1 October 2012Patents

CJEU issues landmark ruling on SPC law in Europe

Europe’s highest court has issued a landmark ruling on the law governing supplementary protection certificates (SPCs) in the EU.

SPCs extend the period of monopoly for patentees who experience delays in marketing their patented products owing to the need to obtain regulatory approval. They apply only to patents covering human or veterinary medicines, or plant protection products.

National patent offices have previously granted SPCs only to the first product containing a particular active ingredient that regulators have approved. The term of the combined patent and SPC protection has been capped at 15 years (15 years 6 months in some cases).

In a ruling on July 19, 2012, the Court of Justice of the EU (CJEU) said Neurim Pharmaceuticals can obtain an SPC for melatonin (to treat humans), regardless of earlier (veterinary) authorisations for products containing that active ingredient.

Neurim had used melatonin as an active ingredient in a medicinal product, Circadin, to treat insomnia in humans.

The UK Intellectual Property Office and the UK High Court had rejected Neurim’s SPC for melatonin. The company appealed, arguing that, among other things, the regulatory burden and delay it had experienced before marketing Circadin should give rise to an SPC.

The UK Court of Appeal was inclined to agree, but believed the strict case law would hold back Neurim. It referred a number of questions to the CJEU, asking it to clarify whether Neurim could receive an SPC. In May, the Advocate General opined that Neurim should not be precluded from having an SPC for melatonin just because a diff erent medicinal product contained that active ingredient.

However, the court’s reasons are different from those proposed by the Advocate General, and have left specialists struggling to square the decision with the court’s decisions in earlier cases.

“The court’s reasoning focuses upon a ‘different application’ of the active ingredient, and the need for that ‘different application’ to fall within the protective scope of the patent relied upon,” said Mike Snodin, partner at law firm Potter Clarkson in the UK.

"This could perhaps suggest that any new, patented use of an active ingredient can, once authorised, become the subject of an SPC. However, it is hard to make sense of this in the context of prior case law of the CJEU, which states that the use of an active ingredient does not form part of its definition for the purposes of an SPC application.”

He said the decision appears to be great news for the innovative pharmaceutical industry. It is the first time the CJEU has said an SPC can be issued for products containing a particular ingredient that are not the first to be approved.

But Snodin also said it will be some time before the full impact of the decision can be appreciated. “This is because the national courts and patent offices are unlikely to find a sufficiently clear and consistent line of reasoning in the decision that will allow them to confidently apply the ruling to different factual scenarios.

“The CJEU has further muddied the waters in relation to what was already a complex area of law that is very difficult for non-experts to understand. Companies producing different medical innovations will still not be certain whether they can benefit from SPCs."

"Those companies are still likely to have a battle on their hands when seeking supplementary protection for their innovative products, at least until the CJEU has tackled the unenviable task of bringing true clarity to this area of the law.

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