Understanding the Scope and Claims of United States Patent 8,003,126
Introduction
United States Patent 8,003,126, titled "Stable Tablet Formulation," is a significant patent in the pharmaceutical industry, particularly related to the drug Kuvan® (sapropterin dihydrochloride). This patent, owned by BioMarin Pharmaceutical Inc., is crucial for understanding the patent landscape surrounding Kuvan and its generic equivalents.
Patent Overview
- Patent Number: 8,003,126
- Title: Stable Tablet Formulation
- Assignee: BioMarin Pharmaceutical Inc.
- Inventors: Steven Jungles, Mark Henderson, Victoria Sluzky, and Robert Baffi
- Issue Date: August 23, 2011[4].
Patent Claims
The patent claims are a critical component of any patent, as they define the scope of the invention and what is protected by the patent.
Independent Claims
The independent claims of the patent are particularly important as they stand alone and do not rely on other claims. For Patent 8,003,126, the independent claims focus on the stable tablet formulation of sapropterin dihydrochloride, including specific compositions and methods of manufacture.
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These claims often specify particular aspects of the formulation, such as the presence of certain excipients, the method of tablet formation, and the stability characteristics of the final product[4].
Patent Scope
The scope of a patent is determined by the language of its claims and is a subject of ongoing debate in patent law.
Metrics for Measuring Patent Scope
Research has shown that patent scope can be measured using simple metrics such as independent claim length and independent claim count. Narrower claims, which are more specific and detailed, are associated with a higher probability of grant and a shorter examination process compared to broader claims[5].
Examination Process
The examination process at the USPTO tends to narrow the scope of patent claims. This is evident in the case of Patent 8,003,126, where the claims were refined during the examination to ensure clarity and specificity. Longer examination durations often result in more significant narrowing of the claims[5].
Patent Landscape and Related Patents
The patent landscape surrounding Kuvan is complex, with multiple patents protecting different aspects of the drug and its formulations.
Related Patents
Several other patents are associated with Kuvan, including:
- U.S. Patent Nos. 7,566,462, 7,566,714, 7,612,073, 7,727,987, 8,067,416, RE43,797, 8,318,745, and 9,433,624. These patents cover various aspects such as methods of treatment, compositions, and other formulations[4].
Patent Expiration Dates
Understanding the expiration dates of these patents is crucial for determining when generic versions can enter the market.
- Patent 8,003,126 is set to expire on November 16, 2025[2].
Litigation and Generic Versions
The protection offered by these patents has been the subject of litigation, particularly as generic manufacturers seek to enter the market.
BioMarin vs. Teva Pharmaceuticals
BioMarin Pharmaceutical Inc. and Merck & Cie have been involved in litigation against Teva Pharmaceuticals over the filing of an Abbreviated New Drug Application (ANDA) for a generic version of Kuvan. This litigation highlights the importance of these patents in protecting the intellectual property of the original drug manufacturers[4].
Impact on Innovation and Market
The breadth and clarity of patent claims can significantly impact innovation and market dynamics.
Innovation Incentives
Broad or unclear patent claims can diminish innovation incentives by increasing licensing and litigation costs. In contrast, narrower and clearer claims, as seen in Patent 8,003,126, can facilitate innovation by providing a clear understanding of what is protected and what is not[5].
Market Competition
The expiration of key patents, such as those related to Kuvan, can lead to increased market competition as generic versions become available. However, the approval and commercial availability of these generics are contingent on the resolution of any ongoing litigation and the expiration of relevant patents[2].
Key Takeaways
- Patent Claims: The claims of Patent 8,003,126 are specific to the stable tablet formulation of sapropterin dihydrochloride.
- Patent Scope: The scope is defined by the independent and dependent claims, which were refined during the examination process.
- Related Patents: Multiple patents protect different aspects of Kuvan.
- Litigation: Ongoing litigation with generic manufacturers highlights the importance of these patents.
- Market Impact: The expiration of these patents will influence market competition and the availability of generic versions.
FAQs
-
What is the title of United States Patent 8,003,126?
- The title is "Stable Tablet Formulation."
-
Who are the inventors of Patent 8,003,126?
- The inventors are Steven Jungles, Mark Henderson, Victoria Sluzky, and Robert Baffi.
-
When is the patent set to expire?
- The patent is set to expire on November 16, 2025.
-
What is the significance of the patent in the pharmaceutical industry?
- It protects the stable tablet formulation of sapropterin dihydrochloride, a key component of the drug Kuvan.
-
Why is the patent landscape surrounding Kuvan complex?
- It involves multiple patents covering various aspects of the drug and its formulations, leading to ongoing litigation with generic manufacturers.
Sources
- United States Patent and Trademark Office. Patent No.: US 9,216,178 B2.
- Drugs.com. Generic Kuvan Availability.
- Hoover Institution. Patent Claims and Patent Scope.
- RPX Insight. Case 2:21-cv-15392-ES Document 1 Filed 08/16/21.
- SSRN. Patent Claims and Patent Scope.
