Drugs companies will have less opportunity to extend patent protections for their products in the EU following a ruling by Europe’s top court on Thursday.

In a case brought by
Massachusetts Institute of Technology and focused around a treatment for brain tumours, the European Court of Justice disagreed with an earlier preliminary opinion by a senior court official which had gone in favour of the pharmaceuticals sector. Instead, the ECJ restricted the availability of so-called supplementary protection certificates which can extend monopoly protections by up to five years after a patent has expired. It said that combination products could only qualify for SPCs if they involved two active ingredients.

MIT had been trying to get an SPC for a product used to treat recurrent brain tumours. This involves one active ingredient, carmustine, and a second element which essentially controlled the release of the active substance – in short, a delivery system. Patent offices in the UK and France awarded an SPC but Germany refused.

In total, six EU governments intervened in the case.

But on Thursday, the ECJ said that SPCs could not be given where two substances were being combined, “only one of which has therapeutic effects of its own . . . [and the other renders] possible a pharmaceutical form of the medicinal product which is necessary for the therapeutic efficacy of the first substance.”

Intellectual property lawyers said that the decision was “bad news” for the pharma industry – although generic drug manufacturers could benefit.

“It means that expensive and lengthy research will not be rewarded by SPC protection and therefore it may be difficult for the R&D industry to find the necessary funding to develop such products. It is disappointing that the ECJ has decided to opt for a narrow interpretation of the SPC regulation rather than supporting medical innovation,” said Marie Manley, partner at the Bristows law firm.

Robert Anderson, life
sciences partner at Lovells, agreed.

Had the decision gone in MIT’s favour, he said, it would have opened up the door to other innovative pharma companies to extend their monopoly period for controlled release drugs
and delayed the entry of generic manufacturers to
the market.

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