United States Patent 7,695,734: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 7,695,734, titled "Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof," is a significant patent in the pharmaceutical industry. This patent, granted to Boehringer Ingelheim Pharma GmbH & Co. KG, pertains to an extended release tablet formulation of pramipexole, a drug used primarily for the treatment of Parkinson's disease and restless legs syndrome. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Pramipexole
Pramipexole is a dopamine agonist that mimics the action of dopamine in the brain, helping to alleviate symptoms of Parkinson's disease and restless legs syndrome. The development of an extended release formulation was crucial to improve patient compliance and reduce side effects associated with multiple daily dosages.
Patent Overview
Publication and Legal Status
The patent was published on April 13, 2010, and is currently active, with an expiration date determined by the patent term and any potential extensions or adjustments[4].
Prior Art and Innovations
The patent builds upon prior art related to pramipexole formulations but introduces a novel extended release tablet formulation. This innovation involves the use of specific polymers and excipients to control the release of the active ingredient over an extended period, enhancing the drug's efficacy and reducing the frequency of dosing[4].
Scope of the Patent
Claim Structure
The patent includes multiple claims that define the scope of protection. These claims can be categorized into several types:
Independent Claims
Independent claims define the broadest scope of the invention. For example, Claim 1 describes the extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof, along with specific components such as polymers and excipients[4].
Dependent Claims
Dependent claims narrow down the scope by adding additional limitations to the independent claims. These claims often specify particular ratios of components, specific polymers, or other detailed aspects of the formulation[4].
Metrics for Measuring Patent Scope
The scope of the patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and complexity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process, as indicated by research on patent scope[3].
Claims Analysis
Key Components
The claims of US 7,695,734 focus on several key components:
Active Ingredient
The patent specifies pramipexole or its pharmaceutically acceptable salts as the active ingredient.
Extended Release Formulation
The claims detail the use of specific polymers and excipients to achieve an extended release profile. This includes the type and amount of polymers, such as hydroxypropyl methylcellulose, and other excipients that facilitate the controlled release of pramipexole[4].
Manufacturing Process
Some claims also cover the method of manufacturing the extended release tablets, ensuring that the process aligns with the desired release profile.
Enablement and Written Description
The patent must meet the statutory requirements for enablement and written description under 35 U.S.C. ยง 112(a). This means that the patent must describe the invention in sufficient detail to enable a person of ordinary skill in the art to make and use the invention without undue experimentation. The claims must also be supported by the written description, ensuring that the scope of protection is clearly defined and not overly broad[5].
Patent Landscape
Follow-On Patents and Exclusivities
The patent landscape for pharmaceuticals often involves follow-on patents that extend market exclusivity. These patents can cover new dosage forms, methods of use, or other improvements to the original drug product. The USPTO and FDA have analyzed such follow-on patents to understand their impact on market exclusivity and generic competition[1].
Generic Competition
The launch of generic versions of pramipexole extended release tablets would be influenced by the expiration of the patent and any exclusivities listed in the FDA's Orange Book. The Orange Book provides critical information on patent and exclusivity data for approved drug products, helping to determine when generic versions can enter the market[1].
Industry Impact
Patient Compliance and Side Effects
The extended release formulation of pramipexole has significant implications for patient compliance and side effect management. By reducing the frequency of dosing, patients are more likely to adhere to their treatment regimen, leading to better health outcomes.
Economic Considerations
The development and patenting of extended release formulations can have substantial economic benefits for pharmaceutical companies. These formulations can extend the market life of a drug beyond the expiration of the original patent, providing continued revenue streams.
Expert Insights
Patent Quality and Scope
Experts in the field emphasize the importance of patent quality and scope. For instance, the National Association of Patent Practitioners (NAPP) has expressed concerns about the Federal Circuit's standards for enablement, arguing that overly broad claims can discourage innovation and increase litigation costs[5].
Key Takeaways
- Extended Release Formulation: The patent introduces a novel extended release tablet formulation of pramipexole, enhancing patient compliance and reducing side effects.
- Claim Structure: The patent includes independent and dependent claims that define the scope of protection, with a focus on specific components and manufacturing processes.
- Enablement and Written Description: The patent must meet statutory requirements for enablement and written description to ensure clarity and validity.
- Patent Landscape: The patent is part of a broader landscape that includes follow-on patents and exclusivities, influencing generic competition and market exclusivity.
- Industry Impact: The extended release formulation has significant implications for patient health outcomes and economic considerations for pharmaceutical companies.
FAQs
What is the main innovation of US 7,695,734?
The main innovation is the development of an extended release tablet formulation of pramipexole, which improves patient compliance and reduces side effects.
How does the patent define the scope of protection?
The patent defines the scope through independent and dependent claims that specify the active ingredient, extended release formulation components, and manufacturing processes.
What are the implications for generic competition?
The patent's expiration and any listed exclusivities in the FDA's Orange Book will determine when generic versions of the extended release tablets can enter the market.
How does the extended release formulation impact patient health outcomes?
The formulation reduces the frequency of dosing, improving patient compliance and potentially leading to better health outcomes by minimizing side effects.
What are the economic benefits of this patent for pharmaceutical companies?
The extended release formulation can extend the market life of the drug, providing continued revenue streams beyond the expiration of the original patent.
Sources
- USPTO-FDA Report on Drug Patent and Exclusivity. USPTO, 2018.
- Patent Claims Research Dataset. USPTO, 2017.
- Patent Claims and Patent Scope. SSRN, 2016.
- US7695734B2 - Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof. Google Patents.
- Amicus Brief. Supreme Court of the United States, 2023.
