The patent  system is not  the  appropriate vehicle for  the  regulation of biotechnology  inventions

 by Tzeni Kapsogeorgou  

Abstract

   Modern biotechnology has entered during  last decades in a period of stride with catalytic effects. The developments and results of this scientific field challenges once more the social, ethical and furthermore the legal  regime. The patent system as practically the first point of contact of new biotechnology inventions or presumably discoveries, with a world different from a scientific laboratory, has to judge and justify several subtly aspects of the proposed inventions. While patent has already successfully faced problems of protecting biotechnology inventions at past, unprecedented characteristics of the new inventions have raised numerous moral and other concerns with various implications.

Additionally, the importance of the advances, evince that priority in this case must be in ensuring the good of humanity in a global level than protection of fair industrial profit. In order to examine in detail all the aspects of that situation, I think, that an enumeration of the arguments that vindicate the patent system as the proper vehicle for protecting biotechnology inventions, as well as the arguments against this consideration, is essential. Finally  a citation and evaluation of scenarios alternative to the current patent system would be apposed.

What is Biotechnology

The term of Biotechnology may be generally defined as a wide range of techniques that use, analyse and modify living organisms and biological elements aiming in the production of useful products[1].While some of these techniques were known and applied for centuries, the development of classical biotechnology and microbiology has taken place mainly during the last century.

Furthermore, during the last decades, we have witnessed a number of subsequent technological "revolutions" as the development of new biotechnology with fundamentally new possibilities such as recombinant DNA, gene sequencing and cell fusion methods[2].

Therefore, as an outcome these new methods of biotechnology  due to their nature, complexity and importance have raised new legal and ethical issues. A very important legal issue in the area of biotechnology is the application of patent system for the regulation of biotechnology inventions.

Patents and Biotechnology

Given that a patent is an agreement between the society and an inventor whereby, in exchange for the inventor's complete disclosure of the invention, the inventor has the right to exclude others from using the invention in certain ways. The rationale for a patent system is to provide an advantage to society as a whole by rewarding the development of new inventions. Consequently ,the patent system has two basic purposes: to promote the progress of technology, and to protect the inventor furnishing him with an exclusive right[3].

Biotechnology inventions have caused new considerations and concerns relevant to their regulation through the patent system. The protection of this developing and commercially important new technological dimension constitutes a challenge to the patent system. Thus patenting in the specific field of biotechnology has to respond in many complex legal problems[4].

It is important to be mentioned that patents have facilitated academic research, because of the release of information to the public which is critical to the advancement of knowledge. The fact that an inventor can obtain patent protection on an invention encourages inventors not to withhold beneficial information from the public. In fact the patent system serves to provide strong incentive for sharing information. Not only can a researcher use the information in a patent, but by disclosing scientific information, the patent system avoids expensive duplication and repetition of research efforts.[5]

Patents have been in the past and still are used extensively by universities and biotechnology companies to protect investments in research and development.  Patents have value in this regard through the exclusive rights they provide their owner.  Exclusive rights under a patent can be used to prevent competitors from interfering with the commercial use of the patented technology where there has been no consent to do so, by the patent owner.  Exclusive rights do not constrain the dissemination of information concerning the invention to the public, which occurs when the patent is granted or the patent application is published. Exclusive rights also do not interfere with non-commercially focused experimental use of the technology.[6]

Another facet is that investors who support research and development ventures in the field of biotechnology are provided with a minimum level of financial security and increased expectations through patent exclusivity. The early stages of many biotechnology research and development initiatives involve a lot of effort which has indistinct commercial application at that point and high risk from an investment perspective.  As a result, many products that would be the result of the commercialisation effort of the venture will never appear on the market. So, the inventor privileges which are provided through patent system constitute a basic incentive for financing of research and development activities and the evolvement of science and technology in the industrial environment.

Patents clearly play a significant role in the commercialisation process for biotechnological innovation. What has been less clear is how the grant of exclusive rights over commercialisation of a particular biotechnological invention may relate to certain societal concerns regarding development of biotechnology[7].

It is, however, true that a patent does not automatically  give its proprietor the right to exploit his invention, especially in the field of biotechnology in which the  prerequisite of  previously approval from regulatory  authorities is required. As it is obviously  pointed out ,a patent holder may not be able to exploit his invention if the legal regime prohibit the  exploitation of that specific invention. But on the other hand, it is widely accepted, that the exploitation  of an invention is not dependent on whether that patent is patented or not [8]. Research would not be restricted because of  the denegation of patentability.

