Eli Lilly hits four telehealth providers

[Batscout]

Lilly sued Willow, Henry, Mochi, Delilah, and Fella this past week. I find this legally intriguing and I have been predicting that it was only a matter of time before this happened. I started with Mochi in 2023 and also used Henry for a month. I’m in a discussion group with Mochi users and I’ve been telling them that Lily would get around to suing Mochi and other telehealth providers. All of the compounding telehealth providers continue to tell their customers that they can continue selling compounded tirzepatide simply by prescribing a slightly different dose or adding one substance to it. When all customers from a single telehealth provider have the same formulation, it’s hard to make an argument that the formula is individualized.

https://www.npr.org/sections/shots-health-news/2025/04/23/nx-s1-5374063/eli-lilly-sues-companies-selling-alternative-versions-of-its-weight-loss-drug

 

[Skidude]

Lilly sued Willow, Henry, Mochi, Delilah, and Fella this past week. I find this legally intriguing and I have been predicting that it was only a matter of time before this happened. I started with Mochi in 2023 and also used Henry for a month. I’m in a discussion group with Mochi users and I’ve been telling them that Lily would get around to suing Mochi and other telehealth providers. All of the compounding telehealth providers continue to tell their customers that they can continue selling compounded tirzepatide simply by prescribing a slightly different dose or adding one substance to it. When all customers from a single telehealth provider have the same formulation, it’s hard to make an argument that the formula is individualized.

https://www.npr.org/sections/shots-health-news/2025/04/23/nx-s1-5374063/eli-lilly-sues-companies-selling-alternative-versions-of-its-weight-loss-drug

I do wonder, the argument for many things (think bath salts) being slightly different keeps the DEA at bay. The patent is a specific combination.. as long is there is no insinuation of a comparable medicine, it seems like they have deniability.

 

[lazygardener]

I do wonder, the argument for many things (think bath salts) being slightly different keeps the DEA at bay. The patent is a specific combination.. as long is there is no insinuation of a comparable medicine, it seems like they have deniability.

This is false, the patents cover the API itself in addition to the full formulation. Compounding significant quantities outside of a shortage is disallowed for anything that is "essentially a copy" which is what these all are. Slightly changing a dose or adding B12 doesn't keep it from being essentially a copy.

 

[Calm Logic]

Even if it is not legal, it's how you can play the game in court to buy time.

 

[Skidude]

This is false, the patents cover the API itself in addition to the full formulation. Compounding significant quantities outside of a shortage is disallowed for anything that is "essentially a copy" which is what these all are. Slightly changing a dose or adding B12 doesn't keep it from being essentially a copy.

I would say "false" is a strong statement when addressing a hypothesis-
I would go on to argue that, regarding DEA prosecution, there are numerous cases of formulation changes to avoid scheduling.
I do agree this is an area of contention that apparently will be taken to court to decide.

I am not an attorney and do not claim to know what the outcome will be on this or other cases, it also appears the strategies have not been properly applied, but I think the leapfrog game in designer recreational drugs might be a possible strategy.
Likely EL's attorneys will agree with you and their contention will be it is infringement, the opposing counsel will likely try one of many strategies to argue their case.

Thought process to question the TRUE/FALSE

Yes, drug manufacturers can sometimes slightly change a drug's formulation, delivery method, or manufacturing process to avoid patent infringement. This strategy is known as "design around" and aims to create a product that is functionally similar but distinct enough to not infringe on existing patents.

Here's a more detailed explanation:

• Patent Claims:
  Patents protect specific inventions, including drugs, their formulations, and how they are made. The "claims" within a patent define the scope of protection.
  
  
• "Design Around":
  To avoid infringing a patent, a manufacturer can design a drug that is similar in effect but differs in some way from the patented invention.
  
  • Formulation changes: Altering the active ingredient, excipients, or delivery system.
    
    
  • Method of administration: Changing the route of administration (e.g., oral to injectable).
    
    
  • Manufacturing process: Modifying the way the drug is produced.

There are examples of this strategy:

The case of generic omeprazole (Prilosec) provides a clear example of how generic manufacturers can "design around" a brand-name drug's patents to facilitate market entry. This involves making strategic changes to the formulation, delivery system, or manufacturing process to avoid infringing on the brand's patents.

Here's a more detailed look at how this might work:


1. Patent Coverage: Astrazeneca often protected specific formulations of omeprazole, like the enteric coating to protect it from stomach acid. They also had patents on the alkaline reacting compounds (ARCs) added to the drug core to enhance storage stability.

2. Generic "Design Around": To enter the market, generic manufacturers needed to find ways to create a similar product without infringing on these patents. This could involve:

• Formulation Changes:
  Altering the formulation, excipients, or manufacturing process to achieve the same therapeutic effect without using the patented features. For example, a different enteric coating or a different method of combining ARCs and the active ingredient.
• Delivery System Changes:
  Instead of using the specific capsule or tablet form of Prilosec, generics could have opted for a different delivery method.
• Manufacturing Process Changes:
  Developing a unique manufacturing process to create the generic product without duplicating the patented processes.

3. Legal Challenges: Astrazeneca often challenged generics in court for patent infringement. However, if the generic manufacturer had successfully designed around the patents, they could still gain market access.

In essence, the case of generic omeprazole demonstrates how generic manufacturers can creatively adapt to patented aspects of a brand-name drug while still offering a similar product to the market.