The protection of intellectual property rights in the United States is divided into two parts: one is patent-based legal protection; the other is based on administrative restrictions, and the exclusive right protection of certain drug application data. This article is a translation of the FDA's official website and aims to provide you with a basic understanding of US drug patents and exclusive rights. 1 What is the difference between patents and exclusive rights? Patents and exclusive rights are similar but different and belong to different administrations. A patent is an intellectual property that is administered by the US Patent and Trademark Office (USPTO) and contains a wide range of claims. The exclusive right involves an extension and the exclusionary right to approve the competing product attached to an application by supplemental application. New Drug Application (NDA) and Simplified New Drug Application (see section 314.108, 316.31, 316.34 of 21 C.FR and Sections 505A, 505E, and 50 (j)(5)(B)(iv) of the Food and Drug Administration Act (FD&CA) ANDA) holders are eligible to apply for exclusive rights. Exclusivity is a system designed to balance new drug innovations and generic drug competition to improve the public accessibility of drugs. 2 How long is the patent period? The patent period is set by regulations. Currently, the patent period for the new patent is 20 years from the filing date. There are many other factors that affect the duration of a patent. 3 How long is the exclusive right period? It depends on the type of exclusive rights: Orphan Drug (ODE): 7 years New Compound Entity (NCE): 5 years New clinical study: 3 years Pediatric Use (PED): Existing patent period or exclusive period + 6 months Patent Challenge (PC): 180 days (for generics only) Antibiotic Incentive (GAIN): Other exclusive rights +5 years 4 Why is the expiration of the expiration date before the patent? Before the patent was exclusive? Why are some products only patented or exclusive, or neither? Patents and exclusive rights are applied to medicines in different ways. Regardless of the approval status of the drug, the patent can be released and expired at any time. The exclusive right is attached to the approval action of the drug. Some medicines are protected by patents and exclusive rights, and some have only one or both. Patents and exclusive rights may cover the same parts and may cover different parts. After the patent and exclusive rights expire, the Orange Book will be removed. 5 What information related to pediatric drug monopoly rights will be included in the Orange Book? When the exclusive right to use pediatric drugs is obtained, the holder has an exclusive right of six months for all patents and exclusive rights of the active entity. The exclusive right to use pediatric drugs does not exist alone, but is attached to other existing exclusive rights. When the pediatric drug exclusive right is attached, the Orange Book patent column will show the patent expiration date and a six-month period reflecting the exclusive use of pediatric drugs. 6 How do I find patent and exclusive rights regulations in the US Federal Regulations (CFR)? 7 How do new drug application holders (NDA holders) know that their application has exclusive rights? There is no new notice to notify applicants of their application for exclusive rights. The Orange Book will publish a message in its official media The posting of exclusivity information. 8 When do new drug application (NDA) applicants submit patent information? All new drug applications (NDAs) and certain supplemental applications (sNDAs) require the submission of patent information at the time of filing. The patent information listed in the Orange Book must be submitted within 30 days of the approval of the application in accordance with Form FDA 3542. For patents that are published after the new drug application or supplementary application is approved, the applicant must submit the patent information within 30 days after the patent is published. If a new drug applicant submits the required patent information in a timely manner, but the FDA informs that the Form FDA 3542 format is not completed or is not suitable (in the Orange Book), the new drug applicant must comply with the Form FDA within 15 days of receiving the FDA notification. 3542 Acceptable patent information. 9 What is the patent filing date? The date of filing of the patent is the date the FDA receives the patent information from the holder of the new drug application (NDA). 10 Why do most of the Orange Book records do not include the date of patent filing? The FDA began collecting patent submission dates in 2013. The October 2016 rule “Abbreviated New Drug Applications and 505(b)(2) Applications†states: “The FDA tends to list patent submission time and patent information in the Orange Book after this rule becomes effective.†Thereafter, The Orange Book will publish the patent submission time for all new records. 