want a return on their investment, and no-one wants to invest millions, even billions, of dollars or pounds in a product, only to find that others are capable of copying the product and exploiting it without having incurred any of the major development costs. It is said that the bringing to market of a new drug cost upwards of £50 million. Legal recognition of intellectual property rights is the means whereby the developers of biotechnological processes and products, , and those who funded the development, can prevent others from copying, further developing, or in other ways exploiting what they have not themselves developed (or, at least, prevent them from doing this without having to recompense those holding the intellectual property right.)

In 1989, the OECD concluded that, "society derives satisfactory compensation for the rights it temporarily confers on certain individuals since this exclusivity generates benefits, especially in the long run, that adequately offset any economic disadvantages or risks which ‘exclusive rights’ might possibly entail."

Intellectual property rights are to be distinguished from physical property rights. In the context of genetic resources and biotechnology, ownership of the physical resource – plant, animal – is governed by property laws, while ownership of the genetic information contained in the plant or animal is governed by intellectual property laws.

What are theseese Rights?

• Patents;
• Plant Breeders’ Rights;
• Copyright;
• Trademarks;
• Trade Secrets;
• Industrial designs;
• Appellations of origin

Trademarks are, at this stage of biotechnological development, of very limited application, protecting brand names and titles (though it is conceivable that they might assume greater significance in the future, if or when biotechnological products are marketed in much the same way as cereal crops).

Trade secret rights have a use, insofar as developers wish to keep secret from their competitors what they are doing. However, they are of limited use if the developers wish to exploit what they develop publicly. For, once they put a product on the market, there is no longer trade secret protection. Without any other sort of protection, competitors would be at liberty to analyse the producy to analyse the product, copy it, and sell it themselves. Although the ‘right’ protects the owner from theft of the secret, once discovered, there is no recall for the secret. Coca-Cola have for long kept secret the formula for their successful drink, and nobody has yet succeeded in deciphering the secret effectively.

Copyright could, in principle, be used in biotechnology, and the idea that strands of DNA are forms of coded text suggests this as a possible route. However, while copyright, through a system of royalties would yield a return, copyright does not require registration. This has disadvantages for both investors and those who want the new biotechnology to be as transparent as possible. The absence of a registration system means that there does not have to be full disclosure of the process or product for which the intellectual property is being claimed. This could (and, in many cases would) lead to uncertainty about the scope of the right, which is very undesirable fromm the developer’s point of view. From the point of view of those worried about the accountability of scientists, lack of full disclosure is undesirable because it makes it more difficult to ascertain what has been developed and, thus, to assess it.

The specific advantage of both patents and plant breeders’ rights lies, precisely, in that they both require the processes and products of protection to be registered. The patent system is of much wider application than the system of plant breeders rights, simply because plant breeders rights are restricted to the products and processes of reproduction of plants. However, they are an important, and underused, form of protection. Both Patent protection and the sui generis system of Plant Breeders’ Rights (PBR) require complete disclosure of the process or product for which the protection is claimed, and both limit the protection offered to a fixed time, after which ownership of the ‘intellectual property’ can no lonnger be claimed.

Patents and Plant Breeders’ rights are the main protection for investment in Biotechnology, and the session will dwell exclusively on these. Because the protection offered by PBR is for the physical plant itself, rather than a description of the process or product, a system which ensures that the product is distinct from others already available is needed:

Patents & Plant Breeders’ Rights

Plant breeders’ rights are rights granted by a government to plant breeders to exclude others from producing or commercialising material of a specific plant variety for a period of, minimally, 15-20 years. The variety must be novel, distinct from any existing varieties, and uniform and stable in its characteristics. Plant breeders’ rights were established under the International Convention for the Protection of New Varieties of Plants (the UPOV Convention), adopted initially in 1961 as a European-cn-centred convention, and then revised in 1978 and opened up for general signature. It was further revised in 1991. The 1991 version of the UPOV Convention will come into force when sufficient countries have signed the Convention, which is expected during 1997.

