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Patent system shake-up will follow EU ruling on SPCs

Verdict will have 'dramatic consequences' for the pharma industry in Europe

The EU Court of Justice yesterday clarified its position on Europe's Supplementary Protection Certificate (SPC) system, which provides additional exclusivity for medicinal products to compensate for the long time needed to gain marketing approval.

The verdict will have dramatic consequences on the pharma industry in Europe and should lead a reduction in the use of SPCs to extend patent life, according to Jonathan Radcliffe, partner in Mayer Brown's intellectual property group.

"The EU Court of Justice (CJEU) has given life science companies an unequivocally stark reminder that there can be only one SPC for each relevant patent," said Radcliffe.

"This cuts directly across current patent office and industry practice across Europe, where multiple SPCs are being granted out of the same basic patent despite the prohibition against doing so," he added, noting that competitors will likely try aggressively to enter the market for some products on the back of the ruling.

Confusion about the scope of SPCs has made them a bone of contention in the pharmaceutical industry for years, with one of the key issues revolving around combination drugs and vaccines with multiple active ingredients. One of the catalysts for the decision was a case brought by UK company Medeva, which had been refused SPCs for combination vaccines that consisted of patented and non-patented active ingredients.

The Medeva case was referred to the ECJ for clarification on whether an SPC should be granted for a product comprising additional active ingredients than were specified in the claims of the underlying patent.

The ECJ has now ruled that an SPC can only be granted for active ingredients that are specified in the claims of the underlying patent, and that an SPC is permitted for multi-ingredient products, provided all the ingredients are patent-protected. Only one SPC can be granted for each basic patent, according to the decision.

“The CJEU rulings are welcome and have confirmed a relatively broad scope of SPC protection covering all combinations of a particular active ingredient with others, providing that the active ingredient is supported by the underlying patent," commented Will James, partner at UK law firm Marks & Clerk.

"This is, perhaps, not as narrow a view of SPC protection as it was feared the Court of Justice might support. They have also expressed the legal position succinctly - the circumstances where you cannot obtain an SPC are now clearer."

25th November 2011

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