Intellectual Property Environment
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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
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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
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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
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