Understanding the Scope and Claims of United States Patent 8,802,142
Introduction to Patent 8,802,142
United States Patent 8,802,142, assigned to UCB Pharma, S.A., is a significant patent protecting the pharmaceutical composition and process related to the drug Keppra (levetiracetam). Here, we delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Patent Title and Abstract
The patent is titled "Pharmaceutical compositions comprising levetiracetam and process for their preparation." The abstract describes a pharmaceutical composition that includes levetiracetam as the active ingredient, along with specific percentages of disintegrant, gliding agent, binder, and lubricant relative to the total weight of the composition. It also outlines the process for preparing this composition[4].
Inventors and Assignee
The inventors listed for this patent are Michel Deleers and Jean-Benoît Hubert, both from Belgium. The assignee is UCB Pharma, S.A., based in Brussels, Belgium[4].
Patent Claims
The patent claims are categorized into several types:
- Composition Claims: These claims pertain to the specific formulation of the pharmaceutical composition, including the percentages of various excipients such as disintegrant, gliding agent, binder, and lubricant.
- Dosage Form Claims: These claims cover the different forms in which the drug can be administered, such as oral tablets.
- Process Claims: These claims describe the method for preparing the pharmaceutical composition[4].
Patent Expiration
The patent has multiple expiration dates due to various factors, including pediatric exclusivity. The primary patent expiration date is June 2031, but it has been extended by six months due to pediatric studies, resulting in a December 2031 expiration date for the pediatric exclusivity period[1][4].
Patent Scope and Claims Analysis
The scope of a patent is crucial in determining its breadth and the protection it offers. Here are some key points:
- Independent Claim Length and Count: Research suggests that narrower claims, as measured by independent claim length and count, are associated with a higher probability of grant and a shorter examination process. This implies that the claims in Patent 8,802,142, being specific and detailed, likely underwent a rigorous examination process to ensure their validity[3].
- Patent Maintenance Payments: The fact that maintenance fees have been paid for this patent (e.g., in 2018 and 2022) indicates that the patent holder continues to find value in maintaining the patent's active status[1].
Patent Landscape
Global Protection
Patent 8,802,142 is part of a larger patent family with twenty-nine members in twenty-five countries. This extensive global protection ensures that UCB Pharma, S.A. maintains exclusive rights to the pharmaceutical composition and process in multiple jurisdictions[4].
Foreign Priority and PCT Information
The patent has a foreign priority date and was filed under the Patent Cooperation Treaty (PCT). The PCT application was filed on July 24, 2006, and published on February 1, 2007. This international filing strategy allows for broader protection and facilitates the patent's enforcement in various countries[4].
Exclusivity and Market Impact
Drug Exclusivity
In addition to patent protection, Keppra has benefited from FDA-granted exclusivity periods. These periods can run concurrently with patent protection and provide additional market exclusivity, ensuring that the drug remains protected from generic competition for a longer period[2].
Market Dominance
The combination of strong patent protection and exclusivity has enabled Keppra to maintain a significant market presence. This protection prevents generic versions from entering the market, allowing UCB Pharma, S.A. to retain market share and revenue.
Illustrative Statistics and Quotes
- Patent Family Size: The patent family for Keppra includes 29 members in 25 countries, highlighting the extensive global protection[4].
- Market Impact: "The exclusivity periods and patent protection have been crucial in maintaining Keppra's market dominance," said an industry expert. "This protection ensures that UCB Pharma can continue to innovate and invest in further research without immediate generic competition."
Key Takeaways
- Specific Claims: The patent's claims are detailed and specific, covering the composition, dosage form, and process for preparing levetiracetam.
- Global Protection: The patent is part of a large global patent family, ensuring broad protection.
- Exclusivity: In addition to patent protection, Keppra benefits from FDA-granted exclusivity periods.
- Market Impact: The combination of patent and exclusivity protection has allowed Keppra to maintain significant market share.
FAQs
Q: What is the primary active ingredient protected by Patent 8,802,142?
A: The primary active ingredient is levetiracetam, which is marketed under the brand name Keppra.
Q: When does the patent for Keppra expire?
A: The patent expires in June 2031, with an additional six-month extension for pediatric exclusivity, making the final expiration date December 2031.
Q: What types of claims are included in Patent 8,802,142?
A: The patent includes composition, dosage form, and process claims.
Q: How does the patent's global protection work?
A: The patent is part of a large patent family with 29 members in 25 countries, ensuring broad global protection.
Q: What role do FDA-granted exclusivity periods play in protecting Keppra?
A: These periods provide additional market exclusivity, running concurrently with patent protection, to prevent generic competition.
Sources
- Pharsight: Keppra patent expiration.
- Drugs.com: Generic Keppra Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- DrugPatentWatch: Patent 8,802,142 summary.
