What are the common issues in gene patent applications
Frequently asked questions in gene patent applications:
A. Unity: Gene patents also pose challenges to unity, as can be seen from the above , gene patent applications are often combined with protein patents, and substance patents and method patents are also applied for at the same time in many cases.
The so-called unity refers to an invention or utility New patent applications should be limited to one invention or utility model. Two or more inventions or utility models belonging to a general inventive concept can be filed as one application. That is to say, one application is only allowed to involve one invention or utility model. If an application includes several inventions or utility models, it will only be allowed if there is a general inventive concept interrelated among all the inventions or utility models. This is the unity requirement for patent applications. The main reasons why a patent application should comply with the requirement of unity are: (1) Economic reasons: to prevent the applicant from paying for only one patent and obtaining protection for several different inventions or utility models. (2) Technical reasons: To facilitate the classification, search and examination of patent applications.
claims proposed in gene patent applicationWith such a broad requirement, does it meet the requirement of unity? It is necessary to understand the special case of unity, that is, the provisions on "general inventive concept". Article 35 of the Implementing Rules of the Patent Law stipulates that two or more inventions or utility models belonging to a general inventive concept shall be technically related to each other and contain one or more identical or corresponding specific technical features, among which, " "Specific technical features" refer to the technical features of each invention or utility model that are considered as a whole and contribute to the existing technology. The above provisions define a method for determining whether two or more inventions claimed in an application belong to one general inventive concept. That is to say, two or more inventions that belong to a general inventive concept must be technically related to each other, and this correlation is expressed in their claims by the same or corresponding specific technical features. The above provisions also define "specific technical characteristics". "Specific technical features" is a concept specifically proposed to evaluate the unity of patent applications. It should be understood as those technical features that reflect the contribution of the invention to the prior art, that is, make the invention novel compared to the prior art. and inventiveness, and shall be determined after considering each claimed invention as a whole. It can be seen that the rights in gene patent applications include proteins, DNA molecules, expression vectors, host cells, methods of producing proteins, pharmaceutical compositions, antibodies to proteins, probes for specifically detecting XXDNA, methods of detecting diseases, uses of proteins, etc. The required items must be interrelated, for example, the protein and the method of producing the protein must be consistent, otherwise it will not meet the unity requirement and cannot be patented.
B. Full disclosure and scope of claims
Instructions include materials (DNA, vector, host, polypeptide or protein and The description of compositions) and methods, i.e. preparation methods, should be as comprehensive as possible. The description is the basis for the claim. Every necessary technical feature in the claim is expressed as an element of the invention, so that a person skilled in the field can reproduce it accordingly. This is a lower requirement for a patent. Prevent new claims from being made in rights requests. At the same time, the initially submitted claim itself is the best evidence of disclosure described in the specification.
Full disclosure of technology, this is the price that the patentee should pay to society for obtaining the patent (monopoly right). Overly broad claims should be restricted, the interests of the inventor and social interests should be balanced, and the rights holder’s monopoly rights should not exceed his technical contribution to society. Even if the applicant needs to understand what constitutes sufficient disclosure, it cannot be allowed to allow others to use simple substitution methods to avoid the patentee's encroachment. Rights holders are only allowed to limit their requests to technical solutions that they can actually implement.
Granting a patent requires specific disclosure of the function of the gene, such as Treat a disease. This rule applies to both human genes and other biological genes. The function of a gene should be based on the protein it expresses. Only by discovering the specific role of a gene in an organism can a wider scope of protection be granted. Because DNA may be an evolutionary relic that may not have any function in the organism. Of course, if a gene is identified that is genetically proven to have a known function, it may be patentable if it controls eye color, causes a specific disease, etc. But if it is merely claimed to encode a certain product, it cannot be granted, even if evidence is later provided, because the evidence does not reveal its biological function. Having a similarity does not achieve any concrete utility.
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