This international system of plant breeders’ rights (PBR) was set up under the auspices of the Union for the Protection of New Plant varieties (UPOV) to provide specific protection for the results of traditional plant breeding. To obtain PBR protection, a variety

• must be novel in the sense that it must not have been commercialised prior to certain dates;
• distinct from existing, commonly known varieties;
• sufficiently uniform and homogenous; and
• stable under multiplication in its essential characteristics,

The right can be distinguished from the patent system, outlined below, on the basis that it extends to the reproductive material only of the protethe protected variety and it is granted after the variety applied for has completed a number of years of official trialling to ensure that the DUS criteria are met (distinct, uniform and stable). The 1991 modification of UPOV has brought into being a restriction on plant breeders rights to modify any variety in that ‘essentially derived varieties’ are protected. This is defined as a variety that retains its original genotype except for a specific new characteristic, for example inclusion of a new disease-resistant gene introduced through genetic manipulation or backcrossing. A consequence of the change is that a breeder who inserts say a pesticidal gene into a protected variety will have to obtain the permission from the holder of the original rights before marketing the new variety. The aim was to attempt to protect varieties that only reflect ‘cosmetic’ changes with respect to pre-existing varieties. How this will be implemented, or understood, remains in question. (FAO June 1996).

Thhe system of plant breeders’ rights has previously been regarded as a less than desirable form of protection for the results of biotechnological research than a patent. This is partly because of its limited application to plant varieties and not all plant material, and also because it endorses the policy of permitting farmers to retain seed from one year to the next without having to pay a further royalty to the breeder. The plant biotechnology industry increasingly prefers patent protection over plant breeders’ rights, arguing that the stronger protection provided by patents is necessary. (Under patent law, all unauthorised use of patented material, including on-farm seed saving of patented plant varieties, is prohibited.)

However, following the revision of the UPOV Convention in 1991, and the adoption of the European Community Plant Variety Right in 1995 (which adheres to the 1991 text of the UPOV Convention), the right has been strengthened, making it a viable alternative to the grannt of a patent.

The benefits of a plant breeders’ right, when compared to the patent system are

it applies to any plant variety howsoever bred (and in this it can again be distinguished from the patent system, which would not extend protection to a variety produced using traditional plant breeding techniques);

it is reliant on a practical evaluation of the variety itself, as opposed to an assessment of the written description of the applied for material as contained in the patent system; and

due to the plant breeders’ rights system being overseen by the various Ministries of Agriculture, the plant variety is invariably tested for its incorporation onto the National List of approved plant varieties at the same time as the claim for a plant breeders’ right is being assessed. Without inclusion on such a National List, the plant variety will not be deemed suitable for sale and its seed or reproductive material cannot be commercially sold or grown for the purpose of prodproducing other commercial products (i.e., consumable, fodder or flowers). This additional facet of the process of applying for plant breeders rights does not have a parallel in the patent system.

Systems of Patent Protection

A patent is a right granted by a government to inventors to exclude others from imitating, manufacturing, using or selling a specific invention for commercial use for a certain period. In industrialised countries this lies between 17 and 20 years. A condition of grant of a patent is that the inventor discloses the invention to the public. Patents are ‘territorial’ in that they apply within tn that they apply within the borders of the granting country

The patented ‘object’ has to be:

• novel and inventive (novelty)
• not obvious to a person skilled in the art (often termed ‘inventive’); and
• industrially applicable and useful (utility)

Historically, "the non-patentability of biological matter seemed a topic beyond discussion, or, in any case of limited importance." This changed with the grant in 1873 of a patent to Louis Pasteur on certain yeast strains that were "free from organic germs." However, it has only been in the last fifteen years -- since the 1980 grant of a patent in the United States to Chakrabarty, the inventor of a genetically-engineered bacteria to clean oil spills -- that the laws on patentability of biotechnological inventions have developed at a rapid rate.

Many countries have their own patent laws. Because harmonisation of patent laws is important for regions that have close trade connecti connections, three trans-national systems have developed

The American system, dominated by the United States.

The Japanese system.

The European system, based on the European Patent Convention 1973 (EPC) administered by the European Patent Office (EPO). Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, the Netherlands, Portugal, Spain, Sweden, Switzerland, and the UK are parties to the Convention, which are required to recognise patents granted by the office and to harmonise their domestic laws with it. It is also possible to get protection in each country by applying to its national office.

In addition, in different jurisdictions the scope of a patent may be very different. In general, it is possible to patent a product, a process, or both. In different countries any one of these three approaches may be used.

