Detailed Analysis of the Scope and Claims of United States Patent 6,114,313
Introduction
United States Patent 6,114,313, issued on September 5, 2000, is a significant patent in the pharmaceutical domain, particularly related to the product KENGREAL™. This patent, owned by AstraZeneca, involves pharmaceutical compositions and methods for their manufacture. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Details
- Patent Number: 6,114,313
- Issue Date: September 5, 2000
- Expiration Date: December 11, 2017 (20 years from the filing date of December 11, 1997)[1].
- Inventors: Chris Bland and Gerald Steele
Scope of the Patent
The patent primarily deals with pharmaceutical compositions for freeze-drying, specifically those containing the active ingredient cangrelor, which is used in the product KENGREAL™. KENGREAL is a lyophilized powder for intravenous use.
Active Ingredient and Composition
- The active ingredient, cangrelor, is a potent antiplatelet agent used to prevent platelet activation and aggregation.
- The pharmaceutical compositions claimed in the patent include cangrelor along with excipients such as mannitol and sorbitol[1].
Claims of the Patent
Original and Amended Claims
The patent initially included claims 1-13. However, during the reexamination process, claims 2, 3, 7, and 8 were canceled, claims 1 and 11-13 were amended, and new claims 14-17 were added. The final set of claims includes:
- Claims 1, 4-6, and 9-17, which pertain to the pharmaceutical compositions containing cangrelor, mannitol, and sorbitol.
- Claims 11 and 13, which describe methods of manufacturing these pharmaceutical compositions[1].
Claim Specifics
- Claims 1, 4-6, 9-10, 14, and 16-17: These claims are directed towards the specific formulations of KENGREAL, including the combination of cangrelor with mannitol and sorbitol.
- Claims 11 and 13: These claims outline the methods for manufacturing these formulations, ensuring the stability and efficacy of the final product[1].
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape around U.S. Patent 6,114,313, one must define the relevant technology field and keywords. Key terms include "pharmaceutical compositions," "freeze-drying," "cangrelor," "mannitol," and "sorbitol"[3].
Searching and Organizing Patents
Using databases such as the USPTO Public Search Facility or global patent databases, one can search for patents related to these keywords. Organizing these patents by factors like filing date, assignee, and geographical distribution can provide a comprehensive view of the patent landscape[4].
Identifying Trends and Key Players
The analysis reveals that AstraZeneca is a significant player in this domain, given their ownership of the patent. Other key players may include companies involved in the development of antiplatelet agents or freeze-dried pharmaceuticals. Trends may include an increasing focus on stable and efficient formulations for intravenous use[3].
Analyzing Citations and Evolution
Studying how patents reference each other can help understand the impact and development of the technology. For instance, the reexamination and amendments to the claims of U.S. Patent 6,114,313 indicate ongoing improvements and validations of the invention[3].
Regulatory and Legal Considerations
Patent Term Extension
AstraZeneca petitioned for an extension of the patent term under 35 U.S.C. § 156, citing the regulatory review period for KENGREAL. The petition highlighted that the patent claims the approved product, the term had not expired prior to submission, and the term had never been extended before[1].
Reexamination and Amendments
The patent underwent reexamination, resulting in the cancellation and amendment of several claims. This process ensured that the claims were clear and distinct, meeting the requirements under 35 U.S.C. § 112[2].
Competitive Landscape
Market Impact
KENGREAL, protected by U.S. Patent 6,114,313, has a significant market presence in the antiplatelet therapy sector. The patent's protection period allowed AstraZeneca to maintain market exclusivity, influencing the competitive landscape in this therapeutic area.
Potential Legal Vulnerabilities
The patent's validity and scope were subject to reexamination, which is a common challenge in the pharmaceutical industry. Ensuring that claims are not indefinite and meet the "particularly pointing out and distinctly claiming" requirement is crucial for maintaining patent validity[2].
Generating Insights for Decisions
Strategic Guidance
The analysis of U.S. Patent 6,114,313 provides strategic guidance for companies operating in the pharmaceutical sector. It highlights the importance of robust patent claims, the need for ongoing innovation to maintain market position, and the potential for patent term extensions to extend market exclusivity.
Competitive Analysis
Understanding the patent landscape helps in identifying potential competitors and collaborators. It also informs about the technological advancements and trends in the field, aiding in research and development strategies.
Key Takeaways
- Patent Scope: U.S. Patent 6,114,313 covers pharmaceutical compositions containing cangrelor, mannitol, and sorbitol, and methods for their manufacture.
- Claims: The patent includes claims for specific formulations and manufacturing methods.
- Regulatory Considerations: The patent underwent reexamination and was eligible for term extension under 35 U.S.C. § 156.
- Competitive Landscape: AstraZeneca's market position was influenced by the patent's protection period.
- Strategic Insights: The analysis provides guidance on maintaining robust patent claims and leveraging patent term extensions.
FAQs
Q: What is the active ingredient in the product protected by U.S. Patent 6,114,313?
A: The active ingredient is cangrelor, a potent antiplatelet agent.
Q: What are the key excipients mentioned in the patent?
A: The key excipients are mannitol and sorbitol.
Q: What was the outcome of the reexamination of U.S. Patent 6,114,313?
A: During reexamination, claims 2, 3, 7, and 8 were canceled, claims 1 and 11-13 were amended, and new claims 14-17 were added.
Q: Why was the patent term extension requested for U.S. Patent 6,114,313?
A: The patent term extension was requested under 35 U.S.C. § 156 due to the regulatory review period for KENGREAL.
Q: How does the patent landscape analysis help in strategic decision-making?
A: It provides insights into trends, key players, and potential legal vulnerabilities, aiding in research and development strategies and competitive analysis.
Sources
- AstraZeneca Petition for Patent Term Extension: Regulations.gov
- MAXELL, LTD. v. AMPEREX TECHNOLOGY LIMITED: United States Court of Appeals for the Federal Circuit
- How to Do Patent Landscape Analysis: Goldstein Patent Law
- Search for Patents - USPTO: United States Patent and Trademark Office
- U.S. Patent Small Claims Court: Administrative Conference of the United States
