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    Home > Active Ingredient News > Drugs Articles > Discussion on the patent publicity rules of Chinese medicine orange peel book (2): publicity content

    Discussion on the patent publicity rules of Chinese medicine orange peel book (2): publicity content

    • Last Update: 2017-12-05
    • Source: Internet
    • Author: User
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    Source: Medical magic cube data 2017-12-05 the author mentioned in the previous article that at present, there are no clear detailed rules on the content of patent information in orange book However, from the draft for consultation on the selection of the first batch of Chinese listed chemicals catalogue (hereinafter referred to as the "draft catalogue") issued by the General Administration of food and Drug Administration on November 28, we can still understand the official design ideas for the publicity content In this paper, based on the interpretation of the catalogue draft, combined with the practice of foreign countries and China's national conditions, the author gives some discussions and suggestions on the design of publicity content 1、 What patent information does the foreign Orange Book publicize? The patent link system is a foreign product, not an original one in China, so it is necessary to learn from foreign systems in the creation of rules At present, the United States and South Korea are two representative countries in the world that implement patent link system Here, we briefly introduce the regulations of these two countries on patent information publicity The patent information required to be filed in the United States includes: patent number, authorization date, patent expiration date; name / name, address, telephone number, fax number, email address of the patentee or its representative; orange peel information change history, patent type There are three types of patents in the United States: drug substance patents, drug product patents, and method of use patents If there is no corresponding patent, the United States also requires the fact that there is no patent in the orange book The advantage of doing so is to prevent any confusion in the fact finding when there is a dispute in the future The contents claimed by South Korea include: information of the patentee or its representative, patent number, patent expiration date, and claims involved In addition, the pharmaceutical regulatory authority will determine whether the types of patents belong to the following four categories: substance patents, dosage form patents, composition patents and pharmaceutical patents 2、 How does China's catalogue publish patent information? The catalogue draft contains 189 kinds of listed drugs, which are divided into two parts: "drug catalogue" and "appendix" The "drug catalog" lists the basic information of each drug, such as active ingredients, drug name, dosage form, specification, reference preparation, manufacturer and so on At present, only patent information is listed in the "appendix", specifically including drug approval number / registration certificate number, patent number, patent expiration date, patent type and patent revocation As for the entry rules of each patent information in the appendix, the catalogue draft does not give any explanation It can be seen from the summary of the information entered therein that the column of "patent No." includes patent No (such as zl01822159.9) and authorization Announcement No (such as cn102702119b); the column of "patent type" refers to five types: "product / compound", "salt of product / compound", "product / composition", "product / preparation" and "indication" "Patent revocation" column has not been filled in any content, the author speculates that the content of this column is related to whether the patent right is lost In addition, similar to the regulations in the United States, if the relevant valid patent does not exist, indicate "None" in the column of "patent number" In the following, the author discusses the design of the publication content of orange book in China by comparing the similarities and differences between the catalogue draft of China and the regulations of the United States and South Korea 3、 What should basic patent information include? In the basic information of patent, China's catalogue draft and the United States and South Korea have the same regulations in that both require the publication of patent number and patent expiration date There seems to be no dispute about this, after all, it is the most basic information to judge the status of rights However, compared with the United States and South Korea, the catalogue draft does not require the disclosure of the information of the patentee or his representative, nor does it require the specific disclosure of the number of the claims involved, as is the case in South Korea The author thinks that the above two contents are necessary information, so it is also the place where the catalogue draft of our country needs to be improved First of all, only by disclosing the information of the patentee or his representative, can the generic pharmaceutical factory effectively notify the patentee when it raises the patent challenge and ensure the smooth progress of the patent challenge process Secondly, since the same patent may involve multiple patent types, each type of patent will correspond to different claims In order to avoid confusion, it is necessary to clarify the corresponding claim number 4、 How to determine the type of patent? 4.1 Why should patent type be indicated? As mentioned in the previous article, the patent publicity of orange peel book should follow the principle of correspondence, that is to say, the patent publicized must be able to correspond to the corresponding drugs on the market One of the most convenient ways for the original pharmaceutical companies to abuse the patent link system and use unrelated patents to crack down on generic pharmaceutical companies is to write seemingly related but not corresponding patents into the orange book For example, suppose that the active ingredient of a listed drug is a maleate, and the patent written in the orange peel book by company a, the original pharmaceutical research factory, is a hydrochloride Now company B wants to register and list the generic medicine of a maleate In order to delay the listing process, company a will file a patent infringement lawsuit based on the hydrochloride patent in the orange peel book According to the rules of patent link, once an infringement lawsuit is filed, the drug regulatory authority will suspend the approval of company B's drugs Although company B will be recognized as non infringement of patent rights