There are many arguments about whether the products of biotechnology cogy could be covered by the patent systems. Some argue that the identification of the sequence of DNA cannot be called an invention, but rather is a discovery. Others argue that the private ownership of ‘genetic information’ is abhorrent. The European Patent Convention specifically excludes from patentability any form of therapy for human disease, in contrast to the American system. Those who drew up the EPC have claimed that they did not even envisage the possibility of the new biotechnology at the time, but Article 52 of the Convention prohibits certain products and process from patentability if they have medical uses of certain kinds. According to Article 53,

European Patents shall not be granted in respect of

inventions the publication or exploitation of which would be contrary to "ordre public" or morality, provided that the exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;

plant or animal al varieties or essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.

Difficulties with this, particularly with Article 53(b) and with the lack of clarity about the patentability of inventions related to human genetic material, have led to an attempt in the EU to draw up an EC Directive on Legal Protection of Biotechnological Inventions which is currently being discussed in the European Union. Obviously, this Directive will be of great significance not only to EU nations, or those contemplating joining the EU, but to any nations with strong trade links with the EU (and this will include the EPC nations not members of the EU.)

An exceptionally important development is the GATT TRIPS Agreement. This has been pressed for by those countries that currently are in the forefront of biotechnological development and investment, because it is designed to get the agreement of c countries that do not have a history of granting patent protection (many of these being developing countries) to provide patent protection. The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is a measure resulting from the Uruguay Round of Multilateral Trade Negotiations which may have an impact on the use and protection of products derived from modern biotechnology within the ‘developing’ world. The agreement harmonises patent law within member states so that both process and product may be patented and tightly regulates compulsory licensing of product for members of the WTO. The TRIPS agreement does allow member states to exclude from patentability:

diagnostic, therapeutic and surgical methods for the treatment of humans or animals, and

plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. The second of these categoriries is to be reviewed four years after the entry into force of the WTO Agreement.

The TRIPS Agreement establishes certain minimum standards for intellectual property protection and enforcement in signatory states; requires national treatment, that is, that each member state should protect nationals of other parties by granting them the rights contained in the Agreement; and finally, extends "most favoured nation" treatment to intellectual property rights, namely by requiring that any rights conferred by a member state on their own nationals, or nationals of any other member state, must be granted to nationals of all other member states.

The TRIPS Agreement may threaten plant genetic resource conservation and farmers’ rights. Intellectual Property Rights are seen by some as having been "developed by industrial societies in order to reward inventors of machinery. They are hardly appropriate for life forms, such as plants which have beenen developed over centuries and are constantly changing. ……also disregards the traditional rights of indigenous and local communities over their resources and knowledge". Others argue that that there is no reason not to allow the protection of intellectual property in a specific, newly developed field such as biotechnology. Indigenous, traditional knowledge should not be affected, as only inventions not in the public domain can be protected. On the other hand, many are concerned that the ‘temporary’ exclusion of plants and animals from the TRIPS Agreement is a problem. Bruce Lehman, Commissioner of Patents and Trademarks of the US PTO has been extremely critical. At the Pasteur Centennial Colloquium in 1995 "[H]e criticised the exclusions in the European Patent Convention and the Patent Cooperation Treaty, although acknowledging that that at the time they were made in ignorance of their effects on the subsequent development of biotechnology. He continued:

The public-sector is seen as being extremely important in development of products derived using biotechnology in many developing countries. However, the public sector may be unable on its own to meet the costs of developing new products, and the expertise available from multi-national companies may be vital in the exploitation of biotechnology. Multi-national companies have provided countries with the genes and cassettes to enable their insertion into crops of local importance. Where ‘gene-cassettes’ have been synthesised for insertion into major crop plants, the availability of the genes for insertion into locally important crops may be crucial to the development. In order to use these phenotypes some form of intellectual property protection may be essential. Many agricultural crops and innovations in developing countries are exempted from national legislation governing intellectual property. In a number of cases, Multi-national companies have provideided countries with the genes and cassettes to enable their insertion into crops of local importance.

