Intellectual P roperty E nvironment

1. Intellectual Property Environment

2. Pharmaceutical IP Overview • Biopharmaceutical IP protection fairly standard, but not fully in line with international standards and bilateral commitments • Biotech inventions patentable, except in natural state or processes of reproduction • Patent linkage system ineffective, lacks transparency • IP enforcement improving but insufficient • Significant delays in prosecution common • Injunctions frequently ineffective • Sales of counterfeit medicines in pharmacies undeterred, although efforts to contain are increasingly routine

3. Pharmaceutical ‘Patent Linkage’ Mechanism • Basic linkage system exists based on Presidential Decree (2003) • Requires generic applicants to comment on the patent status of the reference product • Potential infringement issues resolved by Mexican Patent Office (IMPI) and COFEPRIS and published by IMPI • Significant weaknesses: • Does not involve notification or consultation of the patent holder • Only applies to substance patents; despite 2008 Supreme Court ruling requiring inclusion of formulation and use patents, not consistently applied • Process often delayed and ineffective

4. PTE and RDP • Mexico does not offer patent term extensions for pharmaceutical products • COFEPRIS introduced 5 year regulatory data protection term in 2012 • RDP only applies to NCEs thus far • Implementation of RDP still uncertain