Actually I saw several articles where Dr. Fukuda supposedly said that it will probably be 5 years before they even start human clinical trials of this McDonald’s fries compound/hair follicle germ procedure… and an ADDITIONAL 5 years to get from clinical trials to approval and the market. (The articles didn’t quote Dr. Fukuda directly on that, they just paraphrased him, and it was unclear if those comments were actually his, but they implied he made those projections.)
I don’t know what the basis of those predictions (5 + 5 years) is. Supposedly Japan has greatly streamlined and liberalized regulatory policies for cell-based medical procedures, making potential regulatory approval much quicker. Sort of like a fast-track to trials and approval. But Dr. Fukuda seems to be basing his predictions on the old regulatory scheme (or the US procedure of going through the FDA). I wonder why he’d do that.
Also, Dr. Fukuda might not totally understand that his procedure is PRECISELY the kind of treatment that big investors would be interested in. That is, because it’s not only patentable, but once patented, it can be legally protected because it’s not just a medical procedure, but a PROCESS for making hair follicle germs. Both the in vitro follicle germination process and the medical treatment can be patented, but ONLY the patent for the lab process to grow the HFGs can actually be protected. That’s because in most major industrial countries, doctors can copy a medical procedure patented by another doctor, and cannot be successfully sued for copying it. BUT, anyone who infringes a patent for a laboratory procedure can be SUCCESSFULLY sued for patent infringement.
That has been the law in the USA ever since 1996, and is currently the law in the EU and many other countries.
That’s why one doctor can’t sue another doctor for copying, say, a specific type of HT technique, or any other medical procedure.
Am I the only person who has ever posted here on HairSite, or any other hair loss forum, who knows about this law? I never hear anyone else mention it, but IMO it is the #1 reason why big biotech investors won’t invest much money in most HM type discoveries, such as Follica, Replicel, etc. (Note: interestingly, both Follica AND Replicel developed some sort of medical device – which I am certain were developed to get around this issue in patent law.)
Dr, Fukuda’s discovery is NOT JUST a HM procedure, it is also a technique for creating HFGs outside the body, in the lab, so any patent of this procedure would be protectable and this would dramatically increase the valuation of Dr. Fukuda’s enterprise.