Analyzing the Scope and Claims of United States Patent 7,351,701: A Deep Dive into Rucaparib
Introduction
United States Patent 7,351,701, filed on July 23, 2004, is a pivotal patent in the portfolio of rucaparib, a powerful poly (ADP-ribosyl) transferase (PARP) inhibitor. This patent is crucial for understanding the strategic protection and development of rucaparib, particularly in the context of cancer treatment. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Rucaparib
Rucaparib, marketed under the trade name Rubraca, was first prepared and patented by the University of Newcastle in England in 2000. It was approved by the U.S. Food and Drug Administration (FDA) in April 2015 for the treatment of ovarian cancer and launched in the United States in December 2016[1].
Patent Overview: US 7,351,701
Filing and Grant
The patent US 7,351,701 was filed on July 23, 2004, and granted on April 1, 2008. This patent is part of the second stage of the patent portfolio for rucaparib, focusing on specific indications for the drug.
Claims and Scope
The patent claims the use of specific compounds, including rucaparib, for preparing medicines to treat cancers associated with BRCA1 and/or BRCA2 expression deficiencies. Here are the key aspects of the claims:
- Compound Protection: The patent protects the application of three specific compounds in treating cancers. These compounds are part of the broader class of triyclic lactam indole derivatives and triacyclic lactam benzimidazole derivatives[5].
- Disease Mechanism: The claims provide a detailed overview of the disease mechanism, specifically targeting BRCA1 and/or BRCA2 expression deficient cancer cells. This includes breast cancer and other cancers where these genetic deficiencies are prevalent[1].
- Pharmacokinetics: The patent includes data on the pharmacokinetics of the compound, such as plasma and tumor concentrations in mice, which are crucial for understanding the drug's efficacy and safety profile[1].
Technical Details
- Figure 6: This figure in the patent description illustrates the plasma and tumor concentrations of the compound and its pharmacokinetics on peripheral blood lymphocytes (pbl PARP) and SW620 xenograft (tumor PARP) in mice at different times. This data is essential for demonstrating the drug's bioavailability and therapeutic potential[1].
Patent Landscape
Patent Network
The protection of rucaparib involves a complex patent network designed to maximize the value of intellectual property. This includes multiple patents filed at different stages, each focusing on various aspects of the drug:
- Core Patent: The basic core patent for rucaparib is US 6,495,541, which expired on January 10, 2020. This patent covers the compound and its composition[1].
- Indication Patents: Following the core patent, several indication patents were filed, including US 7,351,701. These patents extend the protection to specific uses of the drug, such as treating BRCA1 and/or BRCA2 expression deficient cancer cells[1].
Expiration Dates and Generic Entry
The patent US 7,351,701 is set to expire on July 23, 2024. This expiration date is critical for generic manufacturers, as it marks one of the earliest opportunities for generic entry. However, the overall generic entry date for rucaparib is expected to be August 17, 2035, due to other patents and regulatory protections still in place[2].
Litigation and Challenges
There have been several patent litigation cases involving the patents protecting rucaparib, indicating strong interest in generic launch. Recent data suggest that 63% of patent challenges are decided in favor of the generic patent challenger, and 54% of successful challengers promptly launch generic drugs[2].
Strategic Importance
Extending Patent Protection
The strategy behind filing multiple patents, including US 7,351,701, is to extend the patent protection period of rucaparib. By creating a patent fortress around the drug, pharmaceutical companies aim to delay generic competition and maintain market exclusivity for as long as possible[1].
Market Impact
The expiration of key patents like US 7,351,701 can significantly impact the market dynamics for rucaparib. Generic entry can lead to reduced prices and increased competition, affecting the revenue streams of the original patent holders.
Industry Insights
Expert Views
Industry experts emphasize the importance of a robust patent portfolio in the pharmaceutical sector. "A strong patent portfolio is essential for protecting the significant investments made in drug research and development," notes a pharmaceutical industry expert. "It allows companies to recoup their investments and continue innovating without immediate generic competition"[1].
Statistics
- Patent Family Members: Rucaparib has 234 patent family members in 43 countries, highlighting the extensive global protection strategy[2].
- Litigation Outcomes: The high success rate of generic patent challengers underscores the need for pharmaceutical companies to continually strengthen and expand their patent portfolios[2].
Conclusion
United States Patent 7,351,701 is a critical component of the patent strategy for rucaparib, providing specific protection for the drug's use in treating BRCA1 and/or BRCA2 expression deficient cancers. Understanding the scope and claims of this patent, along with the broader patent landscape, is essential for both pharmaceutical companies and generic manufacturers.
Key Takeaways
- Patent Scope: US 7,351,701 protects the use of rucaparib in treating BRCA1 and/or BRCA2 expression deficient cancers.
- Expiration Date: The patent is set to expire on July 23, 2024.
- Generic Entry: The earliest generic entry date is expected to be August 17, 2035, due to other patents and regulatory protections.
- Strategic Importance: The patent is part of a broader strategy to extend patent protection and maintain market exclusivity.
- Industry Impact: The expiration of this patent will have significant market implications, including potential generic competition and reduced prices.
FAQs
Q: What is the primary focus of United States Patent 7,351,701?
A: The primary focus is the use of rucaparib in treating BRCA1 and/or BRCA2 expression deficient cancers.
Q: When was the patent filed and granted?
A: The patent was filed on July 23, 2004, and granted on April 1, 2008.
Q: What is the expiration date of US 7,351,701?
A: The patent is set to expire on July 23, 2024.
Q: How does this patent fit into the broader patent strategy for rucaparib?
A: It is part of the second stage of the patent portfolio, focusing on specific indications for the drug to extend patent protection.
Q: What are the potential market implications of the patent's expiration?
A: The expiration could lead to generic competition, reduced prices, and changes in market dynamics for rucaparib.
Sources
- Analysis of Strategy for Extending Patent Protection of Rucaparib - SCIRP
- RUBRACA Drug Patent Profile - DrugPatentWatch
- Patent Claims and Patent Scope - SSRN
- Cancer Drug Patents Expiring 2024-2028 - GreyB
- Therapeutic compounds - Patent US-7351701-B2 - PubChem
