PATENTS AND COMMERCIAL TRANSACTIONS OF HUMAN TISSUES^*
Manuel BECERRA RAMÍREZ^**

Original Text (Spanish) PDF

SUMMARY
I. Introduction. II. Patenting. III. Inventions in the biotechnology field. IV. The use of human tissue in biotechnology. V. Jurisprudence on patenting of biotechnological inventions. VI. International obligations of Mexico regarding industrial property. VII. The moral clause. VIII. The exclusion clauses in the Mexican legislation. IX. Conclusions.

I. INTRODUCTION

The antique institution of industrial property, as it has happened in previous industrial revolutions, once again takes place in the States' domestic Law in order to protect the so-called biotechnological "inventions", manipulating the humane genome. An institution created to protect and compensate the inventors of machines and devices that cover certain need to men, when tried to be applied to genetic manipulation and to the products derived from it, then there is a phenomenon of the too-big-sized suit that has to be made suitable, especially regarding the protection of the population. Here we are referring to the institution of the patent. The way it works and how it is applied to biotechnology leads us to discover some of its deficiencies; reason why, it is necessary to adequate it to the needs particularly of our country. With this aim we review the international legislation and the most significant cases of international jurisprudence.

II. PATENTING

The patent is an old legal institution from Europe that helps protecting the inventors. The State grants the inventor, title-holder of the patents, all its strength to protect him from an unauthorized use, that is, from what is commonly known as piracy.¹ The patents regime, providing that its object of protection is invention itself, is directly related to the industrial revolutions.² As we know, the system of patent protection is characterized by is territoriality, because there is no centralized system; each State's sovereignty has to administer the system of patents and protect the title-holders in case of breach. However, since 1883, with the Paris Convention for the Protection of Industrial Property, there is an international uniform system administered by each State.

In 1994 the Treaty on Intellectual Property Rights (also known as TRIPS for its acronyms in English, and ADPIC for its acronyms in Spanish) which at present is the international legal framework, of second generation, applied to all the members of the World Trade Organization (WTO). We shall clarify that it is of second generation because, contrary to the Paris Convention, the TRIPS is linked to world trade and has a system of sanctions and dispute settlement. However, both Paris (first generation) and TRIPS have a sound coexistence because, for example, the TRIPS takes as a basis and recalls the Paris-Berne Convention. In the concept of second generation, we shall not forget the regulation on intellectual property contained in the North American Free Trade Agreement (NAFTA), chapter XVII that is quite similar to the TRIPS. This might be because the model for both documents was the United States of America. The Universal Patent System establishes the requirements for an invention to be patented: a) novelty; b) to be the result of an inventive activity; c) to be susceptible of industrial application. The doctrine adds a fourth requirement: not to be banned by the legislation.³

Novelty is applied all around the world, which generates a particular organization system of the patent offices that have patent assets in the entire world. The inventive character, second element that takes as a point of reference the situation of the technique in the presentation date, is an important referent because an invention that does not have an industrial application will not be considered as patentable. Finally, as we previously mentioned, certain inventions have these three requirements, however, the State excludes them from patentability: this has to do with the States' sovereignty, about how they conduce their industrial, scientific and technological policy.

In its origins, the patent system makes a clear difference between the scientific inventions and findings that are patentable; however, regarding the genetic inventions, biotechnology puts once again this topic into discussion,⁴ as we will see further.

III. INVENTIONS IN THE BIOTECHNOLOGY FIELD

Since the beginning of humankind, the human being has manipulated the living beings for his benefit. He has used a kind of biotechnology to improve agriculture, food, etcetera, by using microorganisms. Although this was common, there is no antecedent that reveals that man has requested a patent for beer, wine or cheese.⁵ The demands of inventions regarding biotechnology were set into question during the Third Industrial Revolution, with the new capacity of selecting and manipulating genetic material in order to create products with unique and specific qualities at a massive scale and in a quite fast way.

The problems set by the patenting of biotechnological inventions identified by the doctrine⁶ are the following:

• The difference between invention and finding, when many of the new technologies in the biotechnology field are based on findings considered as scientific.

• The instruments used in this field (it is a kind of new or biologically active material) raise the question of whether the product is invented or found in nature.

