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BIOTECHNOLOGY, PATENTS AND RISKS FOR THE ENVIRONMENT EU and China perspectives

BIOTECHNOLOGY, PATENTS AND RISKS FOR THE ENVIRONMENT EU and China perspectives. B&P Avvocati caterina.lops@buttiandpartners.com www.buttiandpartners.com. Index. Definitions Patentability and problematic issues Sources of EU and Chinese patent law Patentable subject matter

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BIOTECHNOLOGY, PATENTS AND RISKS FOR THE ENVIRONMENT EU and China perspectives

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  1. BIOTECHNOLOGY, PATENTS AND RISKS FOR THE ENVIRONMENTEU and China perspectives B&P Avvocati caterina.lops@buttiandpartners.com www.buttiandpartners.com

  2. Index • Definitions • Patentability and problematicissues • Sources of EU and Chinesepatent law • Patentablesubjectmatter 4.1) Exclusionsfor policy reasons 4.2) Exclusions for ethicalreasons • Biotechnology and environmentalrisks

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

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

  5. 1. Definitions The technicalcharacterof alltheseapplications can qualifythemas «inventions», makingthemelegible for a PATENT The right, granted by the State to the inventor, to excludeothers from making, using, selling, offering for sale or importingwithoutpermission the patentedinvention in the referenceterritory for a limitedperiod of time (usually 20 years) so called «exclusive» or «negative» right • in return, the inventor must discloseall the details of the invention, so thatit can become public domain after the patentexpires

  6. 2. Patentability and problematic issues To be pantented 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

  7. 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

  8. 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 and China face these issues

  9. 3. Sources of EU and Chinese patent law TRIPs Agreement 1994 (artt. 27 ss) EU • European Patent Convention (EPC) – Monaco 1973 • Directive 98/44/CE (Biotech Directive) • Patent Law 1984 (emended in 1992, 2000 and 2008) CHINA

  10. 3. Sources of EU and Chinese patent law EPC • Council of Europe initiative [ ≠ European Council] • All EU Members + 11 others • Allows the inventor to obtain, with one proceeding and common requirements, a «bundle» of individual national patents (he chooses which ones) • European Patent Office (EPO) • 3 official languages: German, English and French

  11. 3. Sources • 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

  12. 3. Sources of EU and Chinese 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

  13. 3. Sources of EU and Chinese patent law PRC Patent Law 1984 • First patent law in China’s history • General regulations for patents • Biotech inventions played an important role in the revision process, especially: • 1992 = USA impose an agreement to make pharmaceutical products patentable • 2008 = introduction of a controversial disposal that excludes from patentability the invention using biological material without following (complex) national regulations for the protection of genetic resources of the Country

  14. 3. Sources • When China deeplyemendeditsPatent Law in 1992 and 2000 to join WTO (in 2001), Biotech Directive wasusedas a model to regulate biotech inventions EU and China regulations for biotech patents are almost equal Differences will be underlined

  15. 4. Patentable subject matter • A biotech applicationisconsidered a patentable «invention» and not a «discovery» when the biologicalmaterial, even if it previously occurred in nature: • wasisolated from itsnaturalenvironment • or wasproduced by means of a technical process. Whatcountsisnot the naturalorigin of the materialused, but the factthat, by means of a human technicalintervention, it can exist in an artificialenvironment • Evenparts of the human body, especiallygenessequencesbutthe industrial applicationshould be clearlyindicated (ESTs case influence)

  16. 4.1. 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

  17. 4.1. Exclusions for policy reasons EU • plant/animalvarieties in a taxonomicalsense = differentiation, homogeneity and stabilitythroughgenerations notplants and animalsassuch Geneticallymodifiedplants and animals are patentableif the geneticmodification can applyto differentvarieties CHINA • Plants and animals as such Transgenicplants and animals are notpatentable

  18. 5. 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

  19. 5. Exclusions for ethical reasons Some biotech inventions are listedasnotpatentablebecausethey are contrary to social morality and ordre public(notexhaustive list): • processes for cloning human beings; • processes for modifying the germ line genetic identity of human beings; • 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 to man or animal, and also animals resulting from such processes (Harvard onco-mouse case influence)

  20. 4.2. 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? • ECJ = they cannot be patented if the invention implies the previous distruction of the embryo (future researches could avoid it) EU CHINA • Law specifically exludes them from patentability Not real ethical, but policy reason = China has one of the most permissive laws on embryo research

  21. 4.2. Exclusions for ethical reasons In 2008 revision to Patent Law, China introduced an additionalexclusion to protectitshugebiodiversityheritage • Patentscannot be granted to inventionsinvolvinggeneticresourcesacquired or used in violation of related (complex) laws It belongs to that kind of "bio-provisions" that developing countries (rich in genetic resources) are asking to introduce in the TRIPs Agreement for contrasting "bio-piracy"

  22. 5. 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

  23. 5. Biotechnology and environmental risks EU • 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 • national authorities shall establish an emergency plan to deal with accidents • In 90’s Eu enactedtwodirectives, recentelyupdated:

  24. 5. Biotechnology and environmental risks • 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 • national authorities, in authorizing GMOs release, shall follow the precautionary principle • decision based on scientific datas, even if uncertain • evaluation case by case • revision when new scientific datas are available • A specific Regulation (1829/2003) is provided for genetically modified food and feed

  25. 5. Biotechnology and environmental risks • GMOsas the keyfor agriculturalself-sufficiency • In 2001 the State Council enacted the Regulation on Safety Administration of Agricultural GMOs • Adopts EU precautionary principle (they are both big importers) = GMO manufacturer shall obtain a safety license from the Ministry of Agriculture (MoA) and provide for all safety measures • the regulatory competence is delegated to MoA but its primary aim is agricultural production growth = weak control and protectionism by local governments can cause accidents like the illegal plantation of genetically modified Bt rice found out in 2005

  26. THANK YOU FOR YOUR ATTENTION Anyquestions?

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