Eli Lily 's Latest Scheme

[Mr.Tired]

Rumor has it that Eli Lilly wants them reclassified as “biologics”, a category of drug that gets extra patent protection and stricter rules against compounding.

https://twitter.com/x/status/2044896412299931924

View: https://x.com/mansizzzzle/status/2044896412299931924

 

[CNCCurrency]

Rumor has it that Eli Lilly wants them reclassified as “biologics”, a category of drug that gets extra patent protection and stricter rules against compounding.

https://twitter.com/x/status/2044896412299931924

View: https://x.com/mansizzzzle/status/2044896412299931924

Not a rumor, they are trying to get reta classified as a biologic.

 

[CMA Pooky]

This makes me want to order as many kits as I can afford. The greed of Big pharma.

 

[birdwhacker]

This makes me want to order as many kits as I can afford. The greed of Big pharma.

That's always a good idea, but it's unlikely to affect gray to a meaningful degree.

 

[giraffonaut]

This is so absurd. I'm glad I've found this place so I won't be reliant on "regular" methods of acquiring what I want.

 

[sheilarae74]

If you didn't hate big pharma enough. 🤬

 

[Danger1212]

Panic buying Peptides reminds me of COVID times when we would panic buy ammunition, primers, powder, and whatever else we could think of. 👊

They were the best of times and they were the worst of times…

 

[Thistley]

My understanding is if the FDA says you need 8 legs to be a spider ( a biologic) and you show up with your 7 leg creature- ok cool but it just ain’t an 8 legged spider.

All just to get a longer patent window. Have to admire them and their 7 legged thing, I have one, I got him from China and he hella cute.

 

[Chili777]

I found this info at the Reta Overdose Convention, formerly known as Reddit:

 

[HereKittyKitty]

Panic buying Peptides reminds me of COVID times when we would panic buy ammunition, primers, powder, and whatever else we could think of. 👊

They were the best of times and they were the worst of times…

How boring am I? I panic bought paper towels and heated bidets.

 

[HereKittyKitty]

My understanding is if the FDA says you need 8 legs to be a spider ( a biologic) and you show up with your 7 leg creature- ok cool but it just ain’t an 8 legged spider.

All just to get a longer patent window. Have to admire them and their 7 legged thing, I have one, I got him from China and he hella cute.

The thing is there are legit pathways to patent extension.

 

[wonttellyou]

that warm anus feel tho

 

[Jerrey]

Panic buying Peptides reminds me of COVID times when we would panic buy ammunition, primers, powder, and whatever else we could think of. 👊

They were the best of times and they were the worst of times…

And TOILET PAPER must not forget toilet paper!!!!!

 

[chmuse]

How boring am I? I panic bought paper towels and heated bidets.

Rice and beans and canned foods and bird pellets 😂 Then my job got classified as essential anyway. I had customers tipping me in rolls of toilet paper and a bunch of us stole the gigantic rolls from the store restrooms.

 

[chmuse]

The thing is there are legit pathways to patent extension.

Unless you forget in Canada 😂

 

[byefatlicia]

That's always a good idea, but it's unlikely to affect gray to a meaningful degree.

To pretend that Gray peps aren't on BPs dry erase boards already would be naïve. From the shutting down of CN manufacturing facilities and 2 of the biggest vendors in September. The shipping disruptions and customs seizures are on the rise. Banks are tightening up the Crypto access. It's enough to make my tinfoil hat start tingling.

 

[RetCurious]

Reta Overdose Convention

🤣

 

[gimmeshelter]

if that do that, gray market will just get bigger. U think china cares? Think about what you can buy of gray that is controlled by pharmas

 

[NBA_MiddleAgedGirl]

To pretend that Gray peps aren't on BPs dry erase boards already would be naïve. From the shutting down of CN manufacturing facilities and 2 of the biggest vendors in September. The shipping disruptions and customs seizures are on the rise. Banks are tightening up the Crypto access. It's enough to make my tinfoil hat start tingling.

Absolutely. During RFK Jr.'s congressional hearings, he mentioned "inspecting" China's warehouses (under the guise of safety inspections). This is going to get interesting.

 

[Danger1212]

How boring am I? I panic bought paper towels and heated bidets.

And TOILET PAPER must not forget toilet paper!!!!!

During the pandemic, Walmart announced they were going to stop selling ammo in California stores. A buddy called me and said, “Hey, they’ve got 12-gauge shotgun shells for a dollar per case.” My wife and I rushed over, and sure enough, it was true, so we filled the cart to the brim with cases of 12-gauge shells.

I still remember pushing that cart to the front of the store while people were running past us in a panic, grabbing toilet paper and paper towels. One family stopped, did a double take at our cart, looked at me wide-eyed, and then hurried off, muttering, “white people…” 🤣

 

[Danger1212]

How boring am I? I panic bought paper towels and heated bidets.

I think my best panic buy was that bidet and the water pick from Costco!

 

[Jerrey]

Rice and beans and canned foods and bird pellets 😂 Then my job got classified as essential anyway. I had customers tipping me in rolls of toilet paper and a bunch of us stole the gigantic rolls from the store restrooms.

Interstate rest stops being burglarized for their stock of TP became a common occurrence.

 

[tubby]

I personally hope Lilly gets the result they want on this. I'll explain:

If they can't get the classification they want, they still need to stop compounding pharmacies from selling their drug, and they're not going to stop going until that happens. That means they'll get a new law passed that says compounding pharmacies can keep "making" their stuff, but can only source API from the manufacturer at retail price and will likely crush any other exceptions peptides have now that we might enjoy.

