[exclusive] US drug patents and exclusivity FAQ

The protection of drug intellectual property in the United States is divided into two parts: one is the legal protection based on patent; the other is the exclusive protection based on administrative restrictions for some drug application data This paper is a translation of the relevant information on the FDA website, aiming to provide you with a basic understanding of drug patents and exclusive rights in the United States Key words: American drugs, FDA, patents, monopolies 1 What's the difference between patents and monopolies? Patents and monopolies have similar functions but different functions and belong to different authorities Patent is a kind of intellectual property, which is managed by USPTO and contains a wide range of claims The exclusive right involves some kind of extension and the exclusive right to obtain approval for the competitive products attached to one application by supplementary application According to 314.108316.31316.34 of 21C F.R and 505a, 505E, and 50 (J) (5) (b) (IV) of FD & CA, holders of new drug application (NDA) and simplified new drug application (anda) are entitled to apply for exclusive rights Monopoly is a system designed to balance new drug innovation and generic competition to improve public access to drugs 2 How long is the patent period? The patent period is set by laws and regulations At present, the patent period of new patent in the United States is 20 years from the date of application 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 right: orphan drug (ODE): 7-year new compound entity (NCE): 5-year new clinical research: 3-year paediatric drug (PED): existing patent period or exclusive right period + 6-month patent challenge (PC): 180 days (generic only) antibiotic incentive (gain): other exclusive right period + 5 years 4 why the expiration period exclusive right is before the patent? Patent before monopoly? Why do some products have only patents or exclusive rights, or neither? Patents and monopolies are applied to drugs in different ways Patents can be issued and invalidated at any time regardless of the approval status of the drug The monopoly depends on the approval of drugs Some drugs are protected by patents and monopolies, while others are only protected by one or both Patents and monopolies may cover the same or different parts The patent and exclusive right will be removed from the orange book after expiration 5 What information about pediatric drug monopoly will be included in the orange book? When the exclusive right of paediatric medication is obtained, all the patents and exclusive rights of the holder for the active entity are attached with a six-month exclusive right The exclusive right of pediatric medication does not exist alone, but depends on other existing exclusive rights When the pediatric drug exclusive right is attached, the Orange Book Patent column will display the expiration period of the patent and the six-month period reflecting the pediatric drug exclusive right 6 How to find the regulations of patent and exclusive right in C.F.R? 7 How does the NDA holder know that his application is exclusive? No new message has been created to notify the applicant that their application is exclusive The orange peel book will be published in its official media the posting of exclusivity information 8 When does the new drug applicant (NDA) submit patent information? All new drug applications (NDA) and some supplementary applications (sndas) require patent information at the time of filing The patent information listed in the orange peel must be submitted within 30 days after the application is approved in accordance with the requirements of form FDA 3542 For a patent disclosed after the approval of a new drug application or supplementary application, the applicant must submit the patent information within 30 days after the patent is disclosed If the new drug applicant submits the required patent information in a timely manner, but the FDA notifies that the form FDA 3542 format is not completed or is not suitable (in the orange peel book), the new drug applicant shall, within 15 days after receiving the FDA notification, follow the acceptable patent information of form FDA 3542 9 What is the patent filing date? Patent filing date is the date FDA receives patent information from the NDA holder Why do most records of orange peel books not include patent filing date? FDA began collecting patent filing dates in 2013 The October 2016 rule "abbreviated new drug applications and 505 (b) (2) applications" states: "FDA tends to list patent filing time and patent information in the orange peel book after this provision takes effect." Thereafter, the orange peel book will publish all new records of patent filing time 11 How does the new drug applicant correct the submission date? The holder of a new drug application may request correction by email, including a request for reconsideration Requests will be considered on a case by case basis and will be updated in the orange book as soon as possible 12 How do new drug application holders correct or request to remove patent information? The new drug applicant must submit a request to correct or change the previously submitted patent information See "14" for the description of changing the approved use method If the new drug applicant believes that the patent or patent claim is no longer suitable for the requirements included in the orange book, he must immediately notify FDA to revise the patent information or withdraw the patent information or request the patent / patent information to be removed from the list of orange book When seeking to withdraw the patent, the new drug applicant must submit a statement containing the NDA application number, patent number, etc If a new drug applicant is required by the court (from the orange peel book) to amend the patent information or withdraw the patent, an amendment including the court order must be submitted to FDA within 14 days after the order is issued In addition, according to formfda3542, new drug applicants must submit a request for patent validity correction within 30 days after the patent terms are extended 13 Do new drug applicants need to submit patent information when seeking supplementary applications? When the supplementary application seeks to change the dosage form, route of administration, dosage or prescription drug to over-the-counter drug, the holder of the new drug application must submit the patent information When the supplementary application seeks the following changes, whether the patent information is required to be submitted depends on whether the existing patent information included in the orange peel book contains the claims for the changed product If the scope of patent information protection of the original NDA of approved drugs no longer includes the changed drugs, the applicant must submit the request to remove the patent information when the supplementary application is approved If the patent information of the changed product is not previously covered, the applicant must submit the patent information in accordance with 314.53 (c) If the supplementary application involves a change in the usage of the patent information included in the orange peel book, the holder of the new drug application must also submit the patent information for any supplementary application 14 When can the new drug applicant revise the description of usage stated in the patent? The revision of the approved usage description stated in the patent will be considered in a timely manner within 30 days of filing (1) Patent issuance, (2) approval of corresponding product label changes, (3) U.S patent and Trademark Office or federal patent court's decision to change the usage statement in the patent (the amendment will contain a copy of the decision), (4) exceptions provided by the defense of patent collection regulation (21cfr314.53 (f) (1)) and (1-3), the patent declaration Revisions of approved usage descriptions will not be archived in a timely manner If the revision of the approved usage description stated in the patent is within the acceptable time frame, but not completed or included properly, the new drug application holder must submit form FDA 3542 within 15 days after FDA issues the notice of considering filing 15 What actions should be taken when patent information is not filed in time for unresolved generic drug applications or 505 (b) (2) applicants? If patent information is not filed in a timely manner, applicants who have previously filed generic drug applications (anda) or 505 (b) (2) generally do not need to submit patent certificates or statements that may be filed in the future 16 Does the patent information submitted to the competent authority need a special format? If the NDA applicant intends to submit the original NDA, the revision of the application, or the supplementary application of the approved product, use form FDA 3542a If the new drug applicant (NDA) intends to submit a claim for the approved drug or usage in the patent after the original or supplementary application for the new drug is approved, use form FDA 3542 The competent authority will not include or disclose patent information not provided in accordance with form FDA 3542 What is the final rule applicable to the submission of (patent) information? After December 5, 2016, the final effective dates for the simplified new drug application (anda) and 505 (b) (2) applications apply to any submission received by FDA 18 Does the previously submitted patent information need to be resubmitted in accordance with the new format of forms FDA 3542 and 3542a? Unwanted Any patent information submitted after the effective date of the final rule must comply with the final rule, including the use of new formats Holders and applicants of new drug applications who have submitted patent information in the format of previous versions do not need to submit it again 19 Who should be contacted about which patents are suitable for inclusion in the orange book? FDA's patent inclusion rules are internal, and FDA generally does not respond to personalized questions about whether a patent is suitable for inclusion in the orange book.