Article 85(3) (c) of the Industrial Property Law excludes marketing authorisation applications from the scope of patent rights. However, the IP courts’ interpretation of this has been disproportionately weighted against patent holders.
Generic pharmaceutical companies can obtain a marketing authorisation by carrying out a number of procedures before the Ministry of Health. As a result, entities that apply for a marketing authorisation seven to eight months before the expiration of the patent protection period can launch their generic product on the market as soon as the patent has expired.
Further, the court can reject patent infringement and discovery of evidence requests before the sales permission or reimbursement by the Social Security Institution, or even before the launch of the generic pharmaceutical company on the market. The court can also reject the patent holder’s requests for discovery of evidence while the marketing authorisation process of the generic medicine is in progress or has ended. The law’s exemption for marketing authorisation applications from patent infringement includes procedures related to the marketing authorisation only – this exemption ends once authorisation is granted.
Discovery of evidence requests do not impede the authorisation process and therefore can be used by a patent holder to determine whether an infringement has taken place in advance of an authorisation being granted. In accordance with the Ministry of Health’s legislation, regardless of whether any patent infringement has occurred, the price of the patent holder’s product drops automatically by 40% once the generic product is on the market. Therefore, determining whether there is an infringement situation at an early stage provides certainty for both the generic and the patent-holding company.
This broad and erroneous interpretation of the relevant provision has become the biggest obstacle in excercising patent rights and is unfair on innovator companies, which heavily invest in R&D in the pharma industry. The Bolar exemption should be fairly evaluated, with full account take of both parties’ legal interest.
First published by IAM - International Report in Apr 08, 2020.