Lacosamide - UK

On Nov 07, 2017, England and Wales High Court (Patents Court) rejected Accord’s invalidity argument & found Lacosamde compound patent valid.

The patent in suit is EP (UK) 0888289, which covers an anti-epileptic drug called lacosamide. The patent expired on 18th March 2017.  There is a supplementary protection certificate (SPC/GB09/007) which extends protection for lacosamide until 2022. Accord contended that the patent is invalid on two grounds viz. lack of priority & obviousness.

With respect to lack of priority, Accord challenged the patentee’s legal entitlement to claim priority from the 1996 priority document.  Accord contended that the assignment of 4^th February 1997 from Prof. Kohn (inventor) to RCT (patent holder) only took effect as an assignment of the bare legal title to the invention and priority claim.  What it did not do was assign the equitable or beneficial title to that property to RCT.  Court after analysing the relevant case laws held that all the indications available to RCT were that the university was aware of what was going on and that Professor Kohn was executing the assignment because he was obliged to do so pursuant to his obligations to the university.  Those indications do not only derive from Professor Kohn but also from the university itself. Court found that on 4^th February 1997 RCT was not on notice of any possible conflicting interest held by the university.  Therefore, RCT acquired good title to the invention including any priority right. 

Accord’s second challenge was on obviousness.  It was based on the state of the art before the priority date, which included a number of papers and other publications from Prof Kohn’s group relating to their work on anticonvulsant compounds.  Accord relies on mainly master’s thesis by a student called Philipe Le Gall. It is entitled 2-Substituted-2-acetamido-N-benzylacetamides Synthesis. Accord argued that given the Le Gall thesis in 1996, the first thing the skilled team would do is a literature search & identification few lead compounds such as LY274959. Court however disagreed & held that the skilled team would not predict that an aliphatic compound mentioned in arts would have good activity. That was because so much of the data related to aromatic rather than aliphatic compounds. Court finally held that putting it all another way, there are just too many uncertainties to justify a finding of obviousness.  Even if the team got as far as deciding to make and test lead compound they would know that the uncertainties meant that either outcome, good or bad, could just as easily be rationalised after the event as the other.  That is not a fair prospect of success.