Health Law and Bioethics FDUNL 2.Nd Semester Prof. Helena Pereira de Melo 2010/2011 Joana Magalhães n.º

* The use of living organisms or their products to modify human health and the human environment. * Biotechnology is booming. * Produce new medicines, treatments and processes with the potencial to save or transform the lives of millions

* As new technological fronteirs are crossed, our expectations continue to rise * Increase the complexities of the associated bioethics

* Concerns the way in which biotechnological inventions are protected – or excluded from protection – by intellectual property (IP) * The central debate on bioethics and IP revolves around the morality of what is referred to as “patenting life” Human Genes Patents

* Is it morally acceptable to grant exclusive rights over a particular technology, such as isolated DNA? * What ethical concerns arise regarding the way exclusive rights over a technology are exercised, such as patents on diagnostic tools?

“(…) we will soon enter an anxious era, in which many of the current antibiotics will become partly useless, the systematic study of pathogenic mechanisms and discovery of new antibiotics through the study of the genome will be absolutely crucial especially now that we know that microorganisms are highly dissimilar” Santiago Grisolía

* Are exclusive rights, limited in time, to exploit an invention. * Others may not use the invention without permission of the patent owner. * The underlying ideia of the patent system is that the exclusive rights are given in exchange for the disclosure of the invention.

Gene patents comprises: * Genetic technologies; * Natural genetic materials; * Isolated genetic materials; * Genetic products (such as proteins);

* 1873 – Louis Pasteur received a patent on isolated yeast * 1953 – the foundation for modern genetics was laid when the scientific journal Nature published Watson and Crick´s hypothesis about the double hellix structure of DNA. * 1973 – Cohen, Boyer and Chang developed a technique that allowed sections of DNA to be transferred from one life form into another. * 1976 – Boyer and Swanson established the first known biotechnology company, Genentech Inc., in Berkeley, California. * 1977 – Genentech reported the production of the first human protein manufactured in a bacterium.

* 1977 – Sanger identified a method for reading DNA consequences. * 1980s – onward, the debate intensified when patents began to be filled on human genes. * 1980s – Mullis and others at Cetus Corporation developed PCR, a quick and easy method for selective amplification of DNA fragments, removing the need for cloning in micro-organism. * 1980 – USA Supreme Court Decision in Diamond v Chakrabarty allowed a patent to be granted for a recombinant bacterium, thus determining that life forms are patentable subject of matter.

* 1980 – US Congress passed the Bayh-Dole Act. * 1982 – US Food and Drug Administration approved the first recombinant DNA drug for market. * 1988 – first patent over an entire animal “Harvard Mouse”. * 2001 to 2003 – Human Genome Project and the Celera Genomics Group - draft of the human genome sequence, completed in April 2003, bringing a new array of problems for gene patents.

* These include concerns about social impact of gene patents on the conduct of research and the provision of healthcare; * Ethical concerns about sharing the benefits of genetic research, respect for human dignity and consent to the use of genetic material in research that leads to commercial outcomes.

* The goals of a patent system, whether applied to genetic materials and technologies, or other patentable suject matter, are fundamentally economic. * Biotechnology field is dominated by commercial research and private industries. * The purpose of existence of a company is profit making.

* Human genome as the common heritage of humanity: patents on human genetic materials grant exclusive rights over this common heritage to a limited number of entities; concern of fair distribution of the benefits of genetic research;

* Disrespect for human life and dignity: * patents on genetic materials commodify parts of human beings by treating them as objects, or as something to be placed in the stream of commerce for financial gain; * genetic materials have a unique significance, which requires them to be treated with special respect; “Our genetic code is our heritage. It deserves this degree of respect. It is not merely a commercial resource” Dr. Graeme Suthers

* Incompatible with respect for human dignity because it reduces human being to things to which no respect is owed and is ethically unacceptable because it precludes respect for individual autonomy; * Incompatible with respect for an individual´s self-determination (and self-ownership) because they grant ownership rights over genetic material, and consequently over parts of human beings, to someone other than the person from whom the genetic material was taken;

* Gene patenting may have an adverse impact on the cost and quality of healthcare services * The economic rewards of patenting may channel investment into the more profitable areas of research and away from other important goods and services, such as medical treatments for rare diseases.

* Human worth – including the genetic basis for life – derives from the divine aspect of creation. * Patents on genetic materials attribute ownership of the basis of life to someone other than God.

* Encouregement of inventiveness, development of new products and processes with important healthcare applications * Disclosure of the research * Fair reward for their investments * Involving private companies may lead to a greater amount of total knowledge and a more rapid completion date * Principle of autonomy – if I invest in something, I have the right to use that knowledge first * Patents grant intangible intellectual property rights and not physical property rights

* Reflects The insterest of the biotechnology industry The interest of various constituencies concerned about human dignity and the commercialization of life

* The regulatory framework responds to these competing interest in two ways Morality clauses, principles and specific exclusions Biotechnology is to be treated no differently from any other inventive science that comes forward with patents claim

* In the patent law of most countries, the same basic rules and principles govern the patenting of biotechnological inventions as other technologies. * Requirements: Inventive step; Novelty; Industrial application;

* 1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. * 2. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature Article 3.º

* 1 New inventions involving inventive activity can be patented if they have an industrial use, even if they apply to a product consisting of or containing biological material or to a process that produces, treats or uses biological material. * 2 Patents may be obtained for any inventions, be they products or processes, in all fields of technology, provided that these inventions comply with the previous paragraph. * 3 New processes for obtaining known products, substances or compositions may also be patented. * (…) Article 51.º

* 1 An invention is considered new if it does not form part of the state of the art. * 2 An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. * 3 An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry or in agriculture. Article 55.º

* It is sometimes argued that the isolation of proteins and the cloning of genes represents a discovery (since the product already existed), not na invention and so is excluded from patentability.

