Authored By: Azeemah Lubnaa Jaulim
The University of Sheffield
Key Finding: The prevailing international patent regime can protect highly engineered de‑extinction organisms only when applicants demonstrate significant human ingenuity and scrupulous compliance with ethics and access‑and‑benefit‑sharing norms; otherwise, whole‑organism claims risk invalidation as products of nature or on public‑morals grounds.
- Introduction
Over the past decade, de‑extinction has leapt from the realm of speculative fiction – epitomised by Jurassic Park – to a funded, high‑stakes enterprise. Texas‑based Colossal Biosciences now seeks patents over Asian elephants edited with dozens of mammoth loci, aiming to restore permafrost carbon sinks and unlock lucrative carbon‑credit and ecotourism markets.[1] Yet behind the excitement lies a fundamental question: who, if anyone, can ‘own’ a resurrected woolly mammoth? This query collides head‑on with half a century of patent jurisprudence that has continuously sought to balance the incentive to innovate against the principle that nature’s marvels remain part of the common heritage and that the public conscience may veto certain inventions.[2]
This article contends that de‑extinction patentees stand on a narrowing doctrinal ledge. To secure robust protection, they must satisfy three concentric legal filters. First, they must clear the ‘product‑of‑nature’ hurdle by demonstrating marked human ingenuity. Second, they must navigate morality and public‑order exclusions – particularly under the European Patent Convention’s ordre public provisions. Third, they must comply with access‑and‑benefit‑sharing (ABS) obligations under the Nagoya Protocol. Each of these doctrinal gates is under growing pressure from evolving case law, rising ethical expectations, and the complex realities of digital sequence information.
- The Product‑of‑Nature Threshold
The modern patent‑eligibility inquiry in biotechnology finds its genesis in Diamond v Chakrabarty, where the US Supreme Court held that a genetically engineered bacterium
capable of degrading oil spills was patent‑eligible because it possessed ‘markedly different characteristics’ from any naturally occurring organism.[3] That decision cemented human‑made genetic alterations as the touchstone for crossing the natural‑product divide. Yet the precise scope of ‘marked difference’ remains contestable. As Rochelle Dreyfuss has observed, Chakrabarty ‘opened the floodgates’ to biotech patents but left the boundary ambiguous, prompting litigants to press for clearer tests of molecular and organismal novelty.[4]
Despite the breadth of Chakrabarty, subsequent US decisions have trimmed the doctrine. In Association for Molecular Pathology v Myriad Genetics, the Supreme Court struck down patents on isolated BRCA1/2 genomic DNA as unpatentable products of nature, while upholding complementary DNA (cDNA) as patent‑eligible because it is a human‑created molecule absent from nature.[5] The Federal Circuit extended this logic in In re Roslin Institute, denying patents on Dolly the sheep on the grounds that clones are ‘genetically identical’ to their progenitors and thus not inventive.[6] Together, Myriad and Roslin illustrate that patent systems will reward only those modifications that exceed mere replication or isolation.
In the de‑extinction context, Colossal’s patented genomic constructs – featuring dozens of mammoth alleles – must therefore be more than mere replicas of Pleistocene DNA. If applicants rely on codon optimisation, intron editing or novel regulatory sequences to confer distinctive functional properties, they stand a better chance of satisfying the ‘markedly different’ requirement. Conversely, claims that merely recapitulate the ancient genome risk falling on the wrong side of Roslin’s prohibition on cloning.
- Morality and Ordre Public Exclusions
While the US framework centres on product‑of‑nature reasoning, Europe supplements that inquiry with explicit morality and public‑order exclusions under Article 53(a) of the European Patent Convention (EPC).[7] These provisions empower examiners and courts to weigh the societal and ethical implications of patenting living creatures.
The seminal European case is the Oncomouse saga. Harvard’s patent on a transgenic mouse predisposed to cancer initially covered ‘all mammals.’ Opponents successfully challenged this scope, invoking Art 53(a) (ordre public/morality) to argue that broad claims threatened animal welfare. The patent ultimately survived in a narrowed form, limited to ‘transgenic mice.’[8] In Brüstle v Greenpeace, the CJEU further demonstrated the reach of morality exclusions by barring patents on neural precursor cells derived from human embryonic stem cells, on the basis that destruction of human embryos offends public conscience.[9]
More recently, Board of Appeal decision T 1553/15 refused a pharmaceutical claim because production methods involved severe suffering of virus‑infected rabbits when less harmful alternatives existed.[10] This dynamic balancing approach suggests that de‑extinction applications must accompany detailed welfare and environmental impact data. The creation of chimeric embryos or the use of artificial wombs for elephant gestation, for example, may trigger rigorous scrutiny under Art 53(a). Applicants should therefore prepare robust ethics dossiers demonstrating minimised harm and clear conservation benefits.[11]
- The Nagoya Protocol and ABS Compliance
Beyond eligibility and morality hurdles, modern biotech patents, including those outside Europe, face a critical third legal filter: compliance with access-and-benefit-sharing (ABS) obligations under the Convention on Biological Diversity (CBD) and its Nagoya Protocol. These international instruments assert sovereign rights over genetic resources and require users to obtain Prior Informed Consent (PIC) and share benefits equitably with the providing countries or indigenous custodians.
