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Patent landscape, scope, and claims: |
Understanding the Scope and Claims of United States Patent 9,084,802
Introduction to the Patent
United States Patent 9,084,802, titled "Tetracycline compositions," is a significant patent in the pharmaceutical industry, particularly in the context of tetracycline antibiotics. This patent, issued on July 21, 2015, is owned by Melinta Therapeutics, LLC, and plays a crucial role in the protection of their drug product, Minocin® (minocycline HCl).
Patent Overview
Publication Details
- Publication Number: US9084802B2
- Filing Date: June 12, 2014
- Issue Date: July 21, 2015
- Prior Art Date: October 31, 2013[4].
Scope of the Patent
The patent covers various aspects of tetracycline compositions, including methods for preparing and using these compositions.
Tetracycline Compositions
The patent describes tetracycline compositions, with a focus on minocycline, a derivative of tetracycline. These compositions are designed to improve the stability, efficacy, and delivery of tetracycline antibiotics. The patent includes formulations that can be used in various medical applications, such as treating bacterial infections.
Key Components
- Minocycline: The patent details compositions that include minocycline, often in combination with other ingredients to enhance its properties.
- Solution and Composition: The patent covers both solid and liquid compositions, including solutions and suspensions, which are crucial for different modes of administration.
- Molar Ratio: The patent specifies the molar ratios of the components in the compositions, ensuring optimal therapeutic effects and stability[4].
Claims of the Patent
The claims of the patent are the most critical part, as they define the scope of protection.
Independent Claims
- The patent includes several independent claims that describe the tetracycline compositions, their preparation methods, and their uses. For example, Claim 1 might describe a tetracycline composition comprising minocycline and a specific solvent system.
- These claims are broad enough to cover various formulations but specific enough to distinguish the invention from prior art[4].
Dependent Claims
- Dependent claims further narrow down the scope by adding additional limitations to the independent claims. For instance, a dependent claim might specify a particular concentration of minocycline in the composition.
- These claims help in establishing a hierarchy of protection, ensuring that the patent covers a range of variations while maintaining the core invention[4].
Patent Landscape and Litigation
Patent Ownership and Litigation
- The patent is currently owned by Melinta Therapeutics, LLC, which has been involved in litigation to protect its intellectual property. A notable case is Melinta Therapeutics, LLC v. Nexus Pharms., Inc., where Melinta alleged patent infringement by Nexus Pharmaceuticals, Inc. regarding the ANDA (Abbreviated New Drug Application) submission for a generic version of Minocin®[1][5].
Venue and Jurisdiction
- In the litigation, Melinta faced challenges regarding the venue of the case. Nexus argued that the case should be transferred to the Northern District of Illinois, as Nexus is incorporated in Illinois. However, Melinta argued for pendent venue to keep the case in New Jersey, citing the necessity of the non-patent count as a predicate to the patent infringement claims. The court ultimately granted the transfer to the Northern District of Illinois[1][5].
Regulatory Compliance
FDA Requirements
- The patent information for U.S. Patents Nos. 9,084,802 and 9,278,105 was submitted to the FDA by Rempex, the original NDA holder, and is listed in the Orange Book. This is in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires the submission of patent information for drugs for which approval is sought or has been granted[2].
ANDA Submissions
- When Nexus submitted its ANDA for a generic version of Minocin®, it triggered the patent infringement allegations. The FDA carefully considers such submissions and the associated patent information to ensure compliance with regulatory requirements[2].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
- To effectively manage and analyze the claims of this patent, companies can use patent analytics tools. A Claim Coverage Matrix helps in categorizing patents by claims and scope concepts, making it easier to identify which patents and claims are actively protecting the intellectual property. This approach can highlight gaps or opportunities in the patent landscape[3].
Claim Charts
- Interactive claim charts generated by tools like ClaimScape® can be used to review patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, ensuring that the patent claims are aligned with the company's current and future development directions[3].
Expiration and Future Implications
Patent Expiration
- Both U.S. Patents Nos. 9,084,802 and 9,278,105 are set to expire on May 12, 2031. This expiration date is crucial for generic manufacturers and competitors, as it marks the time when they can legally produce and market generic versions of the drug without infringing on Melinta's patents[2].
Future Development
- As the patent approaches its expiration date, Melinta and other stakeholders must strategize to maintain market dominance. This could involve developing new formulations, seeking additional patent protection for new uses or methods, or exploring other avenues of innovation to stay ahead in the competitive pharmaceutical market.
Key Takeaways
- Patent Scope: The patent covers tetracycline compositions, particularly minocycline, including methods for preparation and use.
- Claims: The patent includes independent and dependent claims that define the scope of protection.
- Litigation: Melinta has been involved in litigation to protect its patent against generic manufacturers.
- Regulatory Compliance: The patent information is submitted to the FDA and listed in the Orange Book.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for managing and analyzing the patent claims.
- Expiration: The patent is set to expire on May 12, 2031, which has significant implications for future market strategies.
FAQs
Q: What is the main subject of United States Patent 9,084,802?
A: The main subject is tetracycline compositions, specifically minocycline, including their preparation and use.
Q: Who is the current owner of U.S. Patent 9,084,802?
A: Melinta Therapeutics, LLC is the current owner.
Q: What was the outcome of the venue dispute in Melinta Therapeutics, LLC v. Nexus Pharms., Inc.?
A: The court granted the transfer of the case to the Northern District of Illinois.
Q: How does the FDA regulate patent information related to drug applications?
A: The FDA requires the submission of patent information for drugs for which approval is sought or has been granted, which is then listed in the Orange Book.
Q: What tools can be used to analyze and manage the claims of U.S. Patent 9,084,802?
A: Tools such as Claim Coverage Matrix and Claim Charts generated by patent analytics software can be used.
Sources
- Melinta Therapeutics, LLC v. Nexus Pharms., Inc. - Robins Kaplan
- Jennifer Sanfilippo, General Counsel Melinta Therapeutics, LLC - FDA Docket No. FDA-2023-P-0127
- Patent Analytics - Schwegman Lundberg & Woessner
- US9084802B2 - Tetracycline compositions - Google Patents
- Melinta Therapeutics, LLC v. Nexus Pharms., Inc. - JDSupra
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