A number of countries, notably India, have raised concerns at the conflict between the TRIPS Agreement and the Convention on Biological Diversity (CBD). India has indicated that the TRIPS Agreement should be modified to remove inconsistencies with the CBD In particular India has suggested that the changes should require that applications for patents should clearly mention the biological source material in the country of origin and that there be prior informed consent of the country of origin. In line with the Convention, where the biological material involves traditional or indigenous knowledge, there should be an obligation on the rights holder to share benefits. A Paper was prepared for the third meeting of the Conference of the Parties to the Convention on Biological Diversity held in Buenos Aires in November 1996 which examined the relationships and synergies of the CBD and the TRIIPS Agreement. The document reports that the treatment of Intellectual Property during the debates which led to the CBD was contentious. Many developing countries had argued that the IPR systems hinder the transfer of technology to the developing world and unfairly disregard the contributions of generations of farmers to the world’s plant genetic resources. These countries objected tot he expansion of IPR to new crop varieties and products based on their genetic resources

Requirements of Patentability

There are general requirements of patentability that, as it were, virtually define patentable material. These are

• novelty
• inventive step (mere discovery of something new is not enough); and
• industrial application (Utility)

The interpretation of each of these requirements differs substantially in different jurisdictions, although the TRIPS Agreement is an attempt to standardise patent law amongsaw amongst the signatories.

The exclusion of patentability in Europe on the grounds of immorality has caused considerable controversy. Such exclusion clauses have been opposed on two principal grounds

they place Europe at a competitive disadvantage against the United States and Japan;

morality as such has no business being considered within the patent system.

The main reasons given for 2 are

moral standards are difficult to judge;

patent authorities lack moral expertise or authority;

moral ideas change quite rapidly as compared with patent lifetimes (up to 20 years in Europe);

moral ideas differ across the territory of the EPC; and

technical procedures that are abhorrent should be forbidden by law and not merely denied patent protection.

These exclusions are in the existing patent law and it would be politically very difficult, and probably impossible to change them. Hence, those opposed to exclusions on grounds of immoralif immorality, recognising this, have pressed for a very stringent test of immorality, viz., that it would be so abhorrent to grant a patent that it would be inconceivable that one should be granted.

Biotechnology & Patents?

• Products of nature are not patentable; "mere discoveries" are not patentable.
• The novelty requirement has presented a number of difficulties to biotechnologists, as well as to groups seeking to conceptualize patent-type rights for local and indigenous knowledge. Issues have arisen relating to purified or synthetically produced biological substances, such as vitamins and hormones: was the patent applicant the "first" to reduce the invention to practice, or nature?
• For local and indigenous groups, the novelty requirement has been viewed as an insurmountable barrier to obtaining patent protection, since the knowledge to be protected has been in existence in the community for years, and often generations.
• the utility reqity requirement is often difficult to satisfy: identification, isolation and characterisation of genes can significantly precede knowledge of its utility. Similarly this requirement presents conceptual difficulties in seeking to apply traditional patent rights to the process of identifying and conserving rare species, whose utility is suspected but not yet known.
• the disclosure requirement presented problems in the past, in that traditionally disclosure had to define the way the invention was produced or built. The original means of production of a genetically-altered substance is however not relevant to the public who wishes to reproduce the substance; often a repetition of the inventor's process in fact will not reproduce the substance. However since such substances are self-reproducing, what is crucial is to obtain access to a specimen. This has been resolved through the international practice of deposit of biological materials.

The political nature of the disputes as about patentability (which reflect different and conflicting goals of regulation) is no more clearly to be seen than in the history of the proposed EC Directive on the Legal Protection of Biotechnological Inventions.

Apart from the issue of exclusions on the grounds of immorality, there are a number of problems that have surrounded patents for the processes and products of biotechnology. Amongst these are

The concept of novelty: Discoveries, as such, are not patentable. In what sense may DNA sequences that exist in nature be said to be inventions?

Applications have been filed and patents granted that are very wide in scope as they cover anything that includes what the patent is held on, even when the function of the sequences patented is not known.

The extent to which patents may be held on animals and plants produced by genetic modification, which is particularly severe in Europe because of Article 53(b). In a series of decisions, the EPO went from interpreting Article 53e 53(b) as rendering animals and plants unpatentable, to rendering them patentable, to greatly restricting their patentability.

The question of the extent to which human DNA sequences or processes for modifying human beings genetically (including somatic and germ-line gene therapy) are patentable.

A major issue has been the involvementof animal rights and environmental groups, who wish to use Article 53(b) as a platform for preventing patents for the products of biotechnology, and with this, they hope, development of genetically modified animals or crops, on the theory that without the income-generating capacities of patent protection, large companies will not invest and the steam will be taken out of the new biotechnology.

Acknowledgements: This article was prepared with assistance from Deryck Beyleveld and Margaret Llewellyn)