11 How do new drug application holders correct the submission date? New drug application holders can send an email requesting an error correction, including a request for reconsideration. Requests will be considered one by one, as the request will be updated as soon as possible in the Orange Book. 12 How do new drug application holders correct or request removal of patent information? The new drug application holder must submit a request to correct or change the previously filed patent information. See “14†for a description of the changes in approved usage. If a new drug applicant believes that the patent or patent claim is no longer suitable for the (Orange Book) inclusion, the FDA must immediately notify the FDA to amend the patent information or withdraw the patent information or request the patent/patent information to be removed from the (Orange Book) list. . New drug applicants must submit a statement containing their NDA application number, patent number, etc. to their NDA when seeking to withdraw the patent. If a new drug applicant is required by the court to amend the patent information (from the Orange Book) or withdraw the patent, an amendment, including a court order, must be submitted to the FDA within 14 days of the order. In addition, in accordance with the fixed form of FormFDA3542, new drug applicants must submit a request for correction of the validity period of the patent within 30 days after the extension of the patent terms is approved. 13 Do I need to submit patent information when a new drug application holder seeks a supplementary application? When a supplemental application seeks to change the dosage form, route of administration, dosage, or prescription drug to a non-prescription drug, the new drug application holder must submit the patent information. When the supplementary application seeks the following changes, whether or not the patent information is required to be submitted depends on whether the existing patent information included in the Orange Book contains the claims for the changed product. If the scope of the original NDA patent information protection for the approved drug no longer includes the changed drug, the applicant must submit a request to remove the patent information when the supplementary application is approved. If the patent information of the changed product has not been previously covered, the applicant must submit the patent information in accordance with the requirements of 314.53(c). If the supplementary application involves a change in the usage of the patent information included in the Orange Book, the new drug application holder must also submit the patent information for any supplementary application. 14 When will the new drug application holder be able to revise the description of the usage stated in the patent? Amendments to the approved usage descriptions stated in the patent will be given timely consideration within 30 days of submission. (1) Patent issuance, (2) Approving the corresponding product label change, (3) The US Patent and Trademark Office or the federally-owned patent court's resolution will change the usage statement in the patent (the amendment will contain a copy of the resolution), (4) Exceptions provided by the Patent Collection Defense Regulations (21 CFR 314.53(f)(1)) and cases other than (1-3), the amendments to the approved usage descriptions stated in the patents will not be archived in a timely manner. . If the revision of the approved usage statement stated in the patent is within the acceptable time frame and is not completed or is not suitable for inclusion, the new drug application holder must submit Form FDA 3542 within 15 days of the FDA issuing a notice to consider the filing. 15 For unresolved generic applications or applicants for 505(b)(2), what actions should be taken when patent information is not filed in time? If the patent information is not filed in time, applicants who have previously submitted a generic application (ANDA) or 505(b)(2) generally do not need to submit a patent certificate or statement that may be filed in the future. 16 Does the patent information submitted to the competent authority require a special format? Form FDA 3542a is used if the New Drug Application (NDA) intends to submit a New Drug Original Application (Original NDA), a revised application, or a supplemental application for an approved product. Form FDA 3542 is used if the New Drug Application (NDA) intends to submit a claim for an approved drug or usage in a patent after the original or supplemental application for the new drug is approved. The competent authority will not include or disclose patent information not provided under Form FDA 3542. 17 What is the final rule for submitting (patent) information? After December 5, 2016, the final effective date of the Simplified New Drug Application (ANDA) and 505(b)(2) applications applies to any submissions received by the FDA. 18 Will previously submitted patent information be resubmitted in accordance with the new format of Forms FDA 3542 and 3542a? No need. Any patent information submitted after the effective date of the final rule must comply with the final standards, including the use of the new format. New drug application holders and applicants who have submitted patent information in accordance with the previous version format do not need to resubmit. 19 Who should contact who is suitable for inclusion in the Orange Book? The FDA's patent collection rules are internal, and the FDA generally does not respond to the question of whether patents are suitable for inclusion in the Orange Book.
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