Doc Logic,
I don’t agree with a few things in your post. 1) NWBO might in some kind of bind if they don’t get the USA combo patent on DCVax-L + poly-iclc + PD-1 2) NWBO will first/only operate in countries where they have combo patent protection.
I think we need to review 1) why NWBO sought the combo patents; 2) the purpose of the franchise model and what it provides. In the discussion below I’ll be using Checkpoint Inhibitors. The primary players in the Checkpoint Inhibitor market are Keytruda, Opdivo, Tecentriq, Libtayo, and Imfinzi.
1) Why NWBO sought the combo patents. NWBO sought combo patents so their DCVax-L market wouldn’t be restricted. If Merck got the combo patent on DCVax-L + poly-iclc + PD-1 then only Merck’s Keytruda could be combined with DCVax-L. Merck could block all it’s competitors from combining with DCVax-L, which would initially greatly reduce DCVax-L sales. Sure, over time Merck would pretty much gain the whole Checkpoint Inhibitor market because their product would be many times better than its competitors. If the USA patent office decided not to award NWBO the combo patent they sure as heck aren’t going to award it one of the Checkpoint Inhibitors. Maybe, even hopefully, the USA patent office decides NOT to award any company the combo patent on DCVax-L + poly-iclc + PD-1. No one company having the combo patent is a good thing and NWBO’s DCVax-L market is not restricted.
2) The purpose of the franchise model and what it provides. We have to wait until approval occurs to truly know how NWBO will implement the franchise model. However, using Merck’s Keytruda as an example, I believe that anyone can receive DCVax-L but ONLY if they agree to NOT combine DCVax-L with their immunotherapy if it contains Keytruda’s formulation. Any company seeking DCVax-L will have to sign documentation saying as much. In Keytruda’s franchise documentation, NWBO will commit to not providing DCVax-L to any company with Keytruda’s formulation. This is how Merck gains exclusivity for Keytruda. This exclusivity is gained through the franchise implementation, not through a combo patent. As an example, let’s say it’s January 2029 and Merck’s patent on intravenous Keytruda has expired. A BP called Ultra Low Ball has a Keytruda biosimilar and has signed a contract with NWBO for 100,000 DCVax-L treatments. Merck gets wind of Ultra Low Ball’s scheme and tells NWBO. NWBO promptly cancels the contract with Ultra Low Ball because it violated their franchise agreement; NWBO is also obligated to cancel its contract with Ultra Low Ball because of its franchise agreement with Merck.
To sum up, NWBO will not be in a bind if they don’t get the USA combo patent on DCVax-L + poly-iclc + PD-1. And also, NWBO will not first/only operate in countries where they have combo patent protection. NWBO is sitting very, very pretty regarding patents and is the envy of those who are in the know in the biotech world.
I’m not a lawyer, so if there are any lawyers reading this and I’ve stated something incorrectly, please chime in.
Thoughts or questions? FUDster need not reply.
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