• The possibility of repeating the invention is another problem biotechnology faces; this is directly related with the requirement demanded in every legal system, that the invention has to be clear and complete enough for its realization without the invention. This difficulty is because the invention in this area uses living biologic material, like microorganisms, fungus and bacteria, which are complicated to describe with words. With this difficulty, the legislations of many States have created procedures and institutions to deposit the material, which is taken as a way of describing.

Although there is an international legal framework on second-generation intellectual property that intends to give a proposal to this issue, it is still insufficient. Therefore, the jurisprudence of countries such as the United States and the European Union, we shall analyze further, are a useful element to interpret and apply the legislation in this subject. Before, we shall point out some concepts on human tissue technology.

IV. THE USE OF HUMAN TISSUE IN BIOTECHNOLOGY

Generally, the investigation made about human cells and skin uses three kinds of technology:

1. Technology of cultivation of skin and cells.
   

2. Hibridome technology.
   
3. Recombining technology.

These three types of technology have the characteristic of transforming human biological material into commercial products of a high value. Since the moment the biotechnology products are susceptible of commercialization, a very important transformation in the academy occurred, because the stimuli regarding values such as prestige, fame, the benefit of humanity, development of science, and the academic level, have been replaced. Now we talk about revenues, commercial profit, reason why the publication of research works have also been transformed: the papers have only sufficient information, without discovering the fundamental aspects so that they do not lose novelty, in the case of the patent request.

What is really outstanding is the protection of biotechnological inventions by a legal institution, industrial property, which was originally thought as to protect products of the human talent related to material things such as vehicles and machines, not material living beings such as the genome and microorganisms. Precisely, the insertion of inventions of this kind into industrial property has raised a polemic that is still present. But the States have hurried to create a jurisprudence that traces the pathway the legislations shall follow, without this meaning that the polemic is over.

V. JURISPRUDENCE ON PATENTING OF BIOTECHNOLOGICAL INVENTIONS

It is not strange that the United State has participated more actively in the creation of jurisprudence on genetic manipulation. This could be explained if we take into account its legal system, which gives more importance to the creation of Law through the jurisprudence decisions and its technological development.

In the juridical literature, the case considered as a cornerstone in industrial property law regarding biotechnology is Diamond vs. Chakrabarty. In 1971 the Indian microbiologist, Ananda Chakrabarty, employee of the General Electric Company, requested the US Patents and Trademarks Office to patent a microorganism modified with genetic engineering, with the purpose of consuming the remains of oil in the sea. This time, the PTO rejected the patenting, claiming that the living beings were not patentable. In appellation, before the Tariffs and Trade Appellations Tribunal, Chakrabarty won in a tight decision (three to two), considering that the fact that the patented microorganisms are live lacks legal meaning, and that the microorganism requested for its patenting "was more similar to inanimate chemical compounds…".

The litigation continued before the Supreme Court of Justice of the United States. In 1980, the Court, again with a small margin (five to four) decided in favor of Chakrabarty. Magistrate Warren Burger, on behalf of his colleagues, stated that "the pertinent distinction was not between living and inanimate things", but in whether Chakrabarty's microbe was a "humane invention" or not.⁷

This way, in 1987, following the Supreme Court, the Commissioner of Patents of the US announced: "The Patents and Trademarks Office considers the living non-humane pluricell beings as subject of patenting, including animals created in an unnatural way".

The US Court, by allowing the patenting of the "oil-eater" bacteria, which was genetically modified,⁸ urged the Congress to patent or include in the patent regime "any existing thing under the sun made by man". This meant the balance of leadership in order to seek the patent of the product of biotechnology.

With this legal framework, the University of Harvard, at the end of the 80's received the first patent of an animal's life. In this university, the biologist Harvard Phillip created, through a genetic alteration, what is now known as oncomouse, an animal susceptible of producing cancer. It was benefited with patent 4,736,866 on April 12, 1988.

After the oncomouse, the PTO issued three more patents for types of mice, and dozen more requests have been presented to the Patents Office, including the petition to patent animals such as dogs, cows and sheep that have been genetically modified.

1. The Moore case (the right every person has to control his or her own body)

The Moore case is paradigmatic for two fundamental reasons: the first one, because it extends the compromise and the responsibility in the relationship physician-patient, and the second one because it establishes the criterion to follow in case of petitions for patenting body parts. Then, the analysis of the Moore case is very useful for the better understanding of the situation of art in its legal perspective.