In the last few years many reports have been made in the scientific and general press about patents conflicts in biotechnology. Claims of "biopiracy"   have been raised  in situations when biological materials are used in the development of an invention that is later made the basis of a patent application[9]. The excessive delays and bureaucracy of the procedures that settle out these complex patent disputes that may take years to be resolved in the international arena as well as of the procedures for patent publication themselves practically obstruct the purposes that the patent system is trying to serve. The inventions that do survive the risky and difficult developmental process often enter the market with only a short period of exclusive rights from the remaining patent term when the product can be sold on the market. Additionally, unresolved long conflicts for patent grants finally turn to become major holdback in biotechnology development since the uncertainty concerning a third party's right to use such an invention and the identity of the inventor whose license is needed do not allow the development of new inventions based on that. Another practical problem of the patent system is that these delays and especially the cost of the fees that are required for an application of patent grant as well as for patent renewal may also discourage small and active companies or independent researchers from entering in the area and in that way it contravenes market competition.

The rules governing patents and the way they are applied vary slightly from one country to another. In most of the developed countries though there are similarities and since biotechnology is mainly a collaboration-industry and advances in biotechnology may affect humanity as a whole, a parallel approach would be worthwhile. It should be clear though that differences in the way biotechnology inventions are treated by law in several countries might have the result of a more friendly environment for the development of that industry.

Biotechnological inventions or discoveries ?

  A primitive issue regarding biotechnology protection is the distinction between discovery and invention, as most patent law systems prohibit the patenting of discoveries. This is difficult to be defined in any of the sciences of nature because the act of discovery reinforces the consequent practical application of invention[10].

Considering that, regulations governing the patent system such as article 52 of European Patent Convention (EPC) ,article 3of EU Directive on the Legal Protection of Biotechnological Inventions and section1(2)(a) UK Patents Act 1977 state out that only inventions can be subject to patenting as discoveries are explicitly excluded from patentability, the distinction between discovery and invention is of a great importance.

 The term of invention is not always clearly defined; however in several articles of the legislation mentioned above there is a number of properties that confute the requirements of invention. An argument frequently used against biotechnology patents on living organisms and parts of living organisms e.g. genes, is that this knowledge can only be discovered and not invented.[11]

On the other side there is the point that if a substance found in nature has first to be isolated from its surroundings and a process for obtaining it is developed, that process is patentable. Moreover, if the substance can be properly characterised either by its structure or by the process by which it is obtained or by other parameters, it is a new in the absolute sense of having not previously recognized existence and as such the substance may be patentable[12]. This worries biotechnology scientists, who believe discoveries should be shared for the common good and that the battle for patents for commercial gain may damage research in many cases.

The morality provision

Attempts to patent biotechnological inventions have challenged traditional patent law principles. Paragraph (a) of article 53 of EPC the so called morality provision, states that inventions the publication or exploitation of which would be contrary to "ordre public or morality" are excluded from patentability. Moreover, article 6(1)of the Directive 98/44EC on the legal protection of biotechnological inventions  states that inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre or morality .Section 1(3)(a) of  the UK Patents Act 1977 repeats the above stated that a patent will not be granted for an invention the publication or exploitation of which will be generally accepted to encourage offensive ,immoral or antisocial behaviour[13].

Although, the special nature of living matter, the ability to self-replicate, and the diversity of biotechnology applications distinguishes biotechnology from other fields, making the decision of morality of biotechnology inventions not straightforward. The major problem is that in most cases there is an antithesis in the arguments regarding the question of morality, and an invention that could be judged as immoral at a first glance may benefit humanity in a great extend.

It is true of course that the issue of morality is more revealing for modern biotechnology but it is often risen in traditional biotechnology and other areas of technology as well and what is demonstrated is the need for a revival of the discussion on ethical values in the interaction between society and technology, and on the responsibility of scientists.

