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This document communicates the determination of the regulatory review period for the human biological product PROLIA and includes instructions for public comments and petitions regarding patent term

How to fill out determination of regulatory review

How to fill out Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

1. Obtain the official form for the Determination of Regulatory Review Period for Purposes of Patent Extension.
2. Fill in the product name (PROLIA) in the designated field.
3. Provide the NDA application number or abbreviated application if applicable.
4. Complete the sections detailing the approval dates and the regulatory review period.
5. Include relevant documentation that supports the review period calculations.
6. Review the entire form for accuracy and completeness.
7. Submit the form to the appropriate regulatory body.

Who needs Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA?

1. Pharmaceutical companies seeking patent extension for their product PROLIA.
2. Legal teams handling intellectual property rights on behalf of the pharmaceutical industry.
3. Regulatory affairs professionals involved in the patent application process.

People Also Ask about

Can a patent term be extended?

The time period for a patent can only be extended by following conventional and constitutional laws that explicitly or implicitly allow for an extension, for a maximum of five years.

Does the patent for biologics expire?

A significant number of biologic drugs are expected to lose patent protection by 2030, creating a substantial opportunity for biosimilar manufacturers. The adoption of biosimilars is increasing due to their potential to transform expensive treatments into more accessible and affordable ones.

What is 156 patent term extension?

156 enables the owners of patents that claim certain human drug products, medical device products, animal drug products, veterinary biological products, and food or color additive products to restore to the terms of those patents some of the time lost while awaiting premarket Government approval for the products from a

Can you extend a drug patent?

The Drug Price-Patent Term Act allows an extension for qualifying patents, not to exceed five years.

What is a patent term extension for biologics?

Patent Term Extension (PTE) under 35 U.S.C. 156 enables the owners of patent that claim certain human drug products, medical device products, animal drug products, veterinary biological products to restore to the terms of those patents some of the time lost while awaiting premarket regulatory approvals.

What is the difference between patent term adjustment and extension?

As inventors seek to capitalize on their inventions, understanding the difference between Patent Term Adjustment (PTA) and Patent Term Extension (PTE) is crucial. PTA compensates for delays in the patent examination process, while PTE compensates for the delays in obtaining regulatory approval.

What's the time frame for a patent extension?

How many months can a patent response be extended? If more time is needed to respond to a substantive Office Action, a maximum three-month extension of time may be requested giving the applicant a maximum total of six months from the date of the Office Action.

What is a pharmaceutical patent term extension?

Patent term extensions (PTE) extend the term of a patent covering a pharmaceutical product that undergoes regulatory review in order to obtain marketing authorization. There are two principal types of PTE: patent term restoration and pediatric exclusivity.

What is a patent term extension?

Patent term extensions (PTE) extend the term of a patent covering a pharmaceutical product that undergoes regulatory review in order to obtain marketing authorization. There are two principal types of PTE: patent term restoration and pediatric exclusivity.

What is the term extension for pharmaceutical patents?

Section 70 of the Patents Act allows the patentee of a standard patent to apply for an extension of term if certain conditions are satisfied, namely: The patent must relate to a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology.

For pdfFiller’s FAQs

What is Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA?

The Determination of Regulatory Review Period for Purposes of Patent Extension for PROLIA refers to the formal assessment of the time period during which the regulatory authority reviewed the application for the drug, in this case, PROLIA, to evaluate its potential for patent extension under applicable laws.

Who is required to file Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA?

The manufacturer or sponsor of the drug, specifically the entity that holds the New Drug Application (NDA) or Biologics License Application (BLA) for PROLIA is required to file the Determination of Regulatory Review Period for Purposes of Patent Extension.

How to fill out Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA?

To fill out the Determination of Regulatory Review Period form for PROLIA, the applicant must include information about the NDA or BLA number, the date of approval, the dates of any relevant submissions, and any other required details as specified by the regulatory authority.

What is the purpose of Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA?

The purpose of the Determination of Regulatory Review Period is to establish the official timeframe for regulatory review that can be considered for patent extension applications, thereby potentially extending the exclusivity period for the patent holder.

What information must be reported on Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA?

The information that must be reported includes the name of the drug, NDA or BLA number, dates of regulatory submissions, the approval date, and the duration of the review period, along with other relevant details required by the regulatory guidelines.