TRIPS does not contain a “sequence listing obligation.” No provision of the Agreement mentions nucleotide or amino acid sequence listings, XML formats, or WIPO standards. The requirement to file a sequence listing comes from national and regional patent law, the Patent Cooperation Treaty (PCT) and WIPO technical standards.
TRIPS matters indirectly, in three ways:
- It sets the patentability and disclosure baseline that makes sequence listings necessary in practice.
- It permits formalities, which is the legal footing for national sequence listing rules.
- It contains the transition periods and flexibilities that determine when and how developing countries have to implement patent rules at all.
This article traces those links, explains the current ST.26 standard and covers the practical and policy issues developing countries face, including the overlap with the genetic resources and “biopiracy” debate.
1. What a sequence listing is and where the standard stands
If a patent application discloses nucleotide or amino acid sequences, in the description, claims, or drawings, the applicant must provide a sequence listing to the patent office. The listing forms part of the description and must conform to the relevant WIPO standard. Under the current standard, a sequence listing must be provided whenever an application discloses nucleotide or amino acid sequences and it forms part of the description.
ST.26 replaced ST.25. The current standard is WIPO ST.26, an XML-based format. All applications filed on or after July 1, 2022 that disclose amino acid and nucleotide sequences must include an ST.26 XML sequence listing, while listings for earlier-filed applications should still follow ST.25. A revised version, 1.6, took effect on July 1, 2023.
Key features of ST.26:
- Minimum thresholds. A sequence must have at least 10 specifically defined nucleotides or 4 specifically defined amino acids to be listed and undefined residues such as “n” no longer count toward that minimum.
- XML only. Sequence listings can no longer be filed on paper or in non-XML formats such as PDF images.
- Richer annotation. ST.26 requires annotation of D-amino acids, branched sequences and nucleotide analogs.
- Database alignment. The format is meant to align more closely with public sequence databases, which makes sequence data easier to search and share.
- No simple conversion of old listings for new filings. A PCT application filed on or after July 1, 2022 only accepts ST.26 listings as part of the description and an ST.25 listing filed with it is not treated as part of the description.
WIPO offers a free tool to help. The “WIPO Sequence” desktop tool prepares ST.26-compliant listings and runs on Windows, Mac OS and Linux, though applicants may use any XML tool that produces a compliant file.
2. Where the obligation actually comes from
| Layer | Source | Role for sequence listings |
| TRIPS | Arts. 27, 29, 62 | Sets patentability and disclosure standards. Allows “reasonable procedures and formalities.” No express listing requirement |
| National or regional law | Patent acts, regulations, office practice (including regional offices such as ARIPO and OAPI) | Creates the actual duty to file a listing and specifies the format |
| PCT | Regulations and Administrative Instructions (including Annex C) | Treats the listing as part of the international application and limits what designated offices may demand |
| WIPO standard | ST.26 | Defines the technical format |
| Biodiversity and access regimes | CBD, Nagoya Protocol, WIPO GRATK Treaty | Concern disclosure of origin, which a sequence listing does not itself provide |
That last row is where many developing-country debates sit and it is often confused with sequence listing. I return to it in Section 5.
3. The TRIPS provisions that shape the picture
Article 27 (patentable subject matter). Patents must be available for inventions in all fields of technology, subject to the usual criteria of novelty, inventive step and industrial applicability, without discrimination by field. Article 27.3(b) allows exclusion of plants and animals, but requires protection for microorganisms and non-biological and microbiological processes and requires plant variety protection by patent, an effective sui generis system, or a combination. Together these are why biotechnology inventions and therefore sequence disclosures, reach patent offices in developing countries.
Article 29 (conditions on applicants). The applicant must disclose the invention clearly and completely enough for a skilled person to carry it out and members may require the best mode known at filing. For sequence-based inventions, the listing is part of how that disclosure is made. It does not replace enablement. A listing without a workable description of making and using the invention can still fail Article 29-type standards under national law.
Article 62 (acquisition and maintenance procedures). Members may require compliance with reasonable procedures and formalities as a condition of acquiring or maintaining rights. This is the legal footing for a national rule requiring an XML sequence listing. “Reasonable” is the limiting word: procedures must not be so burdensome that they defeat the substantive rights TRIPS requires.