From the start of biotechnology development ethical queries have been repeatedly raised. A lot of discussion usually takes place about them by politicians and journalists but the time that a clear decision is required is while patent application. On the national and international level, bioethical committees have been set up to clarify boundaries of what is acceptable in biotechnology development and application. The care with which bioethics are addressed is likely to have an influence on the marketability of products derived from biotechnology, since it will finally be the consumers that decide on the prospects of the biotechnology markets.[14]

Since the need to determine the morality in biotechnology inventions is obvious and self-evident, the fundamental question is about the authority that is adequate for that. In Harvand mouse case for example the Patent Office concluded that it was ill-equipped to decide issues of morality and deferred decision on the Article 53(a) issue to the Board of Appeal.[15]

What we call  “ethical biotechnology” cannot be decided just by public opinion. However, something which is  morally offensive to the majority of people in a country or region , or world-wide , is judged to be immoral and is likely to be outlawed. What is seen as immoral is often also unethical, though unethical practices are often tolerated by a society and thus the definition of moral would point out that they are “morally acceptable”, because it is “common morality”. We must remember this distinction between ethical and moral when we look at public opinion. Law is often based on the so called common morality of a country and in the area of biotechnology we can see varying laws established by different countries; even within Europe there are conflicting laws. There are very different viewpoints on what is moral since this strongly depend on the political, cultural and religious environment.[16]

One of the crucial issues of ethical regulation is on what moral principles could be based. Proponents of relativism believe that moral beliefs and principles only relate to individual cultures or individual persons: concepts of right and wrong are meaningless when separated from the specific contexts in which they arise. The only acceptable universal element is that individuals in all societies have moral conscience, i.e. a general sense of right and wrong. Others argue that although there is disagreement about ethics of particular situations and practices, the disagreement about fundamental moral standards is far less. Moreover, it is argued that a universal set of human needs would lead to the adoption of similar or even identical principles in all cultures. Even if individual or cultural beliefs vary, it does not follow that people ultimately or fundamentally disagree about moral standards. Maybe the best known historical precedent of an international consensus on moral concerns is the Universal Declaration of Human Rights. Similarly, the International Bioethics Committee of UNESCO is now developing an International Declaration on the Human Genome and Human Rights, in order to provide "the dignity of individuals and their rights and freedoms" in the context of the progress of molecular biology and genetics. [17]

However, whether the "rights and freedoms" of individuals will be served by the first attempts of ethical self­regulation remains to be seen. Labelling of biotechnologically derived products, a current issue in the European Union, might be an illustrative case. To leave individuals the option whether or not to buy biotechnologically derived products is a kind of a minimum approach towards bioethical concerns, disregarding the ethical theory one embraces. These individual choices can only be respected if the individual consumer is treated as an autonomous citizen, who is provided with objective information on the consumer products and has several alternatives to choose from. It is therefore surprising that private industry still hesitates to implement labelling of biotechnologically derived products.[18]

Representantive examples of morality implications on biotechnology patents are the broadly discussed cases where granted a patent on a plant in 1985 and a transgenic animal (the Harvard onco-mouse) in 1988.[19]

In the first case as is mentioned in the decision, the Board of Appeal first addressed the morality issue, defining Article 53(a) to exclude only "inventions the exploitation of which is likely to breach public peace or social order or to seriously prejudice the environment". Finding no evidence in the record that exploitation of the inventive plant was likely to seriously prejudice the environment, Article 53(a) did not prevent patenting.[20]

The subsequent case of the Harvard Mouse has received much public attention. The invention was the introduction of an activated oncogene sequence into a non-human mammalian genome, resulting in a transgenic animal expressing the myc gene and thereby particularly susceptible to cancer. The EPO's Examining Division rejected claims to a transgenic animal under Article 53(b), finding "animals" excluded from patentable subject matter.[21]

The Internationalisation of patent rights

Traditionally, patent systems are territorial which can be interpreted as the existence of many different national  patent systems regulating the biotechnology inventions providing a differing degree of protection. A supposed and prospective process of internationalisation was the Agreement on Trade-related Intellectual Property Rights (TRIPs) which tries to balance between  the economic health of the nations and the competitiveness of firms and the ability to capture  the economic benefits  of technology, forcing national patent systems to provide protection for national ventures.[22] Within this framework, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) settles a minimum standard for national regulations on patents. It compels developing countries to re-write their patent regulations before the year 2000 and the least developed countries to do so before the year 2005.

