In connection with Neurim Pharmaceuticals (1991) Ltd v The Comptroller-General of Patents [2011] EWCA Civ 228, the Court of Appeal of England and Wales has referred five questions to the Court of Justice of the European Union (CJEU) on the interpretation of Regulation 1768/92/EC (now 469/2009) – The SPC Regulation. The questions relate to the meaning of the term “product”, and what inventive developments in the pharmaceutical field are entitled to protection under a Supplementary Protection Certificate (SPC).  

BACKGROUND  

Neurim holds a patent for the use of melatonin as a medicine for insomnia. In 2007, 15 years after this patent was applied for, Neurim was granted a marketing authorisation to sell its patented formulation. Neurim applied for an SPC on the basis of this marketing authorisation and its patent. The United Kingdom Intellectual property Office (UKIPO) denied this application on the basis of a 2001 marketing authorisation granted to Ceva Animal Health for the use of melatonin in sheep (Regulin). The UKIPO found that the marketing authorisation for Regulin was the first to place the product— melatonin—on the market.  

Neurim appealed this decision and the matter came before Arnold J. He upheld the decision of the UKIPO and considered the questions raised of the SPC Regulation acte clair. However he considered that there was a “tenable argument to the contrary which may lead to the matter being referred to the [CJEU]” and as such gave Neurim permission to appeal.  

THE OPINION OF THE COURT OF APPEAL  

Nuerim argued that the basic principle is one SPC per patent, by which it is meant that there can only be one SPC for a particular patented product. As a result, the marketing authorisation referred to in Article 3(b) of the SPC Regulation is the first relevant authorisation (i.e., authorisation of a product within the scope of the basic patent) to place the product on the market as a medicinal product.  

No one had suggested that Neurim’s claims were not novel and inventive, or that Neurim’s work had not led to a beneficial medicine. The Court of Appeal was entirely supportive of Neurim’s position and strongly expressed the opinion that Neurim should be entitled to SPC protection for their product:  

We consider that Neurim‘s arguments are not only tenable: in our view they are right. Many kinds of valuable pharmaceutical research will not get the encouragement or reward they deserve if they are not. 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.

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.

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.

COMMENT  

The Court of Appeal is clearly of the opinion that second medical use patents should be entitled to SPC protection and that to find otherwise would be both contrary to the principles that underlie the SPC Regulation and moreover would result in the Regulation being unfit for purpose.

However, despite these strong sentiments, there is no guarantee that the CJEU will follow this same path. Neurim is faced with the hurdle of the CJEU’s previous decisions in Massachusetts Institute of Technology C-431/04 and Pharmacia Italia SpA, formerly Pharmacia & Upjohn SpA C-31/03 and the language of the Regulation defining the product to be protected as the active ingredient (with only one SPC per product).  

That said, Advocate General Fennelly has previously acknowledged, in Biogen Inc. v Smithkline Beecham Biologicals SA C-181/95 that the SPC Regulation was drafted with a simple situation in mind; and so one could seek to argue that SPC protection for second medical use patents was another situation that the legislators did not envisage. Previous decisions of the CJEU have also shown that the Court is prepared to ignore express words in a Regulation (AHP Manufacturing BV v Bureau voor de Industriële Eigendom C- 482/07) in order to make sure that the key purposes of the SPC Regulation are achieved.  

Therefore, despite the possible hurdles, if the CJEU is in agreement with the Court of Appeal that the granting of SPCs to second medical use patents falls within one of the key purposes of the Regulation, the CJEU has scope to interpret the SPC Regulation to allow such protection.