In 1984, John Moore started a judgment against doctors David, Gold and Shirley Quan, the University of California in Los Angeles (UCLA), Sandoz Pharmaceutical Corporation and the Genetic Institute Corporation. The reason of the lawsuit was the utilization, without his authorization, of a part of his body.

The story began in 1976, when Moore was diagnosed with leukemia.⁹ In October of that same year, doctor Golde removed Moore's spleen as part of his treatment. Moore, further in his lawsuit, claimed that physicians Golde and Shirley Quan, among others, received part of his spleen without his authorization. The physicians used the spleen's cells in order to establish cellular lines and products they patented as MO cell-line, hiring private firms to commercialize them.

The case Moore, from the legal perspective, has two important aspects. The first one refers to the authorization Moore should give or have given, and the second one deals with the patenting, which was unusual in the date it was established.

With respect to the authorization, Moore signed a form of consent of operation, in which he authorized the hospital to use certain tissues or body parts for their cremation. This authorization did not include his consent to commercialize his skin or spleen. However, for several years, after his operation (1976-1983), Moore, traveling from Washington to Los Angeles, gave Gold his "blood and other products of his body" presumably for controls of his illness.

In April 1983, as a petition of the UCLA hospital, Moore signed for the first time, an authorization, acknowledging that the information derived from investigation of his blood or bone marrow could not benefit him directly. Moreover, he conceded voluntarily to such University what is literally transcribed: "…University of California any and all rights I, or my heirs, may have cell line or any other potential product which might be developed from the blood and/or bone marrow obtained from me".¹⁰

In September of the same year, Moore was asked to sign another authorization identical to the one of April, and this time Moore agreed to have his blood extracted, but he did not grant any right on his cell lines. Despite this, the UCLA continued using it. In 1984 Moore presented his lawsuit.

The California Supreme Court of Justice which, partly rendered a decision in favor of Moore by deciding that the case was based on three basic principles, which are quite transcendental:

• An adult, in full use of his faculties, has the right to decide whether he submits or not to a medical treatment based on his "right to have control over his own body".

• The patient's consent shall be informed.

• The physician has the obligation of giving all the necessary information for the patient's decision.

As we can see, the core point in the discussion before the judge was the principle, widely known among the professionals of medicine, of the "informed consent", of which derives, or is related, the principle of "the right every person has to have control over his or her own body".

In fact, this principle, after the Moore case, may be classified in "informed consent to the treatment", "to research", and mainly (this was the judge's decision in the Moore case) the "informed consent for the trade of human skin" (here we shall take into account that the concept of "human skin" is used in a broad sense). In this sense, (of the "informed consent for the trade of human skin") the Moore case is quite significant, although in the American judicial practice it is quite limited, because it was a local decision that only applies in the State of California.

But, we insist, it is clear that the person has the right to control his or her own body, thus Moore's physicians are responsible for not informing neither having his authorization about all the aspects of the utilization of the human body, including its trade.

On the other hand, it is evident that the case Moore is intimately related to the development of medicine and biotechnology applied to medicine, which requires an intense utilization of human body parts, both for their experimenting and for transplanting. Thus, the demand for body parts has increased; the demand of organs surpasses the supply, resulting in a big legal-medical problem.¹¹

In fact, the current basis of the authorization for the utilization of the organs for medical purposes is the voluntary and free authorization. From the perspective of some specialists, such as Andrew J. Love, this altruist system fails in not providing adequate incentives for the organ donor, bringing as consequences an inadequate and insufficient supply of organs. Therefore, Love proposes the creation of a controlled organ market, which includes the organs of corpses.¹² Precisely, another effect of the Moore case is the consideration, perhaps still emerging, that a human body is susceptible of trade, that the people have "a financial interest towards their tissues". We insist here that the concept of "tissues" is quite broad; it includes other organs, such as the human fetus.¹³

In the Moore case, neither the consequences nor the way of compensating the damage caused by the absence of "informed consent for the trade of human skin" were determined, because there was only a claim so that the affected could participate in the trade of his body. Anyways, the moral debate is still unfinished and the laws are insufficient. There is still fear, well founded, towards a possible robbing of human organs of people from the poor countries, regardless that the moral and religions are against the concept of sale or traffic (onerous or free) of human organs.

