Health Law and Bioethics Prof. Dra. Helena Pereira de Melo 2011/ de Março de 2012 Pedro Marques Gaspar Aluno n.º

[Introduction] [Legal Framework] [Ethical Issues] [Conclusion] “In no other area are patentability issues so controversial as in biotechnology.” Benoît Battistelli, EPO President

Biotechnology means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. *As it is defined in the Convention of Biological Diversity [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

In order for a patent to be issued, there are three requirements that must be fulfilled: Inventive step Novelty Industrial application

A biotechnological patent is a patent relating to an invention in biology. It can be a composition of matter, a method for obtaining or using one or more thereof, or a product combining such things. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Louis Pasteur received a patent on isolated yeast, a living organism In Diamond vs Chakrabarty, a landmark case, a patent was granted for a bacterium, thus determining that life forms are patentable subject of matter. The first patent of an entire animal is issued – The Harvard Mouse A patent is issued regarding relaxin, raising the problem of are human genes patentable? Only time will tell…

 TRIPS Agreement  Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998  European patent convention  Portuguese Industrial Property Code [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Article 51º - Object 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. (…) [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Article 52º - Limitations on Object 1. The following are exceptions to the previous article: a) Discoveries, scientific theories and mathematical methods; b) Materials or substances already existing in nature and nuclear materials; (…) 3. Paragraph 1 only excludes patentability if the object for which a patent is requested is limited to the elements mentioned in it. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Article 53º - Limitations on Patent 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. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Article 53º - Limitations on Patent 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. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Article 54º - Special Cases of Patentability 1. The following may be patented: (…) 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; [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Article 54º - Special Cases of Patentability (…) d) An invention relating to plants or animals, if its technical feasibility is not confined to a particular plant variety or breed of animal; 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. (…) [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Article 54º - Special Cases of Patentability (…) 2. An essentially biological process for obtaining plants or animals is any process that consists wholly of natural phenomena, such as crossing or selection. 3. A microbiological process is any process involving or performed upon or resulting in microbiological material. 4. Biological material is any material that contains genetic information and is capable of reproducing itself or being reproduced in a biological system. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

 Is it ethical to award a patent over humans and other living beings?  How do we articulate the public and the private interest?  Is it possible to limit the access of something that already exists in nature? [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Genetic engineer Ananda Charkrabarty, working for General Electric, had developed a bacterium (derived from the Pseudomonas genus) capable of breaking down crude oil, which he proposed to use in treating oil spills. He requested a patent for the bacterium in the United States but was turned down by a patent examiner, because the law dictated that living things were not patentable. The Board of Patent Appeals and Interferences agreed with the original decision; however, the US Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor, writing that "the fact that micro-organisms are alive is without legal significance for purposes of the patent law”. Sidney A. Diamond, Commissioner of Patents and Trademarks, appealed to the Supreme Court. The Supreme Court case was argued on March 17, 1980 and decided on June 16, [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

We chose this case because it was a landmark decision regarding biotechnology patents, but still, one main question might arise from it: Is it possible / ethical to accept the patentability of living beings? [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

There are two possible answers:  Without the granting of patents, there would be no desire to innovate, to create. Without the possibility of granting a right of exclusive to a creation, namely in the fields of medical and pharmaceutical industries, the companies would stop investigating since they could not get a profit from it. This would lead to the fact that, if and when a new decease or other problem arises, human beings would not be able to fight against it.  Be allowing to a living being to be owned / patented, one might say that we have opened Pandora’s Box, because if a precedent is established, then it would be possible to grant patents to increasingly more evolved living beings – namely animals, and ultimately humans… [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

After Diamond vs. Chakrabarty having established the basis for the registration of biotechnology patents, a patent application was filled to the Harvard Mouse (or Oncomouse). This application regarded a genetically modified animal developed by Philip Leder and Timothy Stewart at the service of Harvard University. This change gave to the animal an “onco-gene” leading to that the animal becomes more susceptible to develop cancer, thus making it an asset in the investigation of this disease. Although this patent raised several oppositions, it was granted in 1988 to Harvard University. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Isn’t this genetic modification contrary to public order and to moral? Is it possible to alter an animal if this leads to its demise? [Introduction] [Legal Framework] [Ethical Issues] [Conclusion] On one hand, we have John Stuart Mill’s utilitarianism: if of this modification comes a common good (it’s good for all), why not? On the other hand, one can defend that if it’s inserted into an animal a gene of a disease of a human being, then it’s most probable that the animal develops the disease in similar terms to those of a human. In this case, is there a real utility?

But this aren’t the only problems that might arise from this case… And what about the well being of the animal? Is it morally tolerable to establish a level of pain, suffering, anxiety and fear of the animal that is acceptable? And if the answer to this question is affirmative, then where is the rationality and humanity that makes us worthy of a special protection? [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

And what about the integrity of the species? If a mouse is altered to possess a gene that only human have, then what the status of the animal? Is it a mouse? Is it part human? Where do we draw the line to state that an animal is one over the other? And what about the risk of escape? If an onco-mouse escapes from a laboratory and starts procreating with normal mice, then the progeny might inherit the onco-gene. If this happens then we would have helped to create a new deceased species of animals. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

In 1975, the Howard Florey Institute isolated and determined the chemical structure of a human form of the hormone relaxin. Their research revealed a second form of human insulin, the existence of which had not previously been suspected. The structure of human relaxin was found to differ from other species, such that only human relaxin could be used for the medical purpose envisaged. In order to obtain sufficient quantities of the hormone to explore its therapeutic use, it was necessary to manufacture it in synthetic form. So having isolated the nucleotide sequence that coded for relaxin, recombinant DNA techniques were used to clone the gene, making it possible subsequently to produce synthetic relaxin. A patent was issued in Europe in 1991, but opposed in 1992 by members of the Green Party in the European Parliament. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Since initially the tissue that led to the discovery of the gene was taken from a pregnant woman, isn’t this an offense to human dignity? Isn’t a patent over human genes considered contrary to “public order”? It was defended that patenting human genes is the same of patenting human life. What the problem with this argument? It seems to imply that humans are no more than the sum of their genes – which is very reductive of the human condition!

[Introduction] [Legal Framework] [Ethical Issues] [Conclusion] But in this case what is a human being? Kant defends that a human being is "any rational being that exists as an end in itself and not merely as a means to an end.” If we accept that genes are worthy of the same protection of a human being in its all, than we cannot accept the possibity of patenting it since that is a means to an end and genes should be considered as a end in itself.

[Introduction] [Legal Framework] [Ethical Issues] [Conclusion] And what about self-determination (and self-ownership)? It is defended that a person is, somehow, owner of their body, being able therefore to dispose of its body as it desires. Looking from this perspective, it’s incompatible with respect for an individual´s self- determination 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. Moreover, one can defend that patenting human genes "amounts to a form of modern slavery since it involves the dismemberment of women and their piecemeal sale to commercial enterprises”

[Introduction] [Legal Framework] [Ethical Issues] [Conclusion] Is patenting human genes acceptable acording to religious beliefs? Christianity believes that human being derives from the divine creation of God. If we accept this theory, then we cannot condone patents over human genes since they are not ours to own, but of God that create them.

After this analysis of some of the many issues that arise from biotechnological patents, we must wonder… Where do we go from here? Wherever it is, something must always be kept in mind… That whatever the future holds, we must remember that not all that is humanly possible is (bio)etically acceptable and that, even if we understand the benefits of granting patents, this must always be done with respect of values such as morality and dignity, not only of humans but of all living beings. [Introduction] [Legal Framework] [Ethical Issues] [Conclusion]

Thank you for your attention.