PYC (ASX) PYC Filed Another Patent

You would think the PYC’s scientists are busy doing drug discovery and the management is working on business planning and possible BD’s. There is another group of staff working tirelessly filing patents! Not only in Australia but all over the world in countries where PYC is going to commercialise its products, such as the US, UK, EU, Israel, Brazil, Singapore, India, China, Japan and Korea. To date, a total of 54 patents have been filed and published on WIPO (International Bureau of World Intellectual Property Organization)

From my limited personal experience in filing for Australian Patents many years ago, it is a mammoth task. The patent has to be framed in such a way that it is broad enough to maximise your claim but specific enough to stake your claim, yet not to give away any trade-secrets to your competitors. Sounds like an oxymoron! The number of iterations and meetings with the patent attorney would add to this time consuming task.

Here are a few pertinent points about patents as explained in FDA’s Orange Book’s FAQ [1]:

1. How long is a patent term?
Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent.

2. How long does an exclusivity period last?
It depends on what type of exclusivity is at issue. For Orphan Drug Exclusivity (ODE) – 7 years.

3. What is the difference between patents and exclusivity?
Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes. Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims.

Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met.

Periods of exclusivity and patent terms may or may not run concurrently. Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition.

[1] https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#

Glaucoma

Most of the patents published so far are related to the 4 drugs in the pipeline already announced. One that caught my attention is a World-Wide Patent on “METHOD OF TREATING GLAUCOMA” published 28/09/2023.

It is estimated that over 300,000 Australians have glaucoma, yet 50% are unaware they have it, thinking they have healthy eyes. Anyone may develop glaucoma, but the incidence increases with age. About 1 in 10,000 babies are born with glaucoma, by age 40 about 1 in 200 have glaucoma, rising to 1 in 8 at age 80.

In many cases, glaucoma is an inherited (genetic) disease that is passed on within families - you are 10x more likely to have glaucoma if you have a direct family member with glaucoma. First degree relatives (parents, siblings and children) are at greater risk - having an almost 1 in 4 chance of developing glaucoma in their own lifetime, and that risk doubles if the relative has advanced glaucoma. So knowing your family history is important.

Projected Prevalence of Glaucoma

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7769798/

US$30b Income from a Glaucoma Drug

Based on a global projection of 76 million cases, and conservatively only 10% (7.6 million) would get the PYC Glaucoma drug at US$2,000/year; that would bring in US$15b per annum. If 20% get treated or the drug is priced at US$4,000/year, that would be $US$30b. Divide this into 37 billion PYC shares, it would translate to A$1.25/share or $12.50/share if P/E is at 10x.

Similar to the PKD drug, efficacy for a Glaucoma drug would be easy to determine as the intraocular pressure could be measured in 2 seconds by an optometrist. And the treatment is confined to the eyeball and the quantity of drug used would be in the range of 30 microgram like in RP11. The risk of toxicity would be equally low and efficacy high. So clinical trials would be a breeze.

If the PKD drug makes PYC’s valuation on steroid, a Glaucoma drug would propel PYC with rocket fuel!

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