In countries like ours, of a culture that codifies Law, the absence of legal dispositions is even more serious. The Mexican legal system includes an old disposition, originated in the Code of Napoleon in article 22 of the Civil Code, which prays: "The legal capacity of the physical people is obtained during birth and is lost with death, but since the moment an individual is conceived, he is protected by the law and he is considered as being born for the effects declared in the present Code".

Opposite to the Anglo-Saxon concept "the right people have to control their own body", the Civil Code remits to the protection of the law; the insufficiency of the law, as is the case here, or the legislators' laziness, affects the people that shall be "sovereign" of their own body. Besides, the protection of the law that remits to the "conception", biological phenomenon that is totally surpassed when we refer to genetic manipulation.

2. The Moore case and the patenting of body parts

Another important aspect derived from the Moore case is that regarding the susceptibility of patenting body parts. Although Moore was acknowledged the domain of his body, on the other hand the UCLA obtained a patent for a cellular line produced by the extirpated spleen of John Moore. The Supreme Court of Justice of California decided there was no interest of property of this cells after being removed from his body, that is, it is a line of cells cultivated in vitro,¹⁴ and was consequently patentable, although Moore, as previously mentioned, had the right to participate in the revenues.

The precedent has had effects in other cases; for example, a biotechnological company has patented the stem of the cells of the human bone marrow, and thus obtained a monopoly for its commercial use.¹⁵

The United States has taken an important step in patenting in 1995 a blood sample that contains a T cell of the leukemia virus, whose carrier is not affected with that illness (patent number 5,397,696). This is very transcendental for medicine, because it could be used in the development of a vaccine against cancer; besides, it means a great business for the "inventors". But in this concrete case, it has raised a great discussion, even at an international level, because the blood belongs to a tribal native from New Guinea, near Australia, and this action is considered as genetic colonialism.¹⁶ In 1996 because of the controversy, he discreetly withdrew his patent.

VI. INTERNATIONAL OBLIGATIONS OF MEXICO REGARDING INDUSTRIAL PROPERTY

Even when Mexico is member of several international treaties on industrial property, particularly the Paris Convention on the Protection of Industrial Property of March 20, 1883,¹⁷ which has been object of several modifications, there are basically the two treaties on intellectual property of commercial character that have direct relations with the biotechnological aspects: NAFTA¹⁸ and the Final Act of the Uruguay Round of Economic Multilateral Negotiations and the Agreement that establishes the WTO¹⁹ that contains the TRIPS.

As we have already mentioned, these treaties are quite important because they are a new generation of industrial property rights that practically create a model to follow by the domestic law of the States.

The NAFTA-TRIPS

The dispositions of chapter XVII of NAFTA that refer to industrial property are not very different to those contained in the TRIPS. The negotiators of NAFTA were based on discussions that in this moment were carried in the Uruguay Round. As we have commented, contrarily to the Paris-Berne axis, these two treaties follow these principles:

1. Extended protection (article 1702, NAFTA). The parties can, in their domestic legislation, grant a broader protection than that required by the Treaty.

2. National treatment (articles 1703 NAFTA and 3, TRIPS). Each one of the parties shall grant the nationals of the other party a not less favorable treatment than the one it grants its own nationals regarding protection and defense of all the intellectual property rights.

3. Most favored nation treatment (article 4 TRIPS). With respect to the protection of intellectual property, every advantage, favor, privilege or immunity a member grants to the nationals of any country shall be granted immediately and without conditions to the nationals of all the other members…

Regarding the objectives, the NAFTA mentions: "to protect and enforce in an adequate way, the intellectual property rights in the territory of each one of the parties" (article 101, clause d).

Although with a quite vague language ("adequate manner") the obligation of the Member States of protecting and enforcing the intellectual property rights, is clear. Of course, the legal framework of intellectual property is provided by the Agreement. On the other hand, the TRIPS refers to the "need of encouraging an efficient and adequate protection of intellectual property rights" (Preamble).

As we can see, the TRIPS supports the idea of encouragement, more than of protection of intellectual property.

On the other hand, the intellectual property rights protected by NAFTA and by the TRIPS are, among others, those regarding vegetal varieties, patents, the scheme of drawing integrated semiconductor circuits, and the industrial and business secrets. These institutions protect the products of biotechnology, that is, they are tightly related to the protection of products from genetic manipulation.

