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This document provides information regarding the regulatory review period for the human drug product CUBICIN, including details of its approval phase, testing phase, and the subsequent patent term
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How to fill out cubicin patent term restoration
How to fill out CUBICIN Patent Term Restoration Application
01
Obtain the CUBICIN Patent Term Restoration Application form from the appropriate patent office.
02
Fill in your patent details, including the patent number and title of the invention.
03
Provide information about the regulatory review period experienced by the drug.
04
Include any data required to demonstrate the period of regulatory delay.
05
Affirm that the application is being filed in accordance with relevant laws and regulations.
06
Submit the completed application along with any required fees to the patent office.
Who needs CUBICIN Patent Term Restoration Application?
01
Pharmaceutical companies that hold patents for drugs experiencing regulatory review.
02
Inventors seeking to extend the patent term for specific drugs due to delayed regulatory approvals.
03
Entities that have developed a drug and need to protect their intellectual property rights for a longer period.
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People Also Ask about
What is patent term restoration for top selling drugs in the United States?
Patents temporarily protect brand-name drugs from generic competition, but some of the 20-year patent term is used up before marketing approval. To compensate for patent life lost to clinical testing and regulatory review, current law provides patent term restoration (PTR) of up to 5 years.
What is patent restoration?
What does Restoration of patent mean? A patent is lapsed where the renewal fees have not been paid. It is possible to restore a patent after it has lapsed provided the application to restore is made in time. An application for restoration is only necessary if the grace period of six month has expired.
What is a patent term restoration?
Most new drugs receive a patent term restoration (PTR) extension. Patents with PTR commonly expire more than 12 years after marketing approval. Patents with PTR typically protect the active ingredients of products. Generic entry typically occurs upon expiry of PTRs or afterwards, but not before.
What is a PTE application?
Patents filed and granted on or after June 8, 1995 typically expire twenty years from the date of the first filing of the patent application ("patent term").[2] However, the patent term may be modified. Here, we discuss one way of extending patent term called "Patent Term Extension" or "PTE."[
How to calculate patent term extension in the US?
Calculation of the Length of PTE PTE is the sum of the “testing period” and the “approval period,” less: The number of days which were on or before the patent issued. The number of days during which the applicant did not act with due diligence. One-half the number of days of the testing period after the patent issued.
What is the drug price competition and patent term restoration act?
The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C
What is the drug price competition and patent term restoration act?
The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C
What is the cost of patent restoration?
For a small entity – INR 6,000. For anyone other than small entity – INR 12,000.
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What is CUBICIN Patent Term Restoration Application?
The CUBICIN Patent Term Restoration Application is a request for an extension of the patent term for the drug CUBICIN, based on regulatory delays associated with obtaining marketing approval.
Who is required to file CUBICIN Patent Term Restoration Application?
The company that holds the marketing approval and the patent for CUBICIN is required to file the Patent Term Restoration Application.
How to fill out CUBICIN Patent Term Restoration Application?
To fill out the CUBICIN Patent Term Restoration Application, the applicant must complete the required forms, provide detailed information about the patent, the drug, and the regulatory review period, and submit supporting documents as specified by the relevant patent office.
What is the purpose of CUBICIN Patent Term Restoration Application?
The purpose of the CUBICIN Patent Term Restoration Application is to seek an extension of the patent term to compensate for the time taken to obtain regulatory approval, which allows the patent holder to maintain market exclusivity for a longer period.
What information must be reported on CUBICIN Patent Term Restoration Application?
The application must report information including patent details, dates of regulatory submissions and approvals, the duration of the clinical trials, and any other relevant timelines that illustrate the duration of regulatory review.
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