harryostrer.com

Frequently asked questions — Harry Ostrer and the Myriad case

Who is Harry Ostrer?

An American medical geneticist — Professor of Pathology and Genetics at the Albert Einstein College of Medicine, director of genetic and genomic testing at Montefiore Medical Center, previously 21 years at NYU — and a named plaintiff in AMP v. Myriad Genetics.

Was Harry Ostrer an expert witness in the Myriad case?

No — he was a named plaintiff. The Federal Circuit held him the only plaintiff with Article III standing, because Myriad's 1999 warning letter had directly stopped his clinical BRCA testing. The Supreme Court's opinion upheld his standing in footnote 3.

What exactly did Myriad's letter to Ostrer say?

It asserted that the BRCA testing he performed infringed Myriad's patents. The opinion records: "After learning of GDL's testing and Ostrer's activities, Myriad sent letters to them asserting that the genetic testing infringed Myriad's patents." Ostrer stopped offering the testing.

What did the Supreme Court hold in AMP v. Myriad?

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." Decided June 13, 2013; unanimous judgment; opinion by Justice Clarence Thomas; Justice Scalia concurred in part.

What happened to BRCA test prices after the ruling?

Competition arrived the same day: DNATraits announced BRCA1/2 testing at $995 within hours (Myriad's list price had been about $3,340); Ambry Genetics announced a competing test at roughly $2,200; the University of Washington and Quest Diagnostics moved to enter.

Did the ruling destroy Myriad Genetics?

No. cDNA claims survived; only the isolated-natural-DNA claims at issue were invalidated; Myriad sued new entrants such as Ambry in July 2013, and most of those suits settled. Its stock spiked intraday on decision day, then closed down 5.6%.

Did Harry Ostrer say that peptides cannot be patented?

There is no record of such a statement. The accurate version: the case he carried as plaintiff established that naturally occurring sequences are products of nature and unpatentable — and under the USPTO's 2014 guidance the same doctrine reaches natural peptide sequences, while engineered analogues remain patentable.

Can a naturally occurring peptide be patented today?

As a composition of matter, no — a natural sequence is a product of nature under the Myriad/Mayo framework and the USPTO's 2014 Interim Guidance. Modified forms (lipidated, PEGylated, cyclized, substituted analogues such as semaglutide or insulin analogues) can still be patented because they do not occur in nature.

What is Panacea Bio Chem's position on gene and peptide patents?

Panacea agrees with Ostrer and with the Court: natural sequences are a commons and should carry no toll. What a company may fairly protect is its own invention — formulations, processes, engineered analogues. See Our View for the full editorial position and The Story for the chronicle.

Is anything on this site medical advice?

No. This is a historical and scientific editorial record, sourced from court opinions, regulators and the press. Nothing here is medical advice.