United States Patent 5,116,863: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,116,863, titled "Olopatadine Formulations," is a significant patent in the field of pharmaceuticals, particularly for the treatment of allergic and inflammatory disorders of the eye. This patent, assigned to various entities over its lifetime, including Alcon Research, Ltd., is crucial for understanding the intellectual property landscape surrounding olopatadine formulations.
Background and Invention
Olopatadine is an antihistamine and mast cell stabilizer used in the treatment of allergic conjunctivitis. The patent in question focuses on specific formulations of olopatadine for topical administration, particularly in the form of eye drops.
Claims and Scope
Claim Structure
The patent includes multiple claims that define the scope of the invention. These claims typically cover the composition of the olopatadine formulations, including the concentration of olopatadine, the presence of other ingredients, and the method of preparation.
- Claim 1: Often the broadest claim, it defines the basic composition of the olopatadine formulation, including the active ingredient and any necessary excipients.
- Subsequent Claims: These claims narrow down the scope by specifying particular concentrations, additional ingredients, and specific methods of preparation[1][4].
Key Components
- Olopatadine Concentration: The patent specifies a range of concentrations for olopatadine, typically around 0.1% w/v, which is clinically relevant for therapeutic use[1][4].
- Excipients and Stabilizers: The formulations may include other ingredients such as benzalkonium chloride as a preservative and polyvinylpyrrolidone as a stabilizer[4].
Prior Art and Obviousness
Prior Art Considerations
The validity of the patent is often challenged based on prior art. The court examines whether the differences between the subject matter of the patent and the prior art are such that the subject matter as a whole would have been obvious to a person having ordinary skill in the art at the time of the invention[1].
Obviousness Analysis
- Scope and Content of Prior Art: The court reviews the existing literature and patents to determine if the claimed invention was already disclosed or suggested.
- Differences Between Prior Art and Claims: The court assesses whether the claimed invention introduces significant improvements or novel combinations not evident in the prior art.
- Level of Ordinary Skill: The court considers the expertise and knowledge of a person skilled in the field to determine if the invention would have been obvious.
- Objective Considerations: Factors such as commercial success, long-felt need, and the failure of others to achieve the same result are also considered[1].
Patent Litigation and Enforcement
Alcon Research, Ltd. v. Apotex Inc.
A notable case involving this patent is the litigation between Alcon Research, Ltd. and Apotex Inc. Apotex filed an Abbreviated New Drug Application (ANDA) to market a generic version of Alcon's Patanol®, which is protected by the '805 patent (a related patent to 5,116,863). Alcon sued Apotex for patent infringement. The court ultimately held that certain claims of the '805 patent were valid and not obvious over the prior art, affirming the enforceability of the patent[1].
Patent Analytics and Landscape
Claim Coverage Matrix
To manage and analyze the extensive patent portfolio related to olopatadine formulations, companies use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, enabling a comprehensive understanding of the patent landscape. This includes identifying which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Interactive Claim Charts
Tools like ClaimScape® generate interactive claim charts that facilitate the review of patent coverage by technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage is lacking and identifying future design opportunities[3].
Commercial and Therapeutic Impact
Market Dominance
The patent has played a significant role in allowing Alcon to maintain market dominance for its Patanol® product. The enforcement of this patent has prevented generic competitors from entering the market, ensuring Alcon's continued revenue from this product[1].
Therapeutic Benefits
Olopatadine formulations, as protected by this patent, have provided significant therapeutic benefits for patients suffering from allergic conjunctivitis. The specific formulations and concentrations covered by the patent ensure effective and safe treatment options[4].
Expiration and Future Implications
Patent Expiration
The patent has expired, which means that the exclusive rights to the invention are no longer in effect. This opens the market for generic versions of olopatadine formulations, potentially increasing competition and reducing costs for consumers[2].
Future Developments
With the expiration of the patent, companies can now develop and market their own versions of olopatadine formulations without infringing on the original patent. This could lead to further innovations and improvements in the treatment of allergic and inflammatory disorders[2].
Key Takeaways
- Patent Scope and Claims: The patent covers specific formulations of olopatadine for topical administration, including concentrations and excipients.
- Prior Art and Obviousness: The validity of the patent is determined by analyzing prior art and assessing whether the invention was obvious to a person skilled in the art.
- Patent Litigation: The patent was involved in significant litigation, affirming its enforceability against generic competitors.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for managing and analyzing the patent landscape.
- Commercial and Therapeutic Impact: The patent has maintained market dominance for Alcon and provided significant therapeutic benefits.
- Future Implications: The expiration of the patent opens the market for generic versions and potential future innovations.
FAQs
What is the main subject matter of United States Patent 5,116,863?
The main subject matter of United States Patent 5,116,863 is olopatadine formulations for the treatment of allergic and inflammatory disorders of the eye.
What are the key components of the olopatadine formulations covered by the patent?
The key components include olopatadine as the active ingredient, typically at a concentration of 0.1% w/v, and other ingredients such as benzalkonium chloride and polyvinylpyrrolidone.
How has the patent been enforced in litigation?
The patent was enforced in the case of Alcon Research, Ltd. v. Apotex Inc., where the court held that certain claims of a related patent were valid and not obvious over the prior art, preventing Apotex from marketing a generic version.
What tools are used to analyze the patent landscape for olopatadine formulations?
Tools such as Claim Coverage Matrix and interactive claim charts, like those provided by ClaimScape®, are used to analyze the patent landscape and identify gaps or opportunities.
What are the implications of the patent's expiration?
The expiration of the patent allows for the development and marketing of generic versions of olopatadine formulations, potentially increasing competition and reducing costs for consumers.
Cited Sources:
- Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362 - Casetext
- US7402609B2 - Olopatadine formulations for topical administration - Google Patents
- Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
- United States Patent US007977376B2 - Google Patents Storage
- Print 5116863FOIA - USPTO
