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Is the European Patent System for (Bio)Pharmaceuticals in Need of Change?

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Notes

  1. Vogler S, et al. (2016) Cancer drugs in 16 European countries, Australia, and New Zealand: a cross-country price comparison study, Lancet Oncol. 17:39–47, https://doi.org/10.1016/S1470-2045(15)00449-0.

  2. European Commission, Pharmaceutical Sector Inquiry. Final Report (2009), http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/staff_working_paper_part1.pdf.

  3. Bostyn S.J.R. (2020) Personalized Medicine, Intellectual Property Rights and Human Rights. In: Torremans P. (ed.) Intellectual Property and Human Rights, Kluwer Law International, pp. 907–986.

  4. Bostyn S.J.R. (2016) Personalised medicine, medical indication patents and patent infringement: emergency treatment required, Intellectual Property Quarterly, pp. 151–201.

  5. For details, supra note 4.

  6. Warner-Lambert Company LLC v. Generics (UK) Ltd et al., [2018] UKSC 56 (14 November 2018); Carvedilol II, German Federal Supreme Court (Case X ZR 236/01); Östrogenblocker, Düsseldorf Court of Appeal (Case I-2 W 6/17); Dexmedetomidin, Düsseldorf Court of Appeal (Case I-2 U 30/17), BeckRS 2018, 2410; Fulvestrant, Düsseldorf Court of Appeal (Case I-2 U 27/18), GRUR, 2019, 279.

  7. Already proposed in 2016, supra note 4.

  8. I appreciate that we would need to find a good definition of “sub-setting”, but that should not present a major issue.

  9. Article 10(4) Directive 2001/83; Art. 14(11) of Regulation (EC) No. 726/2004. See de Jongh T, et al. (2018) Effects of Supplementary Protection Mechanisms for Pharmaceutical Products, Technopolis Group, https://www.technopolis-group.com/wp-content/uploads/2020/02/Effects-of-supplementary-protection-mechanisms-for-pharmaceutical-products.pdf, pp. 62–63.

  10. There are two other exceptions, but they do not matter here. See supra note 9.

  11. The periods of protection can seem rather discretionary, but then the terms of protection under the current patent and regulatory exclusivity systems are rather discretionary as well and not founded on science or even economics.

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  1. Lic. Jur., LL.M, PhD, Dr. Jur.; Associate Professor of Innovation Law, Faculty of Law, University of Copenhagen, Copenhagen, Denmark

    Sven J. R. Bostyn

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  1. Sven J. R. Bostyn
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Correspondence to Sven J. R. Bostyn.

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This work was supported by the Collaborative Research Program for Biomedical Innovation Law, which is a scientifically independent collaborative research program supported by the Novo Nordisk Foundation (Grant NNF17SA0027784).

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Bostyn, S.J.R. Is the European Patent System for (Bio)Pharmaceuticals in Need of Change?. IIC 54, 171–175 (2023). https://doi.org/10.1007/s40319-022-01259-7

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