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Last Updated: December 22, 2024

Details for Patent: 8,748,481


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Which drugs does patent 8,748,481 protect, and when does it expire?

Patent 8,748,481 protects AMITIZA and is included in one NDA.

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

Summary for Patent: 8,748,481
Title:Method for treating gastrointestinal disorder
Abstract: The present invention relates to a method for the long term treatment of gastrointestinal disorders in a human subject, which comprises administering an effective amount of a halogenated prostaglandin compound and/or its tautomer to the subject. The method induces substantially no electrolyte shifting during the term of the treatment. The compound used in the present invention can improve quality of life in the human subjects with gastrointestinal disorders, are similarly effective in treating male and female subjects, and also effective in a human subject aged even 65 years and older.
Inventor(s): Ueno; Ryuji (Montgomery, MD)
Assignee: Sucampo AG (Zug, CH)
Application Number:11/216,012
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,748,481
Patent Claim Types:
see list of patent claims
Use; Delivery; Composition;
Patent landscape, scope, and claims:

United States Patent 8,748,481: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,748,481, titled "Method for treating gastrointestinal disorder," is a significant patent in the field of medical treatments. This patent, granted to its inventors, outlines a method for the long-term treatment of gastrointestinal disorders. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication Details

  • Publication Number: US8748481B2
  • Filing Date: Derived from the application number US11/216,012
  • Grant Date: The patent was granted and is currently active[4].

Invention Description

The patent describes a method for treating gastrointestinal disorders in human subjects. This method involves administering specific compounds, particularly focusing on prostaglandin derivatives, which are known for their therapeutic effects on the gastrointestinal system[4].

Scope of the Patent

Protected Subject Matter

The patent protects a specific method of treatment rather than a product or device. This method includes the administration of prostaglandin compounds to treat gastrointestinal disorders. The scope is limited to the specific application of these compounds in a therapeutic context.

Geographic and Temporal Scope

The patent is valid within the United States and has a term of 20 years from the date of filing, as per U.S. patent law. However, the enforceability of the patent begins from the date of issuance[1].

Claims Analysis

Claim Structure

The patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims.

  • Independent Claims: These claims stand alone and define the invention without reference to other claims. For example, Claim 1 might describe the method of administering a prostaglandin compound to treat a gastrointestinal disorder.
  • Dependent Claims: These claims refer back to and further limit the independent claims. For instance, a dependent claim might specify the dosage or the particular type of prostaglandin compound used[4].

Key Claim Elements

  • Prostaglandin Compounds: The patent specifically mentions the use of prostaglandin compounds, which are crucial for the therapeutic effect.
  • Administration Method: The claims detail how these compounds are to be administered, including the route of administration and the dosage.
  • Therapeutic Effect: The claims emphasize the treatment of gastrointestinal disorders, highlighting the specific therapeutic outcomes expected from the method[4].

Patent Landscape

Prior Art and Related Patents

The patent landscape for gastrointestinal treatments is extensive, with numerous patents covering various aspects of treatment, including pharmaceuticals, surgical methods, and dietary interventions. Prior art in this field includes other patents related to prostaglandin derivatives and their therapeutic applications.

Competing Patents

Other patents in the same field may cover similar or overlapping subject matter. For example, patents like NZ-553434-A also deal with prostaglandin derivatives for treating gastrointestinal disorders, though they may differ in specific details such as the type of compound or the method of administration[5].

Patentability and Eligibility

The patentability of US8748481B2 was determined under Section 101 of the U.S. Patent Act, which governs the subject matter eligibility of inventions. The patent office would have evaluated whether the method falls within the four statutory categories (process, machine, manufacture, or composition of matter) and whether it involves an abstract idea, natural phenomenon, or something markedly different from these exceptions[1].

Economic and Market Impact

Market Dominance

Patents like US8748481B2 can provide significant market advantages to the patent holders. By excluding others from using the same method, the patentee can monopolize the market for this specific treatment, potentially leading to higher profits and market dominance.

Licensing and Collaboration

The patent can also be a valuable asset for licensing agreements or collaborations with other pharmaceutical companies. This can expand the reach of the treatment and generate additional revenue streams.

Legal and Regulatory Considerations

Enforcement and Litigation

The patent holder must enforce the patent rights to prevent infringement. This involves monitoring the market for unauthorized use and taking legal action when necessary. The cost of enforcing patent rights can be substantial, but it is crucial for maintaining the exclusivity granted by the patent[1].

Regulatory Approvals

In addition to patent protection, any new treatment method must also obtain regulatory approvals from bodies like the FDA. This ensures that the treatment is safe and effective for public use.

Future Developments and Trends

Advancements in Treatment Methods

The field of gastrointestinal treatments is continuously evolving, with new research and technologies emerging. Future patents may build upon or challenge the existing methods protected by US8748481B2.

Patent Expiration and Generic Competition

As the patent term expires, generic versions of the treatment method may enter the market, potentially reducing the market share of the original patent holder.

Key Takeaways

  • Specific Method Protection: The patent protects a specific method of treating gastrointestinal disorders using prostaglandin compounds.
  • Geographic and Temporal Scope: The patent is valid in the United States for 20 years from the filing date.
  • Claims Structure: The patent includes independent and dependent claims that define the scope of the invention.
  • Market Impact: The patent can provide market dominance and licensing opportunities.
  • Regulatory and Legal Considerations: The patent must be enforced, and regulatory approvals are necessary for public use.

FAQs

What is the main subject matter protected by US8748481B2?

The main subject matter protected is a method for treating gastrointestinal disorders using prostaglandin compounds.

How long is the patent term for US8748481B2?

The patent term is 20 years from the date of filing.

What are the key elements of the claims in US8748481B2?

The key elements include the use of prostaglandin compounds, the method of administration, and the therapeutic effect on gastrointestinal disorders.

How does the patent impact the market for gastrointestinal treatments?

The patent can provide market dominance and licensing opportunities for the patent holder.

What happens when the patent term expires?

When the patent term expires, generic versions of the treatment method may enter the market, reducing the market share of the original patent holder.

Sources

  1. BitLaw, "Patent Law in the United States" - https://www.bitlaw.com/patent/index.html
  2. Google Patents, "US8748481B2 - Method for treating gastrointestinal disorder" - https://patents.google.com/patent/US8748481B2/en
  3. USPTO, "Patent Claims Research Dataset" - https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Google Patents, "US8748481B2 - Method for treating gastrointestinal disorder" - https://patents.google.com/patent/US8748481B2/en
  5. PubChem, "Prostaglandin derivatives for treating gastrointestinal disorder" - https://pubchem.ncbi.nlm.nih.gov/patent/NZ-553434-A

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Drugs Protected by US Patent 8,748,481

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-002 Apr 29, 2008 AB RX Yes No ⤷  Subscribe ⤷  Subscribe METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT WITH IRRITABLE BOWEL SYNDROME ⤷  Subscribe
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT ⤷  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

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