In re Roslin Institute (2014)

Quick Summary

Question: Are cloned animals patentable as products? The Federal Circuit said no when the clone is genetically identical to the donor. Such a clone is a natural copy. A product claim needs markedly different characteristics from nature. Method claims were separate and not before the court here.

Issues

• Are cloned animals, identical to their donors, patentable under 35 U.S.C. § 101?
• What level of difference makes a clone patent-eligible?

Rules

• Products of nature are not patentable. A natural copy remains ineligible.
• Eligibility may exist if the claimed clone has markedly different characteristics from the donor.
• Organisms found in the wild (or newly discovered) are not patentable as products.

Facts (Timeline)

1996: At the Roslin Institute, scientists clone Dolly the sheep.

Technique: Somatic cell nuclear transfer—nucleus from a body cell placed into an enucleated egg.

Key step: Donor cell paused in a resting phase to help development into an embryo.

Result: The clone carries the same nuclear DNA as the adult donor—genetic identity.

USPTO: Rejects product claims as ineligible natural phenomena; method claims allowed (not at issue here).

Appeal: Case reaches the Federal Circuit as In re Roslin Institute.

Arguments

Judgment

The Federal Circuit affirmed: a cloned animal, identical to its donor, is not patentable as a product under § 101. The court noted the applicant did not create or alter the genetic information. The core achievement—preserving donor DNA for an identical copy—left the claimed product within nature’s domain.

Ratio Decidendi

• Natural phenomena are excluded from § 101 unless claims show marked differences.
• Genetic identity to the donor signals no marked difference.
• Human effort alone (process) does not make the product eligible.

Why It Matters

This case sets the line for biotechnology product claims. If a claimed organism mirrors nature, it fails § 101. To pass, point to concrete, marked differences in characteristics—not just how it was made.

Key Takeaways

1. Cloned animal identical to donor = ineligible product of nature.
2. Show markedly different characteristics to cross § 101.
3. Method claims can be eligible even if product claims are not.
4. Discovery ≠ invention; nature remains unpatentable.

Mnemonic + 3-Step Hook

Mnemonic: “ID → MD → OK?”

1. ID: Is the claim a natural identity to nature?
2. MD: Are there Marked Differences in characteristics?
3. OK? If yes, product may be eligible. If no, § 101 bar applies.

IRAC Outline

Glossary

Product of Nature

A thing that exists in nature or is a natural copy; not patentable as a product.

Markedly Different

Clear changes in characteristics that make the product more than a natural copy.

Somatic Cell Nuclear Transfer

Technique where a donor nucleus is placed into an enucleated egg to create an embryo.

FAQs

Related Cases

• Diamond v. Chakrabarty — human-made microorganism patentable.
• Association for Molecular Pathology v. Myriad — DNA products of nature ineligible.
• Mayo v. Prometheus — natural laws and eligibility limits.