Dr. Attila Mándi:

Protection and challenge of pharmaceutical patents

ABSTRACT

Recent trends of patent enforcement in the pharmaceutical industry are discussed with particular reference to chemical process patents, formulation patents, patented salts and derivatives, polymorph patents, second indication inventions, metabolite patents and dosage regime patents.

Practical recommendations are disclosed on the patentability, enforceability and invalidation of the patent-types discussed above.

Some tactical advice are presented for generic companies how to endeavour the avoidance of patent conflicts and what to do in case of an infringement suit. The importance of patenting the R+D results of generic companies created in the chemistry and biology of generic products is emphasized.