4.7 Sequence Listings in Biotechnology Cases

Patents / Biotechnology / US Biotechnology Practice

In recent years problems in identifying new materials in the field of biotechnology so compared to the prior art (particularly when the materials contain long sequences of amino acids or nucleotides) have led to additional requirements for the specification. In 1990 the Patent Office issued rules requiring that for applications filed after October 1, 1990, relating to the requirements to be applied to applications referring to amino acid or nucleotide sequences. The rules now apply to any application which contains disclosure of an unbranched sequence of four or more L-amino acids commonly found in naturally-occurring proteins and listed in WIPO Standard ST (1998), Appendix 2, Table 3 or of an unbranched sequence of ten or more nucleotides as set out in Table 1 of the same WIPO standard: [71]

(1) Specified symbols and format must be used in which each sequence mentioned in the description and claims is listed using symbols and format as specified in the rules, with each sequence to be given an identification number. [72] Each time a sequence appears or is discussed in the description and claims, its identification number must be given.

(2) The sequence listings must be included in the application in a separate section starting on a new page. Such pages should contain no more than 66 lines and have no more than 72 characters per line. [73] Additionally they should contain specified information not only about the patent application with which they are filed but also information about the organism from which the sequence comes and in some cases information about features of the sequence also.

(3) A copy of the Sequence listing section must also be submitted in computer readable form (diskette or magnetic tape), which must be readable by one of a number of computer/operating systems specified in the rules. [74] This must be accompanied by a statement that the paper and computer copies of the sequence are the same for example “the information recorded in computer-readable form is identical to the written sequence listing”. [75]

(4) If the computer readable listing is identical with a computer readable copy submitted by the applicant in another application on file in the U.S. P.T.O., reference may be made to the other application in lieu of filing a duplicate computer readable copy in the application. [76]

[71] 37 CFR 1.821.

[72] 37 CFR 1.822. The symbols comply with WIPO Standard ST.25 (1998).

[73] 37 CFR 1.823.

[74] 37 CFR 1.824.

[75] 37 CFR 1.821 (f). As amended in September 2000, the rule simply refers to the copy being in “computer readable form” and so permits the use of, for example, CD-ROMs.

[76] 37 CFR 1.821(e).

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