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Last Updated: December 22, 2024

Details for Patent: 9,925,138


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Which drugs does patent 9,925,138 protect, and when does it expire?

Patent 9,925,138 protects TASCENSO ODT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 9,925,138
Title:Stable solid fingolimod dosage forms
Abstract: The present invention relates to a solid pharmaceutical dosage forms and methods for preparing the solid pharmaceutical dosage form that contains fingolimod or its pharmaceutically acceptable salts, conjugates or complexes thereof. The solid pharmaceutical dosage forms may rapidly disintegrates in a patient's oral cavity.
Inventor(s): Liu; Fangyu (Saratoga, CA)
Assignee: Handa Pharmaceuticals, LLC (Fremont, CA)
Application Number:15/084,226
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 9,925,138: A Comprehensive Analysis

Introduction

When analyzing a patent, particularly one like the United States Patent 9,925,138, it is crucial to delve into the specifics of its scope, claims, and the broader patent landscape. This analysis will help in understanding the patent's significance, its protection, and its position within the intellectual property ecosystem.

Patent Basics

  • Patent Number: 9,925,138
  • Issue Date: This information is not provided in the sources, but typically, a patent's issue date can be found on the patent document itself or through the USPTO database.
  • Inventors and Assignees: Similarly, this specific information is not provided, but it can be obtained from the patent document or the USPTO database.

Claim Construction

Claim construction is a critical aspect of patent law, as it defines the metes and bounds of the invention and the rights conferred to the patentee[2][3].

Intrinsic Evidence

When construing claim terms, courts primarily rely on intrinsic evidence, which includes:

  • Claims Themselves: The language of the claims is paramount.
  • Specification: The detailed description of the invention.
  • Prosecution History: The interactions between the patent applicant and the USPTO during the patent application process[2].

Ordinary and Customary Meaning

Claim terms are assigned their ordinary and customary meaning, which is the meaning that a person of ordinary skill in the art (POSITA) would understand at the time of the invention[2].

Scope of the Patent

The scope of a patent is defined by its claims. Here are some key points to consider:

Claim Types

  • Independent Claims: These claims stand alone and define the invention without reference to other claims.
  • Dependent Claims: These claims refer back to and further limit the independent claims.

Claim Language

The language used in the claims is precise and technical. For example, terms like "controlled release" and "modified release" may have specific meanings within the context of the patent, and courts must determine these meanings based on the intrinsic evidence[1].

Patent Landscape Analysis

Analyzing the patent landscape involves understanding the broader context in which the patent exists.

Related Patents

Identify other patents in the same family or those that cover similar technologies. This can include continuation applications, divisional applications, and patents that have been cited as prior art[4].

Competitor Patents

Understand the patents held by competitors in the same field. This can help in identifying potential infringement issues and gaps in coverage[3].

Claim Coverage Matrix

A Claim Coverage Matrix is a tool used to categorize patents by their claims and scope concepts. This helps in:

  • Identifying which patents and claims actively protect the intellectual property.
  • Spotting gaps or opportunities in the current coverage[3].

Claim Charts

Claim charts are interactive tools that help in reviewing patent coverage. They can be used by technical experts to determine whether a particular scope concept is applicable to a target product or method. These charts can highlight areas where there are gaps in the current coverage and suggest future design opportunities[3].

Obviousness-Type Double Patenting (OTDP)

OTDP is a doctrine that prevents IP owners from extending their monopoly over an invention by obtaining a later patent with claims that are patentably indistinct from a commonly-owned earlier patent. This is particularly relevant in life sciences, where continuation applications are common[4].

Terminal Disclaimers

Terminal disclaimers can be filed to overcome OTDP challenges by limiting the term of the later patent to the expiry date of the earlier patent. However, proposed rule changes by the USPTO may make this option less attractive by introducing additional conditions that could render all bound patents unenforceable if any claim is found invalid[4].

Industry Impact

Understanding the scope and claims of a patent like 9,925,138 is crucial for industry players, especially in highly competitive fields such as pharmaceuticals and life sciences.

Infringement and Litigation

Accurate claim construction and understanding of the patent landscape can help in identifying potential infringement and preparing for litigation. For instance, a company like Novartis would need to ensure that its products do not infringe on existing patents, as seen in cases involving GILENYA®[5].

Strategic Planning

Companies can use patent analytics to strategize their product development and intellectual property protection. By identifying gaps in coverage and future design opportunities, companies can make informed decisions about where to focus their research and development efforts[3].

Key Takeaways

  • Claim Construction: Courts rely on intrinsic evidence to determine the meaning of claim terms.
  • Patent Scope: The claims define the scope of the patent, and understanding these claims is crucial.
  • Patent Landscape: Analyzing related patents and competitor patents helps in identifying gaps and opportunities.
  • OTDP and Terminal Disclaimers: These are critical considerations in managing patent portfolios, especially in life sciences.
  • Industry Impact: Accurate understanding of patent scope and claims is vital for strategic planning and litigation.

Frequently Asked Questions (FAQs)

Q: What is the primary source for claim construction in patent law? A: The primary source for claim construction is intrinsic evidence, including the claims themselves, the specification, and the prosecution history of the patent[2].

Q: How do courts determine the meaning of claim terms? A: Courts determine the meaning of claim terms based on their ordinary and customary meaning to a person of ordinary skill in the art (POSITA) at the time of the invention[2].

Q: What is a Claim Coverage Matrix, and how is it used? A: A Claim Coverage Matrix is a tool used to categorize patents by their claims and scope concepts, helping to identify which patents and claims actively protect the intellectual property and spot gaps or opportunities in the current coverage[3].

Q: What is Obviousness-Type Double Patenting (OTDP), and why is it important? A: OTDP is a doctrine that prevents IP owners from extending their monopoly over an invention by obtaining a later patent with claims that are patentably indistinct from a commonly-owned earlier patent. It is particularly relevant in life sciences[4].

Q: How can terminal disclaimers be used to overcome OTDP challenges? A: Terminal disclaimers can be filed to limit the term of the later patent to the expiry date of the earlier patent, but proposed rule changes may introduce additional conditions that could render all bound patents unenforceable if any claim is found invalid[4].

Cited Sources:

  1. JAZZ PHARMACEUTICALS, INC., Plaintiff - District of Delaware

  2. TEVA PHARMACEUTICALS USA., INC., Defendant.

  3. Patent Analytics | Intellectual Property Law

  4. Federal Circuit's latest obviousness-type double-patenting decision ...

  5. COMPLAINT FOR PATENT INFRINGEMENT

More… ↓

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Drugs Protected by US Patent 9,925,138

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cycle TASCENSO ODT fingolimod lauryl sulfate TABLET, ORALLY DISINTEGRATING;ORAL 214962-001 Dec 23, 2021 RX Yes No 9,925,138 ⤷  Subscribe Y ⤷  Subscribe
Cycle TASCENSO ODT fingolimod lauryl sulfate TABLET, ORALLY DISINTEGRATING;ORAL 214962-002 Dec 9, 2022 RX Yes Yes 9,925,138 ⤷  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

International Family Members for US Patent 9,925,138

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016209466 ⤷  Subscribe
Canada 2974375 ⤷  Subscribe
China 107530301 ⤷  Subscribe
European Patent Office 3247341 ⤷  Subscribe
Japan 2018502168 ⤷  Subscribe
Taiwan 201642842 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2016118515 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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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.