This way we see that regarding the vegetal varieties, the States Parties of NAFTA shall apply, at least, chapter XVII and the substantive disposition of the 1978 International Convention for the Protection of New Plant Varieties (UPOV Convention) or the 1991 International Convention for the Protection of New Plant Varieties (UPOV Convention) (article 1701, NAFTA).

On July 9, 1997 Mexico ratified the UPOV Convention of 1978, which it has subscribed on July 25, 1979. However, Mexico had previously adapted to them with the 1996 Plant Variety Law, which protects, by means of vegetal obtainers (a concept equivalent to patents, though not equal) the new plant varieties.

In fact, the law has the "purpose of setting the bases and procedures for the protection of the rights of the obtainers of plant varieties", understanding by obtainer, the physical or moral person who, through a process of improvement had obtained and developed a vegetal variety of any genre and species. On the other hand, vegetal variety is the subdivision of a species that includes a group of individuals with similar characteristics considered stable and homogeneous.

Regarding patents, NAFTA's and TRIPS' dispositions are quite similar, although we will see some difference that are not essential.

Both disposition establish the requirements for the patenting, which are actually world scale standards: novelty, inventive character (not obviousness) and industrial application. We shall mention that the 1991 Industrial Property Law, reformed in August 1994, also follows the international standards regarding the requirements for patenting (article 16).

VII. THE MORAL CLAUSE

Both the North American Free Trade Agreement²⁰ and the Agreement about the Aspects of Intellectual Property Rights²¹ contain two types of patentability exclusions. The first one refers to the exclusion that the intellectual property doctrine has called "moral clause", since it implies exclusion from patenting given moral reasons or public order. This moral clause has the purpose of "protecting the public order or moral, even protecting human, animal and plant life and health, or preventing serious damage to nature or the environment".

The second exclusion refers to a series of exclusions. The interesting thing is that microorganisms, according to the clause, are not excluded of being patented. This issue is transcendental because it is precisely among microorganisms where we find the biggest wealth regarding biodiversity.

In fact, the TRIPS establishes:

The members may exclude from patenting those inventions whose commercial exploitation in their territory shall be necessarily impeded in order to protect the public order or morality, even to protect people's or animals' lives or health or to preserve plants, or to avoid serious damage to the environment, whenever this exclusion is not made only because the exploitation if banned by the national legislation.

Evidently, the concepts of "public order" and "morality" are abstract. With the development of biotechnology, their interpretation and scope is urgent, especially because there is a strong presence of society which demands more limitations for certain research.

Following this concern, aiming to harmonize the criteria to "secure the interpretative uniformity of the Patents Office", the European Parliament approved the Directive 98/44/CE of July 6, 1998 about the legal protection of biotechnological inventions. The European Directive also contains a "moral clause" by not granting patents to inventions whose commercial exploitation is contrary to the public order or to morality (article 6.1 of the Directive); article 6.2 makes reference to specific practices that go against morality:

1. Human being cloning.
   

2. Modification of the human germinal line.
   
3. Use of human embryos with commercial means, and
   
4. Modifications of animals that imply unjustified suffering for "substantial" medical benefits.

The so-called moral clause, which does not have parallel in the American or Japanese Law, has been subject of doctrinal debate. Of course, there are certain detractors who consider moral as an unclear element, which besides has modifications along time and space. However, there is a proneness between Europeans to accept it.

The Members could exclude from patentability:

1. The diagnosis, therapeutic and surgical methods for the treatment of human beings and animals;

2. The plants and animals except microorganisms, and the essential biological procedures for the production of plants and animals, which are neither biological nor microbiological procedures. However, the Members shall grant protection to all the vegetal obtentions through patents, through an efficient sui generis system or through a combination of the former and the latter.

It is important to point out that the TRIPS supports this second exclusion that has been in revision for four years after its coming into force: "The dispositions of the present section shall be object of examination four years after the Agreement that establishes the WTO comes into force".

VIII. THE EXCLUSION CLAUSES IN THE MEXICAN LEGISLATION

The Mexican legislation, in its Industrial Property Law (IPL) contains several "exclusion clauses".

The first one establishes that no patent, registration or authorization shall be granted, nor publicity shall be given in the newspaper to any legal figure or institution regulated by this law, when their contents or form are contrary to the public order, to moral and the good customs or if they breach any legal disposition (article 4).