 Moreover, the question about the way the patent system works for inventions in biotechnology was investigated in depth in 1985 by the organisation for Economic Co-operation and Development (OECD). The OECD report on “Biotechnology and Patent Protection: an international review” was a report published by OECD on aspects of biotechnology, but unfortunately this enquiry was limited to its member states. Subsequently the World Intellectual Property Organisation (WIPO) extended its own enquiry world-wide and set up a “Committee of Experts” to review the law and meet annually for discussion. The members are generally representatives of Patent offices from all countries which consider the subject important from their point of view. Representatives from industry and other interested parties attend as observers.[23]

Even the GATT agreement identifies that the legal system which applies in Europe is surely, not the only one  and it suggests that the member states may exclude from patentability inventions the prevention of which is necessary to protect human, animal or plant life or health, or to avoid serious prejudice to the environment, a criterion which does not included in the European Patent Convention.[24]

In Europe the internationalisation of patent law is combined with the  target to harmonise patent laws so as to fully integrate  the European Common Market. Since 1988, the European Union has attempted to draw up a harmonised biotechnology patent system. The main aim was  to establish a unified-equal legal regime replacing national patent law.The first step was the enactment of the European Patent Convention (EPC). The EPC creates a centralised procedure for granting patents valid in the contacting states, avoiding to apply for a patent in the national office of each state in which the inventor seeks patent protection. In most EU countries, patenting decisions are broadly governed by the provisions of the EPC, to which some non-EU countries are signatories as well. Patent decisions under the EPC are made by the European Patent Office (EPO.

Furthermore, in March 1995, the European Parliament rejected the proposed EU  Directive   on "The Legal Protection of Biotechnological Inventions." The proposal codified principles for granting patents for genetically engineered plants and animals as well as the patentability of plant and animal varieties. Although many in the industry were in favour of a more clearly defined patent system, they also felt that the directive had become watered down because of numerous compromises. They preferred instead to work within the current system of EPO case law, filing through the EPO or with individual patent agencies. Finally, in May 1998 the amended Directive 98/44EC  on "The Legal Protection of Biotechnological Inventions" was approved by the European Parliament.[25]

Arguments supporting patent system

Generally, for the defenders of patent system its structure is adequate for biotechnological inventions and patent protection has an important function and as that cannot  be dismissed  in favour of  commercial secrecy .On the other hand many academic research workers who have either boycotted the patent system  or have found it incompatible with their main aims, have played an insignificant role in its process leaving patents to the exclusive domain of industry. So, separate legislation for biotechnology is unnecessary, the legal regime concerning biotechnological inventions through patent system is sufficient and desirable.[26]

Patent protection is of major importance in biotechnology industry. A company is able through a few successful patented products to remunerate the enormous investments that  spent into developing the product and supporting research activities in the first place. There are many examples of companies on the biotechnology area that become giants of the market through such a process. Also, patent protection attracts investors when research activities are stressed, since it implies that the company will be able to generate an increased future profit from product sales. Patents even when are pending are significant bargaining chips in deal-making among biotech firms. [27]

Patents have a significant role in drug research. Developing a new medicine is a difficult, expensive and risky process; it  may need several years to accomplish with an uncertain result. It usually entails performing years of research and conducting clinical studies at multiple medical centres, a necessary safeguard for the public that nevertheless imposes heavy burdens, especially for small companies. Patents do not allow competitors to immediately copy and sell an innovative drug as soon as it was approved for sale. Since an substantial part of drug price is related with the research and the clinical studies, the competitors could afford selling these drugs without including these costs, and capture the market by offering the drug at a lower price. Following that scenario, the company that originally developed the drug would never manage a depreciation on its research and development costs.[28] So, without patent protection, companies would simply have neither the way nor the motivation to invest in research and discovery of drug programs. The final result would be to block the circuit of science and technology advancement through industry growth. 

Modern biotechnology offers new opportunities for developing drugs to treat  diseases that cannot be cured by existing medical treaties, using gene-based inventions. Patents on gene-based inventions protect the inventions from misuse by rivals and allow a company to have confidence that it will flourish an easy commercial success based on  its development efforts. Without patents on gene-based inventions, the rate of medical innovation coming from biotechnology would therefore slow dramatically. Ultimately, patients would be deprived of new therapies.[29]

Arguments against patent system

Some frequently mentioned objections against biotechnology patents are based on cultural and religious beliefs and raise the point if  man should or not interfere with genes or implement many of the new biotechnology techniques at all. Opponents of patent protection for biotechnology  inventions argue that genes are property of  the entire human race and therefore they should be preserved and passed on unchanged to next generations ,otherwise there is always a danger that man will finally behaves like being the God. Patents, therefore comprise a direct justification on biotechnology inventions without taking into consideration any of these issues.[30]

 It is important to emphasise that biotechnology inventions have faced different attitudes .Some  describe it as the ultimate means to solve all the major problems our society has ,whereas others consider biotechnology to be the proof that humankind is digging its own grave.[31]

 Many consider genetic information provided through biotechnology inventions to be the common heritage of the entire mankind and do not consider patents appropriate for the regulation of the specific kind of biotechnology inventions. They also claim that man do not really has desirable and deep knowledge on the complex process of life and just experiments on it without realising possible effects and dangers on the future of the humanity. For example a great fear of the public opinion has always be, that biotechnology research may lead to the creation of new viruses and diseases.

