United States Patent 9,572,819: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,572,819, titled "Oral composition of celecoxib for treatment of pain," is a significant patent in the pharmaceutical industry, particularly in the realm of pain management. This patent, issued to the inventors associated with Dr. Reddy's Laboratories Ltd, introduces a novel oral liquid pharmaceutical composition of celecoxib. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background on Celecoxib
Celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for treating pain, inflammation, and various conditions such as arthritis. It was first approved by the FDA in 1998 under the brand name Celebrex. The patent in question focuses on a new formulation of celecoxib, enhancing its stability and efficacy in oral liquid form[4][5].
Scope of the Patent
The patent 9,572,819 pertains to a stable oral liquid pharmaceutical composition of celecoxib or its pharmaceutically acceptable salts. The key innovation lies in the formulation's stability, particularly in Fasted-State Simulated Gastric Fluid (FaSSGF) at pH 2.0, which ensures that the celecoxib does not precipitate under these conditions. This stability is crucial for maintaining the drug's bioavailability and effectiveness[4][5].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Composition Claims: The patent claims cover the oral liquid pharmaceutical composition of celecoxib, including its pharmaceutically acceptable salts. These compositions are designed to be stable in various physiological conditions[4].
- Process Claims: The patent also includes claims related to the process of preparing the oral liquid composition. This involves specific steps and conditions to ensure the stability and efficacy of the final product[4][5].
- Method of Use Claims: These claims outline the methods for using the composition for treating pain and other related conditions. This includes the administration route and dosage forms[4].
Key Components of the Composition
The patent specifies several key components that contribute to the stability and effectiveness of the oral liquid composition:
- Celecoxib: The active ingredient, which is a well-known NSAID.
- Pharmaceutically Acceptable Salts: These salts are included to enhance the solubility and stability of celecoxib.
- Excipients: The composition includes various excipients such as hydroxypropyl methyl cellulose, polyvinylpyrrolidone, and polyethylene glycol, which help in maintaining the stability and consistency of the liquid formulation[4][5].
Patent Landscape
Related Patents
The patent landscape around celecoxib and its formulations is complex and includes several related patents:
- Patent 10,722,456: This patent, also related to celecoxib, focuses on a stable oral liquid pharmaceutical composition and has a similar expiration date of May 27, 2036[2].
- Other Formulations: There are numerous patents and applications related to different formulations of celecoxib, including tablets, capsules, and other oral forms. These patents often overlap in terms of the active ingredient but differ in the formulation and manufacturing process[2][4].
Exclusivity and Patent Term
The exclusivity period for a drug can run concurrently with its patent term. However, for drugs like celecoxib, which have been previously approved, the exclusivity period may have already expired. The patent term for U.S. Patent 9,572,819 is expected to expire in 2036, assuming no extensions are granted[2][4].
Regulatory Considerations
For a drug product with multiple active ingredients, like the combination of celecoxib and tramadol hydrochloride in SEGLENTIS®, the regulatory review process is critical. The FDA's approval and the first commercial marketing or use of at least one of the active ingredients determine the eligibility for patent term extension under 35 U.S.C. § 156(a)(5)(A)[1].
Industry Impact
The invention covered by U.S. Patent 9,572,819 has significant implications for the pharmaceutical industry:
- Improved Patient Compliance: The oral liquid formulation can enhance patient compliance, especially for those who have difficulty swallowing tablets or capsules.
- Competitive Advantage: The stability and efficacy of this formulation can provide a competitive edge in the market, particularly in the treatment of pain and inflammation.
- Innovation in Formulations: This patent encourages further innovation in pharmaceutical formulations, driving the development of more stable and effective drug delivery systems[4][5].
Challenges and Controversies
- Patent Scope and Quality: Debates around patent quality and scope are relevant here. The breadth and clarity of patent claims can impact innovation and litigation costs. Metrics such as independent claim length and count can help measure patent scope and its implications[3].
- Generic Competition: The absence of a generic version of Elyxyb, another celecoxib formulation, highlights the challenges in developing therapeutically equivalent versions of complex formulations. This can affect the competitive landscape and patient access to affordable treatments[2].
Key Takeaways
- Stable Oral Liquid Formulation: U.S. Patent 9,572,819 introduces a stable oral liquid pharmaceutical composition of celecoxib, enhancing its bioavailability and patient compliance.
- Specific Claims and Components: The patent includes detailed claims on the composition, process, and method of use, highlighting key components like celecoxib and various excipients.
- Patent Landscape and Exclusivity: The patent is part of a broader landscape involving multiple formulations of celecoxib, with considerations around exclusivity and patent term extensions.
- Industry Impact: The invention has significant implications for patient care and pharmaceutical innovation, offering a competitive advantage in pain management.
FAQs
What is the main innovation of U.S. Patent 9,572,819?
The main innovation is the development of a stable oral liquid pharmaceutical composition of celecoxib that does not precipitate in physiological conditions.
What are the key components of the composition?
The key components include celecoxib, its pharmaceutically acceptable salts, and various excipients like hydroxypropyl methyl cellulose and polyvinylpyrrolidone.
When is the patent expected to expire?
The patent is expected to expire on May 27, 2036, assuming no extensions are granted.
How does this patent impact patient care?
The oral liquid formulation can enhance patient compliance, especially for those who have difficulty swallowing tablets or capsules, and ensures better bioavailability of the drug.
What are the regulatory considerations for this patent?
The patent's eligibility for term extension depends on the first commercial marketing or use of at least one of the active ingredients under the relevant regulatory provisions.
Cited Sources:
- United States Patent and Trademark Office, "Application for Patent Term Extension of U.S. Patent No. 10,548,909" [PDF].
- Drugs.com, "Generic Elyxyb Availability".
- SSRN, "Patent Claims and Patent Scope".
- Google Patents, "US9572819B2 - Oral composition of celecoxib for treatment of pain".
- PubChem, "Oral composition of celecoxib for treatment of pain - Patent US9572819".
