‘Unitary SPC’ Proves Popular With EU Stakeholders
A consultation has found that most stakeholders support the idea of a unitary supplementary protection certificate to complement the future unitary patent system in the EU, and that a re-examination of the way the “Bolar” research exemption works would be worthwhile. Interestingly, the consultation revealed that while some innovator company respondents saw the SPC as the main factor in making investment decisions in the EU, most rated it only "moderately" important.
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A European Commission legislative proposal to change the EU’s rules on supplementary protection certificates and allow for the production of versions of patent-protected medicines for sale outside the EU has been welcomed by the generics and biosimilars industry – albeit with caveats – but criticized by the originator industry as an attack on intellectual property that could hit investment in Europe.
Coronavirus Notebook: Italy Makes First Use Of EU’s Vaccine Export Control System, More Regulators Issue Guidance On Variants
Ukraine has established a system for issuing emergency use authorizations for COVID-19 vaccines that recognizes authorizations granted by other world regulators.
The Russian backers of the vaccine’s development say that if it receives a marketing authorization in the EU, distribution could begin in June this year.