This is flatly false and there is typically no point in debating it. But for this moment, it may be worth laying some of the broad details out.
As you have argued many times here, other companies have tried many different efforts to make dendritic cell vaccines and you also pointed out, many times, that they all failed, except one, previously, and Provenge went bankrupt because their manufacturing process was poorly conceived. No one else has taken that success and invented another version of Provence and gotten it approved, despite your claim and even though it's a much simpler vaccine than DCVax-L to manufacture, as it's not personalized to every patient's particular tumor.
Since then, DCVax has apparently had an incredible success that will likely increase as combination therapies and other innovations further reveal in side trials and real world data/real world evidence. It has succeeded except in the fantasies. of course, of those wishing ill will upon all of the world for commercial, professional or other personal money making purposes, otherwise known as greed.
As mentioned, Provenge did succeed, for prostate cancer only, not as a general cancer vaccine, but manufacturing was a technological nightmare for them and was the primary reason they went bankrupt.
Further, their product was not even personalized to the patient’s cancer, they used a single protein, antigen prostatic acid phosphatase (PAP), which is present in 95% of prostate cancer cells, so they did not need to personalize the vaccine part of the process. Of course it was autologous, but not the same as a personalized, cancer agnostic universal vaccine.
No one else will have 5 years of survival data for a product like DCVax, data that took many years to collect (a competitor would need years in excess of five years to collect that data). Also, a competitor would not have Flaskworks, nor will they have the right to create a generic version of DCVax in any manifestation for various legal and regulatory reasons. So your argument is total nonsense.
NWBO has numerous patents and evolving automation technology generating new patents likely on a continuous ongoing basis. They have a huge head start including validating clinical trials and real world data, for almost 2 decades of development AND they have orphan status, which provides exclusivity for 7 years in the US. They also have orphan status in Europe and the UK (evolving but mirrors EU for now) which provides 10 years of market exclusivity.
But that’s not all…
Further, there are special protections for biologics in the US, Europe and the UK.
In the U.S., biologic drugs can obtain a lengthier period of exclusivity, primarily due to the Biologics Price Competition and Innovation Act (BPCIA) which was enacted as part of the Affordable Care Act in 2010.
Here are some of the basics:
Biologics Exclusivity:
1. 12-Year Exclusivity for Biologics:
- Under the BPCIA, a new biological product that has been licensed (i.e., approved) by the FDA is granted 12 years of exclusivity from the date of first licensure.
- During this 12-year period, the FDA cannot approve a biosimilar or interchangeable biologic that references the original biologic.
- This 12-year exclusivity is separate from patent protection. A biologic could potentially be protected from competition by both its patents and by the 12-year exclusivity.
2. 4-Year Data Exclusivity:
- In addition to the 12-year exclusivity, the original biologic also receives a 4-year data exclusivity from the date of first licensure.
- During this 4-year period, the FDA cannot accept applications for biosimilars or interchangeable biologics that reference the original biologic.
- This means, in practice, that a company wishing to develop a biosimilar or interchangeable version of a new biologic can't even submit their application until 4 years after the original biologic has been licensed.
The rationale behind these exclusivity periods is the complexity and cost of developing biologic drugs. Biologics are typically more complex and costly to develop than traditional small molecule drugs. They are made from living organisms, and their development, manufacturing, and validation processes are intricate.
And both the European Union (EU) and the United Kingdom (UK) also have provisions for biologics exclusivity, though they differ somewhat from the U.S. system. Here's a breakdown:
European Union (EU):
1. Data Exclusivity:
- A new biologic drug (or any other medicinal product) approved in the EU benefits from an **8-year** data exclusivity period. During this time, generic or biosimilar manufacturers cannot rely on the data of the originator's product for their marketing authorization application (MAA).
2. Market Exclusivity:
- After the data exclusivity period, there's a **2-year** market exclusivity period, during which a biosimilar can be approved (using the originator's data), but cannot be marketed.
3. Additional One-Year Protection:
- An additional year of market protection (making it a total of 11 years from the initial authorization) can be granted if, during the first eight years of those 10 years, the marketing authorization holder obtains approval for one or more new therapeutic indications that are judged to bring significant clinical benefit in comparison with existing therapies.
United Kingdom (UK):
- Post-Brexit, the UK largely mirrors the EU's provisions for biologics.
- However, given that the UK might adapt its regulations further after leaving the EU, there could be changes in biologics exclusivity. At this time I know of no such changes.
In both the EU and the UK, these regulatory exclusivity periods are separate from patent protection. This means a biologic can be protected by its patents and also benefit from the regulatory exclusivity, leading to multiple layers of protection against competition.
So the protections are vast, multi-layered and continue to evolve as more process and manufacturing patents for Flaskworks are likely to be filed continuously over coming years by NWBO and/or its successors as they continuously improve their manufacturing and automation processes.
Further, trade secrecy and other substantial protections can last indefinitely, as we see with the bottled sugar water known as Coca Cola. It’s one of many IP protection reasons to control the manufacturing evolution in your own plant and to tightly control which third-party companies touch the process.
But you can pretend you have a leg to stand on still… we get it, shorts need to throw any sand in the eyes of retail and the markets that they can find. You keep inventing and we'll keep rebutting.
