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Presentation Materials in English [pdf] - United States Patent and ...

Presentation Materials in English [pdf] - United States Patent and ...

U.S. Practice•

U.S. Practice• Paragraph IV certification– -30 month stay on FDA marketing approvalfor resolution of patent infringement action– -If patent is invalidated, approval is grantedas of date of court decision– -If successful: 180-day generic drugexclusivity to first ANDA with a paragraph IVcertification

Patent vs. Data ProtectionPatent Protection and Undisclosed Information Protectionare Separate IP Protections Under TRIPS and ProtectDifferent Subject MatterPatents• Protect:– The pharmaceuticalproduct; or– The method of making thepharmaceutical product;or– The method of using thepharmaceutical productData Protection• Protects:– The test or other datagenerated by theinnovator in clinicalstudies to prove safetyand efficacy;– Does not provideprotection for a competitorwho produces their ownphase I, II & III clinicaldata

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