Article 1.1 (freedom to implement). Members may choose the method of implementing TRIPS within their own legal systems, so long as they meet the minimum standards.
Articles 7 and 8 (objectives and principles). These support tailoring implementation to public interest goals, including development and technology dissemination, which is relevant when designing formalities that developing-country applicants must meet.
Articles 65, 66 and 67 (transition and cooperation). Developing countries received transition periods that have largely expired, but least-developed countries (LDCs) still benefit from extended ones. As I understand the latest TRIPS Council decisions, LDCs are exempt from most TRIPS obligations until 1 July 2034, with a separate longer pharmaceutical exemption to 1 January 2033. Verify the current dates. Article 66.2 requires developed countries to provide incentives for technology transfer to LDCs and Article 67 contemplates technical and financial cooperation, including help implementing patent systems.
The practical result is that a country still within its transition period may not have a modern biotechnology patent regime at all and so no meaningful sequence listing practice, while other developing countries, especially larger ones with PCT-driven filing volume, apply ST.26 in full.
4. The PCT channel: how developing countries meet the standard in practice
For most developing countries, the effective obligation flows through the PCT rather than TRIPS.
- As receiving offices, they must accept international filings in the required format.
- As designated or elected offices, the PCT Regulations generally prevent them from requiring a sequence listing in a format different from the international standard. A properly filed ST.26 listing should therefore carry into the national phase without a separate national version.
- Transition rules matter. Listings for applications filed before July 1, 2022 should still follow ST.25, even when submitted later, for example in amendments or translations on national phase entry. Offices need to handle both formats for a period.
- Coordinated switch, uneven readiness. Offices at the international, regional and national levels were meant to transition to ST.26 simultaneously on July 1, 2022. In practice, readiness in filing systems, examiner training and search infrastructure varies widely across offices, especially smaller ones.
For regional systems such as ARIPO and OAPI, the applicable requirement depends on the regional instruments and each office’s own practice. Check the current national phase guidance for the specific office rather than assuming uniformity.
5. Where the real controversy lies: sequence listings versus disclosure of origin
A sequence listing tells an office what the sequence is. It does not tell the office where the biological material came from, or whether it was accessed lawfully, or whether benefits were shared. For many developing countries, that gap is the central concern.
Why sequence data raise these issues. Sequence data disclosed in patent filings enter public databases and can be reused widely. That’s part of the point of ST.26’s database alignment, but it also sharpens the “digital sequence information” debate under the Convention on Biological Diversity, where developing countries have argued that benefits from use of sequence data should be shared. The ST.26 source and organism annotations aren’t designed to serve as a disclosure-of-origin mechanism.
The TRIPS-side proposals. Since the Doha Ministerial Declaration, a group of developing countries has pushed to amend TRIPS to require disclosure of the origin of biological resources, prior informed consent and benefit-sharing evidence in patent applications, often described as the proposed “Article 29bis.” That proposal has not been adopted and the discussion has been stalled for years.
The WIPO GRATK Treaty. The debate moved to WIPO. The Treaty, adopted on May 24, 2024, establishes a mandatory patent disclosure requirement: applicants must disclose the country of origin of the genetic resources, or the Indigenous Peoples or local community that provided associated traditional knowledge, when the claimed invention is based on them; if unknown, the source; and if that is also unknown, a declaration to that effect. The Treaty also encourages information systems (such as databases) of genetic resources and associated traditional knowledge that patent offices can use in search and examination.
Status. The Treaty is not yet in force and requires 15 ratifications or accessions, with entry into force three months after the 15th. Reports I found put the number of parties at only a handful, for example Malawi in December 2024 and Uganda in July 2025 were among the early ratifiers, so it appears well short of the threshold. Please check WIPO’s current membership list for the latest position. Once in force, its reach would be broad: the disclosure requirement would apply to all applicants filing in a contracting party’s jurisdiction, including applicants from countries that have not ratified.
Interaction with sequence listings. Together, a future disclosure regime and existing listing rules would give an examiner two separate data sets: the sequence and its stated organism (from the listing) and the origin and provider (from the disclosure declaration). Cross-checking them is a natural enforcement tool, but it requires the databases and training the Treaty itself contemplates.
