Article 85(3)(c) of the Industrial Property Law, which excludes marketing authorisation applications from the scope of patent rights, is interpreted by the IP courts against the patent holder in a disproportionate way. The exemption covers the procedures that generic companies are required to perform before the Ministry of Health in order to obtain a marketing authorisation. It enables generic pharmaceutical companies that applied for marketing authorisation seven or eight months before the expiration of the patent protection period to continue their procedures before the Ministry of Health and to launch their generic product in 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 sales permission or reimbursement before the Social Security Institution or even before the launch of the generic pharmaceutical company in the market. The exemption provision of the law includes only the procedures related to the marketing authorisation and this exemption ends once the marketing authorisation is granted. The court also rejects patent owners' requests for pure discovery of evidence while the marketing authorisation process of the generic medicine is in progress and/or once it has been concluded.
However, pure discovery of evidence requests do not impede the authorisation process and simply allow the patent owner to determine the evidence in order to understand whether there is 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 into 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 has become the biggest obstacle to the exercise of patent rights. This is not fair on innovator companies which heavily invest in research and development in the pharma industry. This exemption should be evaluated in a fair manner and take into account both parties' legal interests when it comes to the purpose of the Bolar exemption.
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