Department for Industrial Property Rights, EGIS Pharmaceuticals Ltd, PO Box 100, H-1475 Budapest, Hungary, Tel: +36 1 265 5537, Fax: +36 1 265 5763, Email: patent@egis.hu

Revised 17 July 2003.

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 regimen patents. The basic principles of patent rights are summarised and practical recommendations are disclosed on the patentability, enforceability and invalidation of the patent types discussed above. Some tactical advice is presented for generics companies on how to endeavour to avoid patent conflicts and what to do in case of an infringement suit. The importance of patenting the R&D results of generic companies, in terms of the creation of chemical and biological generic products, is emphasised.