* Demand a specific regulation; * Deeper analysis of the traditional patents criteria throughout principles and morality clauses;

* The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity. Article 1.º

* (a) Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics. (b) That dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity. Article 2.º

* The human genome in its natural state shall not give rise to financial gains. Article 4.º

* Practices which are contrary to human dignity, such as reproductive cloning of human beings, shall not be permitted. States and competent international organizations are invited to co-operate in identifying such practices and in taking, at national or international level, the measures necessary to ensure that the principles set out in this Declaration are respected. Article 11.º

* (a) Benefits from advances in biology, genetics and medicine, concerning the human genome, shall be made available to all, with due regard for the dignity and human rights of each individual. (b) Freedom of research, which is necessary for the progress of knowledge, is part of freedom of thought. The applications of research, including applications in biology, genetics and medicine, concerning the human genome, shall seek to offer relief from suffering and improve the health of individuals and humankind as a whole. Article 12.º

* The human body and its parts shall not, as such, give rise to financial gain. Article 21.º

* 1. The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. * 2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. * 3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application. Article 5.º

* 1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation. * 2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: * (a) processes for cloning human beings; * (b) processes for modifying the germ line genetic identity of human beings; * (c) uses of human embryos for industrial or commercial purposes; * (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, an also animals resulting from such processes. Article 6.º

* European patents shall not be granted in respect of: * (a) 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; Article 53.º

* 1 Inventions whose commercial exploitation is against the law or contrary to public policy, public health or morality are not patentable and their exploitation may not be considered as such due to the simple fact that it is forbidden by law or regulations. * 2 Under the previous paragraph, the following are not patentable: * a) Processes for cloning human beings; * b) Processes for modifying the germinal genetic identity of human beings; * c) The use of human embryos for industrial or commercial purposes; * d) Processes for modifying the genetic identity of animals which may cause them suffering without any substantial medical benefit to man or animal and also animals resulting from such processes. * 3 The following are also not patentable: * a) The human body, at the various stages of its formation and development and the simple decoding of one of its elements, including the discovery of a sequence or partial sequence of a gene, without prejudice to (1)(c) of the following article; * b) Plant and animal varieties and essentially biological processes for obtaining plants or animals; * c) Surgical or therapeutic methods for treating the human or animal body and diagnostic methods used on the human or animal body, though products, substances or compositions used in any of these methods may be patented. Article 53.º

* (…) * C) A new invention that involves an inventive step and is susceptible of industrial application relating to any isolated element of the human body or produced in any other way by a technical process, including a sequence or partial sequence of a gene, even though the structure of this element is identical to that of a natural element, provided that the industrial application of a sequence or partial sequence of a gene is expressly observed and specifically described in the patent application; * e) A biological material isolated from its natural environment or produced on the basis of a technical process, even if it pre-exists in a natural state; * f) An invention relating to a microbiological process or other technical processes or products obtained by means of these processes. Article 54.º

* Relaxin is a hormone which relaxes the uterus during childbirth. * Medical application reducing the need for caesarean deliveries in difficult pregnancies. * It was first described from pigs back in * Only in 1973 the chemical structure of human form of the hormone was isolated and determined. * The subsequent research revelead a second form of human insulin. * The structure of human relaxin was found to differ from another species, such that only human relaxin could be used for the medical purpose envisaged. * A patent was issued in Europe in 1991 but opposed in 1992 by members of the Green Party in the European Parliament

Challenge by the opponentsResponse by the EPO Opposition Division The claimed invention was not novel, since the gene encoding relaxin had always been present in the female human body. There was no inventive step, because a conventional method was used to isolate the DNA. Relaxin was a mere discovery, and as such “no more patentable than the moon or a new animal found in a remote area.” The patent was contrary to morality or ordre public; Isolating a gene from tissue taken from a pregnant women was an offence to human dignity, as it used the pregnancy for a technical profit-oriented process; Patenting human genes "amounts to a form of modern slavery since it involves the dismemberment of women and their piecemeal sale to commercial enterprises;” Patenting human genes was tantamount to patenting human life, and would as such be intrinsically immoral. This gene sequence was itself novel, as it was in the form of complementary DNA, which does not exist in nature. The form of relaxin that it coded for was also unknown until the inventor isolated it for the first time. As the inventor was providing to the public for the first time a product whose existence was previously unknown, the method used to obtain it was immaterial. A discovery of a substance freely occurring in nature was not patentable; but if the substance was newly isolated and characterized, then it was not a mere discovery; it was an industrially applicable technical solution to a technical problem. It would not be viewed by the public as too abhorrent to be patentable. The tissue was donated with consent within the framework of gynaecological operations. Many life-saving substances were isolated in this way, patented and welcomed by the public; Gene patents do not confer any rights over individual human beings. There was no dismemberment of humans since the point of the invention was to synthesize the hormone; "The patenting of a single human gene has nothing to do with the patenting of human life. Even if every gene in the human genome were cloned it would be impossible to reconstitute a human being from the sum of its genes". No moral distinction was seen between the patenting of genes and the patenting of other important human substances, such as adrenaline.