United States Patent 9,254,267: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 9,254,267, titled "Composite Hydrogel Drug Delivery Systems," was granted to Ocular Therapeutix, Inc. and is associated with the drug Dextenza. This patent focuses on innovative methods and compositions for delivering therapeutic agents using hydrogel technology.
Background of the Invention
The patent addresses the need for controlled release of therapeutic species, particularly in the context of ophthalmic treatments. It aims to improve the efficacy and convenience of drug delivery systems, especially for conditions like dry eye syndrome[4].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they outline the novel aspects of the composite hydrogel drug delivery systems.
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Claim 1: This claim describes a composite hydrogel drug delivery system comprising a hydrogel matrix and a therapeutic agent. The hydrogel matrix is designed to release the therapeutic agent in a controlled manner[4].
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Claim 2: This claim specifies the composition of the hydrogel matrix, including the types of polymers and cross-linking agents used. It also details the method of preparing the composite hydrogel[4].
Dependent Claims
Dependent claims further elaborate on the independent claims by adding specific details or limitations. These claims help in narrowing down the scope and ensuring the patent's uniqueness.
- Dependent Claims: These include specifications on the types of therapeutic agents, the structure of the hydrogel matrix, and the methods of administration. For example, some dependent claims describe the use of specific polymers like polyethylene glycol (PEG) and poly(lactic-co-glycolic acid) (PLGA)[4].
Patent Landscape
Related Patents
The patent landscape for Dextenza includes several other patents that protect various aspects of the drug and its delivery system.
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US Patent 11,458,041: This patent, titled "Punctal Plug and Bioadhesives," is related to the use of bioadhesives with punctal plugs for treating conditions like dry eye. It is set to expire on November 16, 2037[2][5].
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US Patents 8,409,606 and 8,563,027: These patents focus on drug delivery through hydrogel plugs and are set to expire in 2030[2][5].
Exclusivities and Litigations
In addition to patent protection, Dextenza benefits from FDA-granted exclusivities.
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Exclusivity Periods: Dextenza had several exclusivity periods, including New Product (NP), New Indication (I-800), and New Indication (I-876), which have all expired as of 2024[2].
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Litigations: There have been legal proceedings challenging the validity of Dextenza's patents. For example, a petition was filed against patent US9254267 in August 2012, which was decided in 2015[2].
Expiration and Generic Launch
The patent US9254267 has already expired, which is a significant factor in the potential generic launch of Dextenza.
- Generic Launch Date: Despite the expiration of this patent, the generic launch of Dextenza is estimated to be November 16, 2037, due to other active patents and exclusivities[2][5].
Impact on Innovation and Market
The scope and claims of this patent have significant implications for innovation in drug delivery systems.
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Innovation: The use of composite hydrogel technology has opened new avenues for controlled drug release, enhancing treatment efficacy and patient compliance[4].
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Market Protection: The patent and exclusivity landscape ensures that Ocular Therapeutix, Inc. maintains market exclusivity for Dextenza, protecting its investment in research and development[2].
Criticisms and Debates
Patent scope and claim clarity are often subjects of debate, particularly in the pharmaceutical industry.
- Patent Quality: There are concerns about the breadth and clarity of patent claims, which can affect innovation and litigation costs. Narrower claims are generally associated with a higher probability of grant and shorter examination processes[3].
Key Takeaways
- Composite Hydrogel Technology: The patent introduces a novel method for controlled drug release using composite hydrogel systems.
- Scope and Claims: The patent includes detailed claims on the composition and preparation of the hydrogel matrix and the therapeutic agents used.
- Patent Landscape: Dextenza is protected by multiple patents and exclusivities, delaying the generic launch until 2037.
- Expiration and Generic Launch: The expiration of US9254267 does not immediately allow for generic competition due to other active patents.
- Impact on Innovation: The patent has significant implications for drug delivery innovation and market protection.
FAQs
What is the main focus of United States Patent 9,254,267?
The main focus of this patent is on composite hydrogel drug delivery systems, particularly for ophthalmic treatments.
When did the patent US9254267 expire?
The patent US9254267 has already expired, as indicated by its legal status[4].
How does the patent landscape affect the generic launch of Dextenza?
The generic launch of Dextenza is delayed until 2037 due to other active patents and FDA-granted exclusivities protecting the drug[2][5].
What are the implications of this patent on innovation in drug delivery systems?
This patent has opened new avenues for controlled drug release using composite hydrogel technology, enhancing treatment efficacy and patient compliance[4].
What are the criticisms related to patent scope and claim clarity in this context?
There are concerns about the breadth and clarity of patent claims, which can affect innovation and litigation costs. Narrower claims are generally preferred for their clarity and reduced litigation risks[3].
