Turkish IP law does not explicitly define ‘indirect infringement’. However, legislators refer to Article 86 of the Industrial Property Code, which clarifies a patent holder’s right to prevent third parties from supplying the essential means of the invention (ie, that which serves the working of the patented invention) to unauthorised parties. In order for this provision to apply, third parties must be aware that these elements or instruments are sufficient to implement the invention and that they either will be used for this purpose or that the potential infringement is otherwise obvious.
In a recent case, a generic company filed a determination of non-infringement action against an originator company. The latter responded by requesting that Article 86 be applied. The patent subject at issue was related to a second medical-use claim, which disclosed use of certain indications. The generic company carved out summary of product characteristics (SmPC) and patient information leaflet (PIL) documents after the action was filed in order to circumvent patent infringement.
The generic company asserted that all elements protected by the patent had been taken into account while formulating the generic product and it therefore did not infringe the patent. The originator company asserted that even though certain indications had been carved out in the SmPC and PIL of the generic product, it still infringed the patent as the formulation and the expected effect of the product was the same.
The court-appointed panel of experts confirmed that carving out certain indications in the SmPc and PIL documents do not alter the technical impact of the product. The panel concluded that the changes made to circumvent infringement “do not create substantial changes” and in this respect, implementation of Article 86 may be taken into consideration.
The court did not accept that the generic company had infringed the patent literally or indirectly using the patented invention as per Article 86 and therefore handed down its decision of non-infringement.
The court’s judgment is still pending; once it is issued the parties will be entitled to appeal the decision before the district court. This case will be the first example of an interpretation of Article 86 for second medical-use claims in Turkish IP practice.
First published by IAM - International Report in Apr 22, 2020.