Detailed Analysis of the Scope and Claims of United States Patent 9,750,684
Introduction
United States Patent 9,750,684, issued on September 5, 2017, is a significant patent in the field of ophthalmic formulations, particularly for the treatment of allergic conjunctivitis and allergic rhinoconjunctivitis. This patent, assigned to Nicox Ophthalmics, Inc., involves stable topical formulations of cetirizine. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Inventors and Assignees
The patent was invented by Mark Barry Abelson, Matthew J. Chapin, Paul Gomes, George Minno, and Jackie Nice, and is assigned to Nicox Ophthalmics, Inc.[2].
Issue Date and Expiration
The patent was issued on September 5, 2017, and is set to expire on January 9, 2033, assuming no extensions or adjustments[2].
Scope of the Patent
Subject Matter
The patent covers stable topical formulations of cetirizine, which are designed to provide a comfortable formulation when instilled in the eye. These formulations are effective in treating allergic conjunctivitis and allergic rhinoconjunctivitis[2].
Claims
The patent includes several claims that define the scope of the invention. These claims typically cover:
- The composition of the cetirizine formulations.
- The methods of preparing these formulations.
- The methods of treating allergic conjunctivitis and allergic rhinoconjunctivitis using these formulations.
For example, one of the claims might specify the concentration of cetirizine, the type of solvent used, and any additional ingredients that enhance stability or comfort upon application[2].
Claim Analysis
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims stand alone and define the invention without reference to other claims. Dependent claims, on the other hand, refer back to and further limit the independent claims. For instance, an independent claim might describe the general formulation, while a dependent claim might specify a particular concentration of cetirizine within that formulation[3].
Claim Language and Scope
The clarity and breadth of claim language are crucial in defining the patent's scope. Narrower claims are generally more specific and less likely to be challenged, while broader claims may encompass more variations but are also more susceptible to invalidation due to anticipation or obviousness[3].
In the case of Patent 9,750,684, the claims are designed to be clear and specific enough to allow a person skilled in the art to prepare and use the cetirizine formulations without undue experimentation.
Patent Landscape
Related Patents
There are several related patents that cover similar ophthalmic formulations of cetirizine. For example:
- Patent 8,829,005, issued on September 9, 2014.
- Patent 9,254,286, issued on February 9, 2016.
These patents also pertain to stable topical formulations of cetirizine and methods of treating allergic conjunctivitis and allergic rhinoconjunctivitis[2].
Patent Expiration Dates
Understanding the expiration dates of related patents is crucial for navigating the patent landscape. For instance, Patent 8,829,005 expires on March 15, 2030, while Patent 9,254,286 expires on July 9, 2032. These dates can influence when generic versions of the drug might become available[2].
Innovation and Value
Innovation Value
The innovation value of Patent 9,750,684 lies in its provision of stable and comfortable cetirizine formulations that are effective in treating specific eye conditions. This innovation is significant because it addresses a specific medical need and improves patient comfort and treatment outcomes.
Critique of Patent Quality
There is ongoing debate about the quality of patents, particularly regarding their breadth and clarity. Some studies suggest that a significant percentage of patents may lack innovation value or be overly broad, leading to increased licensing and litigation costs[4].
However, in the case of Patent 9,750,684, the specific and detailed claims suggest a well-defined scope that is less likely to be challenged on grounds of lack of innovation or clarity.
Regulatory and Legal Context
U.S. Patent and Trademark Office (USPTO)
The USPTO plays a critical role in evaluating patent applications, including those related to pharmaceutical formulations. The office ensures that patents meet the requirements of novelty, non-obviousness, and utility, and that the claims are clear and specific enough to enable one skilled in the art to practice the invention[3].
FDA Exclusivity
In addition to patent protection, the FDA grants exclusivity periods for new drugs, which can run concurrently with patent protection. This exclusivity prevents other manufacturers from marketing generic versions of the drug during the specified period[2].
Key Takeaways
- Patent Scope: The patent covers stable topical formulations of cetirizine for treating allergic conjunctivitis and allergic rhinoconjunctivitis.
- Claims: The patent includes specific claims regarding the composition and methods of use of these formulations.
- Related Patents: There are several related patents with overlapping but distinct claims and expiration dates.
- Innovation Value: The patent provides significant innovation in the field of ophthalmic formulations.
- Regulatory Context: The patent is subject to USPTO and FDA regulations, including exclusivity periods.
FAQs
Q: What is the primary subject matter of United States Patent 9,750,684?
A: The primary subject matter is stable topical formulations of cetirizine for treating allergic conjunctivitis and allergic rhinoconjunctivitis.
Q: Who are the inventors and assignees of this patent?
A: The inventors are Mark Barry Abelson, Matthew J. Chapin, Paul Gomes, George Minno, and Jackie Nice, and the assignee is Nicox Ophthalmics, Inc.
Q: What is the expiration date of this patent?
A: The patent is set to expire on January 9, 2033.
Q: How does this patent differ from related patents?
A: While related patents cover similar formulations, each has distinct claims and expiration dates, ensuring a nuanced patent landscape.
Q: What regulatory bodies are involved in the protection and oversight of this patent?
A: The USPTO and FDA are involved in evaluating and regulating this patent, ensuring it meets the necessary standards for novelty, non-obviousness, and utility, as well as granting exclusivity periods.
Sources
- The Analysis of the Temporary Patent Application System in the US - Clausius Press.
- Generic Zerviate Availability - Drugs.com.
- Patent Claims and Patent Scope - Hoover Institution.
- Where's the Innovation? An Analysis of the Quantity and Qualities of Patents - SSRN.
