The development of a pharmaceutical starts with the search for an adequate active ingredient. Often more than 100'000 substances have to be screened. Promising active ingredients will be submitted for patent application as soon as possible. On the average after the patent application has been granted 10 - 12 years are needed until a pharmaceutical is ready for market introduction.
During this time period research and development costs in excess of 1 billion USD will have arisen for one single product. The pharmaceutical companies pay for these expenses from the revenues that will come from sales during the remaining patent protection duration.
The commercially utilizable patent life time of a new pharmaceutical starts with its market introduction. In reality this period is hardly longer than 8 years. Often after the expiration of the patent protection, the producer is forced to lower the price of the product substantially due to the entry of generic alternatives into the market place.
As a result of additional safety requirements mandated by government authorities, the original aim of substantively promoting innovation has diminished. Therefore some countries have introduced supplementary protection certificates (SPC). These certificates restore the originally intended patent protection duration of 20 years at least in part. |