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Overview of Intellectual Property in the Pharmaceutical Sector: Challenges and Developments

This overview examines the state of intellectual property (IP) protection in the biopharmaceutical sector, highlighting its alignment with international standards. It notes that while biotech inventions are generally patentable, challenges remain regarding patent linkage systems and enforcement transparency. Delays in prosecution, ineffective injunctions, and ongoing counterfeit sales are persistent issues. The existing patent linkage mechanism requires generic applicants to address patent statuses, yet lacks comprehensive consultation with patent holders. The introduction of regulatory data protection (RDP) is a recent development, though its implementation remains uncertain.

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Overview of Intellectual Property in the Pharmaceutical Sector: Challenges and Developments

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Presentation Transcript

  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

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