The concepts "public order", "moral" and "good customs", used in the wording are quite vague, which generates looseness in the application of the law as well as insecurity for the governed people. However, they are "locks" the authority may use in order to avoid the protection attempt, through the intellectual property Law, of the human genome. That is, the Mexican authority, in this case the Mexican Institute of Industrial Property (IMPI) could refuse to receive a petition of protection of a genetic manipulation in the human being in accordance with article 4.

The second one deals with the concept of invention: "Invention is any human creation that allows to transform matter and energy existing in nature, for its exploitation by man in order to satisfy his particular needs" (article 19, IPL).

Even when the concept provided by the law is quite broad, at the same time, the fact it circumscribes to the "human creation" implies a limitation. With this limitation, it is unconceivable to patent a microorganism as such, because it would not be an invention, because it would not be a "human creation". This idea is confirmed with the patentability exceptions to which the Law refers:

1. The essentially biological processes for production, reproduction and propagation of plants and animals;
   

2. The biological and genetic material as it is found in nature;
   
3. Animal races;
   
4. The human body and the living parts that compose it, and
   
5. The vegetal varieties (article 16, IPL)

The absence in the Law of a reference to microorganisms as the TRIPS and NAFTA is notable.

Here we shall notice that although there is no disposition that literally refers to the human genome, or genetic manipulation, the exception of patenting the "biological and genetic material as it is found in nature" could be interpreted in the opposite way, that is, if it refers to biological and genetic material not as it is found in nature, it would be patentable, like in the Moore case.

This is logically related to the other patentability exclusion: "the human body and the living parts that compose it". It is clear that they are not susceptible of being patented, but they are when substances are obtained from these elements. Should not in this case the subject have participation in the revenues in case of trade? However, in the Mexican Law this is not very clear, thus the legislator shall be more careful and aware about what is happening in other places.

On the other hand, we shall notice that the IPL clearly establishes that the following are not considered inventions:

1. The theoretical or scientific principles;

2. The discoveries that consist in revealing something that already existed in nature, even when it was previously ignored by man;

3. The schemes, planes, rules and methods to carry out mental actions, games or business and the mathematical methods;

4. Computer software;

5. Forms of presentation of information;

6. Aesthetical creations and artistic or literary works;

7. Surgical, therapeutic or diagnosis treatment methods applicable to human body and those related to animals, and

8. The juxtaposition of known inventions or mixtures of known products, their variation of utilization, of form, of dimensions or of materials, unless it is actually their combination or fusion in such a way they could not operate separately or that their specific qualities or functions are modified in order to obtain an industrial outcome or a non-obvious utilization for a technician in the subject (article 19, IPL).

We shall point out that the fact that they are not inventions and that consequently they are not susceptible of patents, does not mean that they are not subject of protection through another means, as the case of computer software and the schemes of circuit drawing. Besides, article 19 in an accurate way, establishes the difference between inventions and discoveries, by stating that "the theoretical or scientific principles" and "the discoveries that consist in revealing something that already existed in nature, even when it was previously ignored by man" are not inventions. However, in the practice the limitation of these two concepts, invention-discovery, is complicated, reason why the scientists' intervention to clarify the concepts in the specific cases is quite necessary.

IX. CONCLUSIONS

As it commonly happens, the scientific-technological revolutions surpass the legal regulation: the current biotechnological revolution has surpassed the normativity. It is necessary to establish a balance between the need to protect the technological development in the biotechnology field and to stop the trade of the human body. It is calculated that the business regarding the human genome project would be of billions of dollars. If we take into account that the big pharmaceutical transnational firms are the benefited ones, and those who manage the genomic investigation, it becomes frightening that the urge to obtain revenues could make incontrollable managing the risk that could be generated. In this sense, the legislation shall be very cautious and establish properly that the human body cannot be object of trade, besides, it shall:

— Clearly establish the moral clause in our legislation.

— Clearly establish in the corresponding legislation the principle that establishes the right people have to control their own body.

— In this sense, publicity shall be made in order to prevent the body and genome from being used without the population's consent.

— Contemplate indemnifications for the population whose genome is used.

