The purpose of this guide is to provide you with basic facts on Intellectual Property (IP) aspects in commercialisation activities.
View this resource Bookmark this resourceIntellectual Property
What is Intellectual Property?
Published by WIPO
Industrial DesignGeographical IndicationTrade SecretWIPOIntellectual PropertyPatentCopyrightTrademarkWorld Intellectual Property Organization (WIPO) will help you understand different types of IP and how to protect them.
View this resource Bookmark this resourceUsing PATENTSCOPE you can search for patents published following international PCT route
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Market exclusivity in orphan medicines in Europe Union
Published by EMA
IncentiveOrphan IncentivePaediatric IncentiveMarket ExclusivityThis 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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Market exclusivity in orphan medicines in USA
Published by FDA
Orphan IncentivePaediatric IncentiveMarket ExclusivityThis guide provides an incentive of FDA. Orphan products once they receive a marketing authorisation in USA, they benifit additional 7 years of market exclusivity regardless patent expiration. This incentive is to encourage the development of drugs for rare diseases to prevent from other competitors selling similar drugs for similar diseases.
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Rewards and incentives for paediatric medicines in European Union
Published by EMA
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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Rewards and incentives for paediatric medicines in USA
Published by FDA
Paediatric IncentiveMarket ExclusivityRewardThis guide provides an incentive of FDA. Drugs for peadiatric once they receive a marketing authorisation in USA, they benifit additional 6 months of market exclusivity regardless patent expiration. This incentive is to encourage the development of drugs for children to prevent from other competitors selling similar drugs for similar diseases.
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Teaching materials in IP organised by European Patent Office (EPO)
Published by EPO
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.
View this resource Bookmark this resourceThis guide helps you understand the PCT and how to submit a patent application worldwide with World Intellectual Property Office (WIPO)
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European pharmaceutical incentives framework
Published by EFPIA
Paediatric IncentiveMarket ExclusivityIntellectual PropertyOrphan IncentiveThis 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
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