I. Our Practice Tips Relating to Reasonable Protection for Biological Sequence Inventions

Article 26 (4) of the Patent Law is intended to provide the inventor are a reasonable protection commensurate in scope with his contribution to the art. This article is basically the same as the PCT which prescribes claims shall be fully supported by the description. Permission to generalize a biological sequence claim reasonably not only meets the legislative intent of Article 26 (4),but also promotes the technological innovation and development in the biotechnology field.

1. New trends for biological sequence claims

During the retrial procedure of the above-discussed case, SPC denied the strict criteria taken by lower courts, and articulated judgment rules and granting criteria for the biological sequence claims. That is the claims defined in the homology plus source and function manner are supported by the description, which is instructive for the drafting,examination and trial for the biological sequence related patent applications.

Accordingly, the protection scope is still limited for the applicants and patentees of the biotechnology field,but it has shown that the criteria for examination and trial of the biological sequence claims in China have begun to become more rational.

2. Strategies for drafting the biological sequence related invention

From the above case, it can be seen that the examination and trial criteria for the biological sequence claims in China are still rather strict.

Accordingly, in order to get the more reasonable protection scope,the applicants should draft the claims using as many as possible defined manners. In addition to the above-mentioned four manners,"the combination of the terms' substitution, deletion or addition 'plus functions" and "the combination of the terms 'hybridize under stringent conditions' plus functions"could be taken for claim drafting Furthermore, if a gene, polypeptide or protein could not be described by the above-mentioned manners,the physio chemical properties of the polypeptide or protein and the process for processing the gene, polypeptide or protein could be used by the applicants to draft the claims too.

As we all know, biotechnology is an experimental science, and it is unpredictable for its experimental results in some cases. Therefore, for the person skilled in the art, it is very helpful to describe the background art (such as the gene homologous evolution, the research and development of the related variants, etc.) in the description in detail. Furthermore, in order to get relatively broad protection scope, at the time of drafting the patent applications related to the biological sequences, as many as possible actual examples should be provided in the description to describe the variants' functions and effects, so that the reasonable expectation for the variants could be made by the examiner based on these experimental data and the gene homologous evolution between different strains or species.

In addition, in order to support the claims sufficiently, it is better to describe the origin of the biological sequences, the technical means forgetting them, and their functions and technical effects when drafting the patent application documents.Especially, it is necessary to describe the relationship between the biological sequences and their functions as much as possible,for example, introducing and verifying the functional and structural domains for the biological sequences in the examples, so that the examiner would understand the whole invention and creation,the key sections for the sequence, and the important functions for the variants better in this way, which will be helpful to acquire reasonable protection scope.

In summary, the retrial judgment made by SPC shows the possibility that biological sequence claims are reasonably protected in China. The applicants should pay more attention when drafting the patent application documents, describe the relationship between the biological sequences and their functions, provide enough examples to describe the variants' functions and effects, and draft the claims using as many as possible defined manners, so that the reasonable protection scope could be granted.

1. Decision No. 85: Supreme People’s Court [2016] Retrial Judgment

2. Examination Decision on Request for Invalidation No. 17956

3. Wherein, the “function” means having the glucoamylase activity, the “comprising” means the claim is an open-ended mode, the “homology” means the homologous enzyme of at least 99% with the full-

4. length sequence shown in SEQ ID NO: 7, and the “source” means the enzyme is derived from a strain of the filamentous fungus T. emersonii.

5. Decision No. 2721: Beijing First Intermediate People's Court [2012]

6. Decision No. 3524: Beijing Higher People's court [2014]