Intellectual Property Environment 1

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 2

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 3

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 4