What is the difference between a patent for a substance and a patent for a pharmaceutical compound?

Jite intellectual property rights: there are three types of patents in China: 1. Invention patents, the first paragraph of Article 2 of the Detailed Rules for the Implementation of the Patent Law of China defines the invention as: "Invention refers to the new technical solution proposed for a product, process or its improvement.

The so-called products refer to all kinds of new products that can be manufactured in industry, including solids, liquids, gases and other items with a certain shape and structure. The so-called method refers to the method of processing raw materials into various products.

The invention patent does not require that it is a technical achievement that has been proved in practice to be directly applied to industrial production, it can be a solution to a technical problem or an idea, and has the possibility of industrial application, but this cannot be confused with the simple proposal of the topic or idea, because the simple topic or idea is not

The similarity between the two: both are pharmaceutical patents.

The differences between the two:

1. Patent for Pharmaceutical CompositionThe patent for pharmaceutical composition is a patent protection for the active ingredients of drugs composed of two or more compounds, such as compound preparations of chemical drugs, extracts of traditional Chinese medicines, etc. For a composition patent, in addition to the composition of the composition, the description shall also record the chemical and/or physical state of each component, the selectable range of each component, the content range of each component and its influence on the performance of the composition.

2. Pharmaceutical compound patentsPharmaceutical compound patents generally refer to the patents applied for chemical raw materials (APIs), and most pharmaceutical compound patents need to use the name of the compound or the structural formula or molecular formula of the compound to characterize the scope of the patent to be protected. Pharmaceutical compounds generally include inorganic compounds, organic compounds, and polymer compounds, which are commonly referred to as "chemical substances".

Since drug process patents and drug use patents all involve specific compounds, the scope of protection of pharmaceutical compound patents is relatively large, and most original drugs have patent protection for compounds to restrict imitation by competitors.

Legal Analysis: Pharmaceutical Patents: 1. Drug invention patents, new drugs, new drug preparation methods, and new uses of drugs can be applied for invention patents.

2. Utility model patents for drugs, changes in drug dosage form, shape, and structure bring about changes in drug functions, and inventions of pharmaceutical equipment can apply for utility model macrobend patents. 3. The design patent of the drug is not trusted, and the new design involving the appearance of the drug outer balance wheel and the appearance of the packaging container can apply for the appearance patent.

Legal basis: Patent Law of the People's Republic of China Article 2 The term "invention-creation" as used in this Law refers to inventions, utility models and designs.

An invention refers to a new technical solution proposed for a product, a process or an improvement thereof.

Utility model refers to a new technical solution suitable for practical use proposed for the shape, structure or combination thereof of a product.

Design refers to a new design that is aesthetically pleasing and suitable for industrial application made on the whole or part of the shape, pattern or combination thereof, as well as the combination of color and shape and pattern.

A patented product refers to a utility product that is suitable for public use and has all the technical features recorded in the patent claims. Patents literally refer to exclusive rights and interests, meaning public letters or public documents, which were used by blind monarchs in the Middle Ages to enact certain privileges, and later referred to the certificate of exclusive rights signed by the King of England himself.

A patent is generally a document issued by a ** organ or a regional organization representing several countries according to the application, which records the content of the invention and creation, and produces such a legal state within a certain period of time, that is, the patented invention can only be exploited by others with the permission of the patentee under normal circumstances. In China, patents are divided into three types: invention, utility model and design.

A patented product refers to a product that has all the technical features described in the patent claims. The patented product platform refers to the public service platform for patented products jointly created by the Changzhou Municipal Bureau of Commerce and Jiangsu Baiteng Technology.

Patent Law of the People's Republic of China

Article 11 After a patent right for invention or utility model is granted, except as otherwise provided in this Law, no unit or individual may exploit the patent without the permission of the patentee, that is, it may not manufacture, use, offer to sell, sell, or import its patented product for production or business purposes, or use its patented process, or use, offer to sell, sell, or import the first product directly obtained in accordance with the patented process.

