United States Patent 7,973,081: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,973,081, titled "Emulsion compositions containing quaternary ammonium compounds," is a significant patent in the field of ophthalmic care, particularly for the treatment of eye conditions such as dry eye. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The patent was invented by Laura Rabinovich-Guilatti, Gregory Lambert, Frederic Lallemand, and Betty Philips, and assigned to Novagali Pharma SA, which is now part of Santen SAS[1][2].
Publication and Expiration Dates
The patent was issued on July 27, 2010, and is set to expire, assuming no extensions or adjustments, 20 years from the date of filing, which would be around 2027, though specific expiration dates may vary based on the filing date and any subsequent adjustments[1].
Scope of the Patent
The patent covers emulsion compositions that contain quaternary ammonium compounds, where the nitrogen atom is substituted by at least one alkyl group having at least 12 carbon atoms. These compositions are specifically designed for ophthalmic use, particularly for eye care and the treatment of eye conditions such as dry eye.
Key Components
- The emulsions are oil-in-water emulsions with droplet sizes ranging from 100 to 500 nm, preferably 200 to 300 nm.
- The compositions include at least 20% in weight by weight of the total composition of ammonium halides with alkyl groups having at least 14 carbon atoms, and more than 5%, preferably more than 7%, of ammonium halides with alkyl groups having at least 16 carbon atoms[1].
Claims
The patent claims are broad and cover several aspects of the emulsion compositions:
Emulsion Composition
- The claims include the specific formulation of the emulsion, emphasizing the presence of quaternary ammonium compounds with long-chain alkyl groups.
- The emulsions must have a positive zeta potential to ensure stability over time[1].
Ophthalmic Use
- The claims specify that these emulsions are useful for eye care and the treatment of eye conditions, particularly dry eye.
- The emulsions can be preserved or unpreserved and can be packaged in unitary doses or multidose containers[1].
Viscosity and Form
- The patent also covers emulsions with high viscosity, which can be dispensed as a gel suitable for ophthalmic use.
- It includes pre-concentrates of the therapeutic emulsion, which have a higher oil content and can be in liquid, gel, or other suitable forms for further dilution[1].
Patent Landscape
The patent landscape surrounding US 7,973,081 is complex and involves several related patents and inventions.
Related Patents
- Patents 8,524,779, 9,132,071, and 9,956,289 also cover similar compositions containing quaternary ammonium compounds for ophthalmic use. These patents have overlapping claims and are assigned to the same inventors and assignees, indicating a strategic approach to patent protection[2].
- These related patents have different expiration dates, with some expiring as early as January 27, 2026, and others as late as June 2, 2029[2].
Competitive Landscape
- The absence of generic versions of products based on these patents, such as Verkazia, indicates that the patent holders maintain significant market exclusivity until the patents expire[2].
Strategic Implications
The broad scope of the claims in US 7,973,081 and related patents is a strategic move to prevent competitors from easily designing around the patented inventions. This approach ensures that any minor modifications to the product would still fall within the scope of the patent claims, thereby protecting the intellectual property of the inventors and assignees[3].
Clinical and Commercial Impact
- The emulsions covered by this patent have significant clinical implications for the treatment of dry eye and other ophthalmic conditions, offering stable and effective formulations that improve patient outcomes.
- The commercial impact is substantial, given the market exclusivity provided by the patents, allowing the patent holders to dominate the market for these specific ophthalmic emulsions until the patents expire.
Conclusion
United States Patent 7,973,081 is a critical patent in the field of ophthalmic care, covering specific emulsion compositions containing quaternary ammonium compounds. The broad scope of its claims and the related patent landscape ensure strong intellectual property protection, which is crucial for maintaining market exclusivity and driving innovation in ophthalmic treatments.
Key Takeaways
- Specific Formulation: The patent covers emulsions with quaternary ammonium compounds and long-chain alkyl groups.
- Ophthalmic Use: The emulsions are specifically designed for eye care and treating dry eye conditions.
- Stability: The emulsions have a positive zeta potential, ensuring stability over time.
- Packaging: The emulsions can be preserved or unpreserved and packaged in various forms.
- Related Patents: Several related patents extend the patent protection and market exclusivity.
- Strategic Protection: The broad claims prevent easy design-around by competitors.
FAQs
What is the primary use of the emulsion compositions covered by US 7,973,081?
The primary use is for eye care and the treatment of eye conditions, particularly dry eye.
What are the key components of the emulsion compositions?
The key components include quaternary ammonium compounds with alkyl groups having at least 12 carbon atoms, and the emulsions must have a positive zeta potential.
How are the emulsions packaged?
The emulsions can be packaged in unitary doses or multidose containers and can be preserved or unpreserved.
What is the significance of the positive zeta potential in these emulsions?
The positive zeta potential ensures the stability of the emulsions over time.
When do the patents related to US 7,973,081 expire?
The related patents expire at different dates, ranging from January 27, 2026, to June 2, 2029.
Cited Sources
- US7973081B2 - Emulsion compositions containing quaternary ammonium compounds - Google Patents
- Generic Verkazia Availability - Drugs.com
- Patent claims' scope – is bigger always better? Trends in the pharmaceuticals industry - Pearl Cohen
