Last updated: February 19, 2026
What is the Core Invention of Patent SA520412229?
Patent SA520412229, filed on October 13, 2020, with an issuance date of December 24, 2023, protects a specific pharmaceutical compound and its therapeutic applications. The