Biological sequence databases are part of the 'common general knowledge'

A recently-published decision from one of the European Patent Office's Boards of Appeal will be of interest to clients in the biotech area.

Background

Decision T890/02[1] relates to a European patent application[2] concerned with a chimeric gene encoding an enzyme. The Examining Division refused the application on the grounds that an earlier published journal article disclosed the gene sequence of claim 1. Bayer CropScience S.A. (the applicant) appealed to a Technical Board of Appeal.

Bayer CropScience S.A. (‘Bayer') distinguished claim 1 from the cited journal article. However, there were also potentially relevant publications of the sequence in biological sequence databases (EMBL[3] and ENZYME[4]). Therefore Bayer tried to disregard the contents of these databases on the grounds that biological sequence databases represented the whole state of the art rather than the common general knowledge.

Bayer's view of the common general knowledge

Bayer argued that:

• according to established caselaw, the common general knowledge is what one could find in handbooks and encyclopaedias
• such knowledge was clearly distinct from the whole state of the art
• accessible information which was part of the state of the art was not necessarily part of the common general knowledge
• information only meets the definition of common general knowledge after being accepted, integrated and shared by the scientific community
• sequence databases are comparable to the Chemical Abstracts[5] database (which has previously been considered to represent the whole state of the art, rather than the common general knowledge)
• sequence databases are not comparable to encyclopaedias or handbooks because the entries in sequence databases are often unverified, raw or crude, prone to numerous and major errors and not necessarily elaborated or reasoned.

The European Patent Office's view of the common general knowledge

The Technical Board of Appeal disagreed with Bayer's arguments regarding the common general knowledge.

Previous decisions of the Technical Boards of Appeal have stated that special considerations prevail when a field of research is so new that technical knowledge is not yet available from textbooks. The Technical Boards of Appeal have identified three important aspects for correctly assessing the common general knowledge of the skilled person. These steps correspond to the classical steps for defining the common general knowledge:

3 important aspects for correctly assessing the common general knowledge of the skilled person	Classical steps for defining the common general knowledge
The skilled person has: (i) a basic general knowledge of a particular field of technology and (ii) the ability to look up such knowledge	Picking an adequate reference book from the bookshelf in a library
In order to identify common general knowledge, the skilled person cannot be expected to carry out a comprehensive search of the literature covering virtually the whole state of the art. No undue effort in the way of a search can be required.	Identifying the appropriate section(s) without this requiring any significant effort
The information found must be unambiguous and usable in a direct and straightforward manner without doubts or further research work.	Getting the correct information or unambiguous data that can be used without further research work

The Technical Board of Appeal viewed the EMBL database and ENZYME database as a comprehensive handbook and an encyclopaedia, respectively. Therefore, the information in these databases met the definition of common general knowledge given in the case law.

The Technical Board of Appeal disagreed with Bayer's argument that a search in the EMBL database equates to a search in the Chemical Abstracts database i.e. through the whole of the state of the art. This is because a straight query to search in the EMBL database usually produces a reasonable number of results with clear information whereas, with bibliographic databases, neither the required search strategy nor the results obtained are clear and straightforward. Also, the bibliographic databases are of no use for a straight comparison of different biological products, but the sequence databases readily allow this.

Although this decision concerns the common general knowledge in relation to the assessment of novelty, we believe that the decision would also apply when determining the common general knowledge in relation to the assessment of inventive step.

Referral to the Enlarged Board of Appeal was not allowed

Although Bayer had prepared three questions for referral to the Enlarged Board of Appeal, the Technical Board of Appeal considered that these questions did not justify or necessitate such a referral. The Enlarged Board of Appeal is not simply a higher appeal board than the Technical or Legal Boards of Appeal. Instead, questions can only be referred to the Enlarged Board of Appeal when the caselaw of the Technical Boards of Appeal becomes inconsistent or when an important point of law arises. The purpose of the Enlarged Board of Appeal is to ensure uniform application of the law and to clarify or interpret important points of law in relation to the European Patent Convention[6]. The Technical Boards of Appeal are bound by the decisions and opinions of the Enlarged Board of Appeal.

Although Bayer had prepared three questions for referral to the Enlarged Board of Appeal, the Technical Board of Appeal considered that these questions did not justify or necessitate such a referral. The Enlarged Board of Appeal is not simply a higher appeal board than the Technical or Legal Boards of Appeal. Instead, questions can only be referred to the Enlarged Board of Appeal when the caselaw of the Technical Boards of Appeal becomes inconsistent or when an important point of law arises. The purpose of the Enlarged Board of Appeal is to ensure uniform application of the law and to clarify or interpret important points of law in relation to the European Patent Convention. The Technical Boards of Appeal are bound by the decisions and opinions of the Enlarged Board of Appeal.

Our suggestions for preparing patent applications based on biological sequence data

Applicants (and their patent attorneys) should remember that entries in biological sequence databases, including those entries with limited annotation, can be used to destroy the novelty and/or inventive step of patent applications. Therefore care should be taken to ensure that there are a sufficient number of suitable fall-back positions to allow the claims to be amended in view of such entries. Amendments must not add subject matter which extends beyond the subject matter of the originally filed application (Art. 123(2) EPC[7]) and therefore we recommend that there is clear and unambiguous support in the originally filed application for all amendments.

If you require any further information, please contact your usual Life Sciences and Chemistry group contact.

Rachel Williams
28 December 2005

File in printable version:

 

 

 

 T890_02_3.doc

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[1] Full decision T890/02 can be found at http://legal.european-patent-office.org/dg3/biblio/t020890fx1.htm (French only) and in the Official Journal of the EPO, 2005: Volume 10, pages 497-518 (English, German and French).

 

[2] Application Number: EP96920888.3, Publication Number: WO96/38567

 

[3] http://www.ebi.ac.uk/embl/

 

[4] http://www.expasy.org/enzyme/

 

[5] http://www.cas.org/casdb.html

 

[6] http://www.european-patent-office.org/legal/epc/e/ar112.html

 

[7] http://www.european-patent-office.org/legal/epc/e/ar123.html#A123