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Last Updated: March 18, 2025

Details for Patent: 10,918,615


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Which drugs does patent 10,918,615 protect, and when does it expire?

Patent 10,918,615 protects BAFIERTAM and is included in one NDA.

This patent has nineteen patent family members in seven countries.

Summary for Patent: 10,918,615
Title:Fumarate esters
Abstract:Described herein are pharmaceutical compositions comprising one or more fumarate esters, processes for making the same, and compositions and methods for treating multiple sclerosis subjects with the compositions. In particular, oral pharmaceutical compositions comprising fumarate esters in liquid vehicles are described. One embodiment is an oral delayed release pharmaceutical dosage form comprising a soft capsule encapsulating an immediate releasing liquid comprising one or more fumarate esters.
Inventor(s):Jason M. Vaughn, Justin R. Hughey, Tanesha Roberts, Tatyana Dyakonov, Sunil Agnihotri, Aqeel A. Fatmi
Assignee:Banner Life Sciences LLC
Application Number:US16/129,860
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,918,615

To conduct a detailed analysis of the scope and claims of a specific patent, such as United States Patent 10,918,615, it is essential to delve into several key aspects of patent law and the specific details of the patent in question.

What is a Patent?

A patent is a grant of exclusive rights to an inventor for their invention, as empowered by the U.S. Constitution to "promote the Progress of Science and useful Arts, by securing for limited Times to ... Inventors the exclusive Right to their respective ... Discoveries"[2].

Components of a Patent

A patent typically includes several key components:

  • Cover Page: Provides basic information such as the names of the inventors, the title of the patent, the date of issuance, an abstract, and a representative drawing[2].
  • Claims: These are the legally binding descriptions of the invention that define the scope of the patent. Claims are crucial as they determine what is protected by the patent[2][3].
  • Description and Drawings: These sections provide detailed explanations and illustrations of the invention, including background technology and various aspects of the invention[2].

Patent Claims Analysis

Claim Structure

Patent claims are divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[2].

Claim Scope

The scope of a patent is often measured by metrics such as independent claim length and independent claim count. Narrower claims, which are more specific, are generally associated with a higher probability of grant and a shorter examination process compared to broader claims[3].

Patent 10,918,615 Specifics

Title and Abstract

To begin, one would need to review the title and abstract of the patent to understand the general nature of the invention. The abstract provides a brief summary of the invention, which helps in identifying its core aspects.

Claims Review

  • Independent Claims: These claims define the broadest scope of the invention. Analyzing these claims will help in understanding what is specifically protected by the patent.
  • Dependent Claims: These claims further limit the independent claims and provide additional details about the invention.

Description and Drawings

The detailed description and drawings will offer a comprehensive understanding of how the invention works, its various components, and how it is implemented.

Patent Landscape

Family Members and Continuations

If the patent is part of a family of patents, it is important to identify any continuations, continuations-in-part, or divisional applications. This can impact the patent's term and scope, as seen in cases like In re Cellect LLC, where multiple patents in a family were analyzed for obviousness-type double patenting (ODP)[1].

Patent Term Adjustments and Extensions

Understand if the patent has received any Patent Term Adjustments (PTA) or Patent Term Extensions (PTE). PTAs are granted for delays caused by the USPTO during prosecution, while PTEs are granted for regulatory review periods. These adjustments can affect the patent's expiration date[1].

Enforcement and Litigation

Patent Infringement

To enforce the patent, the owner must be able to identify potential infringers and take legal action. The scope of the claims is crucial in determining what constitutes infringement[2].

Administrative Proceedings

Patents can also be challenged through administrative proceedings such as inter partes review (IPR) or ex parte reexamination. Understanding the outcomes of such proceedings can provide insights into the patent's validity and scope[5].

Industry Impact

Economic and Technological Significance

Patents, especially in technology and healthcare, play a critical role in innovation. For example, a single smartphone can be protected by as many as 250,000 patents, highlighting the extensive use of patents in complex technologies[2].

Pharmaceuticals and Biotechnology

In the pharmaceutical sector, patents are essential for protecting new drugs and encouraging research and development. A study found that pharmaceutical manufacturers obtained an average of seventy-one patents on each of the top twelve drugs by gross U.S. revenue[2].

Key Takeaways

  • Patent Claims: The scope and validity of a patent are largely defined by its claims.
  • Patent Family: Understanding the relationships between patents in a family is crucial for determining their term and scope.
  • Administrative and Legal Proceedings: Patents can be challenged and validated through various administrative and legal processes.
  • Industry Impact: Patents are vital for innovation and economic growth, particularly in technology and healthcare sectors.

Frequently Asked Questions (FAQs)

1. What is the purpose of patent claims in a patent?

Patent claims define the scope of the invention and determine what is protected by the patent.

2. How do Patent Term Adjustments (PTA) affect a patent's term?

PTAs extend the term of a patent to compensate for delays caused by the USPTO during prosecution, ensuring the patent holder receives the full term of protection[1].

3. What is the difference between a Patent Term Adjustment (PTA) and a Patent Term Extension (PTE)?

A PTA is granted for delays in prosecution, while a PTE is granted for regulatory review periods, such as those required for pharmaceutical products[1].

4. How can the scope of a patent be measured?

The scope can be measured using metrics such as independent claim length and independent claim count, which have been shown to have explanatory power for various correlates of patent scope[3].

5. Why are patents important for innovation?

Patents provide exclusive rights to inventors, incentivizing innovation by protecting their inventions from unauthorized use and allowing them to recoup their investment in research and development[2].

Cited Sources:

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
  2. Patent Law: A Handbook for Congress, Congressional Research Service, September 16, 2020.
  3. Patent Claims and Patent Scope, SSRN, September 29, 2016.
  4. Invention, Knowledge Transfer, and Innovation, National Science Foundation, February 29, 2024.
  5. IOENGINE, LLC v. INGENICO INC, United States Court of Appeals for the Federal Circuit, May 3, 2024.

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Drugs Protected by US Patent 10,918,615

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Banner Life Sciences BAFIERTAM monomethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 210296-001 Apr 28, 2020 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y METHOD OF TREATING MULTIPLE SCLEROSIS ⤷  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

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