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

摘要

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.