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