1 / 34

BIOTECHNOLOGY PATENTABILITY AND RISKS FOR THE ENVIRONMENT The European perspective

BIOTECHNOLOGY PATENTABILITY AND RISKS FOR THE ENVIRONMENT The European perspective. B&P Avvocati caterina.lops@buttiandpartners.com www.buttiandpartners.com. Index. Definitions P atentability and problematic issues 2.1. Sources of EU patent law 2.2. Patentable subject matter

brigit
Download Presentation

BIOTECHNOLOGY PATENTABILITY AND RISKS FOR THE ENVIRONMENT The European perspective

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. BIOTECHNOLOGYPATENTABILITY AND RISKS FOR THE ENVIRONMENTThe Europeanperspective B&P Avvocati caterina.lops@buttiandpartners.com www.buttiandpartners.com

  2. Index • Definitions • Patentability and problematicissues 2.1. Sources of EU patent law 2.2. Patentablesubjectmatter • Biotechnology and environmentalrisks 3.1. Contained use of geneticallymodified micro-organisms 3.2. Deliberate release of geneticallymodifiedorganisms

  3. DEFINING BIOTECHNOLOGY: 1. Definitions Boundaryobjectbetweenbiology and engeneering Allapplicationsthatanalyse and use biologicalmaterialand/or processes to exploit them in a technological way

  4. 1. Definitions Rio Convention on Biological Diversity (CBD) – 1992 Article 2 "Biotechnology" means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.

  5. 1. Definitions Beerbrewing by Babylonians They can be OLD NEW WHITEREDGREEN Geneticengeneering

  6. 2. Patentability and problematic issues The technical character of all these applications can qualify them as «inventions», making them elegible for a PATENT The right, granted by the State to the inventor, to exclude others from making, using, selling, offering for sale or importing without permission the patented invention in the reference territory for a limited period of time (usually 20 years) so called «exclusive» or «negative» right • in return, the inventor must disclose all the details of the invention, so that it can become public domain after the patent expires

  7. 2. Patentability and problematic issues To be patented an invention shall: • be an invention = new and original solution to a technical problem • not a discovery or a pure theoretical elaboration (i.e. mathematical or business methods) • it could be a product, a process or a combination of both • (in some jurisdictions) not be contrary to social morality and ordre public • satisfy 3 requirements: • Novelty = be new in respect of what is already public domain • Inventive step = not be obvious to an ordinary technician in the field • Industrial application = be usable in an industry of any kind

  8. 2. Patentability and problematic issues Moreover, to be accepted the patent application shall contain: • Sufficient description of the invention (for the purposes of public disclosure) • Claims = specific sentences that exactly define the object for what the patent is requested

  9. 2. Patentability and problematic issues Biotechnological inventions, because of the natural origin of materials used, raise various problematic issues: • they hardly fall within traditional patentability requirements. Above all: • what about ethical implications? • Are they inventions or discoveries? • Are they inventions if they just recreate in a laboratory what already exists in nature? Let’s see how EU face these issues

  10. 2.1. Sources of EU patent law EU TRIPs Agreement 1994 (artt. 27 ss) • European Patent Convention (EPC) – Monaco 1973 • Directive 98/44/CE (Biotech Directive)

  11. 2.1. Sources of EU patent law EPC • Council of Europe initiative [ ≠ EuropeanCouncil] • All EU Members+ 19 others • Allows the inventor to obtain, with oneproceeding and common requirements, a «bundle» of individualnationalpatents (he chooseswhichones) • EuropeanPatent Office (EPO) • 3 officiallanguages: • German, English and French

  12. 2.1. Sources of EU patent law • EPC contains general regulations for patents • Just references to some biotech inventionsexcluded from patentability (for policy reasons) • Necessity for a specific law regulating biotech inventionspatentability in respect of traditionalrequirements • Legal uncertanintywasdeepening the technological gapbetweenEU and the more advanced USA and Japan EU intervenes with the Biotech Directive

