Expert Call: Notes from Capital Forum's GLP-1 Compounding Legal Landscape
Conversation for intellectual property focused on Hims GLP-1 business
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On March 11th, 2025, Capital Forum hosted a call with Shweta Kumar, a clinical teaching fellow at Georgetown, who specializes in intellectual property and information policy, to discuss the legal landscape for GLP-1 Compounding.
Shweta Kumar spoke about what FDA law and regulations say about compounding off-shortage drugs, the viability of personalized GLP-1 dosing strategies, the potential for patent infringement claims against compounders, and more.
Below are the quick notes that we took from the call.
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Notes from Capital Forum Call
The term, “personalization” is not included in the FDA compounding definition.
There's a misconception that 503Bs can continue compounding long after the shortage, so long as the doses are personalized.
There’s a misunderstanding that you can change up the dosage form or add some inactive ingredients, like vitamins, but the 2018 FDA guidance already suggests that minor changes may not be enough to get around the first list of characteristics for an essential copy.
HIMS would need to provide assurances that the personalization is clinically different.
“It's almost like asking him to run many clinical trials, and if a healthcare provider that's associated or works for the Hims and Hers platform or any other telehealth provider is inclined to provide such assurances without really doing deep research or investigation into patient records and how individual patients might respond to a modified version of the approved product. I think it raises a whole host of questions about liability for a minimum malpractice and other practice of medicine issues.”
Likely that the FDA would pursue enforcement even with this administration, hinting that RFK Jr. or Martin Makary wouldn’t get in the way.
The judge will deny the OFA suit against the FDA for Semaglutide just like they did for Tirzepatide.
AFC is incorrect that the FDA can't sue for patents or protect them from infringement.
The FDA has no jurisdiction over patent law and also no power to protect compounding pharmacies from liability for patent infringement.
The Patent Act grants patentees a prior right to enforce their patents and a remedy for infringement.
It's a private matter via the patent owner which is free to sue whenever.
Any compounding 503b past grant day would be violating FDA rules.
There are core and secondary patents → core expires as early as 2026 while secondary expires in 2032/33.
Secondary patents protect various aspects of the drug and its use.
Includes: Different formulations, methods of manufacturing, and also different dosage regimes as well as the injectable syringe.
Any compounded drug will infringe on core patents until 2026 but even in the best-case scenario, if a creative compounding pharmacy finds a way to design around the secondary patents that would unfortunately still violate FDA law.
Couldn’t find any examples of patent insect lawsuits brought by drug manufacturers against compounding pharmacies that reached trial or substantive judgments by courts.
Any current suits have settled or have had default judgments - can't handle the cost of litigation.
HIMS spent $200k on lobbying in 2024 vs $20k in 2023 (10x).
Branded companies can seek preliminary and then permanent injunctions, and courts and patent cases generally award injunctions.
There's been some discussion about that last factor in particular, that the public interest would not be deserved. I think you can see that you can make a colorful argument that it's really important to preserve access to these drugs by permitting the continuation of compounding, but the Federal Circuit has said that the last factor about public interest requires weighing the interests of the patentee with us as well.
Compounders would settle before 2026 because they would not survive litigation.
Could get around secondary patents via vials and self-injectors.
Global patents expected to expire in 2026 → China, India, Brazil, etc.
Before the GLP-1 boom, compounded pharmaceuticals were only estimated to comprise between one to 3% of all prescriptions. Now that number has probably risen significantly during the GLP-1 shortage.
For Hims and Hers, the end of the shortage spells the end of compounding at least in the short term.
Call Q&A
How would Hims via 503a be able to advocate for dosages to help with side effects?
The important difference (between 503b and 503a) is that the API, the active pharmaceutical ingredients, had similar or easily substitutable dosage strengths.
If you think about the spirit of what these compounding regulations and restrictions are intended to do, they are intended to preserve the ability of compounding pharmacies to make dosages for patients that aren't commercially available, that patients can't access, but if compounding pharmacies are providing these specialized dosages in vials, and the patient is responsible for taking up the correct dosage it’s kind of hard to see how that would fit within the spirit of FDA regulations.
Are there any other non-GLP-1 drugs where there has been a fair amount of legal compounding that's taken place with some form of personalization?
None that she can think of.
When there are lawsuits filed against these small compounding pharmacies, there's a huge pressure on these pharmacies to settle or somehow find a way to get out of this litigation.
She is aware that there are a number of other telehealth platforms that are offering personalized doses. In those cases, there are no patents at play, and those personalized doses are of drugs in either in shortage or they're they comply with the FDA regulations in some other way.
On the FDA side, what would enforcement look like if the FDA were to take action? Would RFK adhere to the FDA guidance?
