United States Patent 11,045,470: A Detailed Analysis
Overview of the Patent
United States Patent 11,045,470, assigned to AbbVie Inc., is a significant patent in the pharmaceutical industry, particularly in the treatment of heavy menstrual bleeding and uterine fibroids.
Patent Assignee and Application Details
- Assignee: AbbVie Inc., North Chicago, IL[1].
- Application Number: 16/355,359[1].
Patent Claims and Types
The patent includes various claim types, such as use claims and dosage form claims. Here are some key aspects of the patent claims:
- Use Claims: The patent covers methods of treating heavy menstrual bleeding in subjects with or without uterine fibroids. This indicates the therapeutic application of the invention[1].
- Dosage Form Claims: The patent specifies the dosage forms and regimens for the treatment, which is crucial for the efficacy and safety of the medication[1].
Protected Products
The patent protects the product ORIAHNN (COPACKAGED), which is a combination therapy involving elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, and estradiol and norethindrone acetate. This combination is used to treat heavy menstrual bleeding associated with uterine fibroids[1].
Patent Family and Global Coverage
The patent has eight patent family members across five countries, including the United States, Canada, Japan, New Zealand, and several European countries. This extensive global coverage ensures broad protection for AbbVie's intellectual property[1].
Patent Expiration and Supplementary Protection
- Estimated Expiration: The patent's expiration date is crucial for understanding the timeline of exclusivity. While the exact expiration date is not provided in the sources, it is typically calculated from the filing date or grant date, considering any supplementary protection certificates (SPCs)[1].
- Supplementary Protection Certificates (SPCs): SPCs can extend the patent term beyond the standard 20 years from the filing date. The presence of SPCs in various countries can further protect AbbVie's product[1].
Litigation and Patent Infringement
The patent has been involved in several litigation cases, particularly against generic manufacturers like Teva Pharmaceuticals. AbbVie has filed complaints alleging patent infringement related to ANDA (Abbreviated New Drug Application) filings by Teva, which sought to market generic versions of AbbVie's products before the patent expiration[2].
Recent Litigation
- First Suit: Filed on February 3, 2023, this suit included counts for infringement of U.S. Patent Nos. 10,881,659 and 11,045,470[2].
- Second Suit: Filed on March 30, 2023, this suit included counts for infringement of U.S. Patent No. 11,542,239[2].
Patent Scope and Quality
The scope of the patent is defined by its claims, which are a critical aspect of patent quality. The debate over patent quality often involves metrics such as independent claim length and count, which can indicate the breadth and clarity of the patent[3].
Metrics for Patent Scope
- Independent Claim Length: Longer independent claims may indicate more detailed and specific inventions, potentially reducing the risk of overly broad patents[3].
- Independent Claim Count: A higher number of independent claims can suggest a more comprehensive coverage of the invention[3].
Abbvie's Patent Portfolio
Abbvie has a substantial patent portfolio, with over 47,000 patents globally, of which more than 57% are active. This portfolio includes a wide range of pharmaceutical and biotechnological inventions, reflecting AbbVie's diverse product lineup[4].
Global Patent Filing Activity
Abbvie's patent filings are most prominent in the United States, followed by Europe and Australia. This aligns with AbbVie's major market presence and R&D focus in these regions[4].
Key Takeaways
- Patent Protection: U.S. Patent 11,045,470 provides significant protection for AbbVie's product ORIAHNN, covering its use and dosage forms.
- Global Coverage: The patent has extensive global coverage through its patent family members.
- Litigation: AbbVie has been actively defending this patent against generic manufacturers through litigation.
- Patent Scope: The patent's scope is defined by its detailed claims, which are crucial for its validity and enforcement.
- Abbvie's Portfolio: The patent is part of AbbVie's large and active patent portfolio, reflecting the company's strong commitment to innovation and intellectual property protection.
FAQs
1. What is the main product protected by U.S. Patent 11,045,470?
The main product protected by this patent is ORIAHNN (COPACKAGED), a combination therapy for treating heavy menstrual bleeding associated with uterine fibroids.
2. Which company is the assignee of this patent?
The assignee of U.S. Patent 11,045,470 is AbbVie Inc.
3. In which countries does this patent have family members?
This patent has family members in the United States, Canada, Japan, New Zealand, and several European countries.
4. What are the key claim types in this patent?
The key claim types include use claims and dosage form claims.
5. Why is AbbVie involved in litigation related to this patent?
Abbvie is involved in litigation to defend against generic manufacturers that seek to market generic versions of ORIAHNN before the patent expires.
Sources:
- Drug Patent Watch: "Pharmaceutical drugs covered by patent 11,045,470."
- RPX Insight: "IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ABBVIE INC., Plaintiff, v. TEVA PHARMACEUTICALS, INC. and TEVA PHARMACEUTICAL INDUSTRIES LTD., Defendants."
- Hoover Institution: "Patent Claims and Patent Scope."
- GreyB Insights: "Abbvie Patents - Insights & Stats."
