As the procedures of EMEA and FDA are similar to the patent granting procedures of the European Patent Office and the US Patent and Trademark Office, simultaneous patent and orphan drug applications are recommended.
Additionally, the combination of patent protection for 20 years and exclusive marketing rights for 7 or respectively 10 years is perfect for protecting a market segment for your company and for holding off competitors.
It should also be considered that Orphan Drug Status can be liberally traded and a combination of patent and Orphan Drug Status can be sold with profit.