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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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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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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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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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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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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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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