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Abstract
In part one of Patent Strategy’s survey, 30 pharmaceutical in-house counsel commented on the timeframe, challenges and opportunities surrounding the SPC waiver, with almost a third of innovator lawyers saying they supported or were not against the regulation A new poll from Patent Strategy shows that some innovator drug makers support the EU’s SPC Manufacturing Waiver despite strong industry opposition, indicating a conflict of interests among companies invested in generics manufacturing in some way. [...]the rules, which will allow businesses to manufacture SPC-protected drugs for sale outside the EU or to stockpile them for sale in the EU after the certificate expires, are supported by generics companies and their representative bodies – although they have only fully backed it since the stockpiling provision was introduced. Sources point out that these results are perhaps not surprising because generics will need to be careful to ensure that they are following the new rules to the best of their ability when stockpiling drugs in the EU or manufacturing for sale in jurisdictions where the product is not protected. Peter Thomsen, global head of IP policy and senior manage or IP litigation at Novartis in Switzerland, adds that many respondents may not have chosen ‘managing notifications’ as the biggest challenge because many will have gained experience dealing with the paperwork that came when the special mechanism was introduced, which set out new provisions on the exhaustion of rights and parallel imports between the member states that acceded to the EU in 2004 and those that were already in the bloc.