What are the results of biological fields to apply for patents?

Author: Tianrui Lichu Intellectual Property Law Zhicheng Patent Agency Biological Patent Agency Department (consultation, please add WeChat Boyyxw)

Biology is a science of the structure, function, occurrence and development law of graduate (including plants, animals, and microorganisms), and is a part of natural science. The purpose is to clarify and control life activities to serve the practice of agriculture, industry and medicine. In the process of research, what results can apply for patents?

Table of contents

1. The provisions of the patent part cannot be applied for the biological field

2. The scope of patent can be applied for patents in the biological field

1. Involved nucleotide or amino acid sequence

(1) New cloning gene or promoter

(2) Other sequences with valuable value.

2. Cell class

(1) Cell vaccine

(2) Cell line

(3) Microorganism

3. Preparation class

4. Method class

3. Preparation skills for technical intercourse when applying for patents in the biological field

1. The provisions of the patent part cannot be applied for the biological field

Because the research objects in the biological field include animals and humans, they may involve sensitive information such as ethics and genetic resources. In this regard, the patent law and patent review guidelines have clearly stipulated the situation that cannot be awarded patent rights in the biological field.

Article 5 of the Patent Law stipulates that the invention and creation of violations of laws, social ethics or abound public interests will not be awarded patent rights. Obtaining or using genetic resources that violate laws and administrative regulations, and rely on the invention and creation of the completion of the genetic resources, and do not grant patent rights. In general, it should be noted that the technical solution of public morality of illegal society cannot be awarded patent rights, such as: the method of changing the genetic of the reproductive system, the method of cloning people, the application of human embryonic industries or business purposes, in each formation and formation of each formation and the formation of each formation and business purposes. The human body (reproductive cells, fertilized eggs, embryos and individuals) during development.

Article 25 of the Patent Law stipulates that the following items are not granted patent rights: (1) scientific discovery; (2) the rules and methods of intellectual activity; (3) diagnosis and treatment of diseases; (4) animals and plants Variety ... For the production methods of the products listed in the previous paragraph (4), patent rights can be granted in accordance with the provisions of this Law. Mainly the technical solutions listed in the (3) and (4) items cannot be awarded patent rights. It should be noted that the varieties described in (4) also include genetically modified, hybrids and other methods to obtain varieties. Plant varieties may apply to the Ministry of Agriculture and Rural Ministry or the Ministry of Forestry in accordance with the "Regulations on the Protection of Plants".

Article 22 of the Patent Law stipulates that the invention and practical new model of the granting patent rights shall be novel, creative and practical. ... Practicality means that the invention or practical new model can be manufactured or used, and can produce positive results. Although the practicality is the last one in the law, it is the first to be judged during the narrow patent review process.涉及生物领域的，在审查指南中列举了主要的两类情况：一是人体或动物体的非治疗目的的外科手术方法，例如美容外科手术、从活牛身上摘取牛黄的外科手术方法、为Auxiliary diagnosis is used to use surgical surgical methods (such as surgical surgical methods before coronal angiography), etc.; Second, measure the physical parameters of the human body or animals under the limit, for example Animal measurement method of cold tolerance.

2. The scope of patent can be applied for patents in the biological field

Except for the above laws and regulations, which clearly stipulate that it does not belong to the patent law to protect objects, the main types of patented technical solutions in the biological field will be listed below.

1. A nucleotide or amino acid sequence

(1) New cloning gene or promoter

Without the sequence, these sequences can apply for patents themselves. If the sequence is public, the application of the sequence can be considered to apply for a patent. This type of technical scheme requires a cloning process and application experiments in the sequence. The primer sequences and carriers used in all experiments should be made public.

Further, the reorganization carrier, reorganized protein, fusion cells, polypeptides, antibodies, vaccines, etc., which are developed based on serial development with value, are all applying for patents. Experiments of obtaining reorganization carrier, restructuring protein, fusion cells, polypeptides, antibodies, vaccines, as well as experiments on the application of restructuring carrier, restructuring protein, fusion cells, polypeptides, antibodies, and vaccines, and can provide corresponding experimental data to prove it. Has positive experimental effects.

(2) Other sequences with valuable value.

