United States Patent 7,795,316: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,795,316, titled "Topical ophthalmic compositions containing tobramycin and dexamethasone," is a significant patent in the field of ophthalmic medications. This patent, assigned to Alcon Research, Ltd., protects a specific formulation of a topical ophthalmic composition used to treat ocular inflammation with infection or the risk of infection.
Patent Overview
Patent Number and Expiration Date
The patent number is US7795316B1, and it is set to expire on August 3, 2028[1][2][4].
Inventor and Assignee
The patent was invented by Bhagwati P. Kabra and assigned to Alcon Research, Ltd.[1][2].
Scope of the Patent
Topical Ophthalmic Compositions
The patent covers topical ophthalmic compositions that contain a combination of tobramycin, an antibiotic, and dexamethasone, a corticosteroid. These compositions are designed to treat ocular inflammation and infections[1][2][4].
Key Components
- Tobramycin: An antibiotic effective against a wide range of bacterial infections.
- Dexamethasone: A corticosteroid that reduces inflammation.
- Xanthan Gum: A thickening agent that enhances the viscosity of the composition upon application to the eye, improving its retention and efficacy[4].
Claims of the Patent
Composition Claims
The patent claims cover specific formulations of the ophthalmic composition, including the concentrations of tobramycin and dexamethasone, as well as the use of xanthan gum to achieve the desired viscosity properties. These claims are crucial as they define the boundaries of what is protected under the patent[4].
Method of Use Claims
The patent also includes claims related to the method of using these compositions to treat ocular conditions. This ensures that not only the composition itself but also the specific use cases are protected[4].
Patent Landscape
Related Patents
There are several related patents that cover similar compositions and uses, including US8101582 and US8450287, both of which are also assigned to Alcon Research, Ltd. and are set to expire on December 19, 2027[1][2].
Generic Applications
Several generic versions of the Tobradex ST formulation have been approved, with the first generic version approved on October 27, 1999, and the latest on February 11, 2022. Companies such as Bausch And Lomb Pharmaceuticals Inc and Padagis Us Llc have filed for generic versions[2].
Legal Activities and Updates
Maintenance Fees and Power of Attorney Changes
Recent legal activities include the payment of maintenance fees and changes in power of attorney, which are critical for maintaining the patent's validity and ensuring that the patent holder's rights are protected. For example, a payment of the 12th-year maintenance fee was made on June 9, 2024, for patent US8450287[2].
Impact on Generic Launch
The expiration dates and any changes in the patent's legal status can significantly impact the timing of generic launches. Tracking these activities is essential for understanding when generic versions of the drug may become available[2].
Patent Protection and Industry Impact
Drug Patent Protection
Patents like US7795316B1 are crucial for pharmaceutical companies as they provide exclusive rights to market the drug, allowing companies to recoup their significant investment in research and development. The expiration of these patents can lead to the entry of generic competitors, which can significantly alter the market dynamics[1][3].
Challenges in Pharmaceutical Patents
The pharmaceutical industry faces unique challenges in patent protection, particularly with genus claims. The Federal Circuit's rigid position on patent disclosure laws can make it difficult for innovators to obtain broad and meaningful patent protection, as they must balance between claiming too broadly and risking invalidation, or claiming too narrowly and allowing competitors to design around the claims[3].
Technical Details of the Composition
Viscosity and Formulation
The compositions described in the patent have lower viscosities in the bottle but increase significantly upon application to the eye due to interactions between tobramycin and xanthan gum. This property enhances the retention of the medication on the eye surface, improving its efficacy[4].
Ionic Strength
The patent also specifies that the total ionic strength of the composition should be approximately 120 mM or less to ensure that the composition gels upon topical application to the eye[4].
Market and Clinical Significance
Therapeutic Use
The combination of tobramycin and dexamethasone is highly effective in treating ocular inflammation and infections, making this patent significant in the clinical management of eye diseases[2].
Market Impact
The expiration of this patent will likely lead to increased competition from generic versions, which can reduce the cost of treatment and make the medication more accessible to a wider population[2].
Key Takeaways
- Patent Expiration: The patent is set to expire on August 3, 2028.
- Composition: The patent covers a specific formulation of tobramycin and dexamethasone with xanthan gum.
- Claims: The patent includes claims for the composition and method of use.
- Related Patents: Other related patents expire on December 19, 2027.
- Generic Applications: Several generic versions have been approved.
- Legal Activities: Recent activities include maintenance fee payments and changes in power of attorney.
Frequently Asked Questions
What is the primary use of the composition described in US7795316B1?
The primary use is to treat ocular inflammation with infection or the risk of infection.
Who is the assignee of US7795316B1?
The assignee is Alcon Research, Ltd.
What are the key components of the ophthalmic composition?
The key components are tobramycin, dexamethasone, and xanthan gum.
When is the patent set to expire?
The patent is set to expire on August 3, 2028.
Have generic versions of this composition been approved?
Yes, several generic versions have been approved, with the first one approved on October 27, 1999.
Cited Sources
- Drugs.com: Generic Tobradex ST Availability.
- Pharsight: Drug Patents containing Dexamethasone; Tobramycin.
- DigitalCommons@NYLS: Eviscerating Patent Scope.
- Google Patents: US7795316B1 - Topical ophthalmic compositions containing tobramycin and dexamethasone.
