What did the Federal Circuit decide in Re Roslin Institute?

It held that animal clones identical to their donors are not patentable under 35 U.S.C. §101 unless the claimed clones have markedly different characteristics.

Does this case ban all cloning patents?

No. Method claims may be eligible, and product claims might be if the clone has features that are markedly different from the donor.

What is meant by 'markedly different characteristics'?

Differences that make the claimed subject materially unlike what exists in nature, not just incidental or trivial changes.

How is Re Roslin different from Chakrabarty?

Chakrabarty involved a genetically engineered bacterium with new characteristics. Roslin’s claimed sheep was an unmodified natural copy.

Re Roslin Institute (Edinburgh)

U.S. Court of Appeals, Federal Circuit 2014 750 F.3d 1333 (Fed. Cir.) Patent • §101 • Biotech ~8 min read

35 U.S.C. §101 Product of Nature Markedly Different India

Author: Gulzar Hashmi

Location: India

Slug: re-roslin-institute-edinburgh

Published: 2025-11-01

CASE_TITLE: Re Roslin Institute (Edinburgh) PRIMARY_KEYWORDS: §101, clones, product of nature SECONDARY_KEYWORDS: Dolly, markedly different, Federal Circuit PUBLISH_DATE: 2025-11-01 AUTHOR_NAME: Gulzar Hashmi LOCATION: India

Quick Summary

The Roslin team cloned Dolly the sheep using somatic cell nuclear transfer. They sought patents on the cloned animals. The Federal Circuit said: no. If a claimed clone is genetically identical to the donor animal, it is a product of nature and not patentable under 35 U.S.C. §101, unless the claim shows markedly different characteristics. Method claims were separate and not at issue here.

Court judgment concept with DNA double helix

Issues

Are animal clones that are genetically identical to donors patentable subject matter under §101?
Do such claims become eligible if the clone has markedly different characteristics from the donor?

Rules

§101 Eligibility: Laws of nature, natural phenomena, and abstract ideas are not patentable. Products of nature are excluded.
Markedly Different Test: A clone must show characteristics that make it materially unlike its natural counterpart to qualify.
No Patents on Existing Organisms: Naturally occurring animals/plants found in the wild are not patentable as such.

Facts (Timeline)

1996: Dolly is cloned at the Roslin Institute by Ian Wilmut, Keith Campbell, and team using somatic cell nuclear transfer.

Technique: remove nucleus from an egg; insert nucleus from a somatic (body) cell; stimulate to develop into an embryo.

Key insight: donor somatic cell in quiescent phase improves embryo development.

Result: the cloned animal is a genetic duplicate of the donor mammal.

USPTO: Rejects product claims under §101 as a natural phenomenon lacking markedly different traits. (Method claims allowed but not in issue.)

Federal Circuit (2014): Affirms rejection: identical clones are not patentable subject matter.

Timeline from Dolly’s cloning to Federal Circuit decision

Arguments

Appellant (Roslin Institute)

Clones are made by humans using advanced techniques.
Clones may show epigenetic or phenotypic differences.
Should be treated like other human-made inventions.

Respondent (USPTO)

Claims cover an animal that is a natural copy of a mammal.
No markedly different characteristics are recited in the claims.
Thus, the claims are to a product of nature, excluded by §101.

Judgment

Affirmed. The Federal Circuit upheld the USPTO’s rejection. Because the claimed animals were genetically identical to donor mammals, they were not patentable subject matter under §101. The inventive contribution was mainly the preservation of donor DNA—this does not make the animal itself eligible.

No alteration of the animal’s genetic information was claimed.
Eligibility could differ if claims recited markedly different traits.

Ratio (Core Principle)

A claim to a living thing that is a natural duplicate of a donor is a product of nature and not patentable under §101 unless the claim requires markedly different characteristics.

Why It Matters

Clarifies limits on biotech product patents in the U.S.
Signals that claim drafting must focus on differences from nature.
Separates methods (which may be eligible) from products that mirror nature.

Key Takeaways

Product of Nature

Identical clones are treated as natural products, not inventions.

Markedly Different

Eligibility turns on claimed differences, not the effort behind making them.

Method vs Product

Methods may pass §101 even when products do not.

Draft Precisely

Include traits that make the clone materially unlike the donor.

Mnemonic + 3-Step Hook

Mnemonic: “Clone ≠ Known” — a clone must depart from what is known in nature.

Identify Nature: What is the natural counterpart?
Mark the Difference: Are markedly different traits claimed?
Choose the Path: If not, consider method claims or add concrete differences.

IRAC Outline

Issue: Are cloned animals identical to donors patentable under §101?

Rule: Products of nature are excluded unless the claim shows markedly different characteristics.

Application: Claims covered animals that were genetic duplicates; no distinct traits were required by the claims.

Conclusion: Not eligible. Rejection affirmed.

Glossary

§101: U.S. law that defines what kinds of inventions are patentable.
Product of Nature: Something that exists in nature without human-created differences.
Markedly Different: Clear, material traits that make the claimed thing unlike its natural version.