Patent for Pharmaceutical Products

Patent Types

1.  Intermediate patents

2.  Process patents

3.  Formulation patents

4.  Use patents

5.  Mixture patents

* Licensing agreement

 

Europe 20 years

Basic patent (20 years) +

supplementary protection certificates, SPC (5 years, EEC No. 1768/92 to compensate the loss caused by long regulatory requirements) +

extension (2 years, if marketed after 7 years)

 

Marketing exclusivity 6 to 10 years

Cf. US: first to invent rather than first to file, so 17 years.

US generic can prepare in advance (Waxman-Hatch Act: pro-generics)

Bolar provision: pre-patent expiry development and registration of generic medincines. Not covered in any EU treaty, regulation….