Forum (Genoa, Italy)最新文献

{"title":"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.","authors":"G Morelli Gradi","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"25-36"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21464804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biotechnologies and genetic resources for food and agriculture.","authors":"J T Esquinas-Alcázar","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The article stresses the complimentarity of genetic resources and biotechnologies in ensuring food security. Genetic resources are being lost at an increasing and alarming rate. A small number of crops and farm animals contribute an ever increasing percentage of human food. The conservation and sustainable use of genetic resources have many socio-economic, political, cultural and legal implications. Genetic resources are the raw material to which biotechnology is applied. Biotechnologies are increasingly protected by intellectual property rights, no such incentive for the conservation and sustainable use currently exists. The article discusses the role of the International Undertaking on Plant Genetic Resources, currently being negociated in FAO countries, and of the Code of Conduct on Biotechnology being developed by the FAO Commission on Genetic Resources for Food and Agriculture.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"84-7"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21465321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biotechnologies and acute hepatic failure.","authors":"L R Fassati,&nbsp;S Gatti,&nbsp;L Caccamo,&nbsp;L Latham,&nbsp;G Rossi,&nbsp;P Prato,&nbsp;G Giammarinaro","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Orthotopic liver transplantation survival for patients with acute liver failure is poor (50%). Mortality on the waiting list is high due to the lack of donors. For these reasons, the possibility of sustaining hepatic function by extra-corporeal liver perfusion must be considered. In this experimental research, two groups of pigs have been submitted to total de-vascularisation of the liver causing acute hepatic failure. In the first group (4 pigs) no extra-corporeal assistance has been used after total de-vascularisation. All pigs died between 16 and 33 hours after the acute hepatic failure was induced. In the second group (8 pigs) after complete hepatic de-vascularisation an extra-corporeal hepatic support by continuous allo-perfusion of isolated liver was performed using the Abouna-Costa extra-corporeal circuit. All pigs were observed during the acute hepatic failure which lasted from 6.30 to 7.30 hours. The data that were more positively influenced by the extra-corporeal assistance were ammonia and lactates that improved after the application of hepatic assistance.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"67-73"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21506537","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The patentability of living organisms between science, law and ethics.","authors":"L Frati,&nbsp;R Foà,&nbsp;P Frati","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"8-14"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21464803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biotechnologies and liver diseases.","authors":"S Sherlock","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Viral hepatitis is surveyed as a European problem. The economic implications of including vaccines against hepatitis A and B in infant and adolescent immunisation programmes are discussed. The urgent need for vaccine against hepatitis C is stressed. Antiviral therapy for hepatitis B and C infections remains unsatisfactory. Costs of widespread implementation, particularly for hepatitis C, would be enormous and the selection of candidates for therapy is still under discussion. Increasing use of liver transplantation is prevented by donor shortage. Methods of artificial liver support must attract more research support.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"63-6"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21465319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Angiogenesis and angiogenesis inhibitors in cancer.","authors":"R Giavazzi,&nbsp;G Taraboletti","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Angiogenesis, the development of a new blood supply, is an essential process of tumour growth and metastasis. Over the past few years, this has led to the consideration of the tumour vasculature as an optimal target for anti-cancer strategies. The process of angiogenesis consists of a series of interactive events: quiescent endothelial cells are stimulated by angiogenic factors to degrade the underlying basement membrane, to migrate within the interstitial matrix, to proliferate and to organise themselves into tubular structures which become mature blood vessels. During angiogenesis, the endothelial cells undergo functional changes and show molecular features which are different from normal, quiescent endothelium. These differences can be exploited in order to selectively target tumour endothelium and to prevent neo-vessel formation. Two main approaches have been followed: i. the inhibition of the angiogenic process and vessel formation (anti-angiogenesis), and ii. direct targeting and destruction of tumour vasculature (vascular targeting). Compounds of different origin and mechanism of action have the potential to inhibit angiogenesis and hence tumour growth. This review takes into consideration some angiogenesis antagonists that are in development and the leader compounds that are under clinical trial for the treatment of cancer.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3","pages":"261-72"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21366255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biotechnology and molecular diagnostics.","authors":"A Gulino","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Molecular diagnostic applications of biotechnology have allowed the exploitation of biological processes for the industrial production of bio-products that are used for diagnostic purposes. Advances in genetic-related technologies together with a multidisciplinary interplay of several fields led to the development of genomics which is focusing at the detection of pathogenetic events at the genome level. Both structural and functional genomic approaches are shaping the technological challenge of the discovery of disease-related genes and the identification of their structural alterations or elucidation of gene function. Some of the emerging technologies and diagnostic applications of both structural and functional genomics will be summarised, including the issues related to identification of disease-genes, detection of genetic alterations, mutation scanning and DNA chip technology or those related to expression genetics (hybridisation-, PCR- and sequence-based technologies), two-hybrid technology and bioinformatics and computational biology, respectively. Further advances of genetic engineering have also revolutionised immunoassay biotechnology via engineering of antibody-encoding genes and the phage display technology. A comment will also be given about some of the issues related to the commercialisation and widespread diffusion of genetic information derived from the exploitation of the biotechnology industry and the development and marketing of diagnostic services.