Chinese Patent Examination Guidelines Clarify Genetic Claiming Requirements

According to HongQiang Liu (csptal@csptal.com or csptal@china.com) at China Science Patent Trademark Agents Ltd (http://www.csptal.com) the requirements for the characterization of genes, proteins, or polypeptides have now been clarified so that a gene (protein) characterized by the phrasing "substitution, deletion or addition" in combination with the functions of the gene, and a gene characterized by the wording "hybridization" are acceptable under certain conditions.

Specifically, the new Chinese Patent Examination Guidelines Guidelines effective July 1, 2006 provide that:

"The following expressions are acceptable to characterize a gene:

a. A gene may be defined directly by the base sequence.

b. A structural gene may be defined by the amino acid sequence of the polypeptide or protein encoded by the gene.

c. If the base sequence of the gene or the amino acid sequence of the polypeptide or protein encoded by the gene is described in the sequence listing or the figures accompanying the specification, the gene may be expressed by referring to the sequence listing or the figures.

d. For a gene having certain special functions, such as a gene encoding a protein having the activity of enzyme A, said gene may be defined by using the wording "substitution, deletion or addition" in combination with the functions of the gene.

e. For a gene having certain special functions, such as a gene encoding a protein having the activity of enzyme A, said gene may be defined by using the wording
"hybridization" under stringent conditions in combination with the functions of the gene.

f. Only when a gene cannot be described by using the above-mentioned five expressions can said gene be defined by its function, physicochemical characteristics, origin or source, the process for producing said gene, etc."

"The following expressions are acceptable to characterize a polypeptide or protein:

a. A polypeptide or protein may be defined by the amino acid sequence or the base sequence of the structural gene encoding said amino acid sequence.

b. If the amino acid sequence of the polypeptide or protein is described in the sequence listing or the figures accompanying the specification, the gene may be expressed by referring to the sequence listing or the figures.

c. For a polypeptide or protein having certain special function, such as a polypeptide or protein having the activity of enzyme A, said polypeptide or protein may be defined by using the wording "substitution, deletion or addition" in combination with the functions of the polypeptide or protein.

d. Only when a polypeptide or protein cannot be described by using the above-mentioned three expressions, may said polypeptide or protein be defined by its function, physicochemical characteristics, origin or source, the process for producing said polypeptide or protein, etc."