After the design patent right is granted, no unit or individual may exploit the patent without the permission of the patentee, that is, it shall not manufacture, offer to sell, sell or import its design patented products for the purpose of production and operation.

Patentable patent applications for pharmaceutical products mainly include the following 7 categories:

1 Medicinal compounds, including new compounds obtained by chemical or biosynthesis, or separation from animals and plants or other raw materials, and which have at least one medicinal use.

2 Pharmaceutical compositions, comprising: a compositions containing a new compound and a medicogenic vehicle; b Compositions containing a new medicinal compound and one or more known medicinal compounds; c Compositions containing two or more known medicinal compounds, the composition must be new and pharmacodynamic comparative data demonstrate that two or more components of the pharmaceutical composition have a significant synergistic effect; d. New TCM compound products with pharmacodynamic data proving that they have good effects; e Improvements, subtractions or substitutions of known TCM compounds that have been improved and have comparative data to prove that the improvements have brought unexpected effects.

3. New active extracts refer to biologically active mixtures extracted from animal and plant sources or other raw materials through solvents, especially those extracted from single or compound formulas of traditional Chinese medicine; If the active ingredient of such an active mixture cannot be characterized by chemical structure and content, it can be limited by its preparation method, as long as the preparation method is new, and there are experimental comparative data to prove that the active extract has better efficacy or less toxicity or dosage, more convenient application and other advantages than the unextracted API, the patent right of Xiyan can be obtained.

4 New pharmaceutical formulations or dosage forms, including:a new formulations or dosage forms containing known pharmaceutical compounds or known pharmaceutical compositions; b. New formulations or new dosage forms of known Chinese medicine formulas or proprietary Chinese medicines; As long as the said formulation or dosage form is new, and there is comparative data to prove that the new formulation or dosage form has brought obvious beneficial effects, such as increased efficacy or reduced toxicity or dose, the patent right can be obtained.

5 New crystal forms, including: a crystal forms of new compounds; b New crystal forms of known compounds; There must be data, especially the X-ray diffraction pattern and melting point of the crystal, to prove that the new crystal form exists and is stable, and has obvious beneficial physical and chemical properties and beneficial pharmaceutical uses.

6 New hydrates or solvates including:a hydrates or solvates of new compounds; b New hydrates or solvates of known compounds; Data such as spectra, crystal form and melting point must be available to prove that the new hydrate or solvate is present and stable, and has obviously beneficial physicochemical properties and beneficial uses in order to be patented.

7. Biological drugs: such as new proteins, peptides, nucleotides, gene fragments, monoclonal antibodies, vaccines, microorganisms capable of producing drugs, vectors used in genes, and host cells containing vectors.

The national patented drug refers to the new chemical monomer drug for which the patent has been applied. Its development process includes the discovery stage, preclinical development, preclinical application of new drugs, phase I of clinical trials of new drugs, clinical trials of new drugs, clinical trials of new drugs, and new drug applications. These drugs can only be produced by the companies that own these patented drugs, or they can be transferred to others to produce them.

Legal basis: Drug Administration Law of the People's Republic of China

Article 1 This Law is enacted in order to strengthen drug management, ensure drug quality, protect the safety of drug use and legitimate rights and interests of the public, and protect and promote public health.

Article 2 This Law shall apply to those engaged in the development, production, operation, use and supervision and management of drugs within the territory of the People's Republic of China. The term "drugs" as used in this Law refers to substances used to prevent, diagnose and diagnose human diseases, purposefully regulate human physiological functions, and stipulate indications or functional indications, usage, and dosage, including traditional Chinese medicine, chemical drugs, and biological products.

Article 3 drug management should be centered on people's health, adhere to the principles of risk management, whole-process control, and social co-governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs.

Article 6 The state implements the drug marketing authorization holder system for drug administration. The marketing authorization holder shall be responsible for the safety, effectiveness and controllable quality of the drug in the whole process of drug development, production, operation and use in accordance with the law.