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