The article 85(3) (c) of the Industrial Property Law, which excludes the marketing authorization application from the scope of the patent right, is interpreted by the IP courts against the patent holder in a disproportionate way. The exemption here is the procedures that generic companies required to perform before the Ministry of Health in order to obtain a marketing authorization. Thus, for example, it enables the generic pharmaceutical company that applied for marketing authorization 7-8 months before the expiration of the patent protection period, to continue its procedures before the Ministry of Health and to launch their generic product to the market as soon as the patent expires.
However, by interpreting this provision very broadly, the court may reject patent infringement and/or discovery of evidence requests before the sales permission or reimbursement before the Social Security Institution or even before the launch of the generic pharmaceutical company to the market. The exemption provision of the Law includes only the procedures related to the marketing authorization and this exemption ends once the marketing authorization is granted. The court also rejects the patent owners' requests for pure discovery of evidence while the marketing authorization process of the generic medicine is in progress and/ or has been concluded.
However, pure discovery of evidence requests do not impede the authorization process and only allow the patent owner to determine the evidence in order to understand whether there is an infringement in advance. In accordance with Ministry of Health legislation, regardless of whether there is patent infringement, the price of the patent owner's product automatically drops by 40% once the generic product comes on the market. Therefore, determining whether there is an infringement situation at an early stage will provide certainty for both the generic company and the patent owner company.
This broad and erroneous interpretation of the relevant provision becomes the biggest obstacle to the exercise of patent rights which is not fair on innovator companies which heavily invest in research and developer in pharma industry. So this exemption should be evaluated in a fair manner and assess both parties’ legal interest considering the purpose of “bolar exemption”.
First published by Managing IP – International Briefings, in 17.03.2020