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Last Updated: March 24, 2025

Details for Patent: 11,246,866


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Which drugs does patent 11,246,866 protect, and when does it expire?

Patent 11,246,866 protects MAVYRET and is included in one NDA.

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

This patent has fifty-six patent family members in twenty-four countries.

Summary for Patent: 11,246,866
Title:Solid pharmaceutical compositions for treating HCV
Abstract: The present invention features solid pharmaceutical compositions comprising Compound 1 and Compound 2. In one embodiment, the solid pharmaceutical composition includes (1) a first layer which comprises 100 mg Compound 1, as well as a pharmaceutically acceptable hydrophilic polymer and a pharmaceutically acceptable surfactant, all of which are formulated in amorphous solid dispersion; and (2) a second layer which comprises 40 mg Compound 2, as well as a pharmaceutically acceptable hydrophilic polymer and a pharmaceutically acceptable surfactant, all of which are formulated in amorphous solid dispersion.
Inventor(s): Sever; Nancy E. (Northbrook, IL), Westedt; Ulrich (Schriesheim, DE), Lander; Ute (Dannenfels, DE), Schneider; Katrin (Mannheim, DE), Steitz; Benedikt (Kallstadt, DE), Mueller; Thomas (Ludwigshafen, DE), Reul; Regina (Mannheim, DE), Obermiller; Constanze (Heidelberg, DE), Jayasankar; Adivaraha (Naperville, IL), Simon; Michael (Landau, DE), Gao; Yi (Vernon Hills, IL), Hach; Harald (Oberotterbach, DE), Kyeremateng; Samuel (Mannheim, DE), Asmus; Katharina (Neustadt a.d.W., DE), Tong; Ping (Potomoc, MD), Zhu; Donghua (Vernon Hills, IL), Naris; Marius (Downers Grove, IL), Garrett; Colleen (Chicago, IL)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:16/654,442
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

United States Patent 11,246,866: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 11,246,866, titled "Solid pharmaceutical compositions for treating HCV," is a significant patent in the field of pharmaceuticals, particularly for the treatment of Hepatitis C Virus (HCV). This article provides a comprehensive analysis of the patent's scope, claims, and the broader patent landscape in which it resides.

Background of the Patent

Overview of HCV Treatment

Hepatitis C Virus (HCV) is a major public health concern, and the development of effective treatments has been a priority in the pharmaceutical industry. The patent in question addresses this need by introducing solid pharmaceutical compositions designed to treat HCV effectively.

Patent Details

  • Publication Number: US11246866B2
  • Authority: United States
  • Prior Art Date: The patent builds upon previous research and developments in the field of HCV treatment, incorporating compounds and formulations that have been refined over time[4].

Scope of the Patent

Definition and Purpose

The patent describes solid pharmaceutical compositions that include specific compounds and formulations aimed at treating HCV. These compositions are designed to enhance the bioavailability and efficacy of the treatment.

Key Components

  • Compounds 1 and 2: The patent specifies the use of two primary compounds, each combined with pharmaceutically acceptable hydrophilic polymers and surfactants. These compounds are formulated into amorphous solid dispersions, which are then compressed into tablets or mini-tablets[4].

Formulations

The patent outlines various formulations, including:

  • Tablets: Comprising layers of amorphous solid dispersions with specific compounds.
  • Mini-tablets: Sized between 2 mm to 5 mm, these are designed for easier administration and better patient compliance[4].

Claims of the Patent

Independent and Dependent Claims

The patent includes several independent and dependent claims that define the scope of the invention. These claims are crucial as they delineate what is protected under the patent.

  • Independent Claims: These claims define the core aspects of the invention, such as the composition of the solid pharmaceuticals, the specific compounds used, and the method of preparation[4].
  • Dependent Claims: These claims build upon the independent claims, providing additional details and variations of the invention, such as different sizes of mini-tablets and specific dosages[4].

Claim Language and Scope

The language used in the claims is precise and technical, ensuring that the scope of the patent is well-defined. For example, the claims specify the exact composition of the amorphous solid dispersions and the process of manufacturing the tablets or mini-tablets. This precision is critical in patent law to avoid ambiguity and potential infringement issues[3].

