FTO (Freedom to Operate) in the Pharmaceutical Industry
Published by Munich Intellectual Property Law Center
TrainingWhite Paper
Published by Munich Intellectual Property Law Center
TrainingWhite PaperPublished by European Commission (EC)
Intellectual PropertyIP CommercialisationThe purpose of this guide is to provide you with basic facts on Intellectual Property (IP) aspects in commercialisation activities.
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Orphan IncentivePaediatric IncentiveMarket ExclusivityIncentiveThis guide provides an incentive of EMA. Orphan medicines once they receive a marketing authorisation in EU, they benifit additional 10 years of market exclusivity regardless patent expiration. This incentive is to encourage the development of medicines for rare diseases to prevent from other competitors selling similar medicines for similar diseases. If the orphan medicines are intended for paediatric population, the market exclusivity is extended by two additional years for an orphan designated condition.
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Paediatric IncentiveMarket ExclusivityRewardThis guide provides some rewards and incentives to encourage investment in research and development of medicines for children in European Union. E.g Peadiatric medicinces once they receive a marketing authorisation, they benifit additional 6 months of market exclusivity regardless patent expiration. Medicines once approved for children that are not protected by a patent or supplementary protection certificate are eligible for a paediatric-use marketing authorisation (PUMA). If a PUMA is granted, the product will benefit from 10 years of market protection.
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Intellectual PropertyEPOEuropean Patent Office (EPO) provides materials for readers to learn IP by themself. The kit includes modules: IP basics, IP advanced, IP search tools, IP management and case studies.
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Intellectual PropertyOrphan IncentivePaediatric IncentiveMarket ExclusivityThis guide provides a framework of incentives regardless duration of patent protection (generally 20 years from the filing date) in orphan and paediatric medicines in EU
View this resource Bookmark this resourceThis guide helps you understand how to submit a patent application in Europe
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