Replies to post #637161 on NorthWest Biotherapeutics Inc (NWBO)

[abeta]

bio

no need to comment but (as a result of your post) found this with respect to europe/uk

Data exclusivity
A period of 8 years from the initial authorisation of a medicine, during which the marketing-authorisation holder has exclusive rights to the preclinical tests and clinical trials data on the medicine, and during which other applicants cannot rely on these data to support their own applications for marketing authorisation for e.g. generic or biosimilar products.

Market protection
A 10-year period after the initial marketing authorisation of a medicine during which a generic or biosimilar cannot be placed on the market, even if it has already received a marketing authorisation.

theres alot more but not sure where to hunt

https://jakemp.com/en/briefings/data-exclusivity-and-market-protection-in-the-eu-eea-and-uk/

I think the following means that if we use DCVax for brain - if we then use it for Lung -
we get a longer exemption period ....

Article 14(11) of Regulation (EC) No 726/2004
‘(…) medicinal products for human use which have been
authorised in accordance with the provisions of this Regulation
shall benefit from an eight-year period of data protection
and a ten year period of marketing protection, in which
connection the latter period shall be extended to a maximum
of 11 years if, during the first eight years of those ten years,
the marketing authorisation holder obtains an authorisation
for one or more new therapeutic indications which, during
the scientific evaluation prior to their authorisation, are held to
bring a significant clinical benefit in comparison with
existing therapies.

https://www.ema.europa.eu/en/documents/presentation/presentation-data-exclusivity-market-protection-orphan-paediatric-rewards-s-ribeiro_en.pdf