There are currently many molecular marks. It is used for variety appraisal, specific trait screening, parent -child identification, etc. Such technical solutions should provide the process of obtaining the molecular marker, the primer designed for the molecular marker, etc.; The experiments of these molecular markers should also be provided to explain its accuracy.

For example, mutations are used to obtain new functions based on existing genes or protein sequences, and patents can also be applied. The process of mutation is required to verify the function of the sequence after the mutation.

For example, the diagnosis/specific target detection agent/kit of the disease diagnosis/specific target of the target gene amplifier. Such technical solutions should provide sequence information, antibody preparation of diagnostic reagents (antibodies or primers), and effect data for the application of the diagnostic reagent.

2. Cell class

(1) Cell vaccine

At present, the cell vaccine actually contains modification for specific pathogens, so its essence is that it is the key sequence or modification that causes the body's immune response. Such technical solutions should provide a process or modification process in the vaccine, and add other ingredients during preparation, as well as effect experiments. (2) Cell line

Cell lines (such as intestinal epithelial cells, synovial sarcoma cell lines, etc.), which have specific functions, are also protective objects of patent law. Such technologies should provide the processing process, biological characteristics testing and data of the cell system. In addition, the cellular preservation information should be provided.

(3) Microorganism

Although animal and plant species are not protected by the patent law, new microorganisms that are separated from the separation of microorganisms can apply for patents. Experiments of the screening process and appraisal process should be provided, and further use of the new strain can be provided; at the same time, microorganisms should also be provided.

3. Preparation class

The specific functional compounds extracted from the biological body can apply for patents. The extraction and appraisal process of the compound should be provided, and the experiments of the compound should be provided for further application.

In addition, there is a formula scheme, such as the formula of the medium, nutrient solution, etc. can also apply for patents. This type of composition patent should provide the component configuration experiment, the physical and chemical parameter detection experiment and the effect experiment of the physical and chemical parameters after configuration are completed.

4. Method class

Because there are many types involved, it cannot be exhausted, and the main types are listed.

The aforementioned first, second, and third categories mainly list the technical solutions that can apply for patents from the perspective of the product. If these products themselves have the conditions for applying for patent rights, then the use of these products, the method of obtaining the product, extraction method, cloning method, purification method, fermentation method, etc. can also apply for patents.

In addition, the diagnosis and treatment of diseases cannot be applied for patents, but the uses mentioned in the aforementioned first, second, and third categories can apply for patents in the preparation of diseased drugs.

Animals and plant varieties cannot apply for patents, but their cultivation methods, breeding methods, and cultivation methods of animal and plant tissue can apply for patents.

For another example, the new features and new uses of a well -known compound or gene can also apply for patents.

When providing a technical convergence, the method class should provide experiments using this method to prepare the corresponding targets. In the experiment, the order of the steps should be clearly explained and the specific operations in each step should be explained. You can also provide comparative experiments to use similar methods to obtain targets to illustrate the superiority of this method.

3. Preparation skills for technical intercourse when applying for patents in the biological field

No matter what type of technical solution, when providing technical confidence, you should pay attention to three points:

First, the technical solution itself should be clear and complete. For example: molecular labeling patents, sequences and primers of molecular markers, these should be provided; formula patents should clearly provide the name and ratio of each component in the formula. One type of substance should further clarify its lower part.

Secondly, the process of obtaining the technical solution should be clear and complete. This patent for product categories is particularly important. For example: new genes or promoters of cloning cannot only show the sequence of the final gene or a promoter, and it should also provide the process of how to obtain cloning, comparison, and final sequence; reorganized polypeptides, in addition to providing polypeptides amino acids that provides polypeptides of amino acids that provide polypeptides The sequence should also provide how to assemble; when it involves method -class patents, experiments that are optimized should also be provided.

Finally, enough effect experiments. This part is mainly to reflect the creativity of the technical solution. As a discipline of highly dependent experiments, biological science needs to provide experimental data to prove the effect of technical solutions. Therefore, it is necessary to provide effective comparison experiments.

In addition, for the special circumstances of biological patents, it should also be noted that the "Revision Form for the Source of Genetic Resources" involving genetic resources should be filled in; RNA, protein, polypeptide, etc., to provide nucleotide or amino acid sequences; microorganisms, cell lines, monoclonal antibodies prepared by hybridoma technology, etc., should also be kept and provided for preservation and survival certificates.

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