Friday, June 06, 2008

Use of GenBank Accession numbers in patent applications

In a post titled "Patent Office Catch-22", Patent Docs discusses a presentation by Julie Burke, a "Quality Assurance Specialist" in Group 1600 at the Biotechnology/Chemistry/Pharmaceutical Customer Partnership meeting held at the Patent Office on 4 June 08.

Patent Docs noted:

The particular issue involved whether and under what circumstances it was sufficient to identify a nucleic acid by its GenBank Accession Number. Ms. Burke sets out the "problem" in the very first substantive slide:

In patent specifications, every element or ingredient of the product should be set forth in positive, exact, intelligible language, so that there will be no uncertainty as to what is meant.

The relationship between sequence information submitted to a public database and the amino acid or nucleic acid product it identifies is sometimes indefinite, uncertain, and arbitrary.

She goes on to identify the bases for the "uncertainty": sequence information in public databases can "change from time to time," and these changes can be made by third parties.

One comment notes:

While this creates a bit more burden on applicants and practitioners, applicants having claims drawn to nucleic acid sequences (with only reference to GenBank Accession numbers) should be made aware of this potential hitch and be prepared to deal with it.


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