Principles on Patenting of Reference Sequences

Ethical, Legal and Social Issues CommiTee of the Earth BioGenome Project

One goal of the Earth BioGenome Project (EPB) is to establish reference DNA genomic sequences of eukaryotic organisms—that is, organisms whose cells have nuclei—and to make this reference sequence information a global public good, freely available for use anywhere for any purpose. To achieve this, EBP expects the release of sequences in the International Nucleotide Sequence Database Collaboration (INSDC) or other EBP-approved database, with no restrictions on download and as few restrictions on use as is consistent with law and equity.

FAIR (Findable, Accessible, Interoperable, and Reusable) principles apply to EBP reference sequences in public sequence databases. However, EBP does not impose FAIR principles on downstream users for applications and patents that depend on EBP reference sequence data.

The EBP policy thus has three parts:

1. EBP has a no-patent policy for reference sequences. Any party who contributes an EBP reference sequence must ensure that the party has not sought and will not seek patent protection for the DNA sequence itself. Submission of the sequence to the International Nucleotide Sequence Database Collaboration (INSDC) will prevent patenting of the reference sequence anywhere, so long as the contributor is the first to produce the sequence.

2. EBP sequence submissions to INSDC should include (1) geographical location that identifies the country of origin (see EBP policy on data sharing), (2) Indigenous peoples and local communities (IPLC) information for any associated traditional knowledge, (3) sampling permits according to the national legislation of the country of origin, and (4) any other rights associated with the sequence. Where there is any traditional knowledge and/or any rights associated with the sequence, the EBP submitter must have the permission of the respective knowledge custodians and/or rights holders to deposit the sequence in INSDC.

3. It is the intent of the EBP that submitted sequences have no restrictions on download and restrictions on use only insofar as they are consistent with local law and equity. Contributing parties are expected to ensure that samples and the submitted sequences are free of any legal encumbrances except those required by equity and local law in the country of origin, including but not limited to patent rights, non-patent-based exclusive rights, and restrictive use licenses. Any legal encumbrances that are required to remain must be identified in the submitted sequence accession or a linked BioProject accession.

EBP cannot ensure that users who generate commercial products or patents based on the EBP reference sequence information will abide by any national legislation imposed by the country of origin of the sample, including any provisions for benefit-sharing, disclosure, and access as formulated under the Convention on Biological Diversity, the International Treaty on Plant Genetic Resources for Food and Agriculture, the Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge of the World Intellectual Property Organization or other international treaties that may apply. EBP supports these existing treaties and the October 2024 Cali agreement on establishing a multilateral mechanism for benefit-sharing from the use of digital sequence information on genetic resources under the Convention on Biological Diversity. EBP acknowledges that not all countries have ratified these agreements and that not all users are legally bound to abide by them. EBP does, however, expect those who contribute EBP reference sequences to abide by these agreements, regardless of whether their country has signed or ratified them. EBP cannot monitor or enforce provisions of these treaties for all users of reference sequences.