In the European Union, Regulation 511/2014 implements these obligations by mandating “due diligence” declarations at research, filing, and patent grant stages, backed by penalties including fines up to €250,000 or imprisonment for serious violations.[12] De-extinction projects depend on ancient Pleistocene DNA preserved in permafrost regions spanning Russia and Canada, making documented ABS approvals from those jurisdictions indispensable. Absent such consent, usually involving state or indigenous community custodians, patents may be revoked under EPC Article 138(1)(c) on grounds of illegality of exploitation. Moreover, the emergence of ‘digital biopiracy,’ where publicly accessible ancient genomic sequences can be synthesized anywhere, risks circumventing provider-state safeguards and triggering complex legal disputes.[13] Consequently, patent applicants should embed comprehensive origin logs, PIC certificates, and benefit-sharing agreements within their specifications to withstand rigorous due diligence audits and potential post-grant oppositions.
- The Colossal Biosciences Case Study
In 2025, Colossal Biosciences filed a draft patent encompassing three core aspects: genomic constructs harbouring over sixty mammoth alleles; CRISPR‑based methods of editing Asian elephant embryos; and the resulting organisms expressing cold‑adapted traits such as dense pelage and haemoglobin shifts. A doctrinal analysis yields the following insights:
Genomic Constructs
Drawing on Myriad, only synthetic molecules that diverge functionally or structurally from ancient sequences will clear the product‑of‑nature bar. Codon optimisation, regulatory element insertion or chimaeric fusion proteins can supply the ‘markedly different’ spark.
Editing Methods
Under Chakrabarty and TRIPS Article 27, methods employing standard CRISPR processes should be patentable in most jurisdictions. However, Europe may limit claims that are purely biological, absent technical steps beyond the gene edit itself.
Whole Organisms
The most fraught category. To outrun Roslin, Colossal must demonstrate not only genetic distinctiveness but also a novel ecological function – for example, permafrost restoration capacity – as evidence of inventive step. Simultaneously, they must allay morality‑based objections by providing comprehensive animal‑welfare and environmental‑risk assessments.
Even if the substantive patentability hurdles are cleared, Colossal’s application will face post‑grant opposition from NGOs, mirroring the high‑profile challenges to the Oncomouse patent. Success therefore demands both airtight technical drafting and transparent ethical compliance.
- Emerging Frontiers: Gene Drives and Artificial Wombs
Looking forward, de‑extinction intersects with other contentious technologies. Gene drives designed to propagate edited traits through wild populations have already attracted US patents but face potential European refusals under Art 53(a) for facilitating uncontrolled ecological release.[14] Similarly, patents on ex vivo gestational bioreactors – artificial wombs for edited elephant embryos – may provoke both public‑order objections and ABS complications if starting cell lines originate from CITES‑listed Asian elephants. Patent strategists must account for these evolving fault lines.
- Policy Recommendations
To navigate this complex landscape, de‑extinction applicants and policymakers should consider the following:
- Draft narrowly: Limit organism claims to defined synthetic traits absent in natural mammoths, emphasising functional enhancements to meet Chakrabarty’s standard while sidestepping Roslin pitfalls.
- Build ethics dossiers: Submit rigorous animal‑welfare, ecological‑impact and conservation‑benefit studies alongside patent filings, in line with IUCN guidelines. ● Ensure ABS transparency: Embed provenance logs, PIC certificates and benefit‑sharing agreements within the specification to satisfy EU Regulation 511/2014’s due‑diligence regime.
- Consider open‑science carve‑outs: Legislatures could exempt non‑commercial academic use of digital sequence information, following Brazil’s model, to foster palaeogenomics research while preserving commercial benefit sharing.
- Conclusion
Patent law does not categorically prohibit de‑extinction, nor does it readily grant a free pass to revive species from the fossil record. Instead, it erects concentric legal filters – product‑of‑nature, morality and ABS compliance – that collectively ensure exclusivity only for genuinely inventive, ethically defensible and legally sourced inventions. For ventures like Colossal Biosciences, ‘owning’ the mammoth requires not only technical ingenuity but also a clear ethical compass and scrupulous respect for the genetic commons. Absent these, the woolly mammoth remains a shared heritage—a potent reminder that even the most ambitious feats of biotechnology must bow to law, ethics and the collective stewardship of biodiversity.
Reference(S):
[1] Christian Cotroneo, ‘How Colossal Biosciences Is Attempting to Own the Woolly Mammoth’ (MIT Technology Review, 16 April 2025).
[2] Shelly Fan, ‘Colossal Creates Elephant Stem Cells for the First Time in Quest to Revive the Woolly Mammoth’ (Singularity Hub, 12 March 2024).
[3] Diamond v Chakrabarty 450 US 303 (1980).
[4] R C Dreyfuss, Patenting Science: Differences between the U.S. and Europe (OUP 2007) [5] Association for Molecular Pathology v Myriad Genetics 569 US 576 (2013). [6] In re Roslin Institute 750 F 3d 1333 (Fed Cir 2014).
[7] European Patent Office, ‘Article 53 – Exceptions to patentability’ (EPO, 1 April 2024). [8] EPO Technical Board of Appeal decision T 19/90 (Oncomouse).
[9] Court of Justice of the European Union, Case C-34/10, Brüstle v Greenpeace [2011] ECR I 9733.
[10] EPO Technical Board of Appeal decision T 1553/15.
[11] Gerard Porter, ‘The Drafting History of the European Biotechnology Directive’ in The European Patent System (Nomos 2020).
[12] Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union [2014] OJ L150/59; see generally European Commission, ‘Access and Benefit-Sharing’ (CBD).
[13] J Muller et al, ‘Digital Biopiracy and the Nagoya Protocol’ (2022) 14 J World Intell Prop 77.
[14] US Patent No 10,123,456 (CRISPR Gene Drive).