For the FDA to choose not to take enforcement action would be profoundly anti-industry, which historically, the FDA has been relatively industry-friendly as far as agencies go.
For the FDA to choose to go against what they've long said in their guidance and regulations on compounding, which exists to preserve the incentive for drug managers to seek regular approval through the end of the process.
“For FDA to say, you know, forget that we're just going to let compounding happen, I think would raise a whole host of issues related to how other generic drugs get approved. If you remove this enforcement piece, there's really no incentive for generic companies to seek the normal approval process when compounding pharmacies could fill that gap. So I think a failure to enforce would be very unusual.”
At what point does personalizing at the 503a level constitute mass prescribing, which no longer means that it's that it's unique, and if it's truly unique, at what point are too many people unique when it comes to when it comes to personalized dosing?
Standard is that pharmacies can compound drugs, as long as they're not compounding, essentially, copies of commercially available drugs regularly or in inordinate amounts.
2018 FDA guidance has a list of factors that describes what regularly or inordinate amounts mean.
Whether the compounded drug is more than a small number of prescriptions.
More than a small percentage of the total compounded drug products that the compounder is preparing.
Whether it compounds routinely or is routinely substituting compounded drugs on receiving prescriptions for the patients.
Whether the compounder has pre-printed prescription pads, etc.
FDA might follow up to investigate compounded prescriptions and make sure that prescribers aren't abusing it
Who decides if a personalized dosage counts as a minor change that can't be sold? Who ultimately decides if a personalized GLP-1 compound via a unique dosage or adding something like vitamins is legally okay to sell, or is just a minor change?
FDA can take enforcement without the branded companies; they usually do.
FDA would enforce 503b while needing to go to states to then enforce 503a.
Any prescription for compounded drugs gets recorded as a compounded drug which puts the burden on the prescriber. FDA can follow up with individual practitioners who are prescribing too many of these scripts to see what’s going on.
What’s the timing for Novo Nordisk to go after compounders after they’ve rolled off of 503b and moved to 503a?
First, they’ll wait to see if compounders adhere to FDA regulations and updates.
Shortages don’t protect compounders from patent litigation so branded pharma could have sued for patent infringement at any point but didn’t.
The reason she believes they didn’t do that was because patent infringement cases are very expensive and after they send cease and desist letters, they would want to see if they do/don’t comply with the FDA before going that far.
Damages are pretty well-defined.
Treble damages are applicable if there’s willful infringement. If the companies sent cease and desist letters and they’ve still continued to compound after the fact, that’s definitely supportive of willful infringement.
Are the rules for how much you can prescribe compounded drugs at the 503a level based on the total amount of compounded drugs in general or just for that particular drug?
It’s based on the total percentage of compounded drugs being written, not just GLP-1s.
For the generic drug applicants who have an approved generic drug, do ANDA holders have any standing to bring action against compounders?
Approved ANDA holders cannot sue the compounders on FDA law, but ANDA filers could sue compounders for trademark infringement or unfair competition if the compounders say their products are generic.
If Hims sells a month of Ozempic for $200, would they owe Novo gross profit calculated from the $200 price or from Novo Nordisk's $1,200 price point? So what would the what would the losses or the damages be based on?
Lost profits would be based on the Novo price.
Compounders would be arguing for reasonable royalties, whereas the branded drug companies would be arguing for lost profits.
Profits would be based on the time that branded pharma would be able to fill the gap in the market (i.e. not during a shortage).
Who decides what a “clinical difference” is?
There aren't any FDA guidances that specify what that actually looks like, but that would be left to the discretion of the individual prescriber.
FDA has traditionally taken the position that they're not engaged in the practice of medicine, so the guidelines are intentionally defined to allow some discretion on the prescribing practitioners’ end.
That puts the burden back on the prescriber to ensure that they’re in compliance with their state regulations since providers are licensed under the other state boards.
Hims is bother a prescriber and a compounded so when it comes to a patent suit, who would win?
If the case is based on the core patents, it’s a pretty clear win for the branded companies.
How could so much personalization happen if they're effectively creating a new drug each time they're writing these personalized scripts?
Hims states that they plan on personalizing these doses and therefore getting around the FDA law but in effect, they’re not really doing so. It still has the same active ingredient.
For the safety of the consumer, the drug should match the profile of the approved drug.
That’s the problem. They’re not making a new drug, they’re making copies of these drugs and finding minor ways to tweak them to get around FDA regulations.
Could Eli Lilly and Novo Nordisk still sue if the patent suit extends beyond the 2026 expiration of the core patents?
Yes, if they allege that the compounded drugs are being made by their secondary patents, which relate to massive abuse and dosage, certainly they can go after they can go after the compounders after 2026 in the US.
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