Issue 20 of our Intellectual Property and IT Law Update is now live for online subscribers. Authored by subject experts at William Fry solicitors, this update is designed to keep forward-thinking practitioners at the cutting edge of legal developments. An excerpt from the section on SPC protection of patented medicinal products reads:
'The SPC Waiver allows EU based manufacturers of generics or biosimilars to manufacture SPC-protected products or medicinal products containing those products during the entire life of the SPC in the EU provided such manufacture is for export to non-EU countries where patent or SPC protection for those products have expired or never existed. Further it is important to note that the SPC Waiver extends not only to the making of the SPC protected products or a medicinal product containing that product but also to ‘any related act that is strictly necessary for the making in the EU… or for the actual export.’ It was stated by those behind the introduction of the SPC Waiver that its main purpose is to make EU based generic and biosimilar manufacturers more competitive on the global playing field.'
Subscribers to our online services may access this content by clicking here. Non-subscribers can click on the button below to organise a free trial.