Detailed Analysis of the Scope and Claims of United States Patent 8,637,054
Introduction
United States Patent 8,637,054, titled "Polymeric delivery system for a nonviscous prostaglandin-based solution without preservatives," was issued on January 28, 2014, to Fabrice Mercier and assigned to Laboratoires Thea. This patent is significant in the field of ophthalmology, particularly for the treatment of glaucoma.
Background and Context
The patent addresses a critical need in ophthalmic solutions by developing a nonviscous prostaglandin-based solution that does not require preservatives. This innovation is crucial because preservatives in eye drops can be irritating and harmful to the eye tissue over time[4].
Key Components of the Invention
Active Ingredients and Formulation
The ophthalmic solution includes at least one prostaglandin, a solubilizing agent, and a gelling agent of the carbomer type. The carbomers used are defined according to the European Pharmacopoeia and include types such as 910, 934, 934P, 940, 941, 971, and 974P, with 974P being particularly advantageous[1][4].
Solubilizing Agent
The solution also includes a solubilizing agent, such as polyethylene glycol (PEG) or macrogol, which is defined by its average relative molecular mass. PEG 4000, with a CAS number 25322-68-3, is specifically mentioned as a preferred solubilizing agent[1].
Gelling System
The invention relies on a suitable gelling system based on the combination of two gelling agents to achieve a nonviscous polymeric delivery system. This system ensures that the solution remains stable and effective without the need for preservatives[4].
Claims of the Patent
Composition and Ingredients
The patent claims a specific composition that includes the mentioned prostaglandin, solubilizing agent, and gelling agent. The formulation is detailed, including the advantageous amounts of each ingredient[1][4].
Packaging and Stability
The solution can be packaged in single-use (single-dose unit) bottles or multi-dose bottles, such as Abak® or Comod®, made of EP-quality low-density polyethylene (LDPE) containing no additives. The solution is stable for at least 18 months, or even up to 24 months, at ambient temperatures (25°C-30°C)[1][4].
Therapeutic Use
The patent claims the use of the ophthalmic solution for treating glaucoma in humans or animals. The solution is administered at a dose of one drop per day in each eye and is noted for its ability to reduce intraocular pressure and provide neuroprotection to the retinal tissue[1][4].
Patent Landscape and Exclusivity
Patent Expiration
The patent is set to expire on July 8, 2031, which is approximately 20 years from the date of filing, adjusted for any extensions or adjustments under U.S. patent law[2].
Competitive Landscape
Currently, there are no generic versions of this specific ophthalmic solution approved in the United States. This gives Laboratoires Thea exclusive rights to market and distribute this formulation until the patent expires[2].
Advantages Over Prior Art
Reduced Irritation
The delivery system described in the patent is less aggressive to eye tissue compared to previous solubilization systems. It provides a more regular and linear reduction in intraocular pressure after administration[4].
Stability and Convenience
The solution's stability over an extended period without preservatives makes it a convenient and safe option for long-term use. The packaging in single-use or multi-dose bottles further enhances its usability[1][4].
Therapeutic Treatment Method
The patent also describes a therapeutic treatment method for glaucoma involving the instillation of the ophthalmic solution at a dose of one drop per day in each eye. This method is designed to reduce intraocular pressure and provide neuroprotection to the retinal tissue[1][4].
Patent Analytics and Claim Coverage
To fully understand the protection and scope of this patent, patent analytics tools can be used. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent landscape. Claim charts generated by such tools can be reviewed by technical experts to determine the applicability of the scope concepts to target products or methods[3].
Key Takeaways
- The patent 8,637,054 describes a nonviscous prostaglandin-based ophthalmic solution without preservatives.
- The solution uses a combination of carbomers and PEG as key components.
- It is stable for up to 24 months at ambient temperatures and can be packaged in single-use or multi-dose bottles.
- The solution is used to treat glaucoma by reducing intraocular pressure and providing neuroprotection.
- The patent expires on July 8, 2031, and currently, there are no generic versions approved.
FAQs
What is the main innovation of United States Patent 8,637,054?
The main innovation is the development of a nonviscous prostaglandin-based ophthalmic solution that does not require preservatives, reducing irritation to the eye tissue.
What are the key components of the ophthalmic solution described in the patent?
The key components include at least one prostaglandin, a solubilizing agent (such as PEG), and a gelling agent of the carbomer type.
How is the solution packaged and what is its stability?
The solution can be packaged in single-use or multi-dose bottles made of EP-quality LDPE and is stable for at least 18 months to 24 months at ambient temperatures.
What is the therapeutic use of the ophthalmic solution?
The solution is used to treat glaucoma in humans or animals by reducing intraocular pressure and providing neuroprotection to the retinal tissue.
When does the patent expire?
The patent is set to expire on July 8, 2031.
Cited Sources:
- United States Patent and Trademark Office, "Polymeric delivery system for a nonviscous prostaglandin-based solution without preservatives," US Patent 8,637,054 B2, January 28, 2014.
- Drugs.com, "Generic Iyuzeh Availability," November 6, 2024.
- Schwegman Lundberg & Woessner, "Patent Analytics," accessed December 19, 2024.
- Google Patents, "Polymeric delivery system for a nonviscous prostaglandin-based solution without preservatives," US Patent 8,637,054 B2, January 28, 2014.
