The European patent system: dealing with emerging technologies

Abstract

In light of recent controversial patent decisions in biotechnology, this article argues that the current European patent examination and opposition procedures do not suffice to balance the patent system These procedures do not provide sufficient guidance for patent examiners to deal effectively with the emerging life science technologies. The European Patent Office needs to instill more self-reflection into the patent system and foster interaction between the Office and patent stakeholders. In this respect, we propose that the EPO should establish an ex-ante, patent-granting advisory body that would consist of multidisciplinary staff drawn from various technical fields, and collaborate closely with the scientific community and other national bodies. It is expected that such an advisory body would provide an input to the existing patent system, since it would anticipate, control and reduce the possibility that patent examiners would issue low-quality patents with huge socio-economic consequences.

Keywords:

• European patent system
• biotechnology
• patent prosecution
• patent assessment
• third-party participation

Notes

1. Patent claims define the scope of the protection that the inventor seeks in a patent application.

2. According to the OECD definition, gene patents relate to one of the following four categories: “1) whole genes or parts of them, 2) proteins that the genes encode as well as their function in organisms, 3) vectors used for the transfer of genes from one organism to another or 4) genetically modified cells or organisms used for the making of genetically modified products and the uses of genetic sequences or proteins for genetic tests”. Available from: http://www.theinnovationpartnership.org/data/ieg/documents/cases/TIP_Myriad_Legal.pdf [Accessed August, 2010].

3. Recent estimates indicate that a search of 100 sequences requires approximately 15 hours of computing time, whereas it takes 65 hours of examiner time to evaluate these search results.

4. High-quality patents should meet patentability requirements, contribute to the state of the art, offer scientific/social benefit and stand up to the most rigorous challenges in court.

5. Current estimates by Holzer (2005) and Harhoff (2009) indicate that the number of patent opposition cases in Europe is about 1260 per year, 600–700 instances of which relate to European patents. Most of the litigation comes from electrical engineering (165 cases), pharmaceuticals (149 cases), organic chemistry (including biotechnology with 141 cases) and mechanical engineering (139 cases). Cohen et al. (2008) add to this debate, claiming that litigation relating to biotechnology patents is likely to increase in Europe as the industry increases in size and complexity.

6. The European patent system is not exclusive; patent applicants can also obtain strictly national patents if they are only interested in obtaining patent protection in one or a few of the EPC Contracting States.

7. Following these examinations, the EPC might provide the applicant with an opportunity to amend those claims that do not fulfill patentability requirements, whereas the Examination Division may conduct an additional examination of these amended claims.

8. During the “Plants/NOVARTIS” case, the EBOA (referring to the new Rule 23c EPC) rendered plants patentable inventions if the patentability criteria are fulfilled.

9. BRCA1 gene patents awarded Myriad exclusive ownership of genetic testing for hereditary breast cancer, exclusive rights to the isolated BRCA1 gene and to the use of genes in cancer diagnosis. BRCA2 gene patents granted rights to the detection of one specific BRCA2 mutation in a particular population.

10. See Press Office, 2001. Institut Curie against Myriad Genetics’ monopoly on tests for predisposition to breast and ovarian cancer. Available from: http://www.curie.fr/upload/presse/myriadopposition6sept01_gb.pdf

11. See Press Release, 2002. Institut Curie, European-wide opposition against the breast cancer patents. Available from: http://www.curie.fr/upload/presse/europeanoppmyriad_sept02_gb.pdf

12. See note 10.

13. See Niklas Mattsson's comment on “BRCA patents in Europe”, The Awapatent's IP blog, comment posted on 4 January 2010. Available from: http://www.awapatent.dk/?id =;14709&threadid;=;16679

14. See also Managing intellectual property: clash over stem cell patents in Europe. Available from: http://www.managingip.com/Article.aspx?ArticleID;=;1675644

15. EGE is an independent, multidisciplinary body that provides advice to the European Commission on ethical aspects of science and new technologies. Some of the EGE opinions have been very valuable to the development of biotechnology, but during the “Edinburgh” case EGE's opinion (Opinion no. 16) was considered inconsistent and outside patent law and Biotechnology Directive provisions. See EGE, 2008. Opinion no 16: patentability of stem cells the view of the European Group of Ethics. Available from: http://www.grunecker.com/download/publications/stemcells.pdf

16. Pluripotent cells mean that these cells may be different from many other cell types, but not from all possible cell types (Sterckx 2008).

17. See also note 11.

18. See European Patent Convention 1973. Part V opposition procedure. Available from: http://www.epo.org/patents/law/legal-texts/html/epc/1973/e/ar99.html

19. Reports from the corporate and private IP professionals on the practice of the EPO and national courts have been published in the Intellectual asset management magazine. Available from: http://www.iam-magazine.com

20. Austria, France, Italy, Netherlands, Germany, Spain, Sweden, the UK and Hungary.

21. Austria, Hungary, Netherlands, Sweden and the UK.

22. Austria, Belgium, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Luxembourg, Netherlands, Romania, Slovakia, Spain, Sweden and the UK.

23. Belgium, Denmark, Germany, Greece, Italy, Lithuania, Poland, Slovenia and Spain.

24. Following the gene patent controversies in 2005, the European Parliament also emphasized the need for the “EPO to establish a body that would check patents that are sensitive from an ethical point of view before they are granted” (Salter 2009).

25. According to the EPO database, there are 14 technical fields that deal with the majority of patent applications. For more information on technical fields, see The EPO Patent Database: European patent applications per technical field and origin. Available from: http://www.epo.org/about-us/office/statistics/applications.html

26. For more information on the National Bioethics Committees, see Salter and Salter (2007).

27. See Moses, V. et al., 2002. Biotechnology: educating the European public – final report. Brussels: European Commission.