United States Patent 8,945,620: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 8,945,620, titled "Solid pharmaceutical compositions containing pregabalin," is a significant patent in the pharmaceutical industry, particularly for the drug pregabalin, which is used to treat conditions such as epilepsy, fibromyalgia, and neuropathic pain. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
Patent Overview
The patent, assigned to Pfizer Products Inc., describes solid pharmaceutical compositions containing pregabalin. Pregabalin is an active ingredient known for its efficacy in treating various neurological disorders. The patent was granted on February 3, 2015, and is listed in the FDA's Orange Book, which compiles patent and exclusivity information for approved drug products[2].
Inventors and Assignees
The inventors listed on the patent are Howard Norman Bockbrader and Yun Hyung Cho, both associated with Pfizer. The assignee is Pfizer Products Inc., highlighting Pfizer's significant role in the development and commercialization of pregabalin-based products[4][5].
Scope of the Patent
Pharmaceutical Composition
The patent describes a solid pharmaceutical composition that includes pregabalin as the active ingredient. This composition is formulated with a matrix forming agent and a swelling agent, designed to enhance the drug's delivery and bioavailability. The specific formulation is crucial for improving patient compliance and reducing side effects associated with pregabalin[4].
Claims
The patent includes several claims that define the scope of the invention. Here are some key claims:
- Claim 1: A solid pharmaceutical composition comprising pregabalin, a matrix forming agent, and a swelling agent.
- Claim 2: The composition of claim 1, where the matrix forming agent is selected from the group consisting of polyvinyl acetate, hydroxypropyl methylcellulose, and polyethylene oxide.
- Claim 3: The composition of claim 1, where the swelling agent is selected from the group consisting of sodium starch glycolate, croscarmellose sodium, and cross-linked polyvinylpyrrolidone[4].
These claims are specific and narrow, focusing on the particular formulation and components of the pregabalin composition.
Patent Claims and Scope Metrics
Independent Claim Length and Count
Research on patent scope metrics suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For US Patent 8,945,620, the claims are relatively specific and focused on the formulation and components of the pregabalin composition. This specificity is consistent with narrower claims, which are often associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for this patent would have involved a thorough review to ensure that the claimed invention meets the statutory requirements for patentability. The fact that the claims are narrow and specific suggests that the examination process likely narrowed the scope of the patent claims further, ensuring clarity and validity[3].
Patent Landscape and Exclusivity
Listing in the Orange Book
The patent is listed in the FDA's Orange Book, which is a critical resource for tracking patent and exclusivity information related to approved drug products. This listing indicates that Pfizer has asserted that this patent could reasonably be used to prevent the manufacture, use, or sale of generic versions of pregabalin without a license from Pfizer[2].
Generic Competition
Generic manufacturers, such as Sun Pharmaceutical Industries, must submit an Abbreviated New Drug Application (ANDA) and address the patents listed in the Orange Book. For US Patent 8,945,620, Sun Pharmaceutical filed an ANDA with a paragraph IV certification, stating that the patent is not infringed by their proposed generic product. This certification is a common strategy used by generic manufacturers to challenge the validity or enforceability of listed patents[2].
Market Exclusivity
The listing of this patent in the Orange Book and its association with pregabalin products can extend market exclusivity for Pfizer beyond the initial patent expiration. Follow-on patents, such as those for new dosage forms or methods of use, can further extend this exclusivity, delaying the entry of generic competitors into the market[1].
Litigation and Challenges
Declaratory Judgment Actions
The patent has been involved in litigation, with Sun Pharmaceutical seeking declaratory judgment that the patent is invalid, unenforceable, or not infringed by their proposed generic product. This type of litigation is common in the pharmaceutical industry, where generic manufacturers challenge the validity of patents to expedite market entry[2].
Key Takeaways
- Specific Formulation: The patent describes a specific solid pharmaceutical composition containing pregabalin, with a matrix forming agent and a swelling agent.
- Narrow Claims: The claims are focused and narrow, indicating a higher probability of grant and shorter examination process.
- Orange Book Listing: The patent is listed in the FDA's Orange Book, affecting generic competition and market exclusivity.
- Litigation: The patent has been involved in declaratory judgment actions by generic manufacturers challenging its validity or enforceability.
FAQs
What is the main subject of US Patent 8,945,620?
The main subject of US Patent 8,945,620 is a solid pharmaceutical composition containing pregabalin, along with specific matrix forming and swelling agents.
Who are the inventors and assignees of the patent?
The inventors are Howard Norman Bockbrader and Yun Hyung Cho, and the assignee is Pfizer Products Inc.
Why is the patent listed in the Orange Book?
The patent is listed in the Orange Book because Pfizer has asserted that it could reasonably be used to prevent the manufacture, use, or sale of generic versions of pregabalin without a license.
How does the patent affect generic competition?
The patent's listing in the Orange Book requires generic manufacturers to address it in their ANDA filings, potentially delaying their market entry if they cannot successfully challenge the patent.
What is the significance of the claims being narrow and specific?
Narrow and specific claims are associated with a higher probability of grant and a shorter examination process, indicating clarity and validity in the patent.
Sources
- USPTO-FDA Report on Drug Patent and Exclusivity. USPTO, 2018.
- Complaint for Declaratory Judgment. Sun Pharmaceutical Industries Limited, 2019.
- Patent Claims and Patent Scope. SSRN, 2016.
- US8945620B2 - Solid pharmaceutical compositions containing pregabalin. Google Patents.
- Solid pharmaceutical compositions containing pregabalin. PubChem.
