8 ms·

Since it is naturally occurring, it isn't patentable. Which means it is less likely that companies will develop a commercial product from it. Why pay to get FD

by thayne 2y ago

Since it is naturally occurring, it isn't patentable. Which means it is less likely that companies will develop a commercial product from it. Why pay to get FDA approval, if you don't get a government granted monopoly on it afterwards? This is one problem with using patents as the mechanism to incentivise development of medicine.

ramoz 2y ago
The article did refer to patents. https://patents.google.com/?inventor=Katrin+Svensson https://patents.google.com/?inventor=Katrin+Svensson It would seem they are modifying peptides. Which is patentable.
nine_k 2y ago
If the molecule itself is not patentable, the process of efficient extraction or synthesis may be. So, if somebody can come up with it, they may have a thriving business. The substance in question is a peptide. It's not something you simply extract from a plant using a solvent. OTOH, being a peptide, it's likely easy enough to produce in a genetically engineered bacterium or yeast. Efficient extraction may remain a problem though, because you'll need to select a particular protein fragment (the peptide) from reams of other protein fragments of the bacterial / fungal cells you process.
- frodo8sam 2y ago
  The extraction problem has been solved for a long time to make recombinant insuline. Before that it had to be extracted from an animals pancreas. These days peptides are often improved using non-natural amino acids to make them more stable and thus longer acting. Semaglutide is a good example. These are synthesized using solid-phase synthesis.
catigula 2y ago
I've always been very, very skeptical of this claim. If there's an actual natural, identified substance with huge benefits to people, it's going to go gangbusters and you're going to make a lot, LOT of money selling it, even if you're doing it via roadside lemonade stand. It feels like this claim is usually used to promote cures and treatments with extremely low quality RCTs backing their use as a sort of panacea. I used to believe the "just do shrooms to cure depression" claims on principle until I looked into the quality of those studies, which is very low. At that point, you're just making stuff up.
- robbs 2y ago
  Caffeine is an example. Coffee and energy drinks are doing well I'd say.
  - nepthar 2y ago
    That’s an excellent point
  - throwup238 2y ago
    Caffeine is grandfathered in as a Generally Recognized as Safe food additive. If energy drink companies had to go through clinical trials with no patent protection for each drink formula, they wouldn't make them.
    - catigula 2y ago
      Why was caffeine studied? Why does it continue to be studied?
      - throwup238 2y ago
        It’s a lot cheaper to study something in academia than to do a full clinical trial.
      - hadlock 2y ago
        The global coffee market is worth $138 billion, the soft drink industry is $556 billion (and growing). The vast majority of which being caffeinated. Starbucks the company is #116 on the Fortune 500 and #1 in food services. There's sufficient economic activity to warrant continued research in the area.
    - Centigonal 2y ago
      I think the current regulatory regime in many US states allows companies to make a killing off of selling naturally occurring bioactive substances as dietary supplements with few regulatory hurdles. Kratom, CBD, and delta-8 THC are naturally occurring bioactive substances that are newer to the US market. Both have carved out a pretty nice economic niche with a bunch of claimed health benefits. A couple of years back, I saw a sign outside a fancy legal highs shop in Fishtown, Philadelphia touting the benefits of kratom as a pre-workout supplement. The insanity that a business was advertising an addictive opioid to healthy, opioid-naive people for better gains in the gym almost makes me want more regulation in this area.
eightysixfour 2y ago
Other mentioned extraction and such, but semaglutide had been known for some time, the other half of the problem is delivery. You’ll notice the article says the calorie intake was decreased an hour later. You need to make it stable, long lasting, and via a delivery method that people can tolerate. Giving yourself an injection an hour before you eat or an hour before you are hungry isn’t going to work.
nerdponx 2y ago
If only there was a way for the people to pool their collective resources, maybe each contributing a fraction of their annual income (with a greater contribution proportion at higher incomes), and put those resources towards development of thins that benefit the common good but lack a direct profit incentive. Hmm...
bufferoverflow 2y ago
CRISPR is naturally occurring, but got patented to hell.
AmazingTurtle 2y ago
Nestle is making billions of dollars -- off water.
cwmma 2y ago
this is 1000% not true, plenty of naturally occurring substances are turned into profitable medicine, aspirin and insulin are examples off the top of my head.
throwup238 2y ago
That’s not exactly true. Cannabidiol (CBD) is naturally occurring and there’s a commercial FDA approved drug for epileptic seizures in children called Epidiolex. If I remember correctly, the patent is for “Oral cannabinoid formulations”. Even without a patent, companies can get FDA exclusivity but for not as long as a patent grants them so unless the addressable market is huge, it’s a financially riskier bet.
- greggsy 2y ago
  Keyword there being ‘formulation’, not ‘molecule’
  - throwup238 2y ago
    A “formulation” is a “molecule” at a specific concentration, in a specific solvent, etc. The patent is still on using CBD.
xracy 2y ago
I'm sorry, your hypothesis is that people will be less likely to try and build products around a naturally occurring weight-loss drug? Like, less likely than they would be to pay Ozempic to use their patent? I mean, I could believe that if there weren't like Billions of dollars being funneled into weight-loss programs and foods that don't have any demonstrative weight-loss capabilities. If this actually works and is naturally occurring, I'd be surprised if there weren't like enterprising startups and food companies adding this to existing products within a year or 2.
conductr 2y ago
I feel like the natural occurring property makes it more likely a supplement company will bring it to market without FDA requirements. The path to market should be simpler from my understanding of this space, please correct me if that’s incorrect
sizzle 2y ago
Pretty sure this would help save health insurance companies and Medicare billions if it’s a relatively safe defense against obesity and related mortality. There could be a push to get it to market from Medicare? Anyone want to comment with more knowledge of how it could be funded by the government? Note: The current administration is gutting the NIH so those programs and grants are shrinking
JumpCrisscross 2y ago
> Since it is naturally occurring, it isn't patentable Supplements are a $50bn business [1]. [1] https://www.grandviewresearch.com/industry-analysis/us-dietary-supplements-market-report https://www.grandviewresearch.com/industry-analysis/us-dieta...
abirch 2y ago
I'm late to the party and this is not my forte so I'd differ to many people, but if you patent the natural compound for a disease you can do that. In addition to that patenting it for certain formulations. A case in point is https://en.wikipedia.org/wiki/Dimethyl_fumarate https://en.wikipedia.org/wiki/Dimethyl_fumarate Tecfidera (the drug name for the drug used for MS made Biogen Idec billions of dollars. The history from wikipedia The first medical use of fumaric acid was described in 1959 by Walter Schweckendiek, a German chemist, and was a topical formulation for psoriasis. The Swiss company Fumapharm eventually brought Fumaderm, an oral formulation of dimethyl fumarate (along with some monoesters) to market for psoriasis in Germany in 1994. Based on the efficacy and safety of this formulation, and evidence that dimethyl fumarate was the main active component, an oral formulation of dimethyl fumarate was developed by Almirall. This oral formulation, under the brand name Skilarence, was approved by the European Medicines Agency (EMA) in June 2017, for the treatment of moderate-to-severe plaque psoriasis in adults. Initial clinical research on the use of dimethyl fumarate for the treatment of multiple sclerosis was conducted by Fumapharm in collaboration with Biogen Idec; Fumapharm was subsequently acquired by Biogen Idec in 2006. Aditech Pharma in Sweden had also been researching oral formulations of dimethyl fumarate for MS and in 2010, the Danish company Forward Pharma acquired Aditech's patents.
addicted 2y ago
You mean like the entire wellness industry reselling fiber and turmeric and black pepper for you at 100x multiples?

