Natalizumab - Netherlands

On Jul 12, 2017, a District Court The Hague revoked the Dutch part of the patent on Tysabri® (Natalizumab).

Biogen holds EP 1485127, which relates to the treatment of Multiple Sclerosis (“MS”). Swiss Pharma seeks to invalidate the Dutch part of the patent. Swiss Pharma seeks in these proceedings that the court verdict to the extent possible enforceable: (1) the Dutch part of EP 127 will destroy; and (2) Biogen will pay the sum of the reasonable and proportionate costs under Article 1019h of the Code of Civil Procedure (CCP).

Court after analyzing the evidences at hand determined that claims 1, 3 and 4 are invalidated due to lack of novelty as these were disclosed in a conference abstract. This document indeed describes the research results at the 17th ECTRIMS congress in Dublin on September 15, 2001 were presented by Miller. It is disclosed that in this study, 213 patients were randomized with RRMS or SPMS three groups who received 3 mg / kg or 6 mg / kg natalizumab, or placebo followed by a follow-up of 6 months. The fact that in the Conference Abstract mention is made in so many words of "chronic pathological inflammation" Biogen is unable to benefit, now MS, such as was considered in the above, in the light of the patent as such an ignition is to be seen. Biogen further has also not denied that the features of claims 3 and 4, starting from the explanation of claim 1 are disclosed in the sense described above in the abstract. Claims 1, 3 and 4, therefore, are not new and therefore void.

Claim 2 is found to be non-inventive as a man skilled in the art would prolong treatment for chronic MS patients based on his common general knowledge combined with the conference abstract. Claim 2 cannot therefore be maintained for lack of inventive step. The court noting that the right-hand in answering the question whether an invention may or may not belong to the state of the art, or from it to the obvious way arises, it is not required thereby increasing the so-called problem-and-solution -approach 'to apply.

The Dutch part of the patent is therefore revoked. Parties agreed that the provisions of the Enforcement Directive should apply to costs as the nullity proceedings should be seen as proceedings anticipating an infringement claim. Biogen has to pay EUR 200 000 in costs as agreed earlier between parties.