Notes
* Translated by Carmen Valderrama Ramos.
** Researcher at the Legal Research Institute of the UNAM.
1 In a broader acceptation, we could affirm that the patent is a title granted by the State as a certificate so that the inventor makes an invention in exchange of which the State grants him a protection of exclusive and temporal use.
2 We are currently living in the Third Industrial Revolution, that began in World War II and that covers all the aspects of nuclear energy, electronics, information, communication, materials, and particularly, biotechnology. The latter is outstanding as some authors point out, stating that this is the biotechnology century (see Kaplan, Marcos, Ciencia, Estado y derecho en las primeras revoluciones industriales, Mexico, UNAM, 2000, p. 243.
3 Rangel Medina, David, Derecho de la propiedad industrial e intelectual, 2nd ed., México, UNAM, 1992.
4 The element of human intervention is crucial to determine whether it is an invention or not. The human being, as he transforms, he creates, he is inventing. In some legislations, like India's, "… if a starting material is subjected to a process of operation to convert it in such a matter as to produce a new and useful or substance, it is patentable invention" (Subbaram, N. R., "Legal Protection of Invention: Indian Scenario", La propiété intellectuelle dans le domaine du vivant, Paris, 1995, p. 60, International Simposium organized by L'Acadéie des Sciences).
5 Although we can say that there are antecedents of patenting microorganisms in the 20th century. This is the case of Louis Pasteur, to which the Patents and Trademarks Office granted him in 1873 the patent 141,072 to protect a "yeast free of germs of illness as manufacture items". This tendency was abandoned later.
6 Subbaram, N. R., "Legal Protection of Invention: Indian Scenario", op. cit., note 4, pp. 66 and 67.
7 Rifkin, Jeremy, El siglo de la biotecnología, Barcelona, Crítica-Marcombo, 1999, p. 54.
8 Hettinger, Ned, "Patenting Life: Biotechnology, Intellectual Property, and Environmental Ethics", College Environmental Affairs Law Review, Boston, vol. 22, no. 2, 1995, p. 269. On the other hand, Craig Venter, from the firm Celera Genomics, has mentioned that it will decipher the human genome.
9 Here we base on the work of Daniels, Linda B., "Commercialization of Human Tissues: Has Biotechnology Created the Need For an Expanded Scope of Informed Consent?", California Western Law Review, California, vol. 27, no. 1, 1990-1991, pp. 214-216.
10 Ibidem, p. 215.
11 See Love, Andrew J., "Replacing our Current System of Organ Procurement with a Future Market: Will Organ Supply be Maximized?", Jurimetrics Journal of Law, Science and Technology, vol. 37, no. 2, pp. 167-186. Also Zohar, Noam J., "Toward Justice in the Organ Trade", Israel Law Review, vol. 27, no. 4, autumn 1993, pp. 541-565.
12 Ibidem, pp. 185 and 186.
13 Field, Nancy, "Evolving Conceptualizations of Poverty: A Proposal to de-Commercialize the Value of Fetal Tissue", The Yale Law Journal, vol. 99, no. 1, October 1989, p. 181.
14 We shall mention that the commercial potential these cell-lines may produce is 7 billion dollars.
15 Field, Nancy, "Evolving Conceptualizations of Property: A Proposal to de-Commercialize the Value of Fetal Tissue", op. cit., note 13, p. 271.
16 Caplan, Arthur L. and Merz, Jon, "El patentado de secuencias genéticas", BMJ Edición Latinoamericana, vol. 4, 1996, p. 147.
17 Diario Oficial de la Federación (DOF) of July 27, 1976.
18 DOF of December 20 and 27, 1993.
19 DOF of December 30, 1994.
20 "Each one of the parties could exclude inventions of the patentability if it is necessary to avoid in its territory the commercial exploitation of the inventions to protect the public order or the moral, even to protect human, animal and vegetal life and health, or to prevent a serious damage to nature or the environment, whenever the exclusion is not based only in the fact that the Party bans the commercial exploitation, in its territory, of the matter that is object of the patent.
Moreover, each of the Parties may exclude of patenting: (a) The diagnosis, therapeutic and surgical methods for the treatment of human beings and animals; (b) Plants and animals, except microorganisms, and (c) Essentially biological processes for the production of plants or animals, different to the non-biological and microbiological processes for such production. Despite what clause (b) appoints, each of the Parties shall grant protection to varieties through patents, an effective sui generis scheme of protection, or both" (article 1709, NAFTA).
21 Article 27.