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Orphan drug exclusivity, data exclusivity and patent protection (differences and complementarity)


Giulia Tagliafico 
European and Italian Patent and Trademark Attorney
Rome, Italy

Simona Venturini 
IP documentation specialist
Meda, Italy

The orphan drugs (OD) are medicines for the treatment of rare (or orphan) diseases, i.e. illnesses that affect less than 5 individuals in 10.000. A Sponsor can obtain the orphan designation for a drug by sending an application to the European Medicine Agency (EMA). EMA’s Committee for Orphan Medicinal Products (COMP) examines the applications for orphan designation and expresses an opinion that is forwarded to the European Commission. Based on such opinion the European Commission decides whether to grant an orphan designation for the medicine in question. If a medicinal product is designated as OD, it “shall be eligible for incentives made available by the Community and by the Member States to support” (1). The orphan drug designation also “allows a pharmaceutical company to benefit from incentives (…) such as reduced fees and protection from competition once the medicine is placed on the market.” (2)

The OD market exclusivity is one of the above-mentioned incentives. It guarantees that, “where a marketing authorisation in respect of an orphan medicinal product is granted, (…) the Community and the Member States shall not, for a period of ... ...

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