Biotechnology Patents 2026: The Key Pitfalls Regarding Sequences, CRISPR and Genetic Engineering Methods
Patenting biotechnological inventions is one of the most legally challenging areas of industrial property law in 2026 – especially following the recent CRISPR decisions of the PTAB and the EPO, as well as the ongoing EU negotiations on the NGT Regulation. Anyone seeking protection for sequences, gene scissors or genetic engineering processes must confidently navigate formal, substantive and ethical hurdles. This article highlights the key pitfalls and, for in-depth analyses, refers readers to our IP blog at https://legal-patent.com/blog/.transgen+2
Why 2026 is a Pivotal Year
On 26 March 2026, the Patent Trial and Appeal Board (PTAB) confirmed the Broad Institute’s priority for CRISPR/Cas9 in eukaryotic cells for the third time – a milestone for licensees such as Editas Medicine. In parallel, the EPO granted BRAIN Biotech AG a substance protection patent (EP4301852 B1) for the CRISPR-BMC nuclease, showing that the field continues to grow well beyond Cas9. At the same time, the EU Council is wrestling with the patent question in the draft NGT Regulation, aiming to introduce labelling and breeder’s exemption rules.
Pitfall 1: Sequence Disclosure and Enablement
Sequence listings must comply with WIPO Standard ST.26; formal errors in the XML format regularly lead to objections or refusals. A classic mistake is drafting claims too narrowly around a specific wild-type sequence, without covering functional variants or homology ranges – which makes “designing around” easier for competitors, as the CRISPR dispute clearly shows. Conversely, overly broad claims trigger objections for lack of enablement (Art. 83 EPC) and lack of support (Art. 84 EPC).
Pitfall 2: CRISPR and the Priority Trap
The years-long CRISPR dispute between Broad/MIT and UC Berkeley/Charpentier illustrates how crucial a clean priority chain is – in Europe, Doudna and Charpentier lost foundational patents because not all originally named inventors were transferred when claiming priority from the US filing (“any person” doctrine). Anyone filing CRISPR further developments in 2026 (CasX, CasY, Cpf1, base and prime editing) must check whether Freedom-to-Operate exists against the Broad patents and whether all inventors are correctly named. Alternative nucleases such as BRAIN Biotech’s BMC family show that circumvention strategies can be patentable if they demonstrate an independent technical effect.
Pitfall 3: Genetic Engineering Methods vs. “Essentially Biological”
Under Art. 53(b) EPC and Rule 28(2) IR, essentially biological processes for the breeding of plants and animals are not patentable – whereas genetic engineering methods are. The distinction is delicate: the EPO classifies targeted mutagenesis using CRISPR as a technical process, while classical crossing and selection remain excluded. Anyone filing applications for NGT plants should describe the technical intervention precisely and keep an eye on the planned EU regulation, which will introduce labelling and possibly a breeder’s exemption.
Pitfall 4: Ethics, Ordre Public and the Germ Line
Art. 53(a) EPC excludes inventions whose commercial exploitation would be contrary to ordre public or morality – this includes methods for modifying the human germ line identity as well as the use of human embryos for industrial purposes (Rule 28(1) IR). For therapeutic CRISPR applications in somatic cells, by contrast, patentability generally exists, provided the medical indication is sufficiently supported.
Pitfall 5: AI-Assisted Sequence Designs
The combination of NGT and AI – for example at INARI, which claims DNA variants for gene regulation in virtually all plant species – raises new questions regarding inventive step and inventor designation. Under the DABUS case law, the named inventor must be a natural person; AI-generated sequences therefore require careful documentation of the human contribution to selection and validation.
Practice Checklist for Applicants in 2026
- Generate and validate ST.26-compliant sequence listings at an early stage
- Draft claims in a tiered manner (wild-type, variants, functional homologues) with sufficient examples
- Document the priority chain and inventor designation seamlessly, especially for US priorities
- Conduct a Freedom-to-Operate analysis against Broad/Editas and BRAIN
- Clearly distinguish the technical character of genetic engineering interventions from “essentially biological” processes
- Check ordre-public-relevant exclusions (germ line, embryos)
- Continuously monitor the EU NGT Regulation and national decisions on the breeder’s exemption
- Take into account the EU Biotech Act adopted at the end of 2025, including possible 12-month SPC extensions for medicinal products from biotechnological processes
Further Resources
In-depth articles on CRISPR priority law, EPO opposition proceedings and biopatent strategy are continuously updated on our firm’s blog at https://legal-patent.com/blog/ – including analyses of the Broad vs. UC Berkeley priority dispute and the “any person” doctrine. For individual mandates concerning biotech applications, FTO opinions or oppositions, MD LEGAL – European Patent Attorneys is at your service.
