市场独占及专利保护PBP07-P-Market-Exclusivity-and-Patent-Protection_Malaysia_August-2015_MMUNA_Final.pdfVIP

MARKET EXCLUSIVITY AND PATENT PROTECTION – A REGULATORY PERSPECTIVE Michael G Muña Senior Director, Regulatory Affairs International BioMarin Pharmaceutical Inc San Rafael, California USA PURPOSE To provide a regulatory perspective on market protection for drugs AGENDA  Market Protection for Drugs  Exclusivity – Market Protection vs Data Exclusive  US and EU Perspective  Additional exclusivity protections  Intellectual Property  Patent Protection  What is the difference between Patent Protection and Marketing Exclusivity  Conclusion WHY PATENTS AND EXCLUSIVITY  Protecting the intellectual property of new drugs is complicated but essential for pharmaceutical companies.  Both Patents and Exclusivity create period during which a new drug is protected from direct competition.  create a favorable environment to encourage drug development.  promote a balance between new drug innovation and generic drug competition  Allows companies to recoup the cost of investment in producing data required by the regulatory authority MARKET PROTECTION FOR DRUGS  Market Protection for Drugs  Market vs Data Exclusivity  US FDA  EU EMA  Intellectual Property  Patents  Trademarks  Copyrights  Trade Secrets TYPES OF EXCLUSIVITY – US FDA  Filing Exclusivity = Period of time during which a Company cannot submit an application by cross-reference to the data in support of another marketing authorization ie no submission of Abbreviated NDA / 505(b) (2) applications  Approval Exclusivity = Period of time during which a Company cannot gain approval for an application b