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Patent landscape, scope, and claims: |
United States Patent 9,867,810: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,867,810, titled "Ophthalmic pharmaceutical compositions and uses relating thereto," is a significant patent in the field of ophthalmology, particularly for the treatment of presbyopia and other ocular conditions. This patent, assigned to Orasis Pharmaceuticals Ltd., involves the use of pilocarpine or its pharmaceutically acceptable salts in ophthalmic formulations.
Patent Overview
- Issuance Date: January 16, 2018
- Inventors: Feinbaum Claes, Salamun Franc, and Patel Sudhir
- Assignee: Orasis Pharmaceuticals Ltd.[2][5]
Scope of the Patent
The patent covers ophthalmic pharmaceutical compositions that include pilocarpine or its pharmaceutically acceptable salts. Here are the key aspects of the patent's scope:
Active Ingredient
- The primary active ingredient is pilocarpine, a muscarinic receptor agonist known for its ability to reduce intraocular pressure and improve near vision[4].
Therapeutic Uses
- The compositions are designed to correct presbyopia, a condition characterized by the loss of clear close-up vision, and other ocular conditions such as hyperopia and glaucoma[2][5].
Formulations
- The patent includes various formulations of ophthalmic compositions, such as eye drops, which can be tailored with different concentrations of pilocarpine and other additives like thickening agents, preservatives, isotonicity adjusters, and wetting agents[1].
Claims of the Patent
The patent contains multiple claims that define the scope of the invention:
Independent Claims
- These claims outline the core components of the ophthalmic pharmaceutical compositions, including the concentration of pilocarpine, the type of pharmaceutically acceptable salts, and the presence of other ingredients like hydroxypropyl methylcellulose[1].
Dependent Claims
- These claims further specify the details of the compositions, such as the methods of preparation, the use of specific additives, and the therapeutic applications of the compositions[1].
Patent Landscape
The patent landscape surrounding US 9,867,810 is complex and involves several related patents and legal activities.
Related Patents
- Orasis Pharmaceuticals Ltd. holds several related patents, including US 10,639,297, US 11,129,812, and US 11,974,986, all of which relate to ophthalmic pharmaceutical compositions containing pilocarpine and expire on August 18, 2037[2][5].
Patent Expiration Dates
- The patent US 9,867,810 itself is set to expire on August 18, 2037, unless there are any changes due to legal activities such as patent term extensions or amendments to the claims[2][5].
Legal Activities
- Recent legal activities include payments of maintenance fees, issue notifications, and other administrative actions that are crucial for maintaining the patent's validity and ensuring its full term[2].
Impact on Generic Versions
The patent landscape affects the availability of generic versions of pilocarpine-based ophthalmic compositions.
Generic Applications
- Several companies, including Padagis Us LLC and Amneal Eu Ltd, have filed for generic versions of pilocarpine hydrochloride. The first generic version was approved in 2004, and the latest in 2020[2].
Exclusivity and Patent Protection
- The patent and exclusivity periods granted by the FDA protect the proprietary rights of the original patent holder, delaying the entry of generic versions into the market until the patent expires or exclusivity periods end[5].
Industry Expert Insights
Industry experts highlight the importance of precise claim language and the scope of patents in protecting innovation.
"Patent claim scope and claim clarity have been identified as significant concerns for patent quality. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims."[3]
Statistics and Market Impact
- Clinical Trials: Pilocarpine-based ophthalmic compositions have undergone extensive clinical trials, with over 20 Phase 3 trials, indicating a robust development process[4].
- Market Potential: The treatment of presbyopia and other ocular conditions represents a significant market, with millions of people affected worldwide. The exclusive rights granted by this patent provide Orasis Pharmaceuticals Ltd. with a competitive edge in this market until the patent expires.
Key Takeaways
- Patent Scope: The patent covers a broad range of ophthalmic compositions containing pilocarpine for treating presbyopia and other ocular conditions.
- Claims: The patent includes detailed claims on the composition, preparation, and therapeutic uses of pilocarpine-based formulations.
- Patent Landscape: The patent is part of a larger portfolio held by Orasis Pharmaceuticals Ltd., with related patents expiring in 2037.
- Generic Impact: The patent protects the proprietary rights of the original patent holder, delaying the entry of generic versions into the market.
- Industry Impact: The patent's scope and claims are crucial for maintaining innovation and competitive advantage in the ophthalmic pharmaceutical market.
FAQs
Q: What is the primary active ingredient in the ophthalmic compositions covered by US 9,867,810?
A: The primary active ingredient is pilocarpine or its pharmaceutically acceptable salts.
Q: What conditions are treated by the ophthalmic compositions described in the patent?
A: The compositions are designed to treat presbyopia, hyperopia, and other ocular conditions such as glaucoma.
Q: When is the patent set to expire?
A: The patent is set to expire on August 18, 2037.
Q: Are there any related patents held by Orasis Pharmaceuticals Ltd.?
A: Yes, Orasis Pharmaceuticals Ltd. holds several related patents, including US 10,639,297, US 11,129,812, and US 11,974,986.
Q: How does the patent affect the availability of generic versions of pilocarpine-based ophthalmic compositions?
A: The patent protects the proprietary rights of the original patent holder, delaying the entry of generic versions into the market until the patent expires or exclusivity periods end.
Cited Sources:
- US9867810B1 - Ophthalmic pharmaceutical compositions and uses relating thereto - Google Patents
- Drug Patents containing Pilocarpine Hydrochloride - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Pilocarpine: Uses, Interactions, Mechanism of Action - DrugBank
- Generic Qlosi Availability - Drugs.com
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