by thayne 2y ago

ramoz 2y ago

The article did refer to patents. https://patents.google.com/?inventor=Katrin+Svensson https://patents.google.com/?inventor=Katrin+Svensson It would seem they are modifying peptides. Which is patentable.

nine_k 2y ago

If the molecule itself is not patentable, the process of efficient extraction or synthesis may be. So, if somebody can come up with it, they may have a thriving business. The substance in question is a peptide. It's not something you simply extract from a plant using a solvent. OTOH, being a peptide, it's likely easy enough to produce in a genetically engineered bacterium or yeast. Efficient extraction may remain a problem though, because you'll need to select a particular protein fragment (the peptide) from reams of other protein fragments of the bacterial / fungal cells you process.

frodo8sam 2y ago
The extraction problem has been solved for a long time to make recombinant insuline. Before that it had to be extracted from an animals pancreas. These days peptides are often improved using non-natural amino acids to make them more stable and thus longer acting. Semaglutide is a good example. These are synthesized using solid-phase synthesis.

catigula 2y ago

I've always been very, very skeptical of this claim. If there's an actual natural, identified substance with huge benefits to people, it's going to go gangbusters and you're going to make a lot, LOT of money selling it, even if you're doing it via roadside lemonade stand. It feels like this claim is usually used to promote cures and treatments with extremely low quality RCTs backing their use as a sort of panacea. I used to believe the "just do shrooms to cure depression" claims on principle until I looked into the quality of those studies, which is very low. At that point, you're just making stuff up.

robbs 2y ago
Caffeine is an example. Coffee and energy drinks are doing well I'd say.
- nepthar 2y ago
  That’s an excellent point
- throwup238 2y ago
  Caffeine is grandfathered in as a Generally Recognized as Safe food additive. If energy drink companies had to go through clinical trials with no patent protection for each drink formula, they wouldn't make them.
  - catigula 2y ago
    Why was caffeine studied? Why does it continue to be studied?
    - throwup238 2y ago
      It’s a lot cheaper to study something in academia than to do a full clinical trial.
    - hadlock 2y ago
      The global coffee market is worth $138 billion, the soft drink industry is $556 billion (and growing). The vast majority of which being caffeinated. Starbucks the company is #116 on the Fortune 500 and #1 in food services. There's sufficient economic activity to warrant continued research in the area.
  - Centigonal 2y ago
    I think the current regulatory regime in many US states allows companies to make a killing off of selling naturally occurring bioactive substances as dietary supplements with few regulatory hurdles. Kratom, CBD, and delta-8 THC are naturally occurring bioactive substances that are newer to the US market. Both have carved out a pretty nice economic niche with a bunch of claimed health benefits. A couple of years back, I saw a sign outside a fancy legal highs shop in Fishtown, Philadelphia touting the benefits of kratom as a pre-workout supplement. The insanity that a business was advertising an addictive opioid to healthy, opioid-naive people for better gains in the gym almost makes me want more regulation in this area.

