United States Patent 8,071,579: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,071,579, titled "DNA DAMAGE REPAIR INHIBITORS FOR THE TREATMENT OF CANCER," is a significant patent in the field of oncology, particularly in the treatment of cancers using inhibitors that target DNA repair mechanisms. This patent, issued on December 6, 2011, is assigned to The Institute of Cancer Research: Royal Cancer Hospital, London, and Kudos Pharmaceuticals Limited, Cambridge.
Inventors and Assignees
The patent was invented by Alan Ashworth, Stephen Jackson, Nial Martin, and Graeme Smith, all of whom are associated with prestigious institutions in the UK, including the Institute of Cancer Research and the University of Cambridge[4].
Patent Scope
The patent focuses on methods and means for treating cancers that are deficient in homologous recombination (HR) dependent DNA double-strand break (DSB) repair. This is achieved through the use of inhibitors that target enzymes involved in DNA repair, specifically Poly (ADP-ribose) polymerase (PARP) enzymes.
Claim Overview
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
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Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 describes a method for treating a cancer in a patient, where the cancer is deficient in HR dependent DNA DSB repair, using a PARP inhibitor[4].
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Dependent Claims: These claims narrow down the scope by adding specific details. For instance, dependent claims might specify the type of PARP inhibitor, the dosage, or the particular cancer being treated.
Key Claims and Their Significance
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Claim 1: This claim is pivotal as it outlines the method for treating cancers deficient in HR dependent DNA DSB repair using a PARP inhibitor. This sets the foundation for the therapeutic application of the invention[4].
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Claims Related to Compounds: The patent also includes claims related to specific compounds that inhibit PARP enzymes, such as KU-0058684, KU-0058948, and KU-0051529. These compounds are crucial for the practical implementation of the method described in Claim 1[4].
Patent Claims and Their Impact on Treatment
The claims in this patent have a significant impact on the treatment of certain types of cancer, particularly those with defects in the BRCA1 and BRCA2 genes. These genes are involved in the HR pathway, and cancers with mutations in these genes are more susceptible to PARP inhibitors.
Therapeutic Applications
- Olaparib: The patent is closely related to the development of olaparib (LYNPARZA®), a PARP inhibitor used in the treatment of ovarian, breast, and other cancers with BRCA mutations. The therapeutic efficacy of olaparib is a direct result of the research and claims outlined in this patent[4].
Patent Expiration and Generic Challenges
The patent has several expiration dates, but the primary patent (U.S. Patent No. 8,071,579) expired on August 4, 2031, although some related patents have earlier expiration dates.
- Generic Versions: Companies like Zydus and Natco Pharma have submitted Abbreviated New Drug Applications (ANDAs) to the FDA seeking approval for generic versions of olaparib before the expiration of some of the related patents. This has led to patent infringement lawsuits, highlighting the ongoing legal battles in the pharmaceutical industry[2][5].
Litigation and Patent Infringement
The patent has been at the center of several patent infringement lawsuits. For example, AstraZeneca Pharmaceuticals LP has sued companies like Natco Pharma Limited for submitting ANDAs that allegedly infringe on patents related to olaparib, including U.S. Patent No. 8,071,579 and other associated patents[5].
Impact on Innovation and Patent Quality
The scope and claims of this patent have significant implications for innovation in cancer treatment. The patent's clarity and specificity have been crucial in defining the therapeutic use of PARP inhibitors.
- Patent Scope Metrics: Research on patent scope suggests that narrower claims, like those in this patent, are associated with a higher probability of grant and a shorter examination process. This indicates that the patent office has done a thorough job in evaluating the claims, which is important for maintaining patent quality[3].
Conclusion
United States Patent 8,071,579 is a landmark patent in the field of cancer treatment, particularly for cancers deficient in HR dependent DNA DSB repair. Its claims and scope have paved the way for the development of effective treatments like olaparib. The ongoing legal battles over generic versions highlight the importance of this patent in the pharmaceutical industry.
Key Takeaways
- The patent focuses on using PARP inhibitors to treat cancers with defects in HR dependent DNA DSB repair.
- Key claims include methods for treatment and specific compounds like KU-0058684.
- The patent is closely related to the development of olaparib (LYNPARZA®).
- Expiration dates and generic challenges are significant, with ongoing patent infringement lawsuits.
- The patent's scope and claims have a positive impact on innovation and patent quality.
Frequently Asked Questions (FAQs)
What is the primary focus of United States Patent 8,071,579?
The primary focus is on methods and means for treating cancers deficient in homologous recombination (HR) dependent DNA double-strand break (DSB) repair using PARP inhibitors.
Who are the inventors and assignees of this patent?
The inventors are Alan Ashworth, Stephen Jackson, Nial Martin, and Graeme Smith. The assignees are The Institute of Cancer Research: Royal Cancer Hospital, London, and Kudos Pharmaceuticals Limited, Cambridge.
What is the significance of Claim 1 in this patent?
Claim 1 defines the method for treating cancers deficient in HR dependent DNA DSB repair using a PARP inhibitor, setting the foundation for the therapeutic application of the invention.
How does this patent relate to olaparib (LYNPARZA®)?
The patent is closely related to the development of olaparib, a PARP inhibitor used in the treatment of ovarian, breast, and other cancers with BRCA mutations.
What are the implications of the patent expiration dates for generic versions of olaparib?
The expiration dates have led to companies submitting ANDAs for generic versions of olaparib, resulting in patent infringement lawsuits as they seek approval before the expiration of some related patents.
