Patenting and licensing in genetic testing: ethical, legal and social issues

COE: Council of Europe EGE: European Group on Ethics in Science and New Technologies EPC: European Patent Convention EPO: European Patent Office EST: Expressed Sequence Tag HGC: Human Genetics Commission (UK) HUGO: Human Genome Organisation IBC: International Bioethics Committee (UNESCO) IP(R): Intellectual Property (Rights) JPO: Japan Patent Office NAS: National Academy of Science NIH: National Institute for Health OECD: Organisation for Economic Co-operation and Development PCT: Patent Co-operation Treaty R & D: Research and development SNPs: Single Nucleotide Polymorphisms TRIPs: Trade-Related Aspects of Intellectual Property Rights UNESCO: United Nation's Educational Scientific and Cultural Organisation USPTO: United States Patent and Trademark Office WHO: World Health Organisation WIPO: World Intellectual Property Organisation WTO: World Trade Organisation Biological material : Any material containing genetic information and capable of reproducing itself or being reproduced in a biological system (Biotech Dir). Blocking patents : Defensive patent; a patent which does not cover what the patentee is doing, but which he hopes will keep competitors away from his area of interest ( Grubb PW: Patents for Chemicals, Pharmaceuticals and Biotechnology. 4th ed. Oxford University Press, 2004). Claim: The part of the patent specification, which defines the scope of protection. Clinical utility: Benefits and risks of the positive and negative results of the test. Test should be considered only if benefits outweigh harm (Ibarreta D, Bock A-K, Klein C, Rodriguez Cerezo E: Towards quality assurance and harmonisation of genetic testing services in the EU. IPTS Institute of Prospective Technological Studies, Publ. EUR 20977, 2003, p 39). Clinical validity: Clinical sensitivity (positive in the affected) and specificity (negative in the controls), that is, accuracy with which the test predicts the presence or absence of a clinical condition or predisposition ( Ibarreta D, Bock A-K, Klein C, Rodriguez Cerezo E : Towards quality assurance and harmonisation of genetic testing services in the EU. IPTS Institute of Prospective Technological Studies, Publ. EUR 20977, 2003, p.39). Compulsory license: A licence which government authorities or courts force the patentee to grant another party. Dependent claim: A claim incorporating all the features of an earlier claim to which it refers. Microbiological process: Any process involving or performed upon or resulting in microbiological material. Microbiological process: Any process involving or performed upon or resulting in microbiological material. Ordre public: An old legal concept adopted particularly in Constitutional Law, which refers to the conditions under which a democratic state can limit the liberty of its citizens ( MONTESQUIEU 1758: De l'Esprit des lois, Livre XI, Chapitre II-III, p. 324 Editions Gallimard 1995). There is no exact definition, but for instance, the French Constitutional Court, while not exactly defining the notion of ordre public , has on the basis of its praxis and on its the centennial use in French administrative law stated that ordre public can be understood to include at least the following: good order, security, health and peace, whereas it does not refer to the human dignity, which is stipulated by other provisions (Conseil constitutionnel: Libertés et ordre public. 2003 (France). http://www.conseil-constitutionnel . fr/dossier/quarante/notes/libpub.htm . Patent-thickets: Overlapping set of patent rights with different patent-holders to certain technology: multiple licences are needed to use the technology. Prior art: All public knowledge before the priority day relating to the invention level of science when filing a patent. Reach-through claim: In a patent for an assay or screening method, a claim to any compound found using the method, that is, claims to future inventions based on currently disclosed inventions. Reach-through royalties: Royalties paid on the sales of a drug found using a screening method covered by a patent, with or without reach-through claims. Research exemption: Possibility to use the invention for research purposes without a licence. Narrow interpretation. Royalty stacking: The accumulation of royalties to be paid due to the need to acquire several licences to several patents particularly in case of patent thickets. State of the art: The total information in the relevant field known to the hypothetical person skilled in the art. Transcription: The process through which a DNA sequence is enzymatically copied by an RNA polymerase to produce a complementary RNA. Or, in other words, the transfer of genetic information from DNA into RNA. In the case of protein-encoding DNA, transcription is the beginning of the process that ultimately leads to the translation of the genetic code (via the mRNA intermediate) into a functional peptide or protein.