Patent Laws trials

Irrespective of patent law, the holder of a marketing authorisation may be afforded a period of marketing exclusivity under the European regulatory provisions, i.e. a period of freedom from competition from competitors who do not themselves propose to generate and submit their own full data set in order to obtain an AlA. A company that applies for an AlA will be required to produce the results of pharmacological and toxicological tests and the results of clinical trials at the cost of considerable time and expense, unless ... 

Patent protection under general law usually lasts for up to around 20 years. This creates a difficulty in relation to medicinal products, as it can take some 12 years for the products to undergo research, development, the extensive clinical trials that are required in order to obtain a marketing authorisation and the authorisation process itself. These steps are also extremely expensive. The amount of time that remains during which the patent holder can exploit his patent and recoup his massive investment can be severely curtailed in relation to medicinal products. For this reason, the European Community has provided a form of additional patent-related protection for medicinal products authorised within the European Community, by means of a Supplementary Protection Certificate. A patent holder may apply for a certificate that takes effect at the end of the term of the basic patent, for a period equal to the period that elapsed between the date on which the application for the basic patent was lodged and the date of the first authorisation to place a product derived from the patent on the market in the Community, reduced by a period of 5 years. The maximum duration of the certificate is 5 years. The certificate applies to all medicinal products derived from the basic patent, but the additional time that can be obtained under the SPC is calculated in relation to the first product derived from the patent, authorised in the EU. 

Consequently, when USA v. The Chemical Foundation, Inc. opened in 1923, several issues were at stake. At the most basic level, the court case would determine whether the formation of the Chemical Foundation and the sale of patents to it violated U.S. law. Second, the trial raised questions about German chemical patents and patenting strategies. During the... 

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