eightysixfour 2y ago

Other mentioned extraction and such, but semaglutide had been known for some time, the other half of the problem is delivery. You’ll notice the article says the calorie intake was decreased an hour later. You need to make it stable, long lasting, and via a delivery method that people can tolerate. Giving yourself an injection an hour before you eat or an hour before you are hungry isn’t going to work.

nerdponx 2y ago

If only there was a way for the people to pool their collective resources, maybe each contributing a fraction of their annual income (with a greater contribution proportion at higher incomes), and put those resources towards development of thins that benefit the common good but lack a direct profit incentive. Hmm...

bufferoverflow 2y ago

CRISPR is naturally occurring, but got patented to hell.

AmazingTurtle 2y ago

Nestle is making billions of dollars -- off water.

cwmma 2y ago

this is 1000% not true, plenty of naturally occurring substances are turned into profitable medicine, aspirin and insulin are examples off the top of my head.

throwup238 2y ago

That’s not exactly true. Cannabidiol (CBD) is naturally occurring and there’s a commercial FDA approved drug for epileptic seizures in children called Epidiolex. If I remember correctly, the patent is for “Oral cannabinoid formulations”. Even without a patent, companies can get FDA exclusivity but for not as long as a patent grants them so unless the addressable market is huge, it’s a financially riskier bet.

greggsy 2y ago
Keyword there being ‘formulation’, not ‘molecule’
- throwup238 2y ago
  A “formulation” is a “molecule” at a specific concentration, in a specific solvent, etc. The patent is still on using CBD.

xracy 2y ago

I'm sorry, your hypothesis is that people will be less likely to try and build products around a naturally occurring weight-loss drug? Like, less likely than they would be to pay Ozempic to use their patent? I mean, I could believe that if there weren't like Billions of dollars being funneled into weight-loss programs and foods that don't have any demonstrative weight-loss capabilities. If this actually works and is naturally occurring, I'd be surprised if there weren't like enterprising startups and food companies adding this to existing products within a year or 2.

conductr 2y ago

I feel like the natural occurring property makes it more likely a supplement company will bring it to market without FDA requirements. The path to market should be simpler from my understanding of this space, please correct me if that’s incorrect

sizzle 2y ago

Pretty sure this would help save health insurance companies and Medicare billions if it’s a relatively safe defense against obesity and related mortality. There could be a push to get it to market from Medicare? Anyone want to comment with more knowledge of how it could be funded by the government? Note: The current administration is gutting the NIH so those programs and grants are shrinking

JumpCrisscross 2y ago

> Since it is naturally occurring, it isn't patentable Supplements are a $50bn business [1]. [1] https://www.grandviewresearch.com/industry-analysis/us-dietary-supplements-market-report https://www.grandviewresearch.com/industry-analysis/us-dieta...

abirch 2y ago

I'm late to the party and this is not my forte so I'd differ to many people, but if you patent the natural compound for a disease you can do that. In addition to that patenting it for certain formulations. A case in point is https://en.wikipedia.org/wiki/Dimethyl_fumarate https://en.wikipedia.org/wiki/Dimethyl_fumarate Tecfidera (the drug name for the drug used for MS made Biogen Idec billions of dollars. The history from wikipedia The first medical use of fumaric acid was described in 1959 by Walter Schweckendiek, a German chemist, and was a topical formulation for psoriasis. The Swiss company Fumapharm eventually brought Fumaderm, an oral formulation of dimethyl fumarate (along with some monoesters) to market for psoriasis in Germany in 1994. Based on the efficacy and safety of this formulation, and evidence that dimethyl fumarate was the main active component, an oral formulation of dimethyl fumarate was developed by Almirall. This oral formulation, under the brand name Skilarence, was approved by the European Medicines Agency (EMA) in June 2017, for the treatment of moderate-to-severe plaque psoriasis in adults. Initial clinical research on the use of dimethyl fumarate for the treatment of multiple sclerosis was conducted by Fumapharm in collaboration with Biogen Idec; Fumapharm was subsequently acquired by Biogen Idec in 2006. Aditech Pharma in Sweden had also been researching oral formulations of dimethyl fumarate for MS and in 2010, the Danish company Forward Pharma acquired Aditech's patents.

addicted 2y ago

You mean like the entire wellness industry reselling fiber and turmeric and black pepper for you at 100x multiples?