Our View: the ruling's long shadow over peptides
This is an editorial page. Blue boxes are sourced fact; amber boxes are Panacea Bio Chem's opinion. We keep them apart because the Myriad opinion itself was an exercise in keeping things apart — discovery from invention, nature from ownership.
1. The ruling wrote the rule peptides live under
- The USPTO's 2014 Interim Guidance applies the Myriad/Mayo "markedly different" analysis to nature-based products generally, including purified natural products and proteins. Federal Register, Dec. 16, 2014.
- A naturally occurring peptide sequence is not patent eligible as a composition of matter. Engineered analogues — lipidated peptides such as semaglutide and liraglutide, insulin analogues, PEGylated or cyclized forms — remain patentable and are heavily patented.
- Within hours of the ruling, BRCA testing was announced at $995 against a list price of about $3,340 — a same-day demonstration of what monopoly pricing had been worth. PR Newswire, June 13, 2013.
Notice what pharma did next, because it is the strongest proof that the Court got the balance right. The industry did not stop inventing; it stopped enclosing. The money moved from claiming nature's sequences to engineering real analogues — semaglutide is a natural hormone's backbone, modified by human hands until it does something nature's version cannot. That is precisely the bargain Chakrabarty and Myriad describe: invention rewarded, discovery left free. When a patent system channels effort into genuine chemistry instead of fence-building, everyone — including the patent holders — ends up richer.
2. The orphan the ruling left behind
- Most peptides sold as research materials are not FDA-approved drugs; the approval pathway (IND → clinical trials → NDA/BLA) costs what only exclusivity can repay. FDA drug development.
- DSHEA's supplement framework generally does not fit synthetic therapeutic peptides, and its drug-exclusion clause bars substances first investigated as drugs. FDA dietary supplements.
- In September 2023 the FDA placed numerous compounded peptides (BPC-157, ipamorelin, CJC-1295, AOD-9604, thymosin beta-4 and others) in Category 2 of its bulk-substances list; in October 2024 several were moved back pending advisory review. FDA Category 2 list.
- In the EU, peptides marketed for human use without authorization are unlicensed medicines under Directive 2001/83/EC. EUR-Lex.
Here is the uncomfortable corollary of a ruling we celebrate. Myriad made natural peptides unownable — and unownable molecules are unfundable, because no one can charge monopoly rent to recover a billion-dollar trial programme. So the natural peptides sit in a regulatory no-man's land: not condemned by evidence, never given the chance to produce any. We believe the honest fix is not to re-patent nature but to fund open, precompetitive human studies on unpatentable compounds — publicly, transparently, with the data belonging to everyone. Justice Thomas freed the genome. Somebody still has to fund what grows on free ground.
3. Trust after COVID
KFF's Tracking Poll on Health Information and Trust (January 2025) puts trust in the CDC at 61% (from 66% in June 2023), with trust in the FDA and in state and local public health officials each down by double digits in the same window. KFF, January 2025.
We read those numbers as a warning to people like us, not just to agencies. When regulators stumble, the space fills with two kinds of voice: the grifter selling certainty, and the nihilist selling despair. The Myriad story offers a third posture — the one we try to hold. Respect the institutions enough to use them properly: the ACLU used the courts, Ostrer used his standing, the Court used a century of doctrine, and the result was a correction more thorough than any bonfire. Distrust should make us more demanding of evidence, not less. Nothing on this site is medical advice, and no page on it will ever sell you a molecule — that is our small contribution to a slower, more honest trust.
Frequently asked questions
How did pharma adapt to the Myriad ruling?
By patenting what is genuinely engineered: modified peptide analogues (semaglutide, liraglutide, insulin analogues, PEGylated and cyclized forms), formulations, devices and processes — not natural sequences.
Why are so few natural peptides approved as drugs?
Largely economics: a natural sequence cannot be patented as a composition of matter after Myriad, so no exclusivity exists to repay the trial pathway; without trials, no approval. The evidence was never funded — not lost.
What is the FDA's position on "research use only" peptides?
That the label is no shelter: FDA has warned companies selling unapproved semaglutide, tirzepatide or retatrutide products falsely labeled "for research purposes" or "not for human consumption."
What do surveys show about trust in US health regulators?
KFF (January 2025): CDC trust 61%, down from 66% in June 2023; trust in the FDA and in state/local public health officials each down by double digits over the same period.