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Originally posted by GiddyYup: ↑

I can honestly say that haven't worried too much about that. Biotron works in dog years so three years will feel like 20 but the question is valid so I will attempt to answer it.

Firstly I wouldn't take too much notice of any comments about the patents automatically be extended by 9 years because I think you have already figured out that doesn't smell right. Let me clarify why:

Patents generally need to be filed on a country by country basis and each country has its own rules and regulations for the duration of the original patent and about extensions. Here in Australia a patent is typically 20 years (same as the US, UK, EU etc) and there is a provision for extensions for pharmaceuticals called PTE ("Pharmaceutical Patent Term Extensions") which allows companies to apply for extensions to the patent term. PTE rules vary from country to country. In Australia and the EU PTEs can get upto 5 years if they meet certain criteria. The bad news is that extensions in the critical US market are much more complex. Specifically for this conversation you might note the following PTE condition as being particularly relevant:

"The product received FDA permission for commercial marketing or use, and the permission for the commercial marketing or use of the product is the first such permission received under the provision of law under which the applicable regulatory review period occurred (e.g., Federal Food, Drug and Cosmetic Act)."

I suspect you will immediately understand the implications of this so I won't spell it out.

There is nothing in these key markets laws pertaining to an "automatic 9 years" that I am aware of but from the above you might get a better understanding of the legal framework in a couple of the key markets that Biotron has sought patent protection.

Now specifically relating to Biotron's existing patents;

Biotron has applied for 27 patents that I am aware of. Of these 6 are current, 3 are filed but not yet granted and 18 have already expired, lapsed or been withdrawn. This conversation is only going to apply to the 6 current ones.

Of the 6 current patents each of them has a separate expiry date based on the original application date. One is as early as June this year and one is as late as 2038 ! The risk of expiry would depend completely upon which patent we were talking about. Here is a list of current patents (and their AU application number) and their expiry dates so that you can see them for yourself:

Jun 2024 - 2004248859 - Antiviral acylguanidine compounds and methods
Jun 2026 - 2006261593 - Antiviral compounds and methods
Jun 2026 - 2013205388 - Antiviral compounds and methods
Aug 2028 - 2008286240 - Hepatitis C antiviral compositions and methods
Aug 2028 - 2013219202 - Hepatitis C antiviral compositions and methods
Feb 2038 - 2018218179 - Methods of treating influenza

As you can see from the above the first three patents due to expire first relate to novel antiviral compounds for treating HIV, SARS etc. These patents currently range from 2 months or 2 years before expiry (not 3). I wouldn't worry too much about the two Hep C patents due to expire in 2028 since that program is currently going nowhere. Focus on the HIV ones in particular which all expire over the next 2 years.

Biotron has previously mentioned taking steps to protect the IP but we never get detail information. I suspect that since they likely can't extend some of the existing patents due to expire over the next 2 years they have filed new patents specifically to protect the work done on HIV. Look at patent applications 2019271955 and 2020390851 filed in 2019 and 2020 and you will see how they have tried to do this. Please note that these new patents have not yet been granted. It appears that they have tried to change patent agents on these applications on multiple occasions since 2020 but I haven't looked deeply into this so cannot and do not imply anything into it.

So short answer is the 9 years story looks like BS. Certainly there is nothing automatic about PTEs as they are highly conditional and not likely to apply here at this point in time in the primary markets. Maybe in "Chechnya" !

As to the risk, well thats is a moving target. If the new applications are granted then that may protect key aspects of the current and critical HIV program and lets face it, thats where we are hoping to see a commercial deal come from, if one is to come soon. Obviously nobody here is going to be able to tell you exactly which patent will cover what specific territorial situations but I've tried to provide a simple ballpark estimation to answer your risk question.

I hope this helps answer your question.

PS who came up with the automatic 9 year extension story?

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excellent post mate. Really enjoy reading your work. Always brilliantly researched and well written. Thanks for the reply.

certainly a complex area and not an automatic renewal as articulated by another poster.

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