Can a novel natural gene and it's protein identified by QTL-SEQ be patented?

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amorntip
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Joined: Mon Feb 22, 2021 9:55 am

Can a novel natural gene and it's protein identified by QTL-SEQ be patented?

Post by amorntip » Mon Feb 22, 2021 10:13 am

Can a novel natural gene and it's protein identified by QTL-SEQ be patented? Also, can the natural mutant forms of this gene/protein be patent?


EPO / Patent Information
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Re: Can a novel natural gene and it's protein identified by QTL-SEQ be patented?

Post by EPO / Patent Information » Mon Mar 08, 2021 7:16 am

Thank you for your query directed to Directorate Patent Law. Please understand that Directorate Patent Law can only provide general legal advice regarding procedures before the EPO, without prejudice to the decisions of the competent departments in each individual case. With that proviso, we are pleased to inform you as follows:

According to Rule 27(1)(a), ‘biotechnological inventions shall also be patentable if they concern biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature’.

Rule 29 relates to the human bodies and its elements and the corresponding guidelines for examination (G-II,5.2) specifies that ‘although the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions (see G II, 5.3), an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. Such an element is not a priori excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to produce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing itself (EU Dir. 98/44/EC, rec. 21). The examination of a patent application or a patent for gene sequences or partial sequences is subject to the same criteria of patentability as in all other areas of technology (EU Dir. 98/44/EC, rec. 22). The industrial application of a sequence or partial sequence must be disclosed in the patent application as filed (see G III, 4)’.

Rule 26(1) EPC second sentence adds that Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions shall be used as a supplementary means of interpretation.
According to recital 23 of Directive 98/44, ‘’a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention’’. Recital 24 clarifies that ‘’in order to comply with the industrial application criterion it is necessary in cases where a sequence or partial sequence of a gene is used to produce a protein or part of a protein, to specify which protein or part of a protein is produced or what function it performs’’.
Kind regards,

The Patent Information User Support Team


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