Medicine Between Ethics and Scientific Progress: How Much Ethics Needs Medicine, how much ethics can it afford? Some Considerations from Patent Law Perspectives

  • Joseph Straus Max Planck Institute for Intellectual Property and Competition Law
Keywords: ethics, scientific progress, costs of R&D, role of patents, CJEU case law


The progress of medicine is heavily dependent on the progress of science and technology, which in turn depend on costly and risky investment in research and development. In this contribution, based on some concrete examples, new scientific achievements are presented as basis of modern medicine and source of ethical concerns. Addressed are also the role of scientists in coping with safety in ethical concerns as regards hazards of new technologies, costs of R&D investment in drug development and the role of patents in this context. In some detail the legal situation existing at an international and European level as regards exclusions from patentability based on reasons of ethics and morals is presented. A critical appraisal of the case law of the Court of Justice of the European Union as regards patentability of embryonic stem cells is offered.


Download data is not yet available.


Business Wire (2009): BioSante Pharmaceuticals and Cell Genesys Announce September 30, 2009 Special Stockholders Meetings to Approve Merger, BusinessWire, (September, 3, 2009) (San Francisco: Business Wire), available at:

en/BioSante-Pharmaceuticals-Cell-Genesys-Announce-September-30 (October 11, 2015).

Aggarwal, S. (2007) What's fueling the biotech engine?, Nature Biotechnology, 25, pp. 1097-1104, doi: 10.1038/nbt1007-1097.

Aggarwal, S. (2014) What's fueling the biotech engine – 2012 to 2013, Nature Biotechnology, 32(1), pp. 32-39. doi: 10.1038/nbt.2794.

ALLEA (2012) ALLEA Statement on Patentability of Inventions Involving Human Embryonic Pluripotent Stem Cells in Europe of May 2011 and the Judgment of the Court of European Communities (Grand Chamber) of 18 October 2011 in Case C-34/10 of September 2012 (Berlin: ALLEA), available at: (March 6, 2015).

ALLEA (2013) ALLEA Statement on Patentability and Research Funding relating to embryonic Stem Cells (e-SCs) of October 2013 (Berlin: ALLEA), available at (March 6, 2015).

Beier, F. K. & Straus, J. (1986) Genetic Engineering and Industrial Property, Industrial Property, 25, p. 447.

Benkard (Melullis K.-J.) (2012) EPÜ – Europäisches Patentübereinkommen, 2nd ed. (Munich: C. H. Beck).

Berg, P. (2008) Meetings that changed the world: Asilomar 1975: DNA modification secured, Nature, 455, pp. 290-291, available at: (March 8, 2015).

Berg, P., Baltimore, D., Brenner S., Roblin, R. O. & Singer M. F. (1975) Summary Statement of the Asilomar Conference on recombinant DNA molecules, Proceedings of the National Academy of Sciences of the United States of America, 72(6), pp. 1981-1984, available at: (March 12, 2015).

Bock, G., Cohen, D., Goode, J., Novartis Foundation., & Symposium on From Genome to Therapy: Integrating New Technologies with Drug Development (2000) From genome to therapy: Integrating new technologies with drug development (Chichester: Wiley).

The Free Library (2014) Chiron Files Infringement Suit in Japan Against Roche On HCV Patent (n.d.) (Huntingdon Valley: Farlex), available at: (March 20, 2015).

Caskey, C. T. (2007) The drug development crisis: Efficiency and safety, Annual Review of Medicine, 58, pp. 1-16, doi: 10.1146/

Cohen, W. W. & Merrill, S. A. (2003) Introduction, In: Cohen, W. W. & Merrill, S. A. (eds.) Patents in the knowledge-based economy (Washington D.C.: National Academies Press).

Correa, C. M. (2007) Trade Related Aspects of Intellectual Property Rights – A Commentary on the TRIPS Agreement (Oxford: Oxford University Press).

Di Masi, J. A., Hansen, R. W. & Grabowski, G. (2003) The price of innovation: New estimates of drug development costs, Journal of Health Economics, 22(2), pp. 151-185, doi: 10.1016/S0167-6296(02)00126-1.

Drabiak-Syed, K. (2013) New president, new human embryonic stem cell research policy: Comparative international perspectives and embryonic stem cell research laws in France, Biotechnology Law Report, 32(6), pp. 349-356, doi: 10.1089/blr.2013.9865.

Gallagher, J. (2012) Gene therapy: Glybera approved by European Commission, BBC News Health (November 2, 2012), available at: (March 2, 2015).

German Federal Supreme Court (BGH), 18 October 1967, 48 BGHZ 327 (at 330).

Gervais, D. (2003) The TRIPS Agreement: Drafting History and Analysis, 2nd ed. (London: Sweet and Maxwell).

Hill, A. & Cooke, G. (2014) Hepatitis C can be cured globally, but at what cost?, Science, 345(6193), pp. 141-142, doi: 10.1126/science.1257737.

Holden, C. & Vogel, G. (2008) A seismic shift for stem cell research, Science, 319(5863), pp. 560-562, doi: 10.1126/science.319.5863.560.

Hübel, A (2011) Patentability of Pluripotent Stem Cells Unlikely Although they are not Considered as Embryo, Mitteilungen der deutschen Patentanwälte 494 ss.

Straus, J. (2000a) Is patent law getting out of hands? Misconceptions in the outcry against a decision of the European Patent Office, EPO Gazette, Special Edition, May 2000, pp. 8-11.

Johnson, I. S. (1983) Human insulin from recombinant DNA technology, Science, 219(4585), pp. 632-637.

Kaiser, J. (2007) Death prompts a review of gene therapy vector, Science, 317(5838), pp. 580 (August, 3, 2007), doi: 10.1126/science.317.5838.580.

