A proposed exemption allowing generics firms to manufacture in Europe for export or stockpiling during the term of a supplementary protection certificate (SPC) “would have significant detrimental economic impact on research-based companies both in Europe and around the globe” and should lead the US Trade Representative (USTR) to place the European Union (EU) on its watchlist in its upcoming 2018 ‘Special 301’ report on intellectual property (IP), according to US brand industry association PhRMA. Off-patent industry association Medicines for Europe has long called for such a waiver.
“PhRMA is very concerned about proposals... that may weaken the scope of the exclusive rights conferred under an SPC,” the brand body told the USTR. This had been “exacerbated by the public consultation launched in October” (Generics bulletin, 20 October 2017, page 1)
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