And if that doesn't work for some reason then they'll just start making their newer GLP products into much more complicated structures (that gray market labs will struggle to properly produce) to achieve the biologics designation.

I "hate" pharma as much as the next guy, but wanting them to be unable to enforce their patents is short-sighted.

 

[Ragnar]

According to the standardized methods of classification retatrutide is a synthetic peptide that is 39 amino acids. It should be clear cut case for the courts to reject Lilys claim based on the current law that Biologics are defined as 40 amino acids. Courts don’t always like to follow laws as they are written so I wouldn’t be surprised if Lily somehow convinces a judge to interpret it as 40 amino acids.
As far as a crackdown on gray market peptides, I think that AI will continue to play a role in this. The other meaningful way would be changing laws so that peptides can’t be sold to lay people for “research use only”. I hope this doesn’t happen but the fear makes me consider increasing my 2 year supply.

 

[tncc_rn]

My understanding is if the FDA says you need 8 legs to be a spider ( a biologic) and you show up with your 7 leg creature- ok cool but it just ain’t an 8 legged spider.

All just to get a longer patent window. Have to admire them and their 7 legged thing, I have one, I got him from China and he hella cute.

The Comprehensive Methamphetamine Control Act of 1996

Good luck with "analogs". DEA closed that door decades ago....

Don't ask how I know....

 

[tncc_rn]

According to the standardized methods of classification retatrutide is a synthetic peptide that is 39 amino acids. It should be clear cut case for the courts to reject Lilys claim based on the current law that Biologics are defined as 40 amino acids. Courts don’t always like to follow laws as they are written so I wouldn’t be surprised if Lily somehow convinces a judge to interpret it as 40 amino acids.
As far as a crackdown on gray market peptides, I think that AI will continue to play a role in this. The other meaningful way would be changing laws so that peptides can’t be sold to lay people for “research use only”. I hope this doesn’t happen but the fear makes me consider increasing my 2 year supply.

This may be the only thing that keeps Peptides from being reclassified as Biologics. But don't put it past the government to "rewrite" a law if their pockets get lined deep enough by Big Pharma.....

 

[homebrew]

According to the standardized methods of classification retatrutide is a synthetic peptide that is 39 amino acids. It should be clear cut case for the courts to reject Lilys claim based on the current law that Biologics are defined as 40 amino acids. Courts don’t always like to follow laws as they are written so I wouldn’t be surprised if Lily somehow convinces a judge to interpret it as 40 amino acids.
As far as a crackdown on gray market peptides, I think that AI will continue to play a role in this. The other meaningful way would be changing laws so that peptides can’t be sold to lay people for “research use only”. I hope this doesn’t happen but the fear makes me consider increasing my 2 year supply.

40 amino acids is not in the statute. The threshold was adopted through guidance, not formal rule making. Lilly is counting it as 41 amino acids (39 plus two other chains). The FDA called it 40 amino acids, accepting one but not both chains without the required case by case analysis. The judge rejected the FDA classification as "arbitrary and capricious" and sent it back to be re-accessed.

 

[HereKittyKitty]

Rice and beans and canned foods and bird pellets 😂 Then my job got classified as essential anyway. I had customers tipping me in rolls of toilet paper and a bunch of us stole the gigantic rolls from the store restrooms.

That's called rationing, not stealing. 😉😂😂

 

[tncc_rn]

40 amino acids is not in the statute. The threshold was adopted through guidance, not formal rule making. Lilly is counting it as 41 amino acids (39 plus two other chains). The FDA called it 40 amino acids, accepting one but not both chains without the required case by case analysis. The judge rejected the FDA classification as "arbitrary and capricious" and sent it back to be re-accessed.

Oof....guidance. Ask any gun owner about ATF "guidance" letters from the Tech Branch. Nightmare for trying to follow "the rules"....

 

[Ragnar]

40 amino acids is not in the statute. The threshold was adopted through guidance, not formal rule making. Lilly is counting it as 41 amino acids (39 plus two other chains). The FDA called it 40 amino acids, accepting one but not both chains without the required case by case analysis. The judge rejected the FDA classification as "arbitrary and capricious" and sent it back to be re-accessed.

https://www.wsgr.com/en/insights/fda-releases-final-guidance-transition-of-previously-approved-drugs-to-being-deemed-licensed-biologics.html

My understanding is based on The Biologics Price Competition and Innovation Act (BPCIA) of 2009, and the Further Consolidated Appropriations Act, 2020 as described in this article. The following is a direct copy that lead to my interpretation.

Has the determination of which proteins can qualify as biologics changed?

Yes. The BPCIA defined a biologic (biologic product) to include a "protein (except any chemically synthesized polypeptide) …" Further, earlier FDA final guidance clarified that a protein is "any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size." Thus, initially, for a protein to be a biologic, it had to: 1) be greater than 40 amino acids in size; and 2) not be chemically synthesized. The Further Consolidated Appropriations Act, 2020, removes the chemically synthesized exclusion, thereby potentially increasing the number of proteins that can become biologics.

It’s possible I’m missing something amongst all the lawyer talk but I interpret this to mean that based on this definition that retatrutide is not greater than 40 amino acids regardless of how Lily argues it or how a judge rules it.