As some of you know, I was dragged into a patent infringement case by attorneys representing Valensa International because I wrote a blog post on astaxathin and its possible benefits for eye health, and featured an image of the brand I was using.
It wasn’t until I was subpoenaed that I discovered the existence of Patent #5, 527,533 filed on October 27, 1994. This patent claims that high “therapeutic” doses of astaxanthin can retard and ameliorate central nervous system and eye damage…”such as age-related macular degeneration, photic injury, photoreceptor cell or ganglion cell damage, traumatic injury … and inflammatory diseases.”
From what I can gather, Valensa is the exclusive licensee for nutraceutical applications of the patent, which is assigned to the Board of Trustees of the University of Illinois. Here’s a link to the full patent: Astaxanthin 5,527,533. Here’s an excerpt from that patent:
“The above tests show that the administration of a therapeutically-effective amount of astaxanthin to an individual prevents, retards and/or ameliorates damage to the central nervous system and, especially to the eye, resulting from disease or injury. The astaxanthin is administered to the individual in dosages of 5 to about 500 mg (milligram) astaxathin per kilogram (kg) of body weight. Preferably, the astaxathin dose is about 10 to about 200 mg astaanthin per kg of body weight, and to achieve the full advantage of the present invention, the astaxathin dose is about 25 to about 150 mg astaxanthin/kg of body weight.”
The patent claims that therapeutic dosages of astaxanthin not only protected photoreceptor cells in lab rats, but also ameliorated the effects of the photic injury.
I weigh 105 pounds, which converts to 47.6 kilograms. Based on the minimum recommended dosages identified in the patent to receive full therapeutic advantage (25 mg per kg of body weight), I’d need to take 1190 milligrams –nearly 100 times the amount currently available on the market–to prevent or retard the damage to my photoreceptor cells. And I may actually need six times this amount.
The claims were based on a study with rats and this never reached the human clinical trial stage so it’s hard to know how much of the claimed benefits actually apply to humans. Yet I’ve been told that Valensa has been threatening legal action or suing any astaxathin producer that advertises astaxanthin’s benefits for eye health, even when the largest dosage I can currently find on the market is only 12 mg – which is nowhere near the dosages referred to in the patent. (Sounds like some internal industry squabbling has been going on as well: see this article from 2012 about Valensa and Cyanotech).
The idea that information about the potential benefits of large dosages of astaxanthin to help prevent or reverse damage in retinal diseases has been withheld from the public because of a patent is outrageous to me. I’m extremely grateful for research and appreciate the amount of money and time it takes to undertake research that can lead to medical breakthroughs.So I get that the researchers need to be compensated. But somewhere in all of this, people and health have to come first. We aren’t talking about a boat motor or a screwdriver here. We are talking about people’s eyesight and a naturally occurring carotenoid. Makes me wonder what else is out there that might help us save our eyesight that we aren’t hearing about because of disputes over money and IP ownership.
As it turns out, this patent will expire on October 27, 2014, only four months from now. I’m guessing that as soon as it does expire, we are going to see higher dosages of astaxanthin available in the market and will hear plenty more about the connection between astaxanthin and eye health. I hope that at that time the truth—whatever it is—will finally start to come out.
it’s hard to believe,Ingrid – still more difficult to catch good news about research…very curious to see how it will be after the end of the patent
I’m curious too.
Yes, yes, yes, yes! “The idea that information about the potential benefits of large dosages of astaxanthin to help prevent or reverse damage in retinal diseases has been withheld from the public because of a patent is outrageous to me.” The majority of this post got me so mad, and then I read your last two paragraphs and felt like, that’s exactly it – and that last paragraph, haha, just wait till their patent runs out. I believe in karma and I believe that people who would get so crazy over potential gains, keeping information from those who need it for their health, will get what they desrve. And it seems like that patent running out is the answer – seems like they’ll be pretty powerless without it.
Yeah – it seems so unethical to me. A broken system for sure. Hopefully once that patent expires, other companies will pick up the cause and determine if high dosages are safe and effective in terms of treating retinal diseases. Fingers crossed. It’s always an issue because there is little money in nutritional supplements. Would love someone with deep pockets and a big heart to take up the cause.
Ingrid, once the patent expires we will not see higher doses of Astaxanthin available on the market. The highest dose in a supplement not objected to by FDA is 12mg, and that will likely stay for a long time. Unless someone can show efficacy for the doses mentioned in the study/patent (which, as you astutely pointed out, were based on animal models and have little correlation to humans) you will not see anything more than 12mg with a structure function claim. And BTW 12mg for humans is a very high dose for this super potent antioxidant. As I mentioned in an earlier comment to another blog you wrote, you are free to go to the store and purchase any brand of Astaxanthin and take it for eye health benefit (or whatever condition you believe it works for) regardless of this patent. In 4 months, this conversation will be moot. If you need more info, send me an email and we can chat.
Thanks for the info, JZ. Do you know if any company out there plans to look into an astaxanthin study/trial for eye health once the patent expires? Or is it too cost-prohibitive to take on??
Ingrid. I just did some internet research. Look into this company from Japan. http://www.astareal.com/what-is-astaxanthin/health-benefits/eye-fatigue-relief They seem to have a lot of information about eyes already. It looks like they several have studies also.You cna probably find a brand here in US that carries their astxanthin.
Thank you, Jz. It’s great info. I appreciate it. Best – Ingrid
With you 100% Ingrid, have you ever thought about starting a formal organization maybe a 501c for RP effected families and family members? We need to be heard more. I like your style, advocacy group? Anything would help.
Thanks, JB. Yeah…I have thought about it. There is an organization underway that will start raising money to support studies on integrated approaches to treating RP — including nutritional supplements, acupuncture etc. But no question we need to come together as a loud group voice to start lobbying. FYI…I started a Facebook group called Determined to See. If you aren’t already a member, hope you’ll join. Best – Ingrid