Based on findings from the USPTO, it looks like they aren't able to broadly patent "Progenitor Cell Activation" but can patent the methods as it relates to specific conditions. Under the USPTO search, they have a number of patents secured relating to PCA formulations and hearing loss, assuming one or more of these is FX-322.
They also have patent applications filed for using a formulation for regenerating head "hair follicles." So, it stands to reason that they are actively looking to apply the PCA approach to other conditions (many "opportunities" that PCA may help are mentioned in their presentation.)
It's highly likely that they are well ahead of the curve (internal knowledge, research, etc) on their approach for copycats to exist in the United States. Also, they have a basis for prior are protection if FX-322 as a PCA drug works as anticipated. I am not a lawyer, so there may be a loophole.
In Australia (and also in US as they use virtually identical rules), you cannot patent broad items and concepts such as Progenitor Cell Activation and prevent people from using them with exclusive rights. You can however patent something which employs a broad or generic item or concept in the design of your product like PCA, providing there is a specific and also unique aspect combined into it. The unique and specific aspect is what gives rise to the ability to patent something. This nexus is made when Frequency Therapeutics got FX-322 to use the broad treatment being PCA to target specifically the inner ear.
The Australian laws regarding patents is applied consistently in most jurisdictions I know of such as New Zealand, UK, Canada and US. The law is consistent across most countries when it comes to patents so the rights of the entity holding the patent can be easily enforced in disputes. This enables countries to confidently demonstrate that they will protect each other's proprietary rights. Further this demonstrates that if something is patented for example in the US and is copied in Australia (or vice versa) that the patent will be consistently enforced under foreign laws. Even countries clearly known to have issues surrounding copyright/patent infringements such as China are also actively willing to enforce patents from other jurisdictions.
It is likely Frequency Therapeutics' claim for a patent over PCA was rejected for not only being too broad of a concept but also because by preventing other firms using a broad concept such as PCA in their approach to medical development is to the detriment of all. Patenting PCA inevitably restricts innovation in medicine development being made because no other firm can produce medicines harnessing PCA for release until the patent has expired. This ultimately would contradict the very purpose of a patent because instead of encouraging innovation by offering protection for specific, innovative and novel ideas, it actively discourages it through disallowing firms to use PCA to create targeted treatments other than Frequency Therapeutics.
The question now which I am sure you would want to be answered is what Frequency Therapeutics' patent for either Multiple Sclerosis or FX-322 means. The answer is that this will mean that Frequency Therapeutics has an exclusive right over this treatment type for the duration of the patent (20 years). This means any attempt to try and copy a patented treatment like FX-322 will very likely infringe the patent.
The downside to this is that there is a highly limited ability for a potentially improved product similar to FX-322 getting released or even possibly developed by a competing firm for the patent's duration. This is due to Frequency Therapeutics having exclusive control over this treatment type. A good working Australian example of this was the Hills Hoist clothesline which was much improved on the patented Toyne clothesline. Because Hills Hoist's product used multiple elements of the design of the Toyne clothesline and the Toyne clothesline was still patented, it meant Hills Hoist had to defer its release until the patent expired.
Referring specifically to FX-322 this means if a competitor hypothetically created an identical single shot treatment which provided the same benefit as six FX-322 shots, we will almost certainly not see this released until Frequency Therapeutics' patent expires.
The only way around this would be:
- To change the medication in some manner to make it have different properties or use a different form of treatment to FX-322 (very difficult to employ such argument if multiple patents covering Frequency Therapeutics' approach are granted)
- For Frequency Therapeutics to make these improvements internally and release a revised medicine
- Or for an outside party who has improved the treatment to provide it to Frequency Therapeutics and allow Frequency Therapeutics to release this.
Thankfully there seems to be a keen interest from Frequency Therapeutics to improve the medication so hopefully this will enable us to overcome these concerns and limitations.
Frequency Therapeutics is at an amazing advantage by pioneering the concept of PCA because it inevitably means that they have a huge head start on creating novel and also unique treatments which harness PCA. Thus they can develop these and therefore patent these before their competitors can. This however does not mean that Frequency Therapeutics will be the only firm to provide treatments that utilise PCA as there is nothing stopping competitors creating treatments and applying for patents.
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