United States Patent 9,278,105: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,278,105, titled "Tetracycline compositions," is a significant patent in the pharmaceutical industry, particularly in the realm of antibiotic treatments. This patent, owned by Melinta Therapeutics, LLC, is associated with the drug Minocin (minocycline hydrochloride) and is crucial for understanding the patent landscape and regulatory requirements in the pharmaceutical sector.
Patent Overview
Publication and Ownership
The patent, U.S. Patent No. 9,278,105, was issued on March 8, 2016, and is currently owned by Melinta Therapeutics, LLC. This patent is one of the two patents listed in the Orange Book in connection with the New Drug Application (NDA) 050444 for Minocin (minocycline hydrochloride) for injection[2][4].
Scope of the Patent
Subject Matter
The patent pertains to compositions, pharmaceutical compositions, and methods for preparing tetracycline antibiotics with improved properties. Specifically, it covers formulations that include a tetracycline, such as minocycline, and methods for their preparation. The patent aims to enhance the stability, efficacy, and safety of tetracycline compositions[4].
Claims
The patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims.
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Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe a pharmaceutical composition comprising a tetracycline antibiotic and a specific excipient, while Claim 2 might describe a method for preparing such a composition[4].
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Dependent Claims: These claims are narrower and depend on the independent claims. They further specify the characteristics or methods described in the independent claims. For instance, a dependent claim might specify the molar ratio of the tetracycline to the excipient or the conditions under which the composition is prepared[4].
Patent Claims and Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. A shorter independent claim length (ICL) and a lower independent claim count (ICC) often suggest narrower and more focused claims, which can be associated with higher patent quality and a shorter examination process[3].
Application to U.S. Patent 9,278,105
While the specific ICL and ICC metrics for this patent are not provided in the available sources, the detailed description and claims in the patent suggest a focused approach to tetracycline compositions. The patent's claims are structured to cover specific formulations and methods, indicating a well-defined scope rather than overly broad claims.
Regulatory Requirements and Orange Book Listing
FDA Requirements
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), an NDA applicant must submit certain information for each patent that claims the drug or a method of using the drug. This information must be submitted within a specified timeframe after the patent's issuance and is published in the Orange Book[2].
Listing in the Orange Book
The U.S. Patent No. 9,278,105, along with U.S. Patent No. 9,084,802, was timely submitted by Rempex (now part of Melinta Therapeutics) for listing in the Orange Book in connection with NDA 050444. Both patents are set to expire on May 12, 2031[1][2].
Patent Litigation and Certifications
Paragraph IV Certifications
When a generic drug manufacturer files an Abbreviated New Drug Application (ANDA), it must include a certification regarding the listed patents. A Paragraph IV certification asserts that the patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the new drug. In the case of ANDA 214934 filed by Nexus Pharmaceuticals, Inc., the applicant included a Paragraph IV certification, which led to litigation with Melinta Therapeutics[1][2].
Litigation and 45-Day Notice Period
Melinta Therapeutics initiated litigation against Nexus Pharmaceuticals, Inc. following the receipt of the Paragraph IV notice. However, since no action was brought within the 45-day period required by the FD&C Act, the 30-month stay of approval did not apply to ANDA 214934[2].
Impact on the Pharmaceutical Industry
Innovation and Licensing
The patent landscape, including patents like U.S. Patent No. 9,278,105, significantly influences innovation and licensing in the pharmaceutical industry. Patents with clear and focused claims can facilitate licensing agreements and encourage further innovation by providing clear boundaries and incentives[3].
Litigation and Regulatory Compliance
The litigation surrounding this patent highlights the importance of regulatory compliance and the complexities involved in patent disputes. Companies must carefully navigate the requirements for submitting patent information and responding to Paragraph IV certifications to protect their intellectual property[1][2].
Key Takeaways
- Patent Scope and Claims: U.S. Patent No. 9,278,105 covers specific tetracycline compositions and methods, indicating a focused scope.
- Regulatory Compliance: The patent is listed in the Orange Book and subject to FDA regulations, including the submission of patent information and response to Paragraph IV certifications.
- Litigation: The patent has been involved in litigation related to Paragraph IV certifications and the 45-day notice period.
- Industry Impact: The patent influences innovation, licensing, and regulatory compliance in the pharmaceutical industry.
FAQs
What is the subject matter of U.S. Patent No. 9,278,105?
U.S. Patent No. 9,278,105 pertains to compositions, pharmaceutical compositions, and methods for preparing tetracycline antibiotics, specifically minocycline, with improved properties.
Who is the current owner of U.S. Patent No. 9,278,105?
The current owner of U.S. Patent No. 9,278,105 is Melinta Therapeutics, LLC.
What is the significance of the Orange Book listing for this patent?
The listing in the Orange Book is crucial as it publishes the patent information required by the FD&C Act, which affects the approval process for generic drugs and the potential for litigation.
What is a Paragraph IV certification, and how does it relate to this patent?
A Paragraph IV certification is a statement by a generic drug manufacturer that the listed patent is invalid, unenforceable, or will not be infringed. This certification was included in ANDA 214934 filed by Nexus Pharmaceuticals, Inc., leading to litigation with Melinta Therapeutics.
What is the expiration date of U.S. Patent No. 9,278,105?
U.S. Patent No. 9,278,105 is set to expire on May 12, 2031.
Sources
- Jennifer Sanfilippo, General Counsel Melinta Therapeutics, LLC, "Melinta Therapeutics Citizen Petition, Docket No. FDA-2023-P-0127" (June 2, 2023).
- Jennifer Sanfilippo, General Counsel Melinta Therapeutics, LLC, "Melinta Therapeutics Citizen Petition, Docket No. FDA-2021-P-1123" (July 22, 2022).
- Hoover Institution, "Patent Claims and Patent Scope" (August 18, 2024).
- Google Patents, "US9278105B2 - Tetracycline compositions" (March 8, 2016).
