Between pharmaceutical patents and European patients: is a compromise still possible?

References

• World Intellectual Property Organization, WIPO. What is intellectual property?. WIPO Publication No. 450(E); Geneva, 2004. ISBN 978-92-805-1555-0. 25.
   Google Scholar
• Cockburn I, Long G. The importance of patents to innovation: updated cross-industry comparisons with biopharmaceuticals. Expert Opin Ther Pat. 2015 Jul;25(7):739–742.
   PubMed Web of Science ®Google Scholar
• van de Vooren K, Curto A, Garattini L. Biosimilar versus generic drugs: same but different? Appl Health Econ Health Policy. 2015 Apr;13(2):125–127.
   PubMed Web of Science ®Google Scholar
• Feldschreiber P, Breckenridge A. After thalidomide - do we have the right balance between public health and intellectual property. Rev Recent Clin Trials. 2015;10(1):15–18.
   PubMedGoogle Scholar
• Mintzberg H. Patent nonsense: evidence tells of an industry out of social control. CMAJ. 2006;175(4):374–381.
   PubMed Web of Science ®Google Scholar
• Holmes D. Report urges controversial ‘delinkage’ to foster new antibiotics. Nat Med. 2014 Apr;20(4):320.
   PubMed Web of Science ®Google Scholar
• Convention on the Grant of European Patents (European Patent Convention), 29 Nov 2000. Last accessed: May 2017 https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ma5b.html
   Google Scholar
• Gates C. Patenting the life sciences at the European Patent Office. Cold Spring Harb Perspect Med. 2014 Oct 23;4(12):a020792. DOI:10.1101/cshperspect.a020792.
   PubMed Web of Science ®Google Scholar
• Council of the European Union. Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products. Official Journal of the European Communities, 1992. L182/1.
   Google Scholar
• Kupecz A, Roox K, Dekoninck C, et al. Safe harbors in Europe: an update on the research and Bolar exemptions to patent infringement. Nat Biotechnol. 2015;33(7):710–715.
   PubMed Web of Science ®Google Scholar
• Jaenichen HR, Pitz J. Research exemption/experimental use in the European Union: patents do not block the progress of science. Cold Spring Harb Perspect Med. 2014 Nov 6;5(2):a020941.
   PubMed Web of Science ®Google Scholar
• The European Parliament and The Council of the European Union. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004. Official Journal of the European Union, 2004. L136/34.
   Google Scholar
• The European Parliament and the Council of the European Union. Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. Official Journal of the European Union, 2006. L157/1.
   Google Scholar
• The European Parliament and the Council of the European Union. Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. Official Journal of the European Communities, 2000. L18/1.
   Google Scholar
• The European Parliament and the Council of the European Union. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.Official Journal of the European Union, 2006. L378/1.
   Google Scholar
• Adamini S, Maarse H, Versluis E, et al. Policy making on data exclusivity in the European Union: from industrial interests to legal realities. J Health Polit Policy Law. 2009;34(6):979–1010.
   PubMed Web of Science ®Google Scholar
• Gupta H, Kumar S, Roy S, et al. Patent protection strategies. J Pharm Bioallied Sci. 2010 Jan;2(1):2–7.
   PubMedGoogle Scholar
• Raj GM, Priyadarshini R, Mathaiyan J. Drug patents and intellectual property rights. Eur J Clin Pharmacol. 2015 Apr;71(4):403–409.
   PubMed Web of Science ®Google Scholar
• Spilker B. Guide to drug development – a comprehensive review and assessment. Philadelphia: Lippincott Williams&Wilkins; 2009.
   Google Scholar
• Niazi SK. Biosimilar and interchangeable biologics: strategic elements. CRC Press Taylor and Francis Group LLC, Boca Raton, Florida 2016.
   Google Scholar
• International Federation of Pharmaceutical Manufacturers Associations. Encouragement of new clinical drug development: the role of data exclusivity. Geneva: Switzerland; 2000.
   Google Scholar
• Clift Cl. Data protection and data exclusivity in pharmaceuticals and agrochemicals. In: Krattiger A, Mahoney RT, Nelsen L, editors. Intellectual property management in health and agricultural innovation: a handbook of best practices. Davis, California, U.S.A.: MIHR: Oxford, U.K., and PIPRA; 2007.
   Google Scholar
• Garattini S. Time to revisit the orphan drug law. Eur J Clin Pharmacol. 2012 Feb;68(2):113.
   PubMed Web of Science ®Google Scholar
• Côté A, Keating B. What is wrong with orphan drug policies? Value Health. 2012 Dec;15(8):11–91.
   Web of Science ®Google Scholar
• European Parliament, Directorate-General for internal policies. The European patent office – state of play. In: Policy department C: citizen’s rights and constitutional affairs. European Union, Brussels, 2015.
   Google Scholar
• European commission. Directorate-General for Research and Innovation Directorate A. Models of horizon scanning - how to integrate horizon scanning into European research and innovation policies. In: Policy development and coordination unit A.6 - science policy, foresight and data. European Commission, Brussels, 2015.
   Google Scholar
• Curto A, Van De Vooren K, Garattini L. Market approval for drugs in the EU: time to change direction? Eur J Health Econ. 2016 Dec 27. [Epub ahead of print]. DOI:10.1007/s10198-016-0863-5
   Google Scholar
• Garattini S. The European Medicines Agency is still too close to industry. BMJ. 2016;6;353:i2412.
   PubMed Web of Science ®Google Scholar
• Leoni P, Sandroni A. Can patent duration hinder medical innovation? Int J Health Econ Manag. 2016;16(4):397–406.
   PubMed Web of Science ®Google Scholar