Of man and sheep: melatonin saga goes to the ECJ

Looking for a market authorisation, dearie?

In December 2009 a hearing officer at the UK's Intellectual Property Office refused Neurim's application for a supplementary protection certificate for the use of melatonin to correct a distortion or deficiency in the plasma melatonin profile of a human subject. Why? Because the cited marketing authorisation was not the first authorisation to place melatonin on the market as a medicinal product: there was an earlier authorisation to another company for a composition comprising melatonin for use in sheep to initiate an early breeding season -- an authorisation that had nothing whatever to do with Neurim's research or its resulting patent.

Neurim's appeal to the High Court at [2010] EWHC 976 (Pat) was dismissed. Mr Justice Arnold considered the matter acte clair but, considering that there was a tenable argument to the contrary that might lead to a reference for a preliminary ruling, he gave permission to Neurim to appeal to the Court of Appeal.

This morning the Court of Appeal for England and Wales did indeed decide to refer Neurim Pharmaceuticals (1991) Ltd v Comptroller General of Patents [2011] EWCA Civ 228, not yet available on BAILII,  freshly available on http://www.bailii.org/ew/cases/EWCA/Civ/2011/228.html, to the Court of Justice for a preliminary ruling, this being the fifth SPC reference awaiting that court's attention. Delivering the judgment of the court, Lord Justice Jacob had this to say:

"28. ... Pharmaceutical research is not confined to looking for new active compounds. New formulations of old active substances are often sought. Most are unpatentable but from time to time a real invention is made and patented.

29. Moreover there is much endeavour to find new uses for known active ingredients. The European Patent Convention 2000 has indeed made the patenting of inventions in this area clearer. Its effect is that a patent for a known substance or composition for use in a method of treatment is not to be regarded as old (and hence unpatentable) unless use for that method is known. It would be most unfortunate if second medical use patents could not get the benefit of an SPC.

30. In short, if Neurim are wrong, then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose. Whether that is so or not is clearly a matter for the EU’s highest court".