  13. 2.1. Sources of EU patent law Directive 98/44/CE • First draft in 1988 • EuropeanParliamentparalyseddiscussingethicalissues • Twocontroversialcases Harvard onco-mouse Expressedsequencetags (ESTs) • Compromise with the Commission = just ethicalissuesaffectingpatents, not biotech in general

  14. 2.1. Sources of EU patent law • A biotech application is considered a patentable «invention» and not a «discovery» when the biological material, even if it previously occurred in nature: • was isolated from its natural environment • or was produced by means of a technical process. • Even parts of the human body, especially genes sequences but the industrial application should be clearly indicated (ESTs case influence)

  15. 2.2.1. Exclusions for policy reasons Some biotech inventions are excluded from patentability for policy reasons: • Plant or animalvarieties • Essentiallybiologicalprocesses for the production of plants and animals Free access to biodiversity microbiological processes are patentable

  16. 2.2.1. Exclusions for policy reasons • plant/animal varieties in a taxonomical sense = differentiation, homogeneity and stability through generations (not plants and animals as such) ECJ Genetically modified plants and animals are patentable if the genetic modification can apply to different varieties

  17. 2.2.1. Exclusions for policy reasons • Diagnostic, therapeutic and surgical methods for the treatment of humans or animals Free access to usefultools for preservingspecies Products used in such methods are obviously patentable

  18. 2.2.2. Exclusions for ethical reasons Some biotech inventions are listedasnotpatentablebecausethey are contrary to social morality and ordre public(notexhaustive list): • processes for cloning human beings or modifying their germ cells; • uses of human embryos for industrial or commercial purposes; • processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit (Harvard onco-mouse case influence)

  19. 2.2.2. Exclusions for ethical reasons Big problem = embryonic stem cells • Potential revolution in all medical fields • Are they patentable in some cases or a patent is always a commercial use of them? • they cannot be patented if the invention implies the previous destruction of the embryo (future researches could avoid it) ECJ

  20. 2.2.2. Exclusions for ethical reasons Biotech Directive doesn’tcontain an «anti-biopiracy» clause • Resolution of European Parliament of January 15, 2013 “Development aspects of intellectual property rights on genetic resources” pushes in that sense Exemple = in 2008 China reviseditsPatent Law, introducing an additionalexclusion to protectitshugebiodiversityheritage • Patentscannot be granted to inventionsinvolvinggeneticresourcesacquired or used in violation of relevantlaws

  21. 3. Biotechnology and environmental risks Biotechnologies can • helppreventenvironmentalrisks (plantsresistant to deseaseswithoutusingpesticides; cleanprocesses for treatingwaste…) • createthemselvesenvironmentalrisks in particular the so called "genetic pollution" = potentially dangerous dissemination of unwanted genes into the environment

  22. 3. Biotechnology and environmental risks Rio Convention on Biological Diversity (CBD) – 1992 Article 8 Each Contracting Party shall, as far as possible and as appropriate: (g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impactsthat could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health;

  23. 3. Biotechnology and environmental risks Rio Convention on Biological Diversity (CBD) – 1992 • Cartagena Protocol on Biosafety (2000) – regulatesmovements of living modified organisms (LMOs) resulting from modern biotechnology from one country to another: • priorRiskAssessment; • risk management measures; • accompanyingdocumentation; • availability to the public (Biosafety Clearing-House) • Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress (2010) – measures to be takenin the event of damage resulting from the transboundary movements of LMOs

  24. 3. Biotechnology and environmental risks In 90’s EU enacted two directives, recentely updated: • Directive 2009/41 onthe contained use of genetically modified micro-organisms (GMMs) • applies when the GMM user adopts, under the authorities’ control, specific containment measures to limit their contact, providing a high level of safety, with the general population and the environment • Directive 2001/18/CE on the deliberate release into the environment of genetically modified organisms (GMOs) • applies when GMOs are put on the market or anyway deliberately released into the environment A specific Regulation (1829/2003) is provided for genetically modified food and feed

  25. 3.1. Contained use of genetically modified micro-organisms Directive 2009/41/EC Recitals (4) The development of biotechnology is such as to contribute to the economic expansion of the Member States. This involves the use of genetically modified micro-organisms (GMMs) in operations of various types and scales. (5) The contained use of GMMs should be such as to limit their possible negative consequences for human health and the environment, due attention being given to the prevention of accidents and the control of waste. (9) The nature and scale of risks associated with the contained use of GMMs are not yet fully known and the risk involved must be assessed on a case-by-case basis. In order to evaluate the risk to human health and the environment, it is necessary to lay down requirements for risk assessment.