Kling, J. (2012) Fresh from the biotech pipeline – 2011, Nature Biotechnology, 30(2), pp. 128-131, doi:10.1038/nbt.2111.

Landes, W. M. & Posner, R. A. (2003) The economic structure of intellectual property law (London: Belknap Press).

Ledford, H. (2007) Death in gene therapy trials raises questions about private IRBs, Nature Biotechnology, 25(10), pp. 1067, doi:10.1038/nbt1007-1067.

Mansfield, E. (1986) Patents and innovation: An empirical study, Management Science,. 32(2), pp. 173-181.

Moran, N. (2011) European Court Bans Embryonic Stem Cell Patents, Nature Biotechnology, 29(12), 1057-1059, doi:10.1038/nbt1211-1057.

Moran, N. (2012) First gene therapy nears landmark European market authorization, Nature Biotechnology, 30, 807–809, doi: 10.1038/nbt0912-807.

Paton, M. & Denoon, A. (2011) The Ramifications of the Advocate General's Opinion in the Oliver Brüstle case, E.I.P.R., 590 ss.

Pires de Carvalho, N. (2010) The TRIPS Regime of Patents Rights, 3rd ed. (The Hague: Kluwer Law International).

Plomer, A. (2009) Human Dignity, Human Rights and Article 6(1) of the EU Directive on Biotechnological Inventions, In: Plomer, A & Torremans, P. (eds.) Embryonic Stem Cell Patents – European Law and Ethics (Oxford: Oxford University Press).

Plomer, A. (2009) Towards Systemic Legal Conflicts: Article 6(2) (c) of the EU Directive on Biotechnological Inventions, In: Plomer, A & Torremans, P. (eds.) Embryonic Stem Cell Patents – European Law and Ethics (Oxford: Oxford University Press).

Plomer, A. (2011) EU Ban on Stem Cell Patents is a Threat Both to Science and the Rule of Law, The Guardian (December 12, 2011), available at: (March 18, 2015).

Pollaud-Dulian F. (1997) La Brevetabilité des Invention, Etude Comparative de Jurisprudence, France-OEB (Paris: Le Droit des Affaires, LexisNexis).

Porter, G. (2009) The Drafting History of the European Biotechnology Directive, In: Plomer, A & Torremans, P. (eds.) Embryonic Stem Cell Patents – European Law and Ethics (Oxford: Oxford University Press)

Moufang, R. (1991) Europäisches Patentübereinkommen – Münchner Gemeinschaftskommentar, 15th issue, Art. 53 EPC, marginal notes 30-31 (Köln-Berlin-Bonn-München: Heymanns Carl).

Rigby, B. (2011) A Ban on Stem Cell Patents in Europe?, 12 World Intellectual Property Report BNA (Arlington: Bloomberg BNA).

Rogge, R. (1998) Patente auf genetische Informationen im Lichte der öffentlichen Ordnung und der guten Sitten, 1998 GRUR 303ss. (at 303).

Seymour, L. W. & Thrasher A. J. (2012) Gene therapy matures in the clinic, Nature Biotechnology, 30(7), pp. 588-593, doi:10.1038/nbt.2290.

Stollorz, V. (2014) Hepatitis C – Dramatischer Durchbruch, Frankfurter Allgemeine Zeitung (July 29, 2014), available at: (March 22, 2015).

Straus, J. (1996b) Patentrechtliche Probleme der Gentherapie, 1996 GRUR, 10 ss.

Straus, J. (1985) Industrial property protection of Biotechnological inventions, Analysis of certain basic issues, World Intellectual Property Organization, doc. IPD/2867I, Geneva 1985, pp. 22-42.

Straus, J. (1995) Patenting Human Genes in Europe – Past Developments and Prospects for the Future, IIC - International Review of Industrial Property and Copyright Law, 26(6), pp. 920-950.

Straus, J. (1996a) Implications of the TRIPS Agreement in the Field of Patent Law, In: Beier, F. K. & Schricker, G. (eds.) From GATT to TRIPS – The Agreement on Trade Related Aspects of Intellectual Property Rights (Weinheim and New York: Wiley-VCH).

Straus, J. (2000b) Patenting genes and gene therapy – Legal and ethical aspects, In: Bock, G. R., Cohen, D. & Goode, J. A. (eds.) From genome to therapy: Integrating new technologies with drug development (Chichester, New York, Weinheim, Brisbane, Singapore, Toronto: Wiley).

Straus, J. (2001) Intellectual Property Rights: Ethical Aspects, In: Smelser, N. J. & Baltes, P. B. (eds.) International Encyclopaedia of the Social & Behavioural Sciences (Amsterdam, Paris, New York, Oxford, Shannon, Singapore, Tokyo: Elsevier).

Straus, J. (2012) A Marriage of Convenience: World Economy and Intellectual Property From 1990 to 2012, AIPLA Quarterly Journal, 40(4), 633-683.

Straus, J. (2013) Ordre public and morality issues in patent eligibility, In: Takenaka, T. (ed.), Intellectual property in common law and civil law (Cheltenham (UK), Northampton: Edward Elgar), doi: 10.4337/9780857934376.00009.

Ward (2014) Bitter pills – The high cost of a new hepatitis treatment: Is prompting the debate that most alarms industry: Whether to curb the US free market in drugs, Financial Times, August 1, 2014, p. 5.

Whalen, J. (2012) Gene-therapy approval marks major milestone, Wall Street Journal (November 2, 2012), available at: (March 20, 2015).

How to Cite
Straus J. (2015). Medicine Between Ethics and Scientific Progress: How Much Ethics Needs Medicine, how much ethics can it afford? Some Considerations from Patent Law Perspectives. Medicine, Law & Society, 8(1), 47-76.