United States Patent 11,975,001: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,975,001 is part of a broader patent landscape involving pharmaceuticals, specifically the drug olaparib, marketed as LYNPARZA®. This patent is held by AstraZeneca and is central to ongoing litigation regarding generic versions of olaparib. Here, we will delve into the scope, claims, and the surrounding patent landscape to understand its significance.
Background on Olaparib and LYNPARZA®
Olaparib is a medication used in the treatment of certain types of cancer, including ovarian, breast, and prostate cancers. It is a PARP inhibitor, which works by blocking the enzyme poly (ADP-ribose) polymerase (PARP), thereby preventing cancer cells from repairing their DNA and leading to cell death.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent No. 11,975,001. While the specific title of this patent is not provided in the sources, it is part of a series of patents related to olaparib and its formulations.
Patent Holders
The patent is held by AstraZeneca Pharmaceuticals LP and AstraZeneca UK Limited, both of which are involved in the development, manufacture, and sale of LYNPARZA®[2][5].
Scope and Claims
Claims Structure
Patent claims define the scope of protection for an invention. For U.S. Patent No. 11,975,001, the claims would typically include a combination of independent and dependent claims. Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional features or limitations.
Specific Claims
The specific claims of U.S. Patent No. 11,975,001 are not detailed in the provided sources, but they would likely cover aspects such as the composition of olaparib, its method of use, dosage forms, and possibly specific formulations or manufacturing processes. For example, other patents related to olaparib have claims that cover the drug's chemical structure, its use in treating specific cancers, and the dosage regimens[2][5].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent No. 11,975,001 includes several other patents related to olaparib. These include:
- U.S. Patent No. 8,859,562
- U.S. Patent No. 8,475,842
- U.S. Patent No. 11,633,396
- U.S. Patent No. 12,048,695
These patents collectively protect various aspects of olaparib, including its composition, use, and formulations[2][5].
Litigation and Challenges
The patent is currently involved in litigation with generic drug manufacturers such as Cipla and Zydus, who have submitted Abbreviated New Drug Applications (ANDAs) to the FDA seeking approval to manufacture and sell generic versions of olaparib before the expiration of the patents-in-suit. These companies have submitted Paragraph IV Certifications alleging that the patents, including U.S. Patent No. 11,975,001, are invalid, unenforceable, and/or not infringed[2][5].
Expiration Dates
Understanding the expiration dates of these patents is crucial for generic manufacturers. While U.S. Patent No. 11,975,001's specific expiration date is not provided, other related patents have expiration dates ranging from 2027 to later years. For instance, U.S. Patent No. 8,143,241 and U.S. Patent No. 8,071,579, listed in the FDA’s Orange Book, expire on August 12, 2027[2][5].
Impact on Generic Manufacturers
Generic manufacturers like Cipla and Zydus are seeking to enter the market with their versions of olaparib before the patents expire. However, the ongoing litigation and the complexity of the patent landscape pose significant challenges. These companies must navigate the validity and enforceability of the patents, as well as potential infringement issues, to successfully bring their products to market.
Role of the USPTO
The United States Patent and Trademark Office (USPTO) plays a critical role in the patent landscape by issuing and maintaining patents. The USPTO provides resources such as the Patent Assignment Search and the Publication Site for Issued and Published Sequences, which can be crucial for understanding patent ownership and the technical details of patents like U.S. Patent No. 11,975,001[1].
Conclusion
U.S. Patent No. 11,975,001 is a key component in the complex patent landscape surrounding olaparib. Understanding its scope, claims, and the broader patent landscape is essential for both the patent holders and generic manufacturers. The ongoing litigation highlights the challenges and strategies involved in navigating this landscape.
Key Takeaways
- Patent Scope: U.S. Patent No. 11,975,001 covers specific aspects of olaparib, likely including its composition, method of use, and formulations.
- Related Patents: The patent is part of a series of patents protecting olaparib, including U.S. Patent No. 8,859,562, U.S. Patent No. 8,475,842, and others.
- Litigation: The patent is involved in litigation with generic manufacturers who are challenging its validity and enforceability.
- Expiration Dates: Understanding the expiration dates of related patents is crucial for market entry strategies.
- USPTO Role: The USPTO provides essential resources for navigating patent details and ownership.
FAQs
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What is U.S. Patent No. 11,975,001 related to?
U.S. Patent No. 11,975,001 is related to the drug olaparib, marketed as LYNPARZA®, and covers specific aspects of its composition, use, and formulations.
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Who are the patent holders of U.S. Patent No. 11,975,001?
The patent is held by AstraZeneca Pharmaceuticals LP and AstraZeneca UK Limited.
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What is the significance of the litigation involving U.S. Patent No. 11,975,001?
The litigation involves generic manufacturers challenging the validity and enforceability of the patent to enter the market with their versions of olaparib before the patent expires.
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How does the USPTO contribute to understanding this patent?
The USPTO provides resources such as the Patent Assignment Search and the Publication Site for Issued and Published Sequences, which help in understanding patent ownership and technical details.
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What are the potential challenges for generic manufacturers?
Generic manufacturers face challenges such as navigating the validity and enforceability of the patents, potential infringement issues, and understanding the expiration dates of related patents.
Sources
- USPTO - Search for patents
https://www.uspto.gov/patents/search
- Case 3:24-cv-08167 Document 1 Filed 07/31/24
https://insight.rpxcorp.com/litigation_documents/15786920
- Patent Claims Research Dataset - USPTO
https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Editas Medicine - CRISPR Technology
https://ir.editasmedicine.com/static-files/1ab5a0c5-b31b-414e-8f23-3fd0dc41c3d8
- Case 3:24-cv-10458 Document 1 Filed 11/12/24
https://insight.rpxcorp.com/litigation_documents/15913306