Patent Landscape

Global Patent System

The patent is part of a broader global patent system that involves multiple intellectual property offices. Tools like the Global Dossier and Common Citation Document (CCD) facilitate the integration of patent information across different jurisdictions, ensuring that similar inventions are not patented multiple times[1].

Related Patents and Applications

  • Prior Art: The patent builds on existing research and prior art in the field of HCV treatment. Other patents and applications related to HCV treatments can be found through databases such as the USPTO's Patent Public Search and international databases like the European Patent Office's esp@cenet[1].
  • Competing Patents: There are other patents and applications that address similar aspects of HCV treatment, such as interferon- and ribavirin-free therapies. These competing patents highlight the ongoing innovation in this field[5].

International Search and Examination

The patent has likely undergone international search and examination processes, which involve evaluating the novelty, non-obviousness, and utility of the invention. Tools like the CCD help in consolidating prior art citations from multiple offices, ensuring that the patent meets global standards[1].

Impact on Innovation

Patent Quality and Scope

The scope and claims of the patent are critical in determining its impact on innovation. Narrower claims, as validated by research, are associated with a higher probability of grant and a shorter examination process. This patent, with its well-defined claims, contributes to the clarity and validity of the intellectual property landscape in pharmaceuticals[3].

Licensing and Litigation

The clarity and specificity of the patent claims also influence licensing and litigation. Well-defined patents reduce the likelihood of disputes and make it easier for other innovators to understand what is protected, thereby fostering further innovation[3].

Practical Applications

Patient Compliance

The mini-tablet formulations described in the patent are designed to improve patient compliance by making the medication easier to administer. This is a significant practical application, as it can lead to better treatment outcomes[4].

Manufacturing Process

The patent details a specific manufacturing process, which includes milling and mixing the compounds with excipients and then compressing them into tablets. This process ensures the consistency and quality of the final product[4].

Key Takeaways

  • Specific Compounds and Formulations: The patent focuses on specific compounds and formulations for treating HCV.
  • Well-Defined Claims: The claims are precise and technical, ensuring clarity and validity.
  • Global Integration: The patent is part of a global system that ensures consistency and avoids duplication.
  • Impact on Innovation: The patent contributes to innovation by providing clear boundaries and encouraging further research.
  • Practical Applications: The mini-tablet formulations improve patient compliance and the manufacturing process ensures product quality.

FAQs

What is the main focus of United States Patent 11,246,866?

The main focus of this patent is on solid pharmaceutical compositions designed to treat Hepatitis C Virus (HCV).

What are the key components of the pharmaceutical compositions described in the patent?

The key components include specific compounds (Compound 1 and Compound 2) combined with pharmaceutically acceptable hydrophilic polymers and surfactants.

How do the mini-tablet formulations improve patient compliance?

The mini-tablet formulations are designed to be easier to administer, which can lead to better patient compliance and treatment outcomes.

What tools are available for searching and analyzing patents related to this invention?

Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) are available for searching and analyzing related patents.

How does the patent's scope and claims impact innovation in the pharmaceutical industry?

The well-defined scope and claims of the patent contribute to clarity and validity, reducing the likelihood of disputes and fostering further innovation by providing clear boundaries for other researchers.

Sources

  1. USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
  2. U.S. Patent and Trademark Office (USPTO) | USAGov. Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
  3. Patent Claims and Patent Scope. SSRN. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
  4. US11246866B2 - Solid pharmaceutical compositions for treating HCV. Google Patents. Retrieved from https://patents.google.com/patent/US11246866B2/en
  5. US-20130102558-A1 - Methods for Treating Hcv. Unified Patents. Retrieved from https://portal.unifiedpatents.com/patents/patent/US-20130102558-A1

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Drugs Protected by US Patent 11,246,866

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie MAVYRET glecaprevir; pibrentasvir TABLET;ORAL 209394-001 Aug 3, 2017 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

International Family Members for US Patent 11,246,866

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016283018 ⤷  Try for Free
Australia 2016296709 ⤷  Try for Free
Brazil 112017028185 ⤷  Try for Free
Brazil 112018000982 ⤷  Try for Free
Canada 2990855 ⤷  Try for Free
Canada 2992722 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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