  26. 3.1. Contained use of genetically modified micro-organisms • Definitions (Art. 2) • ‘micro-organism’ means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including viruses, viroids, and animal and plant cells in culture; • ‘genetically modified micro-organism’ (GMM) means a micro-organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination [techniques listed in Annex I, Part A] • ‘contained use’ means any activity in which micro-organisms are genetically modified or in which such GMMs are cultured, stored, transported, destroyed, disposed of or used in any other way, and for which specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment;

  27. 3.1. Contained use of genetically modified micro-organisms Risk classes (Art. 4) The user shall carry out an assessment of the contained uses as regards the risks to human health and the environment that those contained uses may pose Class 1 = activities of no or negligible risk [level 1 containment] Class 2 = activities of low risk [level 2 containment] Class 3 = activities of moderate risk [level 3 containment] Class 4 = activities of high risk [level 4 containment] Where there is doubt as to which class is appropriate for the proposed contained use, the more stringent protective measures shall be applied unless, by agreement with the competent authority, there is sufficient evidence to justify the application of less stringent measures.

  28. 3.1. Contained use of genetically modified micro-organisms • Basic principles • Every time a place is used for the first time for a contained use, the user shall submit a notification to the competent authority before starting such use (subsequent uses may require further notification depending on the risk class and the previous uses – Artt. 6-9). • The user shall draw an emergency plan before starting the contained use and immediately inform the competent authority when an accident happens (Artt. 13-14) • The competent authority organisesinspections and other control measures (Art. 16)

  29. 3.1. Contained use of genetically modified micro-organisms • Confidentiality (Art. 18) • The notifier may ask the competent authority to keep some information confidential (protection of IP data) • The following information cannot be kept confidential: • the general characteristics of the GMMs, the name and address of the notifier, and the location of use; • the class of contained use and the containment measures; • the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment.

  30. 3.2. Deliberate release of genetically modified organisms Directive 2001/18/EC Recitals (4) Living organisms, whether released into the environment in large or small amounts for experimental purposes or as commercial products, may reproduce in the environment and cross national frontiers thereby affecting other Member States. The effects of such releases on the environment may be irreversible. (5) The protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs). (9) Respect for ethical principles recognised in a Member State is particularly important. Member States may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products.

  31. 3.2. Deliberate release of genetically modified organisms • Definitions (Art. 2) • ‘organism’ means any biological entity capable of replication or of transferring genetic material; • ‘genetically modified organism (GMO)’ means an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination [techniques listed in Annex I A, part 1] • ‘deliberate release’ means any intentional introduction into the environment of a GMO or a combination of GMOs for which no specific containment measures are used to limit their contact with and to provide a high level of safety for the general population and the environment; • ‘placing on the market’ means making available to third parties, whether in return for payment or free of charge;

  32. 3.2. Deliberate release of genetically modified organisms • The Directive applies to (with different notification proceedings and rules) • Part B – Deliberate release of GMOs for any other purpose than for placing on the market • Part C – Placing on the market of GMOs as or in products

  33. 3.2. Deliberate release of genetically modified organisms • Common principles • Prior environmental risk assessment – prior notification – prior written consentof the competent authority before the deliberate release or the placing on the market . • Before the final decision by the competent authority: • consultation and information to the public; • exchange of information with the Commission and the other Member States • Confidentiality – the notifier cannot ask to keep confidential: • general description of the GMO or GMOs, name and address of the notifier, purpose of the release, location of release and intended uses; • methods and plans for monitoring of the GMO or GMOs and for emergency response; • environmental risk assessment • Possibility to consult relevant Scientific Committees or Committees on Ethics

  34. THANK YOU FOR YOUR ATTENTION Anyquestions?

More Related