According to the last IQVIA survey, Protection Expiry and Journey into the Market. Pharmaceutical products in Europe, regulatory exclusivities and rewards provided the longestlasting form of protection for 57% of the drugs studied. For 31% of innovative medicines, market exclusivity is the last form of protection to expire. As market exclusivity occurs at the height of the drug’s popularity, its scope has decisive meaning for both the innovative and generic industries. While the consequences of patent or SPC monopoly are well known, there has been hardly any discussion or case law concerning the scope of market exclusivity as a stand-alone instrument for protecting medicinal reference products.
The temporal and territorial scope of market exclusivity is uniform throughout the EEA, i.e. the period begins on the date of the first authorization of the reference medicine in that territory and ends on the same date, ten or eleven years after that. The subject of market exclusivity is a medicinal product authorized on the basis of registration data submitted to the relevant medicine agency. This means that the first Marketing Authorization holder (MA holder) has – for a specified period of time – exclusive rights to market the medicine authorized on the basis of these data. However, market exclusivity does not extend to activities other than placing on the market, which otherwise would be subject to patent rights. A generic entity is therefore entitled to manufacture, use, offer, and store medicinal products, as long as these activities do not constitute placing on the market. What is not explicitly resolved is whether the MA holder can commission the manufacture of a generic product and then purchase the manufactured product.
In a recent legal opinion regarding the scope of protection that derives from market exclusivity, I analyzed the issue on the grounds of Art. 10 of Directive 2001/83 and Art. 15 of the Polish Pharmaceutical Law. The literary wording of the provisions, as well as their systemic interpretation, aiming at the best possible coherence among various IP and regulatory instruments, lead to the conclusion that generic drugs can be manufactured, stored and delivered by a third party to the MA holder during the market exclusivity period. Such implementation of the directive’s provisions in Poland holds the potential for developing broad, effective collaboration of pharmaceutical companies and early generic entries to the market.