Understanding the Scope and Claims of United States Patent 8,927,604
Introduction
United States Patent 8,927,604, titled "Diclofenac Formulations and Methods of Use," is a significant patent in the pharmaceutical industry, particularly in the treatment of acute pain and migraine. This patent, assigned to APRA Applied Pharma Research s.a., covers innovative formulations and methods for using diclofenac, a non-steroidal anti-inflammatory drug (NSAID).
Background of the Invention
Diclofenac, chemically known as (2,6-dichloro-anilino)-2-phenyl-2-acetic acid, is widely used for its anti-inflammatory, analgesic, and antipyretic properties. The patent addresses the need for formulations that provide both rapid and sustained relief from acute pain, as well as symptoms often accompanying migraine and acute pain, such as rebound headache, photophobia, phonophobia, nausea, and vomiting[4].
Patent Scope
The scope of a patent is crucial in defining what is protected and what is not. For Patent 8,927,604, the scope is determined by the claims, which are the legally binding descriptions of the invention.
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length and count to measure the breadth of a patent. Narrower claims, as indicated by shorter independent claim lengths and lower claim counts, are generally associated with a higher probability of grant and a shorter examination process[3].
Claims of the Patent
The patent includes several claims that define the invention:
Composition Claims
The patent claims cover specific formulations of diclofenac, including sugar-free powder sachets and other fast-acting dosage forms. These formulations are designed to provide rapid and sustained relief from acute pain[4].
Method Claims
In addition to composition claims, the patent also includes method claims that describe the methods of using these formulations for treating migraine and other acute pain episodes. These methods encompass the treatment of accompanying symptoms such as rebound headache and photophobia[4].
Patent Family and Related Patents
Patent 8,927,604 is part of a larger patent family that includes other related patents and applications. For example, it references earlier patents such as US 7,700,125 B2, US 7,759,394 B2, and US 8,097,651 B2, which also pertain to diclofenac formulations and methods of use[4].
Expiration and Extension
The patent term for US 8,927,604 is subject to adjustment under U.S.C. 154(b) and may be extended due to various factors, including pediatric patent term extensions. The scheduled expiration date for this patent is June 16, 2026, with a potential six-month extension for pediatric exclusivity[1][4].
International Protection
The patent also has international counterparts, as indicated by the listing of foreign patent documents such as EP 0418043, GB A2401547, and others. This international protection is crucial for maintaining global exclusivity over the invention[4].
Practical Implications
The practical implications of this patent are significant for the pharmaceutical industry. It provides a competitive edge to the assignee, APRA Applied Pharma Research s.a., by protecting their innovative formulations and methods. This protection can influence market dynamics, licensing agreements, and litigation strategies.
Litigation and Licensing
The breadth and clarity of the patent claims can impact litigation and licensing costs. Narrower, well-defined claims are generally less contentious and reduce the likelihood of costly legal battles. This is particularly important in the pharmaceutical industry, where patent disputes can be highly litigious and financially burdensome[3].
Regulatory Considerations
The patent is subject to regulatory oversight, particularly in the context of FDA approvals and compliance with pharmaceutical standards. The formulations and methods described must meet stringent regulatory requirements to ensure safety and efficacy[4].
Stakeholder Impact
The impact of this patent extends to various stakeholders, including patients, healthcare providers, and other pharmaceutical companies. Patients benefit from access to innovative treatments, while healthcare providers must be aware of the protected formulations and methods to avoid infringement. Competitors in the pharmaceutical industry must navigate around the protected claims to develop their own products[4].
Future Developments
As the patent landscape evolves, there may be future developments such as new formulations, additional method claims, or challenges to the existing patent. The ongoing examination process and potential for post-grant review can further refine the scope of the patent[3].
Conclusion
United States Patent 8,927,604 is a critical piece of intellectual property in the pharmaceutical sector, particularly for the treatment of acute pain and migraine. Understanding its scope, claims, and practical implications is essential for stakeholders in the industry.
Key Takeaways
- Patent Scope: Defined by the claims, which include composition and method claims for diclofenac formulations.
- Claims Analysis: Narrower claims are associated with a higher probability of grant and shorter examination process.
- Patent Family: Part of a larger family of related patents and applications.
- Expiration and Extension: Scheduled to expire on June 16, 2026, with potential for pediatric exclusivity extension.
- International Protection: Protected in multiple jurisdictions through foreign patent documents.
- Practical Implications: Significant impact on market dynamics, licensing, and litigation strategies.
FAQs
Q: What is the main subject of United States Patent 8,927,604?
A: The main subject is diclofenac formulations and methods of use for treating acute pain and migraine.
Q: Who is the assignee of this patent?
A: The assignee is APRA Applied Pharma Research s.a.
Q: What are the key claims of this patent?
A: The key claims include composition claims for sugar-free powder sachets and method claims for treating acute pain and accompanying symptoms.
Q: How does the patent scope affect the pharmaceutical industry?
A: The patent scope influences market competition, licensing agreements, and litigation strategies within the industry.
Q: What is the scheduled expiration date for this patent?
A: The scheduled expiration date is June 16, 2026, with a potential six-month extension for pediatric exclusivity.
Sources
- UNITED STATES SECURITIES AND EXCHANGE COMMISSION: Ongoing analysis of final year-end data and tax positions.
- U.S. Patent and Trademark Office (USPTO): Agency responsible for granting U.S. patents and registering trademarks.
- Patent Claims and Patent Scope: Metrics for measuring patent scope based on claim language.
- United States Patent 8,927,604: Diclofenac formulations and methods of use.
- U.S. Patent Small Claims Court: Study on designing a small claims patent court.
