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Last Updated: December 23, 2024

Details for Patent: 8,026,284


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Which drugs does patent 8,026,284 protect, and when does it expire?

Patent 8,026,284 protects PROCYSBI and is included in two NDAs.

Protection for PROCYSBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-nine patent family members in nineteen countries.

Summary for Patent: 8,026,284
Title:Enterically coated cystamine, cysteamine and derivatives thereof
Abstract: The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Inventor(s): Dohil; Ranjan (San Diego, CA), Schneider; Jerry (La Jolla, CA)
Assignee: The Regents of the University of California (Oakland, CA)
Application Number:11/990,869
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,026,284
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

United States Patent 8,026,284: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,026,284, titled "Enterically coated cystamine, cysteamine and derivatives thereof," is a significant patent in the field of pharmaceuticals, particularly for the treatment of cystinosis and neurodegenerative diseases. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent, assigned to the University of California, was granted on September 27, 2011. It involves the development of oral formulations of cysteamine and cystamine, which are crucial for treating cystinosis, a rare genetic disorder, and various neurodegenerative diseases[1].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here, the patent covers enterically coated formulations of cysteamine, cystamine, and their derivatives. Enteric coating is a technology that protects the drug from the acidic environment of the stomach, ensuring it is released in the intestines where it can be more effectively absorbed.

Key Components of the Scope

  • Active Ingredients: The patent focuses on cysteamine and cystamine, which are known for their therapeutic benefits in treating cystinosis and neurodegenerative diseases.
  • Enteric Coating: The use of enteric coating is a critical aspect, as it enhances the bioavailability and stability of the active ingredients.
  • Derivatives: The patent also includes derivatives of cysteamine and cystamine, expanding the scope to related compounds that may offer similar therapeutic benefits[1].

Claims of the Patent

The claims section is the heart of any patent, as it defines what is legally protected. For US Patent 8,026,284, the claims can be categorized into several types:

Independent Claims

These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe the enterically coated formulation of cysteamine or cystamine in general terms[1].

Dependent Claims

These claims build upon the independent claims and provide more specific details. For instance, a dependent claim might specify the type of enteric coating material used or the particular dosage form (e.g., tablets, capsules)[1].

Patent Landscape

Understanding the patent landscape is crucial for assessing the impact and uniqueness of the invention.

Prior Art

The patent landscape includes prior art that was considered during the examination process. This involves other patents and publications related to cysteamine, cystamine, and enteric coating technologies. The USPTO's search tools, such as the Patent Public Search and Global Dossier, are essential for identifying relevant prior art[4].

Related Patents

Other patents in the same field can provide insights into the competitive landscape. For example, patents related to cystinosis treatments or neurodegenerative disease therapies might overlap or complement the scope of this patent.

International Patent Filings

The global patent landscape is also relevant. The Common Citation Document (CCD) and databases from other international intellectual property offices, such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO), can reveal whether similar inventions have been patented or applied for in other jurisdictions[4].

Metrics for Measuring Patent Scope

To evaluate the quality and breadth of the patent, metrics such as independent claim length and independent claim count can be used. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Examination Process

The examination process for this patent would have involved a thorough review of the claims and prior art. The USPTO's examination process tends to narrow the scope of patent claims, ensuring that the granted patent is well-defined and not overly broad[3].

Practical Implications

For pharmaceutical companies and researchers, this patent provides valuable insights into the formulation and delivery of cysteamine and cystamine. The enteric coating technology can enhance the efficacy and patient compliance of these treatments.

Market Impact

The patent's impact on the market involves the potential for improved treatments for cystinosis and neurodegenerative diseases. Companies holding this patent can leverage the protected technology to develop new products or improve existing ones, potentially gaining a competitive edge.

Legal Status and Expiration

As of the current date, the patent is active but has an expiration date. Understanding the legal status is crucial for determining the period during which the invention is protected and when it will enter the public domain[1].

Conclusion

The United States Patent 8,026,284 is a significant contribution to the field of pharmaceuticals, particularly in the treatment of cystinosis and neurodegenerative diseases. The scope and claims of the patent are well-defined, protecting the enterically coated formulations of cysteamine, cystamine, and their derivatives. The broader patent landscape highlights the importance of this invention within the global intellectual property framework.

Key Takeaways

  • Enteric Coating Technology: The patent protects the use of enteric coating for cysteamine and cystamine formulations.
  • Therapeutic Applications: The invention is crucial for treating cystinosis and neurodegenerative diseases.
  • Patent Scope: The claims define the specific aspects of the invention, including the active ingredients and coating materials.
  • Global Relevance: The patent's impact is assessed within the context of international intellectual property databases and prior art.
  • Legal Status: The patent is active but has a defined expiration date.

FAQs

Q: What is the main focus of United States Patent 8,026,284?

A: The main focus is on enterically coated formulations of cysteamine, cystamine, and their derivatives for treating cystinosis and neurodegenerative diseases.

Q: What is the significance of enteric coating in this patent?

A: Enteric coating protects the drug from stomach acid, ensuring it is released in the intestines for better absorption.

Q: How does the patent landscape impact this invention?

A: The patent landscape includes prior art and related patents, which help define the uniqueness and competitive position of the invention.

Q: What metrics can be used to evaluate the scope of this patent?

A: Metrics such as independent claim length and independent claim count can be used to assess the breadth and quality of the patent.

Q: When does the patent expire?

A: The patent's expiration date is determined by its filing and grant dates, typically 20 years from the earliest filing date.

Sources

  1. US8026284B2 - Enterically coated cystamine, cysteamine and derivatives thereof - Google Patents
  2. U.S. Patent and Trademark Office (USPTO) | USAGov
  3. Patent Claims and Patent Scope - SSRN
  4. Search for patents - USPTO

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Drugs Protected by US Patent 8,026,284

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No 8,026,284*PED ⤷  Subscribe Y ⤷  Subscribe
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes 8,026,284*PED ⤷  Subscribe Y ⤷  Subscribe
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No 8,026,284*PED ⤷  Subscribe Y ⤷  Subscribe
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes 8,026,284*PED ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,026,284

PCT Information
PCT FiledJanuary 26, 2007PCT Application Number:PCT/US2007/002325
PCT Publication Date:August 09, 2007PCT Publication Number: WO2007/089670

International Family Members for US Patent 8,026,284

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1919458 ⤷  Subscribe C300649 Netherlands ⤷  Subscribe
European Patent Office 1919458 ⤷  Subscribe CR 2014 00013 Denmark ⤷  Subscribe
European Patent Office 1919458 ⤷  Subscribe 194 50001-2014 Slovakia ⤷  Subscribe
European Patent Office 1919458 ⤷  Subscribe 19/2014 Austria ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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