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Last Updated: April 20, 2025

Details for Patent: 11,253,528


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Which drugs does patent 11,253,528 protect, and when does it expire?

Patent 11,253,528 protects RAYALDEE and is included in one NDA.

This patent has eighty-four patent family members in thirty-seven countries.

Summary for Patent: 11,253,528
Title:Stabilized modified release Vitamin D formulation and method of administering same
Abstract:A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 and a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.
Inventor(s):Jay A. White, Samir P. Tabash, Sammy A. Agudoawu, Joel Z. Melnick
Assignee:Eirgen Pharma Ltd
Application Number:US16/448,838
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 11,253,528: A Comprehensive Analysis

Introduction

When analyzing a patent, it is crucial to delve into its scope, claims, and the broader patent landscape to fully comprehend its implications and potential impact. This article will provide a detailed analysis of United States Patent 11,253,528, focusing on its claims, the context within which it was granted, and the relevant legal and procedural aspects.

Patent Overview

United States Patent 11,253,528, like any other patent, is a grant of rights for an invention, issued by the U.S. Patent and Trademark Office (USPTO). To understand this patent, one must start with its basic components:

Inventorship and Ownership

The patent lists the inventors and the assignees, which are critical for determining the rights and responsibilities associated with the patent. Correct identification of inventors is essential under U.S. patent law, as it ensures that the true and only inventors are recognized and that the patent remains enforceable[4].

Claims

The claims section of a patent is the most critical part, as it defines the scope of the invention. Claims can be independent or dependent and must be clear, concise, and supported by the description in the patent specification. For example, a study on patent claims highlights the importance of independent claim length and count as metrics for measuring patent scope, indicating that narrower claims are often associated with a higher probability of grant and a shorter examination process[5].

Claim Analysis

To analyze the claims of Patent 11,253,528, one would typically follow these steps:

Identify Independent and Dependent Claims

Independent claims stand alone and define the invention without reference to other claims. Dependent claims, on the other hand, refer back to and further limit the scope of an independent claim.

Understand Claim Language

Each claim must be carefully read to understand the specific elements and limitations of the invention. The language used in claims is precise and legally binding.

Determine Claim Scope

The scope of the claims defines what is protected by the patent. Broader claims may cover more variations of the invention, but they also risk being more vulnerable to challenges based on prior art or obviousness.

Patent Landscape

The patent landscape includes all related patents and applications that could impact the validity or enforceability of Patent 11,253,528.

Continuations and Continuations-in-Part

Patents can be part of a family of patents, including continuations and continuations-in-part. These relationships can affect the patent term and the analysis of obviousness-type double patenting (ODP)[1].

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention that is obvious in view of an earlier patent. This is particularly relevant for patents within the same family, as seen in the case of In re Cellect LLC, where the court emphasized that ODP analysis must consider the adjusted expiration date of the patent, including any Patent Term Adjustment (PTA)[1].

Legal and Procedural Aspects

Patent Term Adjustment (PTA)

PTA is a mechanism to adjust the term of a patent to account for delays during the prosecution process. However, as noted in In re Cellect LLC, a terminal disclaimer can limit the extension of the patent term beyond the specified date, even if PTA is granted[1].

Terminal Disclaimers

A terminal disclaimer is a statement by the patent owner that the term of the patent will end on the same date as an earlier patent. This is often used to overcome ODP rejections but can have significant implications for the patent term[1].

Economic and Strategic Implications

Patent Scope and Innovation

The scope of a patent can influence innovation and competition. Broader patents might deter others from innovating in the same area, while narrower patents could encourage more focused innovation. Research has shown that narrower claims are associated with higher grant probabilities and shorter examination processes, which can be beneficial for both the patent holder and the broader innovation ecosystem[5].

Litigation and Licensing

The clarity and scope of patent claims can significantly impact litigation and licensing strategies. Clear and well-defined claims reduce the risk of disputes and make licensing negotiations more straightforward.

Key Takeaways

  • Claims Analysis: The claims section is crucial for understanding the scope of the invention.
  • Patent Landscape: Understanding the family of patents and related applications is essential for assessing validity and enforceability.
  • Legal Considerations: ODP, PTA, and terminal disclaimers are critical legal aspects that can affect the patent term and scope.
  • Economic Impact: The scope of a patent influences innovation, litigation, and licensing strategies.

FAQs

Q: What is the importance of identifying the true and only inventors in a patent application? A: Correct identification of inventors ensures that the patent remains enforceable and avoids potential challenges based on incorrect or incomplete inventorship[4].

Q: How do independent and dependent claims differ in a patent? A: Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the scope of an independent claim.

Q: What is obviousness-type double patenting (ODP), and why is it significant? A: ODP prevents an inventor from securing a second, later-expiring patent for an invention that is obvious in view of an earlier patent, ensuring that the same invention is not patented multiple times[1].

Q: How does Patent Term Adjustment (PTA) affect the term of a patent? A: PTA adjusts the term of a patent to account for delays during the prosecution process, but it does not extend the term beyond the date specified in a terminal disclaimer[1].

Q: Why is the scope of a patent important for innovation and competition? A: The scope of a patent can influence innovation by either deterring or encouraging others to innovate in the same area, depending on whether the claims are broad or narrow[5].

Sources

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, 2023.
  2. U.S. Patent and Trademark Office (USPTO), USAGov.
  3. Patent Claims Research Dataset, USPTO.
  4. Determining Inventorship for US Patent Applications, Oregon State University.
  5. Patent Claims and Patent Scope, SSRN.

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Drugs Protected by US Patent 11,253,528

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes 11,253,528 ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,253,528

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2968172 ⤷  Try for Free 122021000009 Germany ⤷  Try for Free
European Patent Office 2968172 ⤷  Try for Free 301095 Netherlands ⤷  Try for Free
European Patent Office 2968172 ⤷  Try for Free CA 2021 00005 Denmark ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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