in the lawsuit, it will also lose valuable listing opportunity due to the suspension of approval It can be seen that the principle of correspondence is the key to ensure that the patent link system is not abused So why should the patent type be indicated in the publicity? This is because different types of patents have different scope of protection If the scope of protection is relatively small, the patent type may not correspond to the corresponding drugs on the market Therefore, it is easier to indicate the patent type to guide the official and the relevant public (especially the imitated pharmaceutical factory) to judge whether the correspondence is established 4.2 What types of patents can be publicized? The patents published in the orange peel Book correspond to the listed drugs, but not all patents in the field of medicine can form such a corresponding relationship Some patents are not directly related to the drug itself, such as synthetic intermediates, metabolites, drug packaging and preparation methods, etc., so in principle, they should not be allowed to be included in the orange peel book The relevant laws of the United States also explicitly exclude the information declaration obligations of process patents, patents claiming packaging, patents claiming substances and patents claiming intermediates Patents corresponding to the drugs on the market, including product patents and method patents Product patents include active substances, derivatives of active substances (salts, crystals, enantiomers, solvent complexes, etc.), preparations and compositions, and method patents include indications For these patent types that can be publicized, China's catalogue draft and the United States and South Korea have made further classification, but the specific classification is not the same In order to intuitively show the corresponding relationship of patent type classification in different countries, the author makes the following comparison table: 4.3 Do compound patents need to be further subdivided? How to subdivide? It can be seen from the above table that the United States and South Korea generally classify compound patents into one category, which are called "drug patents" and "substance patents", respectively In addition to "compounds", the "salt of compounds" is also listed as a separate category in the catalogue draft of China, that is to say, the patent of compounds is further subdivided So, is such subdivision necessary? From the point of view that patent publicity should have correspondence, it is indeed necessary Patents involving only the active compounds themselves without specifically defining their derivative forms (e.g salts) have the largest scope of protection, covering all drug forms and indications As long as the same active substances are used in the drugs on the market, it can be generally considered that there is no corresponding problem However, once a certain salt is limited, the scope of patent protection will be narrowed down, which may lead to the loss of correspondence In the previous example, if only the patent of hydrochloride is available, it cannot correspond to the listed drugs using maleate as the active substance Therefore, listing "salt of compound" as a separate type is equivalent to reminding the public that this patent is only limited to specific salt, as long as the specific salt is different from the salt used in the drugs on the market, there is no corresponding In this way, it is relatively easy for the public, especially the generic manufacturers, to judge However, there are some limitations in the classification of "salt of compounds" After all, the derivative forms of pharmaceutical active compounds include not only salt, but also crystal, enantiomer, solvent complex (such as hydrate), etc If each of these derivative forms is listed as a separate type, it will cause too many types of patents, and it is difficult to distinguish one by one in practice Therefore, the author suggests that compound patents can be divided into two categories: "leading substance" and "derivative substance" The "leading substance" requires the protection of the active substance itself or the so-called "leading compound" and does not limit any derivative form In contrast, "derived substance" includes any patent that defines the derivative form of a compound, such as a specific salt, crystal, enantiomer, solvent complex, etc 4.4 Is it necessary to distinguish preparation patent and composition patent? In the treatment of patent for preparation and composition, the practices of the United States and South Korea are different The United States did not make a distinction between the dosage forms and compositions, which were classified as "pharmaceutical patents"; South Korea classified them as different patent types China's catalogue draft adopts the Korean method to separate the composition from the preparation, but the author thinks it is questionable to do so We need to make clear the definition of preparation patent and composition patent first There are two understandings of pharmaceutical patent In a narrow sense, pharmaceutical patent defines the specific dosage form of the drug; in a broad sense, as long as the information related to the preparation, such as dosage form, content, excipients, etc., is defined, it belongs to pharmaceutical patent In practice, patent for composition is generally divided into two situations: the first is the combination of different active ingredients, and the second is the combination of active ingredients and pharmaceutical excipients In fact, both preparation patents and composition patents are further defined on the basis of active substances, including substance combination, dosage form, content, excipients, etc Since further restrictions are made, the scope of patent protection is bound to be limited, which may result in the loss of correspondence From this point of view, there is no essential difference between preparation patent and composition patent In addition, it can be seen from the above definition that there is no obvious boundary between preparation patent and composition patent The second case of the composition patent is actually covered in the broad understanding of the preparation patent; while the first case of the composition patent essentially limits the first active ingredient with the combination of other active ingredients, so it can be treated similarly with the "derivative substance" patent in Section 4.3 In this sense, "composition patent" is not necessary to exist as a type alone Therefore, the author suggests that China should learn from the practice of the United States and combine the preparation and composition into one
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