Detailed Analysis of the Scope and Claims of United States Patent 9,624,250
Introduction to Patent 9,624,250
United States Patent 9,624,250, issued on April 18, 2017, is a significant patent in the pharmaceutical sector, particularly related to the drug Sivextro. This patent is owned by Merck Sharp & Dohme Corp. and protects various aspects of the drug, including its composition, dosage forms, and methods of administration.
Overview of Sivextro
Sivextro, also known as tedizolid phosphate, is an oxazolidinone antibiotic used for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria. It is a critical drug in the fight against antibiotic-resistant infections[2].
Patent Details
Patent Number and Issue Date
- Patent Number: US 9,624,250
- Issue Date: April 18, 2017
Inventors and Assignees
- Inventors: Katharina Reichenbacher, Robert J. Duguid, Jacqueline A. Ware, and Douglas Phillipson
- Assignees: Merck Sharp & Dohme Corp.[5].
Scope of the Patent
Claims
The patent includes several claims that cover different aspects of the drug Sivextro:
Composition Claims
The patent claims cover specific forms of the active ingredient, tedizolid phosphate, including:
- Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate. These claims are crucial as they protect the specific chemical structure and crystalline forms of the drug, which are essential for its efficacy and stability[5].
Dosage and Administration Claims
The patent also covers various dosage forms and methods of administration, such as oral tablets and intravenous formulations. These claims ensure that the drug can be administered effectively and safely in different clinical settings[2].
Method of Use Claims
Additionally, the patent includes claims related to the methods of using tedizolid phosphate for treating specific bacterial infections. These claims are vital as they protect the therapeutic uses of the drug, ensuring that generic versions must adhere to these methods to maintain efficacy and safety[5].
Patent Landscape
Exclusivities and Challenges
The patents associated with Sivextro, including US 9,624,250, have been open to challenges since June 21, 2023. However, none of the patents have expired yet, with the earliest expiration dates projected for 2028 and 2030. This extended exclusivity period allows Merck Sharp & Dohme Corp. to maintain market exclusivity for the drug until the patents expire[2].
Related Patents
Several other patents related to Sivextro are also in effect, including:
- US 10,065,947: Issued on September 4, 2018, covering forms of the active ingredient.
- US 10,442,829: Issued on October 15, 2019, covering crystalline forms of the active ingredient.
- US 8,426,389: Issued on April 23, 2013, covering other aspects of the drug's composition and use[5].
Claim Coverage and Scope Concepts
Claim Coverage Matrix
To understand the full scope of protection provided by US 9,624,250 and related patents, a Claim Coverage Matrix can be used. This matrix categorizes patents and claims by scope concepts, which helps in identifying gaps or opportunities in the patent landscape. For Sivextro, this matrix would highlight the high-value claims that are currently protecting the drug's composition, dosage forms, and therapeutic uses[3].
Interactive Claim Charts
Using tools like ClaimScape® software, interactive claim charts can be generated to review the patent coverage with technical experts. These charts help in determining whether specific scope concepts are applicable to target products or methods, ensuring that there are no gaps in the current coverage and highlighting future design opportunities[3].
Impact on Generic Drug Development
Generic Launch Date
The expiration of the patents associated with Sivextro, including US 9,624,250, will significantly impact the generic drug market. The estimated generic launch date for Sivextro is December 31, 2030, based on the current patent exclusivities. Generic companies are already preparing to develop generic versions of the drug, which will increase competition and potentially reduce costs for patients[2].
Profitability and Market Dynamics
The expiration of these patents will open up new opportunities for generic drug manufacturers. By analyzing the yearly sales, treatment areas, and disease targets of Sivextro, generic companies can identify the most profitable drugs to develop generic versions for. This analysis is crucial for making informed decisions in the highly competitive generic drug market[1].
Key Takeaways
- Patent Details: US 9,624,250 protects specific forms and uses of tedizolid phosphate, the active ingredient in Sivextro.
- Scope of Claims: The patent covers composition, dosage forms, and methods of use, ensuring broad protection for the drug.
- Patent Landscape: The patent is part of a larger landscape of related patents that extend exclusivity until 2030.
- Generic Impact: The expiration of these patents will enable generic drug development, increasing competition and potentially reducing costs.
- Analytical Tools: Claim Coverage Matrix and interactive claim charts are essential for understanding and managing the patent landscape.
FAQs
What is the main drug protected by US 9,624,250?
The main drug protected by US 9,624,250 is Sivextro (tedizolid phosphate), an oxazolidinone antibiotic used for treating acute bacterial skin and skin structure infections.
When is the estimated generic launch date for Sivextro?
The estimated generic launch date for Sivextro is December 31, 2030, based on the current patent exclusivities.
Who owns the patent US 9,624,250?
The patent US 9,624,250 is owned by Merck Sharp & Dohme Corp.
What are the key claims covered by US 9,624,250?
The key claims cover specific forms of the active ingredient, dosage forms, and methods of use for treating bacterial infections.
How do patent analytics tools help in managing the patent landscape for Sivextro?
Patent analytics tools, such as Claim Coverage Matrix and interactive claim charts, help in categorizing and analyzing the claims to identify gaps or opportunities in the patent landscape, ensuring comprehensive protection and highlighting future design opportunities.
Sources
- GreyB, "List - 30 Drug Patents Expiring in 2028", GreyB Blog.
- Pharsight, "Sivextro patent expiration", Pharsight.
- SLWIP, "Patent Analytics", SLWIP.
- Google Patents, "US20090192197A1 - Novel oxazolidinone derivatives".
- Drugs.com, "Generic Sivextro Availability".
