Understanding the Scope and Claims of United States Patent 8,022,106
Introduction
The United States Patent 8,022,106, titled "Tranexamic Acid Formulations," is a significant patent in the pharmaceutical industry, particularly in the field of hemostatic agents. This patent, owned by Ferring Pharmaceuticals, Inc., covers specific formulations and methods of treatment using tranexamic acid. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Patent Overview
Publication and Legal Status
The patent was published on October 18, 2011, and is currently active, with an expected expiration date of March 4, 2025[1][4].
Inventors and Assignees
The patent was assigned to Ferring Pharmaceuticals, Inc., and the inventors are listed in the patent document. The assignment of this patent to Ferring Pharmaceuticals highlights the company's significant involvement in the development and commercialization of tranexamic acid formulations[4].
Claims of the Patent
Independent Claims
The independent claims of the '106 patent are crucial as they define the scope of the invention. These claims require "not less than about 50% by weight of the tranexamic acid or pharmaceutically acceptable salt thereof" in the formulation. This specification is critical for distinguishing the patented formulations from other existing formulations[5].
Dependent Claims
The dependent claims further elaborate on the independent claims by specifying various aspects such as the dosage form, the presence of specific excipients, and the method of treatment. For example, the patent includes claims for oral dosage forms, including immediate-release (IR) and modified-release formulations, which are designed to achieve specific pharmacokinetic profiles[4].
Key Components
- Tranexamic Acid: The patent focuses on formulations containing tranexamic acid or its pharmaceutically acceptable salts.
- Dosage Forms: The patent covers various dosage forms, including tablets, capsules, and other oral formulations.
- Excipients: The use of specific excipients like hydroxypropyl methyl cellulose is detailed to achieve the desired release characteristics.
- Methods of Treatment: The patent includes methods for treating conditions such as heavy menstrual bleeding, surgical bleeding, and other bleeding disorders using these formulations[4].
Patent Landscape Analysis
Competitor Identification
Patent landscape analysis helps in identifying key competitors in the field of tranexamic acid formulations. Ferring Pharmaceuticals, Inc., is a major player, but other companies like Apotex Inc. have also been involved in the development of generic versions of tranexamic acid tablets, as indicated by their ANDA submissions[1].
Patent Trends and Expiry Dates
The '106 patent, along with other related patents (e.g., U.S. Patent Nos. 7,947,739 and 8,487,005), is set to expire on March 4, 2025. This expiry date is crucial for generic manufacturers who are awaiting the expiration to enter the market with their own versions of tranexamic acid formulations[1][3].
Litigation and Legal Status
The '106 patent has been subject to legal challenges, including paragraph IV certifications by generic manufacturers. These certifications assert that the patent is invalid, unenforceable, or will not be infringed by the generic product. However, the patent's claims carry a presumption of validity under U.S. patent law[2].
Market Developments
Patent landscape analysis also reveals market developments such as mergers and acquisitions, in/out-licensing agreements, and litigation activities. For instance, the litigation between Ferring Pharmaceuticals and generic manufacturers highlights the competitive landscape and the efforts to protect or challenge the patent rights[3].
Technical and Business Insights
Technical Insights
The patent provides detailed technical insights into the formulation and manufacturing of tranexamic acid products. It includes information on the use of specific polymers, the design of immediate-release and modified-release formulations, and the pharmacokinetic profiles achieved by these formulations[4].
Business Insights
From a business perspective, the patent landscape analysis helps in identifying potential licensing opportunities, assessing the commercial potential of existing patents, and developing strategies for new product development. It also aids in understanding the R&D investments required to stay competitive in the market[3].
Categorization and Reporting
Categorization of Patents
Patent landscape analysis involves categorizing the collected data into relevant categories such as patent status (alive, pending, lapsed, revoked, or expired), filing year trends, and top filing countries. This categorization helps in extracting valuable insights and identifying gaps in the technology domain[3].
Reporting Formats
The analysis can be reported in various formats, including World Intellectual Property Organization reports, 3D maps, and MS Excel spreadsheets. These formats help in visualizing the patent landscape and deriving critical insights to minimize business risks and capitalize on opportunities[3].
Key Takeaways
- Patent Scope: The '106 patent covers specific tranexamic acid formulations and methods of treatment, with a focus on dosage forms containing at least 50% by weight of tranexamic acid or its salts.
- Competitor Landscape: Ferring Pharmaceuticals is a key player, but other companies are also involved in developing generic versions.
- Patent Expiry: The patent is set to expire on March 4, 2025, which will open the market for generic versions.
- Technical and Business Insights: The patent provides detailed technical insights and is crucial for business strategies related to licensing, R&D investments, and market competition.
FAQs
What is the main focus of the '106 patent?
The main focus of the '106 patent is on specific formulations and methods of treatment using tranexamic acid, particularly in oral dosage forms.
Who is the owner of the '106 patent?
The '106 patent is owned by Ferring Pharmaceuticals, Inc.
What is the expected expiry date of the '106 patent?
The '106 patent is expected to expire on March 4, 2025.
What are the key components of the '106 patent claims?
The key components include tranexamic acid or its pharmaceutically acceptable salts, specific dosage forms, and the use of certain excipients.
How does patent landscape analysis help in understanding the '106 patent?
Patent landscape analysis helps in identifying competitors, understanding patent trends and expiry dates, and deriving technical and business insights to inform strategic decisions.
Sources
- FDA Approval Document: Tranexamic Acid Tablets, 650 mg - accessdata.fda.gov
- Litigation Document: Case 2:23-cv-03494-SDW Document 1 Filed 06/28/23
- Patent Landscape Analysis: Navigating Technological Domains with Patent Landscape Analysis - sagaciousresearch.com
- Google Patents: US8022106B2 - Tranexamic acid formulations
- Federal Circuit Patent Bulletin: Ferring B.V. v. Watson Labs., Inc. - Wiley Law Alert