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Frequently asked questions — the Myriad ruling

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

In Justice Thomas's words: "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." 569 U.S. 576, decided June 13, 2013.

Was the decision unanimous?

The judgment was unanimous (9-0). Justice Scalia concurred in part and in the judgment, declining to join the portions describing fine details of molecular biology: "I am unable to affirm those details on my own knowledge or even my own belief."

Why did Justice Thomas write the opinion?

Opinion assignment belongs to the senior justice in the majority; with a unanimous Court, the Chief Justice assigns. Thomas delivered a short, tightly constructed opinion grounded in a century of product-of-nature case law.

What is cDNA and why did it survive?

cDNA (complementary DNA) is synthesized in the laboratory from messenger RNA with the non-coding introns removed. Because that sequence does not exist in nature, the Court held it patent eligible — noting that some very short cDNA may be indistinguishable from natural DNA.

What is the product-of-nature doctrine?

The implicit exception to 35 U.S.C. §101: laws of nature, natural phenomena and abstract ideas are not patentable — applied in Funk Brothers (1948), Chakrabarty (1980, the "markedly different" test), Mayo (2012) and Myriad (2013).

Did the Court say Myriad's work was worthless?

No: "To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention." Discovery was credited; ownership was denied.

What happened to Myriad and to BRCA prices afterwards?

Competitors entered the same day — DNATraits at $995, Ambry at about $2,200, against a ~$3,340 list price. Myriad's stock spiked intraday, then closed down 5.6%. Myriad sued Ambry and others in July 2013; most suits settled. cDNA and hundreds of other claims survived.

Does the ruling mean peptides cannot be patented?

No. Naturally occurring peptide sequences cannot be patented as compositions of matter (USPTO 2014 guidance); engineered analogues — lipidated, PEGylated, cyclized or substituted peptides such as semaglutide — remain patentable.

Why does a peptide company celebrate this ruling?

Because Panacea Bio Chem's model is invention on top of the commons, not enclosure of it. The ruling protects exactly what should be protected (engineered chemistry, formulations, processes) and frees exactly what should be free (nature's sequences). See Our View.

Is anything on this site legal or medical advice?

No. It is a legal-historical editorial record sourced from court opinions, the Federal Register and the press. Nothing here is medical advice or legal advice.