It is clear that the vast majority of the oppositions against patent system protection to biotechnology inventions is going to be on the morality issue. There is actually a morality clause not only in the European Patent Convention but also in almost all the legal systems so as to exclude these inventions which society would not wish to endorse with a patent.[32] For example, when the question of the patentability of a genetically altered mouse was presented before the European Patent Office in the late 1980s and early 1990s, a number of organisations filed oppositions citing ethical concerns related to their opposition to the genetic alteration of mammals. There is also a great distinction regarding patents on plants and animals. Generally there are substantially more arguments and opinions that suggest that an extension of patent law to higher organisms is even more not likely to serve the public good. [33]

There are also oppositions that are referring to the way the patent system is currently implemented. By introducing complicated and expensive procedures, it finally serves as a valuable ally of the giant multinational trusts against open market and individual research.

The extraordinary commercial importance of patents is also a factor that usually can cause problems in scientific community. Many scientists simply think that there are too many patents, and that overdue applications for patents on essential methods and techniques from parties that are not even justified for them may represent an obstacle for further technology advances. These methods some times have already been used for a long time by scientists and restrictions on their use would affect negatively other research activities. At last the result of the situation around the patent system is that usually much more importance and funding is given to the procedure of patent acquiring than on research itself.[34]

Patents is also considered as a system which embodies certain ethical and moral values. They may act as a social and moral filter allowing certain forms of culture to pass into mainstream commercial life while blocking others. [35]

Patents are not the appropriate vehicle for regulating biotech inventions

Patent system ,certainly is not the appropriate way to control biotechnology inventions. Whether patents are seen as a reward for the society's benefit or whether they are seen as a recompense for hard work is neutral; both supporting arguments separately suggest the pretence of law to give patent protection to biotechnology inventions. I wonder whether  is it  a false dilemma to say that either we have patent protection or we do not encourage biotechnology invention and  development. For example, often the mainstream of science and technology advances come from the academic area, an area that notably respects more social and ethical concerns and has as the main priority the good of the humankind instead of commercial profit. Increased profits that result from the commercial application of patented products is not the main research funding in an academic environment. 

The exploitation of biotechnology inventions by the rich , developed West countries, which have under control all the means of development and by that way they are not willing to sacrifice their commercial benefits , are those that  insist and encourage patent protection as such. The fact that Western science and technology has extracted the very last ounce of the  primary sources that developing countries have known and shared centuries now. Developing countries are indubitably a rich source of natural ingredients and substances which are the basis of biotechnology  products which, in fact may have been used in its indigenous environment for long. While first world countries own the technology to manipulate that material the countries that should be justified to own it in the first place, are not able to gain patent protection.

Likewise, often the process of what nowadays is called biotechnology invention derives from the common knowledge and attempt originated in the less developed countries. It is  not about an original invention but a repetition and transformation of something already known and broadly used for centuries. Most of the times, these practices are the result of common work and development and as that the owners have never thought about claiming patent protection, since in these cultures is an unknown and unnecessary process.

It is important to be mentioned that  as the share of the benefits of the patenting protection is not , by no  means, equal ,so the existence and the support of the patent protection for the biotechnology inventions is not appropriate. The  patent protection of biotechnology inventions neglects the fact that not all the nations of the world have equal ability to make use of the patent system[36]. In point of fact, only a handful of developing nations have the public or private capacity to enter into such competition. To do so demands both a significant public sector research base and significant private capital to develop patentable materials, to file patent applications and to protect those patents against infringement. Indeed, even in the wealthy nations of the world, small companies often find that their patent rights are unenforceable in the courts simply due to the wealth of their counteractive.

Moreover the provision of morality which exists in all the legal systems is of a great significance and raises a degree of concern about who  decides about the morality clause. There are, justifiably ,objections concerning the  enquiry about who is going to decide for such a general and vague meaning of moral-immoral. Have the patent officers and thereinafter the judges the required background and wisdom to decide about this socially sensitive issue? Whereas patent examiners are not ethicists how are they decide using the morality criterion ?