Several developing countries already have disclosure or access-related patent requirements in their own laws. Examples include India’s requirement to disclose the source and geographical origin of biological material, the Andean Community’s Decision 486 and South Africa’s traditional knowledge and genetic resources provisions. The details vary, so check the current statute.
6. Practical challenges for developing countries
For patent offices
- IT and filing systems. XML validation, secure electronic filing and data storage require investment. A paper-based office cannot easily accept XML-only submissions.
- Examiner capacity. Reading and searching sequence listings requires bioinformatics training and access to sequence databases. Without them, an office may grant claims to sequences that are not novel or that are naturally occurring.
- Formality workload. Notices to correct defective listings consume examiner time.
- Dual-format transition. Handling both ST.25 and ST.26 files for years adds complexity.
For applicants
- Cost and expertise. Preparing a compliant listing typically involves specialist software or attorney help, adding to the cost of filing in each country.
- Errors with real consequences. A non-compliant or incorrectly annotated listing can trigger deficiency notices and delay. Corrections cannot add new matter beyond the original disclosure.
- Local applicants and universities. Researchers in developing countries may be less familiar with the standard, so the burden can fall hardest on the applicants a country most wants to encourage.
Mitigation available in practice
- WIPO’s free Sequence tool and its training and support materials
- WIPO technical assistance, Technology and Innovation Support Centers (TISCs) and patent information services
- Regional cooperation and work-sharing, which lets smaller offices rely on search reports from larger ones
- Pooling sequence-search tools and databases across offices
7. Policy options for developing countries
Because TRIPS leaves room for national choices, a country implementing sequence listing rules can consider:
- Adopt ST.26 without local variations. Departing from the standard adds cost for everyone and the PCT limits what designated offices may demand anyway.
- Keep formalities “reasonable” (Article 62). Provide clear correction periods and avoid loss of rights for curable defects.
- Pair the listing requirement with examiner training and database access, otherwise the requirement generates paperwork without improving examination.
- Decide the substantive law on natural sequences. Whether isolated natural genes or sequences are patentable is a national policy question under Article 27 and national exclusions and it directly affects what the sequence listings are used for.
- Address origin disclosure separately from the listing. If a country wants disclosure of origin, put it in its patent law (as several already have) rather than expecting the listing to serve that purpose.
- Use the Budapest Treaty where deposit of biological material is needed to satisfy enablement, particularly for microorganisms where a sequence alone may not suffice.
- For LDCs still within transition periods, consider whether and when to adopt the standard and seek technical cooperation under Article 67 before doing so.
8. Practical guidance for applicants filing in developing countries
- Check the filing date rule. Applications filed on or after July 1, 2022 need an ST.26 XML listing. Applications claiming priority to pre-2022 filings still generally need a new ST.26 listing when filed after that date. In the United States, for example, a later application claiming priority to a pre-July 2022 filing cannot use the old ST.25 listing.
- Draft the listing with the application, not afterward, so that it forms part of the description at filing and supports the claims.
- Confirm the sequence threshold applies. Sequences below the length minimums, or with too many undefined residues, are not listed.
- Verify national phase requirements for each designated office, including translation and deposit rules.
- Keep provenance records. Even where no disclosure of origin is required today, keep documentation of the source of biological material and any access permits, because national laws are moving in this direction and the GRATK Treaty would formalize it.
- Watch for national additions, such as biological material deposit requirements or origin declarations, which sit outside the sequence listing itself.
9. Open questions
- Will GRATK enter into force and will it change what developing-country offices require alongside the listing?
- Can offices build the capacity to use sequence data for examination and for detecting biopiracy, rather than merely collecting it?
- How will the digital sequence information debate under the biodiversity regime interact with patent sequence data in public databases?
- Will TRIPS itself be amended, or will disclosure of origin remain a WIPO and national-law matter?
- How will the extended LDC transition interact with growing biotechnology filings in those countries?
Bottom line
TRIPS does not impose sequence listing obligations on developing countries. It sets disclosure and patentability standards and permits reasonable formalities and the actual listing requirement comes from national law and the PCT’s adoption of WIPO ST.26. For developing countries the real issues are capacity (systems, examiners and databases) and a policy question TRIPS has left unresolved: how to use patent-related sequence data to deter misappropriation of genetic resources, not merely to record sequences.