The importance of patent protection for pharmaceutical and agricultural chemical products is underlined by special transitional provisions which establish rights not granted to patent owners in other fields of technology. This special treatment is in the following form:
Firstly, applications for pharmaceutical and agricultural chemical products must be filed in a Member country (according to Article 70.8) as from the date of entry into force of the Agreement. However, the patents will only be granted after the Agreement has become binding for the Member in question and (although the relevant provision does not explicitly mention this) after the expiry of the transitional periods set out in Article 65. The time elapsing between the application and the granting of the patent may therefore be considerable. Nevertheless, Article 70.8 manages to preserve the novelty of the application through a legal artifice based on determination of its novelty (and other patentability criteria) as though it had been determined on the date of filing the application in the Member country (or the date of priority if available and claimed) and not on the date when it was in fact evaluated. Patents granted in this way will last for the remainder of the term of the patent, calculated from the date of filing and not the twenty-year period established in Article 33.
Secondly, irrespective of the fact that the aforementioned transitional periods extend the possibilities for non-patentability in developing countries for a total period of ten years after the date of entry into force of the Agreement, Article 70.9 limits this overall period for pharmaceutical and agricultural chemical products. It establishes the right to obtain «exclusive marketing rights» for these products before a patent has been granted. These rights - which appear to be based on the «certificates» granted by the EEC in order to extend the term of pharmaceutical patents21 - can be obtained provided that the following criteria are met:
a) a patent application has been filed in a Member country after the entry into force of the Agreement;
b) an application has been filed in another Member country after the entry into force of the Agreement and a patent has been granted;
c) marketing approval for the protected product has been obtained in the other Member country concerned;
d) marketing approval has been obtained in the Member country referred to in subparagraph a).
21 See the decision of 19 December 1991 by the European Council, which establishes an additional protection certificate for pharmaceutical patents that have expired.
If these requirements are met, the Member concerned must grant these «exclusive marketing rights» for a period of five years after marketing approval has been obtained in that particular country. These rights will be terminated, however, if a) the corresponding patent is eventually granted, or b) the patent application is rejected in the country concerned.
The Agreement does not mention the content and scope of these «exclusive marketing rights». To what extent could the holder of such rights prevent others from marketing the product concerned? What recourse would he have against infringement? Would the provisions on granting compulsory licences be applicable? What procedures would be available to third parties wishing to use the invention, for example, for experiments, tests, marketing approval, etc.? There needs to be an in-depth analysis of these and other questions relating to the implications of Article 70.9.
It is nevertheless relevant to mention that penal remedies are usually reserved for procedures related to patents; the holder of such exclusive rights may only have recourse to civil proceedings. In addition, the holder of the rights may not be placed in a better position than the owner of the patent. It may be argued therefore that exclusive marketing rights give «ius exclusivum» but not «ius excluendi»: compensation could be claimed by the right-holder in case of use by a third party of the invention during the transition period, but not prohibit use itself, since only the patent holder is entitled to do so. Even if more stringent criteria are applied the abuse of a dominant position, public health requirements or other justified grounds could be a sufficient argument to limit the exclusive rights using means like compulsory licences (or revocation in cases of abuse). Finally, exclusive marketing rights should be interpreted as not restricting production for exporting to third countries.
The economic impact of Article 70.9 will vary according to the time needed to obtain the approval and registration required to obtain exclusive marketing rights for a given product. In the pharmaceutical sector, the carrying out of clinical and pre-clinical tests in order to demonstrate the usefulness and safety of a drug, in addition to the time required for government procedures, which is extremely long in the United States and other industrialized countries, often delays the introduction of new products for several years. There are, however, indications that this period is becoming shorter, particularly for biotechnology-based products.