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The face of the patent is not the “Whole Story”: determining effective life of a pharmaceutical patent in the United States |
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| Authors: | Anne Marie Clark Heidi Berven |
| Affiliation: | a Pfizer, 2800 Plymouth Road, Ann Arbor, MI 48105, USA |
| Abstract: | This article provides an overview of the factors that may contribute to the effective term of protection for a pharmaceutical product in the USA––by patent and by FDA market exclusivities, identifies public and commercial sources for collecting relevant patent term and exclusivity data, and provides a strategy for ensuring that the effective term of protection has been calculated accurately. |
| Keywords: | Patent term Patent expiry Pharmaceutical patents Interference Infringement Terminal disclaimers Maintenance fees Correction certificates FDA Hatch– Waxman Market exclusivity NCE exclusivity Orphan drug exclusivity Pediatric exclusivity OTC switches ANDA exclusivity |
| 本文献已被 ScienceDirect 等数据库收录！ | |
