United States Patent 10,639,297: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,639,297, titled "Ophthalmic pharmaceutical compositions and uses relating thereto," is a significant patent in the field of ophthalmic medications, particularly for the treatment of presbyopia and other ocular conditions. This patent, assigned to Orasis Pharmaceuticals Ltd., protects the drug QLOSI, which contains pilocarpine hydrochloride.
Patent Overview
Title and Abstract
The patent is focused on ophthalmic pharmaceutical compositions that include pilocarpine or a pharmaceutically acceptable salt. The abstract outlines the use of these compositions for correcting presbyopia and other ocular conditions in subjects[1][2].
Inventors and Assignee
The inventors listed on the patent are Feinbaum Claes, Salamun Franc, and Patel Sudhir. The assignee is Orasis Pharmaceuticals Ltd.[1][2].
Application and Approval
The patent was filed under the application number US16/032,044 and was approved on October 17, 2023. It is classified under the New Drug Application (NDA) number 217836-001[1].
Scope of the Patent
Pharmaceutical Compositions
The patent covers ophthalmic pharmaceutical compositions that contain pilocarpine or its pharmaceutically acceptable salts. These compositions are designed for topical application to the eye and are formulated to address specific ocular conditions, most notably presbyopia[1][2].
Uses and Preparations
The scope extends to the uses and preparations of these ophthalmic pharmaceutical compositions. This includes various concentrations and formulations of pilocarpine that are optimized for efficacy and safety in treating presbyopia and other ocular conditions[1][2].
Claims of the Patent
Key Claims
The patent includes several key claims that define the scope of protection. These claims cover:
- The ophthalmic pharmaceutical compositions themselves.
- The method of preparing these compositions.
- The use of these compositions for treating presbyopia and other ocular conditions.
- Specific concentrations and formulations of pilocarpine that are effective and safe for ocular use[2].
Claim Types
The patent claims are categorized into various types, including composition claims, method claims, and use claims. These claims are designed to provide broad protection while also specifying the unique aspects of the invention[2].
Patent Landscape
Global Protection
The patent has a significant global footprint, with twenty-four patent family members in fourteen countries. This includes patents in Australia, Brazil, Canada, and other jurisdictions, ensuring broad international protection for the invention[1].
Supplementary Protection Certificates (SPCs)
In addition to the base patent, there are supplementary protection certificates (SPCs) in various countries. These SPCs extend the patent term, providing additional protection for the pharmaceutical compositions beyond the standard patent term[1].
Related Patents and Applications
The patent is part of a larger family of related patents and applications. These related filings may cover different aspects of the ophthalmic pharmaceutical compositions or additional uses, further solidifying Orasis Pharmaceuticals Ltd.'s intellectual property position in this field[1][5].
Market Impact
QLOSI and Presbyopia Treatment
The approval of QLOSI, protected by this patent, marks a significant advancement in the treatment of presbyopia. Presbyopia is a common age-related condition that affects vision, and QLOSI offers a new therapeutic option for patients. This can potentially disrupt the existing market for presbyopia treatments, offering a more effective or convenient alternative[1].
Competitive Landscape
The patent landscape in ophthalmic pharmaceuticals is highly competitive, with several companies and research institutions actively developing new treatments. The protection afforded by this patent helps Orasis Pharmaceuticals Ltd. to maintain a competitive edge in this market[1].
Regulatory Aspects
FDA Approval
The patent is included in one New Drug Application (NDA) and was approved by the FDA on October 17, 2023. This approval is a critical milestone, indicating that the drug has met the regulatory standards for safety and efficacy[1].
Exclusivity
The patent also grants exclusivity for the use of pilocarpine hydrochloride in ophthalmic compositions, preventing generic or biosimilar versions from entering the market until the patent expires. This exclusivity period is crucial for the commercial success of QLOSI[1].
Economic and Social Impact
Market Potential
The treatment of presbyopia is a significant market, given the prevalence of the condition among the aging population. The approval and protection of QLOSI could lead to substantial revenue for Orasis Pharmaceuticals Ltd., contributing to the company's financial health and growth[1].
Patient Benefits
From a social perspective, the availability of QLOSI can improve the quality of life for patients with presbyopia. Effective treatment options can enhance vision, reduce dependency on reading glasses, and improve overall eye health, which are critical for daily functioning and independence[1].
Conclusion
United States Patent 10,639,297 is a pivotal patent in the field of ophthalmic pharmaceuticals, particularly for the treatment of presbyopia. The patent's broad scope, including various claims and global protection, positions Orasis Pharmaceuticals Ltd. as a leader in this market. The approval and exclusivity of QLOSI under this patent ensure a significant market presence and potential economic benefits, while also offering substantial health benefits to patients.
Key Takeaways
- Patent Scope: Covers ophthalmic pharmaceutical compositions containing pilocarpine or its salts.
- Claims: Include composition, method, and use claims for treating presbyopia and other ocular conditions.
- Global Protection: Twenty-four patent family members in fourteen countries.
- Market Impact: Significant advancement in presbyopia treatment with potential to disrupt existing market.
- Regulatory Aspects: FDA-approved under NDA 217836-001 with exclusivity period.
- Economic and Social Impact: Substantial market potential and improved quality of life for patients.
FAQs
What is the main subject of United States Patent 10,639,297?
The main subject is ophthalmic pharmaceutical compositions containing pilocarpine or its pharmaceutically acceptable salts, used for treating presbyopia and other ocular conditions.
Who are the inventors listed on the patent?
The inventors are Feinbaum Claes, Salamun Franc, and Patel Sudhir.
What is the name of the drug protected by this patent?
The drug is QLOSI, which contains pilocarpine hydrochloride.
When was the patent approved by the FDA?
The patent was approved on October 17, 2023.
What is the significance of the patent's global protection?
The patent has twenty-four family members in fourteen countries, ensuring broad international protection for the invention.
Sources
- Drug Patent Watch: "Patent 10,639,297" - https://www.drugpatentwatch.com/p/patent/10639297
- Google Patents: "Ophthalmic pharmaceutical compositions and uses relating thereto" - https://patents.google.com/patent/US10639297B2/en
- USPTO: "Patent Claims Research Dataset" - https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- USPTO: "Search for patents" - https://www.uspto.gov/patents/search
- Unified Patents Portal: "US-20180318264-A1" - https://portal.unifiedpatents.com/patents/patent/US-20180318264-A1
