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Generic Medicines and Second Medical Use Patents: Litigation or Regulation? An Overview of Recent European Case Law and Practice

  • Gabriel Cuonzo
  • Daniela Ampollini
Article
  • 60 Downloads

Abstract

Second medical use patents concern new therapeutic use(s) of known chemical compounds or substances. These patents have gained considerable importance in the last decade since innovation in the pharma sector increasingly depends on the ability of the industry to identify new therapeutic uses of known molecules. When a patent covering the active substance of a compound expires, generic products must gain access to the market. Sensitive legal issues arise when second medical use patents remain in force. European courts and (in Italy) regulators have in recent years provided new principles and practical solutions aimed at ensuring that generic products, once available on the market, are not used in an infringing manner, i.e. in the therapeutic indication(s) covered by the second medical use patents. The diversity in the approaches taken by various jurisdictions does not conceal a common “political” concern: ensuring an adequate level of protection to second medical use patents requires a balancing exercise between the legitimate interests of various stakeholders including originators, generic companies, regulators, prescribing physicians, dispensing pharmacists and, most crucially, reimbursing payers. The Italian regulatory approach, although so far limited to the ad hoc solutions adopted by the Italian medicines agency (AIFA) in Lyrica and Glivec, may be a model for other European systems.

Keywords

Second medical use patents Generic Skinny label Carve-out Direct infringement Indirect infringement 

References

  1. Auteri (2005) Le tutele reali. In: Nivarra (ed), L’enforcement dei diritti di proprietà intellettuale. Atti del convegno di Palermo del 25 e 26 giugno 2004, Giuffrè, MilanGoogle Scholar
  2. Bostyn SJR (2016) Personalised medicine, medical indication and patent infringement: emergency of treatment required. I.P.Q 2:151–201Google Scholar
  3. Butriy O (2018) The interpretation of second medical use claims and the indirect nature of their infringement. J Intellect Property Law Pract 13(1):61–67CrossRefGoogle Scholar
  4. Di Cataldo (2012) “I brevetti per invenzione e per modello di utilità, i disegni e modelli”, in Busnelli (directed by), Il codice civile: commentario. Fondato da P.Schlesinger, Giuffrè, MilanGoogle Scholar
  5. England P (2016) Infringement of second medical use patents in Europe and the UPC. GRUR Int 714Google Scholar
  6. Fisher M (2017a) Second medical indications and the Swiss-form claim: Part 1 – solving one problem creates another. E.I.P.R 39(9):574–581Google Scholar
  7. Fisher M (2017b) Second medical indications and the Swiss-form claim: Part 2 – putting the problem in context. E.I.P.R 39(10):639–647Google Scholar
  8. Fisher M (2017c) Second medical indications and the Swiss-form claim: Part 3 – the Franken-cuckoo comes home to roost. E.I.P.R 39(11):705–718Google Scholar
  9. Franzosi-Scuffi (2014) Diritto industriale italiano, CEDAM, PaduaGoogle Scholar
  10. Moore S, Patterson R (2016) High Court sets out framework for dealing with enforcement of second medical use claims. E.I.P.R 38(1):60–62Google Scholar
  11. Rovati (2011) Le sanzioni. In: Aa VV, Ubertazzi LC (ed), La proprietà intellettuale in Ajani, Bennacchio (directed by) Trattato di diritto privato dell’Unione europea, Giappichelli, TurinGoogle Scholar
  12. Sena (2011) I diritti sulle invenzioni e sui modelli di utilità, in Schlesinger (directed by) Trattato di diritto civile e commerciale già diretto da A.Cicu, F.Messineo, L.Mengoni Giuffrè, MilanGoogle Scholar
  13. Sterckx S, Cockbain J (2010) Purpose-limited pharmaceutical product claims under the revised European Patent Convention: a camouflaged attack on generic substitution? I.P.Q 1:88–107Google Scholar

Copyright information

© Max Planck Institute for Innovation and Competition, Munich 2018

Authors and Affiliations

  1. 1.Trevisan & Cuonzo AvvocatiMilanItaly

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