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"37-46"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21465315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Xenotransplantation: state of the art.","authors":"M Lavitrano,&nbsp;L Frati","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Organ transplantation is unfortunately limited by the number of cadaveric human donor organs that become available. Xenotransplantation - the transplantation of organs and tissues between animal species - would supply an unlimited number of organs and offer many other advantages. The leading candidate as a source of organs for xenotransplantation is the pig, as it is anatomically and physiologically similar to man. However, organ transplantation between distantly related species results in hyperacute rejection (HAR) of the transplant, which consists of a violent immune response involving the complement system, unleashed when organs are transplanted between distant relatives, such as pigs and humans. HAR destroys the blood vessels in the transplanted organs and kills them within minutes. Complement attack is due to the antibody-mediated activation of the complement cascade (human anti-pig antibodies have been identified as being directed against Gal-a1-3galactose epitopes on pig vascular endothelium), and this phenomenon is physiologically subjected to negative regulation by a set of species-specific proteins, known as regulators of complement activation (RCA), such as decay accelerating factor (DAF), membrane cofactor protein (MCP) and CD59. If human RCA are expressed by mammalian cells in vitro, the cells are protected against the lysis by human complement. Therefore the incorporation of human RCA into a xenogeneic organ by transgenesis should protect the transplanted organ or tissue from in vivo lysis by human complement. Major efforts are being made to overcome this hyperacute rejection. Methods being investigated include: i. depletion or inhibition of recipient antibodies or complement; ii. development of immunological tolerance to pig organs in the recipient; and iii. development of transgenic pigs that do not express the a-Gal epitope and/or express a human complement inhibiting protein (i.e., DAF). A small number of research teams, including our group, have embarked on programs to produce transgenic pigs for one of the human RCA, in the attempt to produce animals whose organs may be suitable for transplantation into humans.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"74-83"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21465320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biotechnologies and predictive medicine: legal aspects.","authors":"S Fucci","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Scientific progress in molecular biology and genetics is now providing the medical field with new OtoolsO for diagnosis of possible gene alterations which may be connected with the risk of disease later in life. The development of predictive medicine incurs novel problems in the relationship of the medical doctor and the individual at risk of disease, with particular reference to the identification of situations in which genetic testing may be relevant, the type of information which one should give the individual in order to have the informed consent for the diagnosis and the type of possible therapy taking into account the confidential aspect of using the data produced. These problems are exmined in the light of ethical citations and guidelines which are included in the National Comittee for Bioethics in Gene Therapy, 1991, the Italian privacy law, 1996, the European Convention on Bioethics, 1996, the 98/44/CE Directive on the Patentability of Biotechnological Inventions and the Deontological Medical Code, 1998.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"88-92"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21465322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethical limitations in patenting biotechnological inventions.","authors":"V Lugagnani","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In order to connect ethical considerations with practical limits to patentability, the moral judgement should possibly move from the exploitation of the invention to the nature and/or objectives of Research and Development (R&D) projects which have produced it: in other words, it appears quite reasonable and logical that Society is not rewarding unethical R&D activities by granting intellectual property rights. As far as biotechnology R&D is concerned, ethical guidance can be derived from the 1996 Council of EuropeOs OConvention for the protection of human rights and dignity of the human being with regard to the application of biology and medicineO, whose Chapter V - Scientific research - provides guidelines on: i. protection of persons undergoing research (e.g. informed consent); ii. protection of persons not able to consent to research; iii. research on embryos in vitro. As far as the specific point of patenting biotechnology inventions is concerned, the four exclusions prescribed by Directive 98/44/EC (i.e. human cloning, human germ-line gene therapy, use of human embryos for commercial purposes, unjustified animal suffering for medical purposes) are all we have in Europe in terms of ethical guidance to patentability. In Italy, in particular, we certainly need far more comprehensive legislation, expressing SocietyOs demand to provide ethical control of modern biotechnology. However it is quite difficult to claim that ethical concerns are being raised by currently awarded biotechnology patents related to living organisms and material thereof; they largely deal with the results of genomic R&D, purposely and usefully oriented toward improving health-care and agri-food processes, products and services. ONo patents on lifeOO can be an appealing slogan of militants against modern biotechnology, but it is far too much of an over-simplified abstraction to become the Eleventh Commandment our Society.</p>","PeriodicalId":79489,"journal":{"name":"Forum (Genoa, Italy)","volume":"9 3 Suppl 3","pages":"93-8"},"PeriodicalIF":0.0,"publicationDate":"1999-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21465208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}