United States Patent 9,421,265: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,421,265, titled "Aqueous pharmaceutical compositions containing borate-polyol complexes," is a crucial patent owned by Alcon Laboratories Inc., a leading company in the vision and eye care industry. This patent is central to the protection of Simbrinza, a drug used for treating glaucoma and ocular hypertension.
Patent Overview
Patent Title and Number
- Patent Number: US9421265B2
- Patent Title: Aqueous pharmaceutical compositions containing borate-polyol complexes[4].
Publication and Grant Dates
- Publication Date: August 23, 2016
- Grant Date: August 23, 2016[4].
Claims and Scope
Claim Structure
The patent includes multiple claims that define the scope of the invention. These claims are divided 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 of the ’265 Patent describes the aqueous pharmaceutical composition containing borate-polyol complexes, which is essential for the stability and efficacy of the drug[4][5].
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Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. They help in narrowing down the scope and ensuring that the invention is well-defined and distinguishable from prior art[4].
Key Components of the Claims
- Borate-Polyol Complexes: The patent focuses on the use of borate-polyol complexes in aqueous pharmaceutical compositions. These complexes are crucial for maintaining the stability and antimicrobial properties of the drug[4].
- Preservative Agents: The composition includes preservative agents such as benzalkonium chloride, which is essential for preventing microbial contamination[4].
- Active Ingredients: The patent specifies the use of brimonidine and brinzolamide as active ingredients, which are key components of Simbrinza[4].
Patent Landscape
Patent Expiration
- The patent is set to expire on June 30, 2030. This expiration date is critical as it determines when generic versions of Simbrinza can be introduced to the market[1].
Legal Activities and Maintenance
- The patent has undergone several legal activities, including the payment of maintenance fees. These activities are essential for maintaining the patent's validity and ensuring it remains active until its expiration date[1].
Litigation and Infringement
- Alcon Inc. and its subsidiaries have been involved in litigation with Padagis Israel Pharmaceuticals Ltd. and its affiliates regarding the infringement of the ’265 Patent. Padagis submitted an Abbreviated New Drug Application (ANDA) for a generic version of Simbrinza, which Alcon claims infringes on the asserted patents[5].
Claim Construction and Litigation
Hatch-Waxman Act
- The litigation between Alcon and Padagis is governed by the Hatch-Waxman Act, which allows generic drug manufacturers to challenge the validity of patents listed in the FDA's Orange Book. This act is crucial for determining the timing of generic drug launches[5].
Claim Construction Issues
- The parties have raised several claim construction issues, which are being addressed in the District Court of Delaware. These issues are vital for determining the scope of the patent and whether Padagis's ANDA product infringes on Alcon's patents[2].
Impact on Generic Launch
Generic Launch Date
- The generic launch date for Simbrinza is estimated to be around the patent expiration date, assuming no term extensions or other legal activities that could alter the patent's lifespan. This date is critical for both Alcon and potential generic manufacturers[1].
Market Implications
- The expiration of the ’265 Patent and the potential launch of generic versions of Simbrinza will significantly impact the market. Generic competition can lead to reduced prices and increased market share for generic manufacturers, while Alcon may see a decline in its market share and revenue[1].
Patent Scope and Quality
Metrics for Measuring Patent Scope
- The scope of the ’265 Patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims, which are important for patent quality[3].
Examination Process
- The examination process at the USPTO tends to narrow the scope of patent claims, making them more specific and clear. This process is crucial for ensuring that patents are granted with well-defined claims that do not overly broaden the scope of the invention[3].
Conclusion
United States Patent 9,421,265 is a pivotal patent in the protection of Simbrinza, a drug used for treating glaucoma and ocular hypertension. The patent's claims and scope are well-defined, focusing on the use of borate-polyol complexes and preservative agents. The ongoing litigation and legal activities surrounding this patent highlight its importance in the pharmaceutical industry and the potential impact on the market once the patent expires.
Key Takeaways
- Patent Expiration: The patent is set to expire on June 30, 2030.
- Claims and Scope: The patent focuses on aqueous pharmaceutical compositions containing borate-polyol complexes.
- Litigation: Alcon is involved in litigation with Padagis over the infringement of the ’265 Patent.
- Generic Launch: The generic launch date is estimated to be around the patent expiration date.
- Market Impact: The expiration of the patent will significantly impact the market, potentially leading to generic competition.
Frequently Asked Questions (FAQs)
What is the main focus of United States Patent 9,421,265?
The main focus of this patent is on aqueous pharmaceutical compositions containing borate-polyol complexes, specifically for the drug Simbrinza used in treating glaucoma and ocular hypertension.
When is the patent set to expire?
The patent is set to expire on June 30, 2030.
What is the significance of the Hatch-Waxman Act in this context?
The Hatch-Waxman Act allows generic drug manufacturers to challenge the validity of patents listed in the FDA's Orange Book, which is relevant to the litigation between Alcon and Padagis.
How does the patent's expiration affect the market?
The expiration of the patent will allow generic versions of Simbrinza to enter the market, potentially reducing prices and increasing competition, which could impact Alcon's market share and revenue.
What are the key components specified in the patent claims?
The key components include borate-polyol complexes, preservative agents like benzalkonium chloride, and active ingredients such as brimonidine and brinzolamide.
Cited Sources:
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Simbrinza patent expiration - Pharsight - GreyB
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
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Patent Claims and Patent Scope - Hoover Institution
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Aqueous pharmaceutical compositions containing borate-polyol complexes - Google Patents
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
