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ABSTRACT
This study aimed to analyze the patent protection status at the worldwide level of the medicines in the therapeutic class HMG-CoA reductase inhibitors (statins) and their patent strategies for the period 1995–2008. The three step internet patent database search methodology was developed and applied for published patents during the period 1995–2008. Performing the three step patent publications searching methodology, we found and classified 71 patents from 7 patent classes for 5 international nonproprietary names (INN). There were 31 patents for atorvastatin, 18 for fluvastatin, 11 for pravastatin, 32 for simvastatin and 32 for rosuvastatin. Typically for the group, the patents had been granted either for therapeutic activity or application, very often combined with diuretics, produced by other innovators, owners of the patents. All of the patents were protected with European patents, USA, Australian patents and countries outside the World Trade Organisation (WTO), which have not recognised the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).
The intensity of patent protection policy for the analysed INNs within the statins group during the years after the first granted patent showed that the period of the first six or seven years was relatively calm and the patent activity was slow. Then the patent activity started to increase tremendously around the time of expiration of the first granted patent and in the last two years it declined for some of the molecules insignificantly, while for others, sharply as in the case of atorvastatin and pravastatin respectively.
The study showed that a variety of factors influence the patent protection policy of pharmaceutical manufacturers, such as the time of discovery, application of product, disease priority, technologies, chemical structure of the molecules etc. We found that therapeutic competition is more important than the generic ones for creating the patent profile of an INN, which is in contrast with the beliefs that the patent protection policy affects mainly generic companies.