Alternatives to patent system

The law is there to be changed or to be adapted to new standards if, of course, we choose to do so. There should be a fundamental bottom line  written, registered in the law, which provides that there are some things we shall not be allowed to do .A clear, indisputable written statement of the limits of patentability of biotechnological inventions should be provided in a language that cannot  be misinterpreted.[37]

We can propose and evaluate alternatives to the classical monopoly patent system. One is the abolition of patents in general, another is a system  in which patents give a right to a royalty, but no exclusive rights and finally biotechnology could be protected by a sui generis legal regime.

Abolition

A real world example of a system where patents were abolished has been in Italy which had no patent protection for pharmaceutical inventions from 1939 to 1978 .The proponents of the law of 1939 hoped that the abolition of patent protection for medicines would decrease prices by encouraging competition. The results were not the expected, as  a great number of small companies has been appeared selling the same products on similar prices and spending a lot on advertising. Clearly the abolition of any form of patent system has been proven in that case that does not only discourages research and development since only one new product was originated in Italy during that period while other countries introduced more than thirty, but did not even lead to reduced prices. Some small Italian companies made money by pirating the biotech inventions of research based companies in other countries but the Italian public did not receive any benefit.[38]

Compulsory licensing

Compulsory license provides an alternative model where the owner of a patent has only the right to be compensated from users of the invention and not to establish a monopoly for his product.[39] An obvious problem of this approach is the inability to specify a reasonable compensation, and usually unjustified high or inadequate royalty rates are required.[40]

Interesting cases where this approach has been followed was in United Kingdom before 1977, Canada and India. In United Kingdom there was no specification of a limit for a compulsory license. The compensation that was required in most cases did not allow other companies to gain any significant amount of sales. The patentee did not had a monopoly right but could still control the market in a high extend. In Canada and India the level of royalties for pharmaceuticals, has to be no more than 4 per cent of the price of the final product. This specification has been simply inadequately low in most cases. In any case a fixed proportional price based on the products final price is leveller and correlates the cost of research and development that can be highly variable to the cost of manufacturing the product.[41]

Sui generis

If intellectual property rights must be extended to biotechnology inventions, then a new legal form has to be  designed specifically for them. Such a system might not resemble the current  patent protection system, although it will also have to balance among distinctness, and uniformity qualities that are valuable from a legal perspective. A better system would focus on the specific characteristics  and singularities of biotech inventions so as to resolve all the existing disputes, to enhance the development of biotechnology research stimulating investments, and to insure the wide distribution of the benefits from such research.[42]. 

   To put it simplistically, a completely new  sui generis legal regime especially  tailored for  biotechnology needs should  be applied.[43]Patent law was designed with mechanical and chemical inventions in mind. In those areas the distinction between discovery and invention is clear: tractors and corn flakes are clearly inventions. They are nowhere to be found in nature. In contrast, biotechnology "inventions" often lack such an inventive step. They involve only the recombination in novel ways of genetic material that already exists. [44]

While most biotech inventions are replaced after just a few years, the duration of protection of utility patents generally is about 20 years. Utility patents prohibit research using patented materials. Thus, they may slow down invention or alternatively, create enormously complex cross­licensing arrangements, whereby a given plant or animal variety might be covered by dozens of patents. Granting a monopoly over such an extended period of time prohibits others from using the knowledge covered by the patent to develop still better varieties. [45]

The main characteristic of a new legal system that could differentiate it, would be the involvement  of relevant and specialised adjudicators, consultants and experts, who would have the ability to study and decide on an individual basis. The legal platform should also be tailored in order to be more specific and clearly demonstrate guidelines on biotechnology area. And of course the authority that should be charged in handling that task should have an international identity in order to properly treat and ensure rights of different countries.

And regarding moral issues an independent committee which would be trusted and respected by all the interfering parties and that could represent most major cultures and ethical perspectives should be founded, as patent offices have been proven to be unable to accomplish this ethical review.[46]

Conclusion

Finally, it is important to be mentioned that as the patent system  is nothing but a regulation of competition ,so the problem of granting patents to biotechnology inventions has to be viewed independently because it is subject to complex disputes.

Most of biotechnology  applications have raised ethical and moral issues, discussions and concerns and the most important of them is the question about how inventions on these area could be protected through patent system. National patent systems ,generally are inefficient to regulate biotechnology inventions and are of a great variety throughout the globe. The prospect of international  harmonised and unified regulation of biotechnology inventions is a demand of the time. Possibly, an imaginary  sui generis system tailored to the needs of biotechnology area is probably the only one that could encounter the legal challenges in a satisfactory way[47].

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