A challenge to Eli Lilly's Tirzepatide patent
Empower Pharmacy has challenged the patent on Eli Lilly's Tirzepatide, creating possibly the biggest possible shock to come to compounding GLP1s.
Empower Pharmacy has challenged the patent on Eli Lilly's Tirzepatide, creating possibly the biggest possible shock to come to compounding GLP1s.
After the fights between GLP1 produces (Eli Lilly, Novo Nordisk) and compounders, the dust is mostly settled. Most compounders have stopped creating compounded GLP1s (a few still persist) and the supply shortages that enabled 503A/503B production of GLP1s has ended.
There's another turn in the story – now a firm out of Houston Texas has filed an appeal challenging Eli Lilly's entire patent on Tirzepatide, the most effective FDA approved GLP1 Receptor Agonist.
This is massive change for the GLP1 ecosystem, and while it might not be likely to succeed, the idea of instant increased accessibility to Tirzepatide is worth discussing/diving into.
The Tirzepatide patent is being challenged by Empower Clinic Services LLC, a compounding pharmacy based in Houston:
They're a 503A & 503B compounding pharmacy (that has no doubt benefited immensely from shortages of Semaglutide and Tirzepatide), and they still list Semaglutide on their "trending products" page, along with Tirzepatide:
Unlike other companies that were emphasizing B12, Empower looks to be combining Semaglutide and Tirzepatide to create meaningfully different formulations. This may explain how they're able to keep compounding where many other "simpler" compounding pharmacies had to stop.
Empower is one of the largest 503A compounders in the US.
They're a professional operation, and seem to have the resources to go the distance with this suit, and the requisite experience in navigating the law to continue compounding where others could not.
As reported by American Pharmacy News:
In its submission, Empower argues that Lilly’s peptide is "an obvious variant of a prior art peptide" and claims that its creation was "a simple matter of routine synthesis." Empower seeks cancellation of multiple claims of U.S. Patent No. 9,474,780 on grounds of obviousness and lack of novelty, citing three earlier international publications that allegedly describe every element of Lilly’s molecule.
The AIA review number is IPR2025-01024, and you an find information about the case by using the PTACTS search system. The appeal has many supporting documents, including the appeal itself, as filed.
We'll summarize the introduction below for easy reading (with emphasis & slight reordering added):
Patentee (“Lilly”) claims a peptide that is an obvious variant of a prior art
peptide sharing the same utility (GIP/GLP-1 receptor dual agonism). Lilly seeks to
extend its patent exclusivity years beyond the expiration date of its original patent,
which covered a peptide sequence known to impart significant GIP/GLP-1 receptor
dual agonism. The prior art specifically taught two straightforward ways to
improve such peptides:
(1) employing a common C-terminal motif derived from a
natural agonist to improve in vivo stability in combination with excellent potency
and low immunogenicity; and
(2) conjugating a known albumin-binding moiety to
a lysine amino acid residue at position 20 of the peptide to prolong its duration of
action.
Building on extensive teachings providing structure-activity-relationships
for the very receptors at issue, the prior art successfully applied these techniques to
improve GIP and GLP-1 receptor agonists. These successes were published by the
end of 2014, before Lilly’s January 2015 earliest-claimed priority date. By that
time, making the claimed peptide was a simple matter of routine synthesis of a
structurally-similar analogue expected to share known utility.
In view of the prior
art and level of ordinary skill, a person of ordinary skill in the art (“POSA”) had
good reason with reasonable expectation of success for making what is claimed.
Accordingly, the claims should be found obvious and cancelled.
This is a massive allegation, and while only experts (and the relevant judges) will understand/have to understand the technical side, the implications are massive.
Eli Lilly is actually in the process of suing Empower:
Kyle McClenagan
You can find the text of the complaint/warning letter here:
Center for Drug Evaluation and Research
Knowing this colors the intent of Empower a bit, and makes this seem more like motivated reasoning, but if they are able to prove what they allege (that anyone could have invented Tirzepatide), they would blow up both their business and Eli Lilly's.
A world with no patent on Tirzepatide is massively beneficial for patients, public health and the world, but it is definitely one in which neither Empower nor Eli Lilly make very much money from sales of Tirzepatide – the stakes are high.
This news is very recent, but the law, and appeals process for patents does not play out quickly. Patent appeals (while not the same as petitions) have a lengthy process involved, and timelines can vary.
So what does this mean for a patent petition? A presentation by the patent office gives a really great explainer of the situation:
So right now, we're at the phase of the petition being filed, and there's. long (but certain) path forward to progress – the next step is the preliminary response, and a decision on the petition that should come in no more than 6 months.
We'll be watching with great interest – along with Eli Lilly, Novo Nordisk, every compounding company and patients who are lucky enough to find out this could change everything.
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