Detailed Analysis of the Scope and Claims of United States Patent 9,937,189
Introduction
United States Patent 9,937,189, owned by Glenmark Specialty S.A., is a significant patent in the pharmaceutical sector, particularly for the treatment of allergic rhinitis. This patent is part of a broader family of patents related to the drug Ryaltris, which combines mometasone and olopatadine.
Patent Overview
Title and Description
The patent titled "Stable Fixed Dose Pharmaceutical Composition Comprising Mometasone and Olopatadine" describes a stable aqueous pharmaceutical composition for nasal administration. This composition includes mometasone or its salt and olopatadine or its salt, and may further include a hydrocolloid[1][2].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically cover the composition itself, the method of preparation, and the use of the composition for treating rhinitis. Key claims include:
- The stable fixed dose pharmaceutical composition comprising mometasone and olopatadine.
- The process for preparing the pharmaceutical composition.
- The use of the pharmaceutical composition in the treatment of rhinitis[1].
Dependent Claims
Dependent claims provide additional details and specifications to the independent claims. These may include specific concentrations of mometasone and olopatadine, the presence of additional ingredients like hydrocolloids, and the method of administration (e.g., nasal spray)[1].
Patent Landscape
Family Patents
The patent 9,937,189 is part of a larger family of patents related to Ryaltris. These patents cover various aspects of the drug, including different formulations, dispensing devices, and methods of treatment. Other notable patents in this family include:
- US11679210B2: Dispensing device and pharmaceutical composition for the treatment of rhinitis.
- US10517880: Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine.
- US10016443: Treatment of allergic rhinitis using a combination of mometasone and olopatadine[2][4].
Patent Expiration and Generic Launch
The patent 9,937,189, along with other patents in the Ryaltris family, has a significant impact on the generic launch timeline. The estimated generic launch date for Ryaltris is September 3, 2038, based on the current patent expirations and exclusivities[2].
Legal Activities and Oppositions
The patent has undergone various legal activities, including the payment of maintenance fees and post-issue communications. Additionally, Ryaltris has faced oppositions in the European Patent Office, which can affect the broader patent landscape and potential generic entry points[2].
Technical Details
Composition and Ingredients
The patent describes a stable aqueous suspension composition that includes mometasone and olopatadine. The composition may also include additional ingredients such as hydrocolloids, preservatives (e.g., benzalkonium chloride), and stabilizers (e.g., polysorbate 80)[1][4].
Dispensing Device
The patent also covers the dispensing device for the pharmaceutical composition, which is designed for nasal administration. The device ensures the stable delivery of the fixed dose composition[4].
Market Impact
Exclusivity and Generic Competition
The patent exclusivity period is crucial for Glenmark Specialty S.A. as it prevents generic competition until the patents expire. Understanding the full scope of patent protection is essential for strategizing market entry and identifying potential generic entry points in markets with weaker patent protection[2].
Innovation and Licensing
The patent scope and claims can influence innovation and licensing activities. Broader or overly broad patents can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. However, narrower claims, as seen in the examination process of this patent, can lead to a higher probability of grant and a shorter examination process[3].
Conclusion
United States Patent 9,937,189 is a critical component of the intellectual property portfolio for Ryaltris, a drug used for treating allergic rhinitis. The patent's scope and claims define a stable fixed dose pharmaceutical composition and its method of preparation and use. Understanding this patent and its broader landscape is essential for navigating the pharmaceutical market and planning for future generic competition.
Key Takeaways
- The patent covers a stable aqueous pharmaceutical composition for nasal administration containing mometasone and olopatadine.
- The composition may include additional ingredients like hydrocolloids.
- The patent is part of a larger family of patents related to Ryaltris.
- The estimated generic launch date for Ryaltris is September 3, 2038.
- The patent has faced legal activities and oppositions that can impact its validity and scope.
FAQs
What is the main subject of United States Patent 9,937,189?
The main subject of this patent is a stable fixed dose pharmaceutical composition comprising mometasone and olopatadine for the treatment of allergic rhinitis.
What are the key ingredients in the pharmaceutical composition described in the patent?
The key ingredients are mometasone or its salt, olopatadine or its salt, and optionally a hydrocolloid.
When is the estimated generic launch date for Ryaltris?
The estimated generic launch date for Ryaltris is September 3, 2038, based on current patent expirations and exclusivities.
What is the significance of the dispensing device in the patent?
The dispensing device is designed for the stable delivery of the fixed dose pharmaceutical composition via nasal administration.
How do legal activities and oppositions affect the patent?
Legal activities such as maintenance fee payments and post-issue communications, as well as oppositions in the European Patent Office, can impact the validity, scope, and expiration date of the patent.
Cited Sources:
- United States Patent and Trademark Office. Stable Fixed Dose Pharmaceutical Composition Comprising Mometasone and Olopatadine. US 10,765,686 B2.
- Pharsight. Ryaltris patent expiration.
- SSRN. Patent Claims and Patent Scope.
- Google Patents. Dispensing device and pharmaceutical composition for the treatment of rhinitis. US11679210B2.
