Regulated as pharmaceuticals with a requirement for market approval, ATMPs (cell and/or gene therapy products) need to have a strong business model to survive costs of high-risk development, GMP manufacture and clinical trials. Partnering with commercial entities can often assist in your GMP translation, CMC, device and clinical trials development, but your partners need confirmation of protection for the commercial opportunity of a product – and the most obvious way to secure this is by patenting.
What to do, what not to do and what support is available?
The 13th of October we had a webinar on ”The do’s and dont’s of IP” in regard to ATMP. You can download more detailed presentation slides here;
This is what you will get from this webinar on patentability and IP related to ATMPs. Presented by Joanna Applequist, European Patent Attorney; Ylva Wikmark, Patent Attorney; and Senior Attorney at Law Louise Jonshammar from AWA Sweden and hosted by NextCell Pharma’s CEO Mathias Svahn will discuss some of the tricks to protecting your ATMP IP and the ’what would have been good to have knowns’ that will set you on the right track to a viable commercial model.
Watch the complete recording here!
Questions and Answers
Is Great Britain still part of the European jurisdiction regarding IPR, despite Brexit?
Following Brexit, the United Kingdom (UK) is no longer required to comply with EU legislation and any IP right with effect in all EU member states does not cover the UK anymore. Very few EU legislative acts concern patents, but the Regulations on Supplementary Patent Protections, the Directive on legal protection of biotechnological inventions and the regulations concerning the Unitary Patent (which is not yet enforceable as Germany has not ratified the Agreement on the Unified Patent Court), no longer apply to the UK.
Importantly, the European Patent Convention (EPC), which is administered by the European Patent Organisation (EPO), is an intergovernmental agreement between 38 member states and completely unrelated to the European Union. It is therefore not affected by Brexit – the UK is still a member of the EPC and patents granted by the EPO can be validated in the UK with the same effect as before Brexit.
As regards trademark and design rights, the effects of Brexit are larger as the EU trademark and community design rights no longer protect the trademark/design in the UK. In view of Brexit, all such rights were cloned to a separate British right which has to be handled separately from the EU right, under UK legislation. More information is available for instance on the Swedish Intellectual Property Office’s website: Brexit – PRV (in Swedish, but with many links to reference information in English, for instance to the EUIPO website: Brexit (europa.eu)).