United States Patent 8,163,904: A Detailed Analysis
Introduction
United States Patent 8,163,904, hereafter referred to as the '904 patent, is a significant intellectual property asset owned by Novartis Pharmaceuticals Corporation. This patent pertains to specific salts of a complex organic compound, which has valuable pharmacological properties, particularly as a protein kinase inhibitor.
Patent Overview
The '904 patent, titled "Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide," was granted on April 24, 2012. It covers the preparation, pharmaceutical compositions, and methods of treatment using these specific salts[1][4].
Scope of the Patent
The patent encompasses several key aspects:
Chemical Structure and Synthesis
The patent describes the synthesis and preparation of salts of the compound 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide. This compound is a potent inhibitor of protein kinases, which are enzymes involved in various cellular processes, including those related to cancer and other proliferative disorders[1][4].
Pharmaceutical Compositions
The patent includes methods for preparing pharmaceutical compositions that contain these salts. These compositions can be formulated in various forms, such as capsules, tablets, or other dosage forms suitable for administration to patients[1][4].
Methods of Treatment
The '904 patent covers the use of these salts as therapeutic agents, particularly for treating diseases that respond to protein kinase inhibition. This includes conditions such as certain types of cancer, where the inhibition of specific kinases can help in managing or treating the disease[1][4].
Claims of the Patent
The patent contains multiple claims that define the scope of protection:
Independent Claims
These claims define the broadest scope of the invention, including the specific salts, their preparation methods, and pharmaceutical compositions containing these salts.
Dependent Claims
These claims narrow down the scope by specifying particular aspects of the invention, such as specific salt forms, methods of synthesis, and therapeutic applications.
Patent Landscape
The '904 patent is part of a broader patent portfolio related to the drug Tasigna (nilotinib), which is owned by Novartis.
Related Patents
Tasigna is protected by a series of patents, including US8,163,904, US8,293,756, US8,389,537, US8,415,363, and US9,061,029, among others. These patents cover various aspects of the drug, including different salt forms, crystalline structures, and methods of treatment[3].
Patent Expiration
The '904 patent is set to expire on August 23, 2028. This expiration date is crucial as it marks the period after which generic versions of the drug can be developed and marketed without infringing on Novartis's patent rights[3].
Litigation and Enforcement
Novartis has been active in enforcing its patent rights against potential infringers. For example, Novartis has filed patent infringement actions against Teva Pharmaceuticals, alleging that Teva's Abbreviated New Drug Application (ANDA) for a generic version of Tasigna infringes on several of Novartis's patents, including the '904 patent[2].
Impact on Generic Launch
The expiration of the '904 patent and other related patents will open the door for generic manufacturers to enter the market. However, the complex patent landscape and ongoing litigation may delay the launch of generic versions until all relevant patents have expired or been successfully challenged[3].
Pharmacological Significance
The compound protected by the '904 patent has significant pharmacological properties, making it a valuable therapeutic agent. As a protein kinase inhibitor, it is particularly useful in treating diseases such as chronic myeloid leukemia (CML) and other proliferative disorders.
"Valuable pharmacological properties are attributed to this compound; thus, it can be used, for example, as a protein kinase inhibitor useful in therapy for diseases which respond to inhibition of protein kinase activity."[1]
Conclusion
The United States Patent 8,163,904 is a critical component of Novartis's intellectual property portfolio related to Tasigna. It protects specific salts of a potent protein kinase inhibitor and covers their preparation, pharmaceutical compositions, and therapeutic applications. The patent's expiration in 2028 will be a significant milestone, potentially allowing for the entry of generic competitors into the market.
Key Takeaways
- Patent Scope: Covers specific salts, synthesis methods, pharmaceutical compositions, and therapeutic applications.
- Patent Expiration: Set to expire on August 23, 2028.
- Related Patents: Part of a broader patent portfolio protecting Tasigna.
- Litigation: Novartis is actively enforcing its patent rights against potential infringers.
- Pharmacological Significance: The compound is a valuable protein kinase inhibitor used in treating diseases like CML.
FAQs
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What is the main subject of the '904 patent?
The '904 patent pertains to specific salts of the compound 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide.
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What are the pharmacological properties of the compound protected by the '904 patent?
The compound is a potent protein kinase inhibitor useful in therapy for diseases that respond to inhibition of protein kinase activity.
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When is the '904 patent set to expire?
The '904 patent is set to expire on August 23, 2028.
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Which company owns the '904 patent?
The '904 patent is owned by Novartis Pharmaceuticals Corporation.
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What is the significance of the '904 patent in the context of Tasigna?
The '904 patent is part of the broader patent portfolio protecting Tasigna (nilotinib), a drug used to treat chronic myeloid leukemia and other proliferative disorders.
Sources
- US8163904B2 - Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
- Case 1:24-cv-00428-UNA Document 1 Filed 04/04/24 Page 1 of 20
- Tasigna patent expiration - Pharsight
- US8163904B2 - Google Patents
