United States Patent 8,679,533: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,679,533, titled "Pramipexole once-daily dosage form," is a significant patent in the pharmaceutical industry, particularly for the treatment of Parkinson's disease and restless legs syndrome. This patent, issued to Pharmacia Corporation, covers a specific formulation of pramipexole, a dopamine agonist. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Pramipexole, marketed under the brand name Mirapex ER, is an orally deliverable pharmaceutical composition designed for once-daily administration. The patent was issued on March 25, 2014, to inventors Lee Ernest J., Bredael Gerard M., Baldwin John R., Cox Steven R., and Heintz Mark J.[2][4].
Scope of the Patent
The patent 8,679,533 focuses on a specific formulation of pramipexole that allows for once-daily dosing. This formulation is designed to improve patient compliance and reduce side effects associated with more frequent dosing.
Key Components
- The patent describes an orally deliverable pharmaceutical composition that includes a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof.
- The composition must include at least one pharmaceutically acceptable excipient.
- The formulation exhibits specific in vitro and in vivo release profiles:
- In vitro: No more than about 20% of the pramipexole is dissolved within 2 hours after placement in a standard dissolution test.
- In vivo: The time to reach a mean of 20% absorption is greater than about 2 hours, and the time to reach a mean of 40% absorption is greater than about 4 hours[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention.
Independent Claims
- Claim 1: An orally deliverable pharmaceutical composition comprising a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, with specific release profiles.
- Subsequent claims further detail the composition, including the types of excipients and the specific release characteristics[4].
Dependent Claims
- These claims build upon the independent claims, providing additional details on the formulation, such as the specific amounts of pramipexole and excipients, and the methods of preparation.
Patent Landscape
The patent landscape for pramipexole formulations is complex, involving multiple patents and exclusivities.
Related Patents
- Other patents related to pramipexole, such as Patent 7,695,734, also cover different aspects of pramipexole formulations, including different dosage forms and methods of use[2].
- These patents collectively protect various innovations in the pramipexole product line, ensuring market exclusivity for the innovator company.
Exclusivities and Market Protection
- The Orange Book, maintained by the FDA, lists patents and exclusivities associated with approved drug products. This includes drug substance patents, drug product patents, and method of use patents[1].
- For pramipexole, the exclusivity period can extend beyond the initial patent expiration through follow-on patents and other regulatory exclusivities, such as those granted for new dosage forms or methods of use.
Impact on Generic Competition
The presence of multiple patents and exclusivities can delay the entry of generic competitors into the market.
Follow-On Patents
- Follow-on patents, like the one for the once-daily dosage form, can extend market exclusivity beyond the expiration of the original patent. This is a common strategy in the pharmaceutical industry to protect innovations and maintain market share[1].
Regulatory Environment
- The regulatory environment, including Executive Orders and FDA policies, aims to balance innovation with competition. For example, Executive Order 14036 promotes generic drug and biosimilar competition to lower drug prices and improve access[1].
Patent Scope and Quality
The scope and quality of patents are critical in determining their validity and impact.
Metrics for Patent Scope
- Research has identified metrics such as independent claim length and independent claim count to measure patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].
Critiques and Debates
- There are ongoing debates about patent quality, with some arguing that broader or overly broad patents can diminish innovation incentives due to increased licensing and litigation costs[3].
Conclusion on Patent 8,679,533
United States Patent 8,679,533 is a significant patent that protects a specific once-daily dosage form of pramipexole. The patent's scope and claims are designed to ensure that the formulation meets specific release profiles, enhancing patient compliance and reducing side effects.
Key Takeaways
- The patent covers a once-daily dosage form of pramipexole with specific in vitro and in vivo release profiles.
- The patent is part of a broader landscape that includes multiple related patents and exclusivities.
- Follow-on patents can extend market exclusivity, impacting generic competition.
- The regulatory environment aims to balance innovation with competition.
FAQs
What is the main focus of United States Patent 8,679,533?
The main focus of this patent is a specific once-daily dosage form of pramipexole, designed to improve patient compliance and reduce side effects.
Who are the inventors listed on the patent?
The inventors listed on the patent are Lee Ernest J., Bredael Gerard M., Baldwin John R., Cox Steven R., and Heintz Mark J.
What are the key components of the pramipexole formulation described in the patent?
The formulation includes a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, with specific in vitro and in vivo release profiles.
How does this patent impact generic competition?
The patent, along with other related patents and exclusivities, can delay the entry of generic competitors into the market by extending market exclusivity beyond the initial patent expiration.
What metrics are used to measure patent scope?
Metrics such as independent claim length and independent claim count are used to measure patent scope, with narrower claims often associated with a higher probability of grant and a shorter examination process.
Cited Sources:
- USPTO-FDA Report on Drug Patent and Exclusivity - USPTO
- Generic Mirapex ER Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- Pramipexole once-daily dosage form - Google Patents
