The Wellcome Foundation Limited is the holder of a European patent 0 670 719 B1 for a combination of atovaquone with proguanil for the treatment of protozoal infections. The patent will expire on 24 November 2013. GSK offers and sells a anti-malarial drug on the Dutch market under the trademark Malarone. The product is protected by the patent of The Wellcome Foundation Limited.
On 7 February 2013 the UK part of the patent at hand was declared invalid by the High Court of Justice, Chancery Division, Patents Court (Arnold J) in light of a lecture given by one of the inventors of the patent, Dr. David Hutchinson at the Fourth annual malaria meeting of the British Society for Parasitology on 13 and 14 February 1992, which is prior to the priority date of the patent. Appeal was not granted by Arnold J, but GSK will request the Court of Appeal directly to grant permission to appeal the judgment.
Mylan acquired a market permit for its own generic ant-malarial drug and offers it for sale in the Netherlands. GSK is of the opinion that this constitutes an infringement upon the patent as was limited during the still pending nullity proceedings which was launched against The Wellcome Foundation Limited by Glenmark Generics B.V. before this same court.
Infringement was not contested by Mylan. However, Mylan is of the opinion that the patent is invalid due to a lack of inventive step. The judge follows Mylan in its defense and rules that there is a serious likelihood that the patent in suit shall be invalidated in the proceedings on the merits. On the basis of research results as presented by Hutchinson, his recommendation and the need for new anti-malarial drugs there was a positive pointer for the average skilled person to further conduct research on the combination of atovaquon and proguanil. It was therefore obvious to try and there was a reasonable expectation of success. This research would have brought him, on a routine basis, by making use of general skills and without any inventive steps to the invention of the (limited) patent.
Read the entire decision (in Dutch) here.
Head note: Wim Maas