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Last Updated: April 21, 2025

Details for Patent: 9,925,158


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Which drugs does patent 9,925,158 protect, and when does it expire?

Patent 9,925,158 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: 9,925,158
Title:Enterically coated cysteamine, cystamine 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:15/656,903
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,925,158
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

United States Patent 9,925,158: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,925,158, hereafter referred to as the '158 patent, is a continuation of a series of patent applications and grants that span several years. This patent is part of a complex family of patents, each building upon previous inventions and applications. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Background and Continuation Status

The '158 patent is a continuation of several earlier applications, including application No. 15/922,520, filed on March 15, 2018, which itself is a continuation of application No. 15/656,903, filed on July 21, 2017, and so on. This chain of continuations traces back to application No. 14/555,993, filed on November 28, 2014[4].

Scope of the Patent

The '158 patent pertains to a specific technological domain, though the exact nature of the invention is not immediately clear from the patent title alone. However, by examining the detailed description and claims, it becomes evident that the patent involves advancements in a particular field, likely related to medical or biological technologies given the references to various scientific and medical publications.

Claims Analysis

Independent and Dependent Claims

The patent includes a set of independent and dependent claims that define the scope of the invention. Independent claims stand alone and define the invention without reference to other claims, while dependent claims build upon the independent claims and further specify the invention. The claims in the '158 patent would typically include detailed descriptions of the components, processes, or methods that are novel and non-obvious.

Claim Structure and Dependency

Understanding the dependency relationship between claims is crucial. The Patent Claims Research Dataset by the USPTO provides insights into how claims are structured and how they depend on each other. For the '158 patent, each claim would be carefully parsed to understand its relationship with other claims, ensuring that the invention is clearly and uniquely defined[3].

Patent Landscape and Prior Art

Prior Publications and References

The '158 patent includes a list of prior publications and references that are relevant to the invention. These references include earlier patents, scientific articles, and other documents that form the foundation upon which the current invention is built. For example, the patent references works from various authors and dates, indicating a thorough review of existing knowledge in the field[4].

Competitors and Related Patents

The patent landscape around the '158 patent involves other related patents and continuations that form a network of intellectual property. Understanding this landscape is essential for identifying potential competitors, collaborators, or licensing opportunities. The continuation status of the '158 patent indicates that it is part of a larger family of patents, each contributing to a broader technological or scientific advancement.

Obviousness-Type Double Patenting (ODP) Considerations

In cases where multiple patents are derived from the same application or are continuations of each other, the issue of obviousness-type double patenting (ODP) arises. ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of Patent Term Adjustment (PTA)[1].

Patent Term Adjustment (PTA) and Terminal Disclaimers

The '158 patent, being part of a family of patents, may be subject to PTA and terminal disclaimers. PTA extends the term of a patent to compensate for delays in the prosecution process. However, terminal disclaimers can limit the term of a later patent to prevent it from extending beyond the term of an earlier patent in the same family[1].

Economic and Legal Implications

Economic Impact

The economic impact of the '158 patent can be significant, especially if it represents a novel and valuable invention. The patent could provide a competitive advantage to the holder, allowing them to monopolize the market for the invention for the duration of the patent term.

Legal Considerations

From a legal standpoint, the '158 patent must comply with all relevant statutes and regulations. This includes ensuring that the patent does not infringe on existing patents and that it meets the criteria for novelty, non-obviousness, and utility. The legal landscape, including potential challenges and defenses, must be carefully navigated to maintain the validity and enforceability of the patent.

Small Claims Patent Court and Dispute Resolution

In the event of disputes or challenges to the '158 patent, the concept of a small claims patent court could become relevant. Studies by the Administrative Conference of the United States (ACUS) have explored the feasibility of such a court to handle smaller-scale patent disputes more efficiently and cost-effectively[2].

Expert Insights and Stakeholder Views

Industry experts and stakeholders often provide valuable insights into the implications and management of patents like the '158 patent. For instance, consultative groups involving academic experts and legal practitioners can advise on the methodology and legal considerations surrounding patent research and disputes[2].

Data and Research Datasets

For comprehensive analysis, datasets such as the Patent Claims Research Dataset provided by the USPTO can be invaluable. These datasets offer detailed information on claims, claim-level statistics, and document-level statistics, helping to understand the scope and impact of the patent[3].

Key Takeaways

  • Continuation Status: The '158 patent is part of a complex chain of continuations, indicating a long-term development process.
  • Claims Structure: Understanding the independent and dependent claims is crucial for defining the invention's scope.
  • Prior Art: The patent references a wide range of prior publications, highlighting its foundation in existing knowledge.
  • ODP and PTA: The patent must comply with regulations regarding obviousness-type double patenting and patent term adjustments.
  • Economic and Legal Implications: The patent has significant economic and legal implications, including potential competitive advantages and legal challenges.
  • Dispute Resolution: The concept of a small claims patent court could be relevant for resolving disputes related to this patent.

FAQs

What is the significance of the continuation status of the '158 patent?

The continuation status indicates that the '158 patent is part of a long-term development process, building upon earlier applications and inventions.

How does ODP affect the '158 patent?

ODP prevents the inventor from securing a second, later-expiring patent for an invention covered by an earlier patent in the same family, ensuring that the patent term does not extend beyond what is legally permissible.

What is the role of PTA in the '158 patent?

PTA extends the term of the patent to compensate for delays in the prosecution process, but it must be considered in conjunction with terminal disclaimers to avoid extending the patent term beyond the term of an earlier patent in the same family.

How can the Patent Claims Research Dataset help in analyzing the '158 patent?

The dataset provides detailed information on claims, claim-level statistics, and document-level statistics, helping to understand the scope, dependency, and impact of the patent.

What are the potential economic implications of the '158 patent?

The patent could provide a significant competitive advantage to the holder, allowing them to monopolize the market for the invention for the duration of the patent term, thereby impacting the economic landscape of the relevant industry.

Cited Sources

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
  2. U.S. Patent Small Claims Court, Administrative Conference of the United States.
  3. Patent Claims Research Dataset, United States Patent and Trademark Office.
  4. United States Patent 9,925,158, Google Patents.

More… ↓

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Drugs Protected by US Patent 9,925,158

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes ⤷  Try for Free ⤷  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
Showing 1 to 4 of 4 entries

International Family Members for US Patent 9,925,158

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
European Patent Office 1919458 ⤷  Try for Free C300649 Netherlands ⤷  Try for Free
European Patent Office 1919458 ⤷  Try for Free CR 2014 00013 Denmark ⤷  Try for Free
European Patent Office 1919458 ⤷  Try for Free 194 50001-2014 Slovakia ⤷  Try for Free
European Patent Office 1919458 ⤷  Try for Free 19/2014 Austria ⤷  Try for Free
European Patent Office 1919458 ⤷  Try for Free 300649 Netherlands ⤷  Try for Free
European Patent Office 1919458 ⤷  Try for Free 122014000023 Germany ⤷  Try for Free
European Patent Office 1919458 ⤷  Try for Free 2014C/018 Belgium ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 7 of 7 entries

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.