Biological data sequences, such, as nucleotide and protein sequences play a role in patent applications within the field of biotechnology. The accurate listing of sequences is crucial for distinguishing inventions from existing ones preventing competitors from obtaining patents and fostering future research and innovation. Errors in disclosed sequences can lead to a loss of protection for inventions.
Sequence information may be found in sections of patent documents, including claims, descriptions and figures. Some applications may contain a few sequences while others could feature thousands. These sequences may be natural artificially created or randomly generated. Regardless of their origin or significance to the invention all sequences that meet the criteria set by patent offices must be listed separately in a manner.
It is mandatory to include sequence data when submitting a patent application. Although it is possible to add the sequence listing later with a fee it is advisable to prepare it during the filing to ensure consistent numbering and allow for any necessary modifications.
PCT Applications with Sequences vs. Filing Year
The number of PCT applications incorporating sequences has been steadily increasing over years demonstrating the interest, in such innovative technologies.
Projections indicate that there will be a rise, in PCT filings in the future. Notable contributors to these filings consist of research institutions such as the University of California MIT and Broad Institute alongside leading companies like Roche/Genentech, Novozymes and Novartis. Additionally emerging biotech firms are also seeking protection for their sequences.
It is anticipated that patent offices worldwide will need to manage a growing number of inventions incorporating sequences. Recently a new international standard was introduced to facilitate the publication of sequences and their integration into databases.
WIPO Standard ST.26; A Game Changer?
The newest WIPO Standard ST.26, effective from July 1 2022 employs the language (XML) format for sequence listing. ST.26 offers advantages over the ST.25 format including enhanced data compatibility, standardization, consistency and the ability to incorporate additional information. The WIPO Sequence software for XML file preparation has replaced tools such as PatentIn (USPTO) and BiSSAP (EPO) used for ST.25 listings. It is believed that the ST.26 standard is better equipped to adapt to advancements in biotechnology and meet the evolving requirements of patent offices globally; however its practical utilization by examiners and other stakeholders remains uncertain.
The transition to ST.26 poses challenges, for applicants and their representatives.
The previous standard was viewed as a hassle. The ST.26 regime now demands the participation of experts to ensure accuracy and compliance. Some common challenges faced when preparing sequence listings are;
- Unclear understanding of listing requirements
- Use of standard terms, for sequences
- Sequences scattered across the document without clear identification
- Lack of clear definitions for sequences
- Sequences in unreadable formats (such as image files)
- Manual preparation of sequences by copying from various sources into text files
- Direct conversion from ST.25 without manual verification
- Presence of complex sequence representations and modified sequences
- Bulk sequences
In conclusion incorporating patent sequence data using WIPO Sequence is currently a cumbersome process for life science applicants and their legal representatives. Improvements to this process could help lessen the burden.
Short term solutions may involve fee waivers and procedural relaxations suggested by the European Patent Institute (EPI).
Universities and research institutions proficient, in bioinformatics tools and sequence databases can collaborate with patent offices to meet applicants needs while upholding the standards set by the ST.26 regime.
Providing access, to the WIPO Sequence source code for parties can empower developers to collaborate with life science users enhancing user friendliness incorporating tailored features and streamlining workflows. Developers proficient in sequence databases can develop libraries of sequences that seamlessly integrate with drafting tools to connect sequences to designated sections of patent applications. This integration enables the generation of a sequence listing akin to how reference management tools are utilized in academic research.
Creating sequence listing production can be an intricate and costly task. Until advancements and automation in the sequence listing process come to fruition seeking assistance from expert sequencing services is recommended. Our Sequence Listing Preparation services offer support, in producing error PTO compliant sequence listings alleviating inventors and patent attorneys from the burden of meeting listing requirements. Additionally we provide corrections to address objections concerning sequence listings.
Should you require aid with your sequence listing needs feel free to reach out for an precise process.
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