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PubMed2003

[The generic Research and Development possibilities after Hungary accessed th European Patent Convention].

January 1, 2003 Hungary became a member of the Munich Convention on the Grant of European Patents (European Patent Convention, EPC). As from January 1, 2003 European patents may be claimed and obtained also for Hungary and European applications may be filed with the Hungarian Patent Office as well. This paper focuses on the exceptional generic R&D possibilities which can harmonize in harmony with all the claims of the Union in spite of the fact that it does not follow general European limitations and practises. Based on the amended Hungarian Patent Law (No. XXXIII of 1995 on the Protection of Inventions by Patents; Article 19 (6)b)) the exclusive right of exploitation shall not extend to acts done for experimental purposes relating to the subject matter of the invention, including experiments and tests necessary for the registration of medicines as well. The national and international legal history and background of the operative Hungarian Patent Law are also presented roughly. The paper deals with the divergence of the originator-generic industry and the EU-USA industry and with the incoherence within the EU itself on the early testing permissions and limitations.

Europe↗
PubMed2000

An analysis of moral issues affecting patenting inventions in the life sciences: a European perspective.

Following the 1980 US Supreme Court decision to allow a patent on a living organism, debate has continued on the moral issues involved in biotechnology patents of many kinds and remains a contentious issue for those opposed to the use of biotechnology in industry and agriculture. Attitudes to patenting in the life sciences, including those of the research scientists themselves, are analysed. The relevance of morality to patent law is discussed here in an international context with particular reference to the law of the European Patent Convention administered by the European Patent Office (EPO). The EPO has been the principal forum for opposition to such patents and the few cases under dispute in the EPO are reviewed, including patents for the onco-mouse, human relaxin gene, and the PGS herbicidally resistant plant (gmo). Morality provisions in the European Parliament and Council Directive 98/44/EC are also summarised.

Animals↗
PubMed2005

The immoral gene: does it really exist?

Over the last years several European patents were opposed for protecting technology violating the morality requirement under Article 53(a) EPC. Attempts have been made by the Appeal Boards of the European Patent Office (EPO), as well as by amendments introduced into the Implementing Regulations of the European Patent Convention (EPC), to address this sensitive patentability requirement more precisely. The most recent hot topic coming up in this context is the patentability of stem cells. It is to be expected that this discussion will still go on in the field of biotechnological inventions for the next several years.

Bioethics↗
PubMed2000

Are natural gene sequences patentable?

The title question is answered in the affirmative. The patentability of natural gene sequences is based on general principles of patent law, and depends on novelty, inventive steps and industrial applicability of the subject matter to be patented. Patentability is further confirmed by the particular articles of the European Patent Convention and the recent EC Directive on the legal protection of biotechnological inventions.

Base Sequence↗
PubMedDate not supplied

Bioethics, biotechnology products and humans: Europe between the skilled Theseus and the Labyrinth-Minotaur's syndrome.

Following the approval on May 1998 of the European Union Common position no. 19/98 regarding the legal protection of biotechnological inventions, the debate on bioethical aspects of biotechnologies is increased. The European Union document clearly protects the patentability of inventions (that concerns more than a particular plant or animal variety or a single procedure if they are of industrial interest), but not the finding or discovery of that is in the nature, e.g. a gene. Some safeguards (the dignity and integrity of the person and of the human embryo, the plant diversity, etc.) and exclusions from patentability (plant and animal varieties, processes for the production of plants or animals, the human body at any stage of growth, cloning of human beings, modifications of germ line, use of human embryos for industrial or commercial purposes as well as the inventions whose publication or exploitation would offend against public policy or morality, according to the Article 53a of the European Patenting Convention) are also indicated. Ethical issues discussed include the nature of human life and its protection, the safeguard of plant-animal biological diversity, the safeguard of human dignity and nature, whereas on several aspects (e. g. limits of the use of genetic material, xenotransplantation, etc.) the Parliament Assembly of the Council of Europe has requested a discussion or a moratorium (April, 1999). In this case an evaluation on the basis of the ethical beneficial principles should be performed and society should decide whether to master technologies and emulate the positive action of the hero Theseus against the Labyrinth-Minotaur syndrome or to renounce or "misuse" technologies like Daedalus and Icarus, who met a tragic end.

Bioethics↗
PubMedDate not supplied

The patentability of living organisms between science, law and ethics.

The approval on May 1998 of the European Union (EU) directive on the legal protection of biotechnological inventions has aligned Europe to the international trend about the patenting of biotechnologies. Many questions are still unresolved, i.e. the differences between the article 53b of the European Patent Convention (EPC), which prohibits patenting of plants and animal varieties, whereas the directive states that Oinvention whose object are plants or animals may be patented if the practicability of the invention is not technically confined to a particular plant or animal varietyO (article 12). Again, the interpretation of plants or animal species specificity and that on the threatening public order and morality (which inhibits patenting) may have doubtful interpretations, according to the different EU States morality and law (e.g. Denmark does not admit patentability of transgenic animals). Despite difficulties, biotechnology Research and Development for applications to medicine, veterinary sciences, agriculture and foods is continuously growing. Bioethical independent evaluations of the applications of biotechnologies and of their side-effects (risk for biodiversity of plants and animals, safety of procedures to save mankind, respect of human dignity and of fundamental human rights, etc.) are mandatory to link the interests of science and industrial productions together with those of mankind. This is the original meaning given by van Potter to the word bioethics, as a bridge to the future.

Animal Population Groups↗
PubMedDate not supplied

Patenting biotechnologies: the European Union Directive 98/44/EC of the European parliament and of the council of 6th July 1998 on the legal protection of biotechnological inventions.

Before the Directive 98/44/EC of the European Parliament and the Council of 6th July 1998, notwithstanding some decisions of the European Patent Office (still presently under opposition) and some patents already granted by the Italian Patent Office, the existing legal framework did not allow the patentability of living organisms in the European Community countries. The Directive has dramatically changed the perspectives. It ensures free circulation of patented biotechnological products harmonising the national legal system of each Member State, guaranteeing compliance with the European Patent Convention signed in Munich on 5th October 1973, the Trade-Related Aspects of Intellectual Property Rights agreement of 15th April 1994 and the Rio de Janeiro Convention on Biological Diversity of 5th June 1992. The legal basis of the Directive and the fundamental principles of protection are that discoveries as such are not considered patentable. Plant and animal varieties as such, as well as essentially biological procedures for the production of plants and animals are excluded from protection by patent. On the contrary, the new field of patentability covers plants and parts of animals with new introduced genetic characters. Methods of surgical and therapeutic treatment and diagnostic methods applied to animal bodies are not considered inventions suitable for industrial applications and excluded from protection by patents. Biological materials and material isolated from its natural environment and isolated elements of the human body with technical processes may be patented. Excluded from patentability are inventions that are contrary to law and order or public morality as well as processes for human cloning for reproductive purposes and for modifying the germ-line genetic identity of human beings, as well as the use of human embryos. The processes for modifying the genetic identity of animals without any substantial medical benefit for man (with the exception of studying new medicinal products useful for treating serious diseases such as cancer, hepatitis or AIDS, by means of Oanimal modelsO) are also excluded. The rights of farmers are also guaranteed, by allowing them to re-sow seeds and freely use breeding stock covered by patents on their farms, without paying costly royalties to the holders of patents.

Animals↗
PubMed1984

[Patent protection for living matter].

Inventions are patentable according to the German Patent Law (and the European Patent Convention), if they are new, involve an inventive step and are susceptible to industrial application. Living matter and processes performed therewith are likewise patentable.

Animals↗