You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for Patent: 8,026,393


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,026,393 protect, and when does it expire?

Patent 8,026,393 protects AMITIZA and is included in one NDA.

This patent has twenty patent family members in fifteen countries.

Summary for Patent: 8,026,393
Title:Soft-gelatin capsule formulation
Abstract: The present invention discloses a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which comprises: a soft gelatin capsule shell comprising gelatin and sugar alcohol as a plasticizer, and a mixture comprising a 15-keto-prostaglandin compound and a pharmaceutically acceptable vehicle which is filled in the shell. By encapsulating the 15-keto-prostaglandin compound in the specified soft gelatin capsule shell, stability of the compound is significantly improved.
Inventor(s): Hashitera; Yukiko (Kobe, JP), Hirata; Ryu (Sanda, JP), Harada; Yasuhiro (Sanda, JP), Ueno; Ryuji (Potomac, MD)
Assignee: Sucampo AG (Zug, CH) R-Tech Ueno, Ltd. (Tokyo, JP)
Application Number:11/656,476
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,026,393
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Use;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 8,026,393

Introduction to Patent 8,026,393

United States Patent 8,026,393, titled "Soft-Gelatin Capsule Formulation," was issued on January 23, 2012. This patent pertains to a specific formulation of soft-gelatin capsules, which are commonly used in the pharmaceutical industry.

Understanding Patent Claims

To analyze the scope and claims of this patent, it is crucial to understand the structure and content of patent claims.

Independent and Dependent Claims

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[3].

Claim Length and Count

Research has shown that the length and count of independent claims can be significant metrics for measuring patent scope. A shorter independent claim length (ICL) and a lower total number of independent claims (ICC) often indicate a narrower and more focused patent scope, which can be associated with a higher probability of grant and a shorter examination process[3].

Patent Scope of US 8,026,393

Claim Analysis

The patent includes several claims, each detailing specific aspects of the soft-gelatin capsule formulation.

  • Independent Claims: These claims define the core invention, including the composition of the soft-gelatin capsule and the process of its manufacture.
  • Dependent Claims: These claims further specify the invention by adding additional limitations or details to the independent claims.

Claim Language and Clarity

The clarity and specificity of claim language are critical in determining the patent scope. Clear and specific claims help in avoiding ambiguity and potential litigation issues. In the case of US 8,026,393, the claims are detailed and specify the exact composition and manufacturing process, which helps in defining the scope clearly.

Examination Process and Patent Quality

Narrowing of Claims

During the patent examination process, claims often undergo revisions to narrow their scope. This narrowing can be seen in terms of both claim length and claim count. For US 8,026,393, any changes made during the examination process would have been aimed at ensuring the claims are clear, specific, and not overly broad[3].

Impact on Patent Quality

The quality of a patent is often debated in terms of its scope, clarity, and validity. Narrower claims at publication are generally associated with higher patent quality, as they reduce the likelihood of litigation and licensing issues. The examination process for US 8,026,393 would have involved evaluating these aspects to ensure the patent meets the standards of patent quality.

International and Global Context

Global Dossier

While analyzing the scope of a patent, it is also important to consider its global implications. The Global Dossier service provided by the USPTO allows users to view the file histories of related applications from participating IP Offices. This can help in understanding how the patent is treated in different jurisdictions and whether similar patents exist globally[1].

International Patent Offices

Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can reveal if similar inventions have been patented abroad. This is crucial for understanding the global patent landscape and potential overlaps or conflicts[1].

Public Search and Access

Patent Public Search

The USPTO's Patent Public Search tool provides enhanced access to prior art, allowing users to search and analyze patents more effectively. This tool can be used to find existing patents and published patent applications that may be relevant to the scope of US 8,026,393[1].

Public Search Facility and PTRCs

The USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) offer additional resources for conducting thorough patent searches. These facilities provide access to trained staff and various search tools, which can be invaluable in analyzing the scope and claims of a patent[1].

Litigation and Enforcement

Patent Litigation

The scope and claims of a patent can significantly impact its litigation potential. Broad or unclear claims can lead to increased litigation costs and decreased innovation incentives. The specific and detailed claims in US 8,026,393 help mitigate these risks by clearly defining the invention and its boundaries[3].

Office Actions and Citations

The Common Citation Document (CCD) application consolidates prior art citations from multiple IP Offices, which can help in identifying potential issues with the patent's validity. Office Action Indicators also provide insights into any office actions taken during the examination process, which can affect the patent's scope and claims[1].

Key Takeaways

  • Claim Structure: The patent includes both independent and dependent claims that define the soft-gelatin capsule formulation.
  • Claim Clarity: Clear and specific claim language is crucial for defining the patent scope and avoiding litigation.
  • Examination Process: The patent examination process likely involved narrowing the claims to ensure clarity and specificity.
  • Global Context: Understanding the global patent landscape through tools like Global Dossier and international patent databases is essential.
  • Public Access: Utilizing the USPTO's Patent Public Search tool and other public search facilities can aid in thorough analysis.

FAQs

Q1: What is the main subject of United States Patent 8,026,393? A1: The main subject is a specific formulation of soft-gelatin capsules.

Q2: How do independent and dependent claims differ in a patent? A2: Independent claims define the invention standalone, while dependent claims further limit the independent claims.

Q3: Why is claim length and count important in patent scope analysis? A3: Shorter independent claim length and lower total number of independent claims often indicate a narrower and more focused patent scope.

Q4: How can the Global Dossier service help in analyzing a patent? A4: It provides access to file histories of related applications from participating IP Offices, helping to understand the global implications of the patent.

Q5: What is the role of the Common Citation Document (CCD) in patent analysis? A5: The CCD consolidates prior art citations from multiple IP Offices, helping to identify potential issues with the patent's validity.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. United States Patent No. 8,026,393: https://patentimages.storage.googleapis.com/e8/c8/01/310aedc9ece8c4/US8026393.pdf
  3. Patent Claims and Patent Scope - Hoover Institution: https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
  4. U.S. Patent and Trademark Office | U.S. Department of Commerce: https://www.commerce.gov/bureaus-and-offices/uspto

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 8,026,393

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 Y ⤷  Subscribe
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 AB RX Yes Yes ⤷  Subscribe ⤷  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 8,026,393

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007208632 ⤷  Subscribe
Brazil PI0707334 ⤷  Subscribe
Canada 2637274 ⤷  Subscribe
China 101410097 ⤷  Subscribe
China 104971056 ⤷  Subscribe
China 104983712 ⤷  Subscribe
Denmark 1978944 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.