Understanding the Scope and Claims of United States Patent 10,376,526
Introduction
United States Patent 10,376,526, titled "Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine," is a crucial patent in the pharmaceutical industry, particularly for the treatment of allergic rhinitis. This patent is owned by Glenmark Specialty SA and is part of the broader patent landscape protecting the drug Ryaltris.
Patent Overview
The patent in question, US 10,376,526, focuses on a stable fixed-dose pharmaceutical composition that combines mometasone, a corticosteroid, and olopatadine, an antihistamine. This combination is designed for the treatment of allergic rhinitis and is administered nasally[2][4].
Claims and Scope
The patent claims are central to understanding the intellectual property rights granted to the inventor. Here are some key aspects of the claims:
Composition Claims
The patent claims cover a stable fixed-dose aqueous pharmaceutical composition containing mometasone furoate and olopatadine hydrochloride. These claims specify the formulation, including the active ingredients, excipients, and preservatives necessary to maintain stability and efficacy[4].
Formulation Details
The composition includes specific ratios of mometasone furoate and olopatadine hydrochloride, along with various excipients such as carboxymethyl cellulose sodium, microcrystalline cellulose, and preservative agents like benzalkonium chloride. The formulation is designed to be administered as a nasal spray, ensuring the stability and bioavailability of the active ingredients[4].
Stability and Efficacy
The claims emphasize the stability of the composition, which is critical for maintaining the therapeutic efficacy of the drug over its shelf life. This includes details on the pH range, ionic strength, and other parameters that ensure the formulation remains stable and effective[4].
Patent Landscape
Understanding the broader patent landscape is essential for strategizing market entry and competition.
US Patents
The patent US 10,376,526 is one of 15 US patents filed by Glenmark Specialty SA between 2022 and 2024. These patents cover various aspects of the drug, including dosage forms, modes of administration, and specific formulations. None of these patents have expired yet, with the earliest expiration dates projected around September 2034 and the latest around September 2038[1].
International Protection
Ryaltris is protected by patents in multiple countries, not just the United States. This global protection is crucial for preventing generic entry in different markets. For instance, oppositions filed in the European Patent Office (EPO) indicate ongoing legal activities that can affect the patent's validity and expiration dates[1].
Legal Activities and Exclusivities
The patent landscape is dynamic, with ongoing legal activities that can impact the patent's life and exclusivity.
Maintenance Fees and Amendments
Recent legal activities include the payment of maintenance fees and amendments to the patent claims. These activities are essential for maintaining the patent's validity and can influence the generic launch date. For example, payments of maintenance fees in 2023 and 2024 ensure the patent remains active[1].
Oppositions and Litigations
Oppositions filed in the EPO, such as the one by Ter Meer Steinmeister & Partner Patentanwälte mbB, can challenge the patent's validity. These oppositions are part of the broader legal landscape and can affect the patent's scope and claims[1].
Enablement and Written Description Requirements
The scope of patent claims is heavily influenced by the enablement and written description requirements under US patent law.
Enablement Requirement
The enablement requirement, as outlined in 35 U.S.C. § 112(a), mandates that the patent specification must be written in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the invention. For pharmaceutical patents, this often involves detailed descriptions of the formulation and its components to ensure that the claimed invention is fully enabled[3].
Written Description Requirement
The written description requirement ensures that the patent claims are supported by the specification. This means that the claims must be commensurate with what is taught in the patent application. In the case of genus claims, which cover a broad class of compounds, the written description must include sufficient detail to support the breadth of the claim[3].
Impact on Pharmaceutical Industry
The current jurisprudence on enablement and written description has significant implications for the pharmaceutical industry.
Challenges in Claiming Broad Scope
The rigid position of the Federal Circuit on genus claims makes it challenging for innovators to claim the full scope of their invention. This can lead to a situation where broad claims are invalidated due to lack of full scope enablement, while narrow claims can be easily designed around by competitors[3].
Strategic Implications
For companies like Glenmark Specialty SA, understanding these legal nuances is crucial for strategizing patent protection. It involves balancing the breadth of claims with the need to comply with enablement and written description requirements to ensure robust patent protection[3].
Key Takeaways
- Patent Claims: The patent US 10,376,526 covers a stable fixed-dose pharmaceutical composition of mometasone and olopatadine, with specific formulation details.
- Patent Landscape: The patent is part of a broader landscape of 15 US patents protecting Ryaltris, with international protection and ongoing legal activities.
- Legal Activities: Maintenance fees, amendments, and oppositions can impact the patent's validity and expiration dates.
- Enablement and Written Description: Compliance with these requirements is critical for maintaining the validity of pharmaceutical patents.
- Industry Impact: The current legal environment poses challenges for innovators in claiming broad scope for their inventions.
FAQs
Q: What is the primary focus of United States Patent 10,376,526?
A: The primary focus is on a stable fixed-dose pharmaceutical composition comprising mometasone and olopatadine for the treatment of allergic rhinitis.
Q: How many US patents protect the drug Ryaltris?
A: Ryaltris is protected by 15 US patents filed between 2022 and 2024.
Q: What are the key components of the formulation claimed in US 10,376,526?
A: The formulation includes mometasone furoate, olopatadine hydrochloride, and various excipients like carboxymethyl cellulose sodium and microcrystalline cellulose.
Q: What are the implications of the enablement requirement for pharmaceutical patents?
A: The enablement requirement ensures that the patent specification provides sufficient detail to enable any person skilled in the art to make and use the invention, which can be challenging for broad genus claims.
Q: How do oppositions in the European Patent Office affect the patent landscape?
A: Oppositions can challenge the patent's validity and affect its scope and claims, potentially impacting the generic launch date.
Cited Sources
- Pharsight: Ryaltris patent expiration.
- Pharmacompass: US Patent 10376526.
- DigitalCommons@NYLS: Eviscerating Patent Scope.
- Google Patents: US9078923B2 - Stable fixed dose pharmaceutical composition comprising mometasone and olopatadine.
