Trademarks / Patents / IP Updated annex of patents, pending patent applications, and abandoned/withdrawn patent applications

macgyver

Well-known member
After going through Clinuvel/Vallaurix/Phillipe Wolgen patents, it may come as a surprise to some that Clinuvel's list of granted patents is somewhat limited. I had taken it for granted Clinuvel had the IP protection for most of the various ailments they seek to address, but some are still pending (especially in the U.S.).

Not meaning to state the obvious, but there's a good chance the current list of patents granted and patents pending has had a significant bearing on Clinuvel's strategy or movements of late, and could be behind some of the delays to promised events. This seems a possibility given the US patent for Methods of inducing melanogenesis in a subject was only granted in Dec 2020 (however it follows on from two previous patents so not sure of the significance). This could be due to the US Patent Office requiring FDA approval first, of which I have seen some anecdotal evidence of this occurring (I don't know what scenario would trigger this requirement).

Items that feature in multiple categories I have only posted the most up to date information for that item (e.g. Therapy for vitiligo was previously abandoned but it must have been re-applied for and is now in maintenance status). For now, I won't post patent numbers until I've had time to go through it in more detail. Just the names of the patents and other patent applications with their applicable categories thereof:


Patents granted:
  • Methods of inducing melanogenesis in a subject
  • Compositions and methods for inducing melanogenesis

Patent applications pending or in maintenance:
  • Alpha-msh analogues for use in the treatment of psoriasis (Recent application at early stage of processing)
  • Alpha-msh analogues for use in treatment of Hailey-Hailey Disease (Recent application at early stage of processing)
  • Therapy for vitiligo (Shows active date till 27 March 2031. Possibly granted EU patent and awaiting US patent)
  • A method for inducing melanogenesis in humans with MC1R variant alleles (Shows active date till 2024. Possibly granted EU patent and awaiting US patent)
  • Alpha-msh analogues used in the treatment of xeroderma pigmentosum (Pending decision, filed in 2017. Side note: This was filed fairly recently, has it been a long gestating plan to treat XP or is it a relatively recent development?). *Recieved final rejection April 2021.
  • Alpha-msh analogues for use in bullous diseases (Not abandoned but there has been no recent activity)
  • Method of treatment for photodermatoses (expiration 2029, not clear what this means whether it is EU patent or application will expire this date)
  • Pharmaceutical compound (Vallaurix)

Patent applications abandoned:
  • Hexapeptide with improved activity in the repair of cellular DNA of dermal cells (CUV 9900?)
  • Methods for inducing photoprotection and DNA protection
  • Method for reducing incidence or rate of development of skin cancers and related conditions (This was surprising as the AK trial results could apply to this)
  • Method for treatment of photosensitivity and phototoxicity following the use of photosensitizers in photodynamic therapy
  • Method for treatment of photosensitivity and phototoxicity following the use of a photosensitising agent
  • Method for treatment of photodermatoses
  • New indication for alpha-msh analogues: CNS (Abandoned in both EU and US possibly due to Thomas Luger et al)

Patent application withdrawn:
  • Method for treatment of phototoxicity and photosensitivity
 
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macgyver

Well-known member
Clinuvel is fortunate it has market exclusivity in the EU and US markets, which give it IP protection and time to settle patent claims. What’s important to note here is Clinuvel is looking to patent the ‘methods’ of treating their targeted ailments. Other companies can use generic afamelanotide after market exclusivity ends, but not as the patents describe. This gives increased duration of protection to the patent holder e.g. once Clinuvel loses market exclusivity for Scenesse after 7-8 years, it has patent protection in which it can sue another company if it infringes on its patent claims. Most likely a licensing agreement would take place to ensure promotion of competition in the marketplace. I’m pleased in the knowledge that Clinuvel has secured the patents for inducing melanogenesis as this protects both the pharmaceutical and dermocosmetic rights for their mainstay indication/s. Just need XP/DNA repair and CNS patents and the future is bright.
 
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macgyver

Well-known member
Update: Clinuvel’s patent application for treating XP with an a-msh analog recieved a final rejection notice from the US Patent Office back in April this year. The USPO examiner’s main arguement was centered around previous publications (Malek) stating a-msh can repair DNA damage and that Clinuvel can’t claim the method because it is an obvious consequence. Clinuvel countered with the arguement that you can’t possibly know for sure until you have performed trials to clinically prove this. The Examiner was not persuaded. It doesn’t matter, if Clinuvel hasn’t succeeded then nobody else will. Clinuvel has market exclusivity and an approved a-msh drug.

Given Japan’s high prevalence of XP it’s even more crucial to getting XP trial results in hand before lodging an NDA there so as to secure a lengthy market exclusivity period. I can’t foresee how this might affect future OTC lines, but if for example Clinuvel decide to produce an OTC for XP patients to assist with skin cancers the product will most likely be classed as medicated and will require regulatory approval. That is something else Clinuvel will have as an advantage I guess.

Edit: I’ll follow the progress of this as I don’t think Clinuvel is going to give this one up. As seen with another patent application for a compound, Clinuvel are fighting to the bitter end with time extensions and instant applications applied for. Get the popcorn out.

Final Rejection Document
 
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Alexius

Well-known member
The USPO examiner’s main arguement was centered around previous publications (Malek) stating a-msh can repair DNA damage and that Clinuvel can’t claim the method because it is an obvious consequence.
So do I understand correctly that the examiner is so convinced of our beloved Afamelanotide's ability to repair DNA that he feels it doesn't even need trials to confirm this? As a consequence, the dude would have to be All-In CUV if he really understood the implications of his argument.
So in this case, the XP Trials are a free pass, which would mean that the current fair market cap would have to be somewhere in the $10 billion range. Instant tenbagger ahead, ez money 🤑
 

macgyver

Well-known member
@Alexius I think it was more a case of someone else had reached the conclusion first that afamelanotide can repair DNA. But I’m not clear if there is a competing patent application from Malek and if that is part of the reason why Clinuvel’s application has failed. But your implication is correct. One thing is certain: the patent process is nothing if not rigorous.
 

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