Detailed Analysis of the Scope and Claims of United States Patent 9,238,657
Introduction
United States Patent 9,238,657, titled "Cephalosporin having catechol group," is a significant patent held by Shionogi & Co., Ltd., protecting a crucial antibiotic compound. This patent is one of the key protections for Fetroja, a drug used to treat complicated urinary tract infections and other bacterial infections.
Patent Overview
Patent Number and Title
- Patent Number: US9238657B2
- Title: Cephalosporin having catechol group[4].
Inventors and Assignee
- Inventors: Nishitani Yasuhiro, Yamawaki Kenji, Takeoka Yusuke, Sugimoto Hideki, Hisakawa Shinya, and Aoki Toshiaki.
- Assignee: Shionogi & Co., Ltd.[4].
Issue Date
- The patent was issued on January 19, 2016[4].
Scope of the Patent
Claims Description
The patent describes Cephem compounds, specifically cephalosporins with a catechol group. These compounds are defined by a specific chemical formula where various substituents can be attached to the core structure. The claims include:
- The chemical structure of the cephalosporin compounds.
- The side chains and functional groups attached to the core structure.
- Methods of synthesizing these compounds[4].
Broad vs. Narrow Claims
The scope of the patent is defined by its broadest claims, known as independent claims. These claims are critical because they set the boundaries of what is protected under the patent. In this case, the independent claims cover the core chemical structure and its essential features, making it broad enough to prevent competitors from easily designing around the patent[3].
Dependent Claims
Dependent claims serve as fallback positions and must be narrower than the independent claims. These claims provide additional specificity and help in defending the patent if the broader claims are challenged or invalidated[3].
Patent Expiration Date
The patent is set to expire on November 14, 2033. This date is crucial as it marks when the exclusive rights granted to Shionogi & Co., Ltd. will end, potentially allowing generic versions of the drug to enter the market[1][2].
Exclusivities
In addition to patent protection, Fetroja is also protected by various FDA-granted exclusivities, including:
- New Chemical Entity Exclusivity (NCE): Until November 14, 2024.
- Generating Antibiotic Incentives Now (GAIN): Until November 14, 2029.
These exclusivities further delay the entry of generic competitors, even after the patent expires[1].
Legal Activities and Maintenance
The patent's life can be affected by various legal activities such as:
- Payment of Maintenance Fees: Regular payments are required to keep the patent active.
- Patent Term Extension Certificate: This can extend the life of the patent under certain conditions.
- Changes in Power of Attorney and Correspondence Address: These are administrative changes that do not affect the patent's scope but are part of the patent's lifecycle[1].
Patent Landscape
Family Patents
Fetroja is protected by a family of patents, including:
- US10004750: Salt of cephalosporin derivative, its crystalline solid, and a method of manufacturing thereof.
- US9949982: Preparation containing cephalosporin having a catechol moiety.
These patents cover different aspects of the drug, such as the active ingredient, manufacturing process, and pharmaceutical composition[1][2].
International Protection
While the focus here is on US patents, Fetroja is also protected by patents in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points in regions with weaker patent protection[1].
Impact on Generic Entry
The combination of patent protection and FDA-granted exclusivities significantly delays the entry of generic versions of Fetroja. The estimated generic launch date is September 3, 2035, assuming no changes in the patent landscape or exclusivities[1][2].
Strategic Considerations
For companies considering the development of generic versions of Fetroja, it is crucial to:
- Monitor the patent's legal activities closely.
- Understand the full scope of the patent and its claims.
- Identify potential weaknesses in the patent protection, especially in international markets.
- Plan strategically around the exclusivities and patent expiration dates[1][3].
Key Takeaways
- Patent Scope: The patent covers cephalosporin compounds with a catechol group, defined by broad and narrow claims.
- Expiration Date: November 14, 2033.
- Exclusivities: Additional protection until November 14, 2029, under GAIN exclusivity.
- Family Patents: Multiple patents protect different aspects of Fetroja.
- Generic Entry: Estimated launch date is September 3, 2035.
FAQs
1. What is the main compound protected by US Patent 9,238,657?
The main compound protected is a cephalosporin with a catechol group, a type of antibiotic.
2. Who is the assignee of this patent?
The assignee is Shionogi & Co., Ltd.
3. What is the expiration date of this patent?
The patent is set to expire on November 14, 2033.
4. Are there any FDA-granted exclusivities for Fetroja?
Yes, Fetroja is protected by New Chemical Entity Exclusivity (NCE) and Generating Antibiotic Incentives Now (GAIN) exclusivities.
5. When is the estimated generic launch date for Fetroja?
The estimated generic launch date is September 3, 2035.
Cited Sources:
- Pharsight - GreyB: Fetroja patent expiration.
- Drugs.com: Generic Fetroja Availability.
- Boston University Law: The Ways We've been Measuring Patent Scope are Wrong.
- Google Patents: US9238657B2 - Cephalosporin having catechol group.
