Harry Ostrer is an American medical geneticist, Professor of Pathology and Genetics at the Albert Einstein College of Medicine, and a named plaintiff in Association for Molecular Pathology v. Myriad Genetics — the case in which the US Supreme Court held that naturally occurring DNA cannot be patented.

What did Myriad Genetics do to Harry Ostrer?

In 1999 Myriad sent Ostrer, then at NYU School of Medicine, a letter asserting that the BRCA genetic testing he performed for his patients infringed Myriad's patents. He stopped the testing — and a decade later joined the ACLU lawsuit as a plaintiff.

Can peptides be patented after the Myriad ruling?

A naturally occurring peptide sequence, claimed as a composition of matter, is a product of nature and not patent eligible. Modified or engineered analogues — lipidated, PEGylated, cyclized or substituted forms such as insulin analogues or semaglutide — can still be patented because they do not occur in nature.

Open science · The Myriad fight

The scientist who helped free the genome.

Q: Why did Harry Ostrer matter so much to the case?

Standing. The Federal Circuit held that Ostrer was the only plaintiff with Article III standing to sue, and the Supreme Court's opinion expressly upheld Dr. Ostrer's standing. Without him, the challenge to gene patents could not have been decided on its merits.

Q: What did the Supreme Court decide in AMP v. Myriad?

On June 13, 2013, in a unanimous judgment written by Justice Clarence Thomas, the Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated — while synthetic cDNA remains patent eligible.

In 1999 a letter from a biotech company told Dr. Harry Ostrer to stop testing his patients for breast-cancer genes — because someone owned those genes. He could have forgotten it. Instead he put his name on a lawsuit, became the one plaintiff the courts agreed had the right to be there, and on June 13, 2013 watched a unanimous Supreme Court rule that no one can patent the DNA you are made of. This is his story — and why it still decides what can be owned in peptide science today.

DNA double helix — a naturally occurring sequence, a product of nature that no one may own — Panacea Bio Chem — Scientific illustration — not experimental imagery.

Who Harry Ostrer is

Harry Ostrer is a medical geneticist — Professor of Pathology and Genetics at the Albert Einstein College of Medicine and director of genetic and genomic testing at Montefiore Medical Center, after twenty-one years at NYU School of Medicine. He studies what our genomes say about who we are, and he has spent his career where the laboratory meets the patient. None of that is why this site exists. This site exists because when the ownership of human genes was put on trial, Ostrer turned out to be the one scientist whose legal standing carried the case all the way to the Supreme Court.

The warning letter (1999)

Myriad Genetics held patents on the BRCA1 and BRCA2 genes and enforced them. It sent cease-and-desist letters to university laboratories — including the University of Pennsylvania's Genetic Diagnostic Laboratory and to Ostrer at NYU — asserting that their clinical BRCA testing infringed its patents. Ostrer stopped testing his own patients.

The plaintiff (2009)

Ten years later the ACLU and the Public Patent Foundation sued Myriad on behalf of some twenty plaintiffs — medical associations, researchers, genetic counselors and patients. Ostrer put his name on it. The case was filed on May 12, 2009.

The standing (2011–2012)

The Federal Circuit held that of all the plaintiffs, only Dr. Ostrer had Article III standing — a concrete injury: Myriad's letter had stopped him from doing his work, and he stood ready to resume it. Every judge who reached the question agreed.

The footnote (2013)

In footnote 3 of the Supreme Court's opinion, Justice Thomas expressly confirmed that Dr. Ostrer's standing was sufficient under the Court's precedent. The merits of gene patenting were decided because Harry Ostrer had been injured — and had refused to shrug it off.

What the Court said

On June 13, 2013, in Association for Molecular Pathology v. Myriad Genetics, the Supreme Court held — unanimously in judgment, with Justice Scalia concurring in part — that a naturally occurring DNA segment is a product of nature and cannot be patented merely because someone isolated it. Synthetically created cDNA, which does not occur in nature, remained patent eligible. The full chronicle is on The Story; the Court-side view lives on our sister site justiceclarence.com.

"We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring."

Justice Clarence Thomas, Opinion of the Court, AMP v. Myriad Genetics, 569 U.S. 576 (2013) — full text at Cornell LII

Before: one owner, one price

While its patents stood, Myriad was the sole US provider of BRCA testing. Its BRACAnalysis test listed at roughly $3,340 — about $3,000–$4,000 in most accounts — and laboratories that tried to offer their own versions received letters like Ostrer's.

