Understanding the Scope and Claims of United States Patent 10,022,447: A Detailed Analysis
Introduction to Patent 10,022,447
United States Patent 10,022,447, titled "Solid pharmaceutical compositions containing pregabalin," is a crucial patent in the pharmaceutical industry, particularly for the drug Lyrica CR. This patent, assigned to Warner-Lambert Company LLC, protects specific formulations of pregabalin, a medication used for treating neuropathic pain and other conditions.
Background of Pregabalin and Lyrica CR
Pregabalin, the active ingredient in Lyrica CR, is a gamma amino butyric acid (GABA) analog used to treat conditions such as diabetic peripheral neuropathy and postherpetic neuralgia. Lyrica CR is a once-daily, extended-release formulation designed to improve patient compliance and efficacy[2][5].
Patent Overview
Issuance and Assignee
The patent was issued on July 17, 2018, and is assigned to Warner-Lambert Company LLC, a subsidiary of Pfizer Inc.[5].
Inventors
The patent lists several inventors, including Howard N. Bockbrader, Yun Hyung Cho, Santiago Steven Diaz, Majid Mahjour, Thomas Daniel Reynolds, Pushpa Ganapathi Shao, Zezhi Jesse Shao, and Jiansheng Wan[5].
Claims of the Patent
Primary Claims
The patent primarily claims solid pharmaceutical compositions containing pregabalin. These compositions are designed for once-daily oral administration and include specific components:
- Matrix Forming Agents: The patent specifies mixtures of polyvinyl acetate and polyvinylpyrrolidone as exemplary matrix forming agents.
- Swelling Agents: Cross-linked polymers of polyvinylpyrrolidone are identified as exemplary swelling agents[5].
Detailed Composition
The composition described in the patent is tailored for extended-release properties, ensuring that the pregabalin is released over a prolonged period. This is achieved through the combination of matrix forming and swelling agents, which control the release rate of the active ingredient.
Patent Scope and Breadth
Metrics for Measuring Patent Scope
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. For Patent 10,022,447, the claims are specific and detailed, indicating a well-defined scope[3].
Clarity and Validity
The clarity and validity of patent claims are critical. In the case of Patent 10,022,447, the claims are clear and specific, reducing the likelihood of disputes over claim meaning. This clarity is essential for avoiding legal pitfalls and ensuring that the patent provides strong protection for the invention[3].
Patent Expiration and Exclusivities
Patent Expiration Dates
The patent is set to expire on May 2, 2027. This expiration date is crucial for generic manufacturers, as it marks the period after which they can legally produce and market generic versions of the drug[2][5].
FDA Exclusivities
In addition to patent protection, Lyrica CR has been granted certain exclusivities by the FDA. These exclusivities can delay the launch of generic versions even after the patent expires. For instance, pediatric exclusivities can extend the market exclusivity period, preventing generic competition until these exclusivities expire[2][4].
Litigation and Legal Considerations
Patent Litigations
Patent litigations can significantly impact the patent landscape. For Lyrica CR, various legal proceedings have been initiated to challenge the validity of its patents. However, Patent 10,022,447 has not been subject to such challenges as of the latest available information[2].
Induced Infringement
In cases where generic manufacturers are involved, induced infringement can be a significant issue. For example, in the case of GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC., the court found that Teva induced infringement by marketing its generic version in a manner that led physicians to prescribe it in an infringing way. Similar considerations would apply to any generic versions of Lyrica CR that might infringe on Patent 10,022,447[1].
Impact on Generic Competition
Generic Availability
The approval of a generic version of Lyrica CR by the FDA does not necessarily mean immediate commercial availability. The expiration of Patent 10,022,447 and the end of any FDA-granted exclusivities are critical milestones for generic competition to enter the market[5].
Market Dynamics
The expiration of this patent will likely lead to increased competition in the market for pregabalin formulations. Generic manufacturers will be able to produce and market their own versions of the drug, potentially reducing prices and improving access to the medication[4].
Conclusion
United States Patent 10,022,447 is a significant patent in the pharmaceutical industry, protecting the solid pharmaceutical compositions containing pregabalin used in Lyrica CR. Understanding the scope, claims, and expiration dates of this patent is crucial for both the original patent holder and potential generic manufacturers.
Key Takeaways
- Patent Scope: The patent claims specific solid pharmaceutical compositions with matrix forming and swelling agents.
- Expiration Date: The patent expires on May 2, 2027.
- FDA Exclusivities: Additional exclusivities granted by the FDA can delay generic competition.
- Litigation: Patent litigations and induced infringement are critical legal considerations.
- Generic Competition: The expiration of the patent will open the market to generic competition.
FAQs
Q: What is the primary claim of United States Patent 10,022,447?
A: The primary claim is for solid pharmaceutical compositions containing pregabalin, designed for once-daily oral administration.
Q: Who is the assignee of Patent 10,022,447?
A: The assignee is Warner-Lambert Company LLC, a subsidiary of Pfizer Inc.
Q: What are the key components of the composition described in the patent?
A: The composition includes matrix forming agents (e.g., mixtures of polyvinyl acetate and polyvinylpyrrolidone) and swelling agents (e.g., cross-linked polymers of polyvinylpyrrolidone).
Q: When is the patent set to expire?
A: The patent is set to expire on May 2, 2027.
Q: How do FDA exclusivities affect the launch of generic versions of Lyrica CR?
A: FDA exclusivities can delay the launch of generic versions even after the patent expires, providing additional market protection for the original drug.
Sources
- GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. - https://cafc.uscourts.gov/sites/default/files/opinions-orders/18-1976.OPINION.10-2-2020_1663180.pdf
- Lyrica Cr patent expiration - https://pharsight.greyb.com/drug/lyrica-cr-patent-expiration
- Patent Claims and Patent Scope - https://www.hoover.org/sites/default/files/ip2-wp16001-paper.pdf
- USPTO-FDA Report on Drug Patent and Exclusivity - https://www.uspto.gov/sites/default/files/documents/USPTO-FDA_Report_on_Drug_Patent_and_Exclusivity.pdf
- Generic Lyrica CR Availability - https://www.drugs.com/availability/generic-lyrica-cr.html
