EU clears way for generic research before patent expiry

Belated EU legislation has cleared the way for European generics companies to research copycat drugs before patents have expired. US companies have previously enjoyed a long head start in researching generic treatment, a process that can take up to six years before a drug is ready to market.

The threat of copyright infringement when researching generic versions of patented drugs has held back the EU generics market, which currently only accounts for ten per cent of the €70 billion (?47.45 billion) overall EU drugs trade. The US market has enjoyed similar openness since the 1985 Hatch-Waxman Act.

Up to $50 billion (?29.7 billion) of branded drug sales are set to lose their exclusive patents within the next five years, with at least ?6.39 billion of trademarked drugs losing protection next year alone as at least 15 major branded drugs become available. EU generics manufacturers, many of which have had to relocate manufacturing abroad to countries without such restrictive measures, have welcomed the revision.

Unsurprisingly, the largest pharmaceutical companies who bear the largest burden of new research have largely opposed the change and are due to see a significant erosion of their market share. Others have said that the move has righted the balance between patent holders right to protection and a consumer, market based right to competition however.

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