United States Patent 8,900,638: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,900,638, titled "Solid Preparation Comprising Alogliptin and Metformin Hydrochloride," is a crucial patent in the pharmaceutical industry, particularly for the drug Kazano®. This patent, owned by Takeda Japan, protects a specific formulation of alogliptin and metformin hydrochloride, which is used to treat type 2 diabetes. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent was issued on December 2, 2014, to Takeda Japan as the assignee of inventors Kazumichi Yamamoto and Hiroyoshi Koyama. It is listed in the FDA's "Orange Book" in conjunction with the approved New Drug Application (NDA) for Kazano®, which is a combination of alogliptin benzoate and metformin hydrochloride[1][4].
Scope of the Patent
The patent covers a solid preparation that includes alogliptin and metformin hydrochloride. This formulation is designed to improve the stability and efficacy of the combination therapy. Here are some key aspects of the scope:
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Composition: The patent describes a solid preparation that contains alogliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride, a biguanide antidiabetic agent. The combination is formulated to enhance the therapeutic effects of both drugs[4].
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Stability: The solid preparation is designed to maintain the stability of both active ingredients, which is critical for ensuring the drug's efficacy and safety over its shelf life.
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Dosage Forms: The patent includes various dosage forms such as tablets, which are commonly used for administering the combination therapy.
Claims of the Patent
The claims of the patent are detailed and specific, outlining the exact composition and characteristics of the solid preparation:
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Independent Claims: These claims define the broad scope of the invention, including the combination of alogliptin and metformin hydrochloride in a solid preparation.
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Dependent Claims: These claims further specify the details of the composition, such as the ratio of alogliptin to metformin hydrochloride, the presence of excipients, and the physical characteristics of the solid preparation[4].
Patent Landscape
The patent landscape surrounding U.S. Patent 8,900,638 is complex and involves several other patents related to Kazano® and similar combination therapies.
Related Patents
Several other patents are listed in the Orange Book for Kazano®, including U.S. Patent Nos. 7,807,689, 8,173,663, and 8,288,539. These patents cover various aspects of the drug, such as different formulations, methods of manufacture, and specific uses[1].
Generic Challenges
Generic pharmaceutical companies often challenge these patents through Abbreviated New Drug Applications (ANDAs) with paragraph IV certifications, which assert non-infringement or invalidity of the listed patents. For example, Indoco Remedies filed an ANDA seeking approval for a generic version of Kazano®, leading to a patent infringement lawsuit by Takeda Japan[1].
Patent Expiration
The patent expiration dates for the patents related to Kazano® are critical for understanding the timeline for generic entry. U.S. Patent 8,900,638, like other related patents, has maintenance fees paid to extend its validity. However, the critical expiration dates for these patents have already begun, with some expiring as early as January 2021[5].
Patent Analytics and Claim Coverage
To manage and analyze the complex patent landscape, companies like Takeda use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future design opportunities[3].
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Claim Coverage Matrix: This tool shows which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist.
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Claim Charts: These charts, generated by software like ClaimScape®, facilitate the review of patent coverage with technical experts, helping to determine the applicability of scope concepts to target products or methods[3].
Litigation and Enforcement
The enforcement of U.S. Patent 8,900,638 involves significant litigation efforts. Takeda Japan has taken legal action against generic manufacturers that have filed ANDAs, alleging patent infringement. These cases often involve detailed claim-by-claim analyses and arguments regarding non-infringement or invalidity[1][2].
Industry Impact
The protection afforded by U.S. Patent 8,900,638 has significant implications for the pharmaceutical industry:
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Market Exclusivity: The patent ensures that Takeda maintains market exclusivity for Kazano® until the patent expires, preventing generic competition.
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Research and Development: The revenue generated from patented drugs like Kazano® funds further research and development in the pharmaceutical sector.
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Generic Entry: The expiration of this patent and related patents will open the market to generic versions, potentially reducing costs for patients and increasing access to the medication[5].
Key Takeaways
- Patent Scope: U.S. Patent 8,900,638 covers a specific solid preparation of alogliptin and metformin hydrochloride.
- Claims: The patent includes detailed claims defining the composition and characteristics of the solid preparation.
- Patent Landscape: The patent is part of a broader landscape involving multiple related patents and generic challenges.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for managing and analyzing the patent landscape.
- Litigation: Enforcement of the patent involves significant litigation against generic manufacturers.
- Industry Impact: The patent affects market exclusivity, research and development, and generic entry.
FAQs
What is the main subject of U.S. Patent 8,900,638?
The main subject of U.S. Patent 8,900,638 is a solid preparation comprising alogliptin and metformin hydrochloride, used in the treatment of type 2 diabetes.
Who is the owner of U.S. Patent 8,900,638?
Takeda Japan is the owner of U.S. Patent 8,900,638.
What is the significance of the Orange Book listing for this patent?
The listing in the FDA's Orange Book ensures that the patent is recognized as protecting the approved drug Kazano®, and any generic manufacturer must address these patents in their ANDA filings.
How do generic manufacturers challenge this patent?
Generic manufacturers challenge this patent by filing ANDAs with paragraph IV certifications, asserting non-infringement or invalidity of the listed patents.
What is the impact of patent expiration on the pharmaceutical market?
The expiration of U.S. Patent 8,900,638 and related patents will allow generic versions of Kazano® to enter the market, potentially reducing costs and increasing access to the medication.
Sources
- Case 2:18-cv-00055-SRC-CLW Document 1 Filed 01/03/18
- Court Report - Patent Docs
- Patent Analytics | Intellectual Property Law
- US8900638B2 - Solid preparation comprising alogliptin and metformin hydrochloride - Google Patents
- Kazano patent expiration - Pharsight