After: the same afternoon

Within hours of the ruling, DNATraits of Houston announced BRCA1/2 testing for $995; Ambry Genetics announced a competing test at about $2,200; the University of Washington and Quest Diagnostics moved to enter. That is what the end of a gene monopoly looked like in a single day.

"Thrilled"

Science reported that Ostrer was thrilled by the decision and planned to resume the BRCA testing he had been forced to abandon fourteen years earlier. The patient-testing work the letter had stopped could begin again.

The honest boundary

The ruling did not erase Myriad. cDNA claims survived, only the isolated-natural-DNA claims at issue fell, and Myriad sued new competitors (Ambry, July 2013) before most of those suits settled. The principle won; the trench fighting continued.

Why this matters for peptides

The doctrine the Court applied — products of nature are not patent eligible — did not stay inside genetics. The USPTO's 2014 eligibility guidance applies the same "markedly different" test to nature-based products generally, including purified natural products and proteins. The consequence for peptide science is direct:

Nature's sequences: unownable

A naturally occurring peptide sequence, claimed as a composition of matter, is a product of nature. After Myriad, no company can fence off the unmodified sequence of a human hormone or a natural peptide and charge a toll for the molecule itself.

Engineered analogues: still patentable

What pharma actually patents now is the engineering: lipidated peptides like semaglutide and liraglutide, insulin analogues, PEGylated or cyclized forms, D-amino-acid substitutions. The modification is the invention — not the molecule nature wrote. Accuracy matters here: Myriad broke the ownership of natural sequences, not the patenting of genuine chemical invention.

"Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry."

Justice Clarence Thomas, AMP v. Myriad Genetics (2013)

DNA double helix — the molecule at the heart of the Myriad patent fight — Scientific illustration, not experimental imagery

Where Panacea Bio Chem stands

Panacea Bio Chem is a peptide and amino-acid-chain research company. We work with nature's molecules every day, and we say plainly: we agree with Harry Ostrer and we agree with the Court. The human peptide repertoire — like the human genome — is a commons. No natural sequence should ever have a tollbooth on it. What a company may fairly protect is what it actually invents: formulations, processes, delivery systems, engineered analogues. That distinction is not a legal technicality; it is the difference between science as shared knowledge and science as rent-collection. Panacea publishes its positions and its process philosophy openly — see panaceabiochem.co.uk. Our editorial analysis of peptide regulation and public trust is on Our View.

A rare kind of scientist. Every field produces people who patent, fence, and rent out what nature wrote for free. It produces far fewer who will stand in a courtroom and give that enclosure up — at personal cost, against an industry. Harry Ostrer is one of those few. That is the kind of scientist Panacea Bio Chem exists to honour and to be: people who fight over-monetization through patenting, who treat the genome and the peptide repertoire as an inheritance to study rather than an asset to fence — who refuse, on principle, to let a natural sequence become a tollbooth. In our experience such people are rare in every laboratory on Earth, and we do not care which people they come from — we care what they set free. When we find one, we say their name. His name is on this site.

Bogdan Dicoias — Biochemist and AAC Designer, Panacea Bio Chem

"A peptide your own stomach makes is not an invention — it is an inheritance. Ostrer understood that for genes before the law did. The day the Court agreed with him, the price of a cancer-gene test fell by two-thirds before the markets closed. That is what open science is worth, measured in one afternoon."

Bogdan Dicoias — Biochemist · AAC Designer · Panacea Bio Chem Ltd

Frequently asked questions

Who is Harry Ostrer?

A medical geneticist — Professor of Pathology and Genetics at the Albert Einstein College of Medicine — and a named plaintiff in AMP v. Myriad Genetics, the case that ended patenting of naturally occurring human DNA.

What did Myriad do to him?

In 1999 Myriad sent Ostrer, then at NYU, a letter asserting that his clinical BRCA testing infringed its gene patents. He stopped the testing; in 2009 he joined the ACLU lawsuit.

Why was he decisive?

Standing. The Federal Circuit found him the only plaintiff with Article III standing, and the Supreme Court's opinion expressly upheld it in footnote 3. Without Ostrer there is no merits ruling.

What did the Court decide?

On June 13, 2013 — unanimous in judgment, opinion by Justice Thomas — naturally occurring DNA was held a product of nature, not patent eligible merely because isolated; synthetic cDNA remained eligible.

Can peptides be patented after Myriad?

Natural peptide sequences cannot be claimed as compositions of matter; engineered analogues (lipidated, PEGylated, substituted forms) still can be. More on the Questions page and in Our View.