The Myriad Genetics Decision: We’ve Only Just Begun

Linda MacDonald Glenn, JD, LLMAssistant Professor, Alden March Bioethics Institute

Consultant and Counselor-at Law

• Legal ≠ Ethical

• Ethical ≠ Legal

• Legal and moral justification are not identical, and it is possible for a legal decision to be immoral although consistent with legal precedent and procedure. It is not surprising that this decision has not significantly allayed doubts about the morality of gene patents.

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• What is ‘naturally occurring’ or ‘product of nature’? (Is it like Justice Stewart’s comment on porn “I know it when I see it.”?) Where the category is subjective or lacks clearly defined parameters?

What else didn’t the Court address in Myriad?

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• This court decision is not restricted to human genes…Commodification?

• But are humans genes to be treated differently?

• What does it mean to be human, anyway?

What else didn’t the Court address in Myriad?

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• The science was faulty – “it is not the scientists who removed the introns from the officially unpatentable original DNA sequence to make the new, patentable cDNA sequence. It is nature itself, through the magic by which pre-RNA, which includes the introns, becomes messenger RNA, which does not.”

What else didn’t the Court address in Myriad?

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• Who benefits from this decision? • Brings costs down for patients, but

still supports economic incentive

What else didn’t the Court address in Myriad?

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Conclusion• Court found that cDNA is patent eligible,

that is, it is a human creation, not a product of nature.

• Court did NOT rule on whether it is patentable, meets the other requirements of the Patent Act. (Speculation that it will fail the obviousness test).

• The case serves as a reminder that human genetics policy is in its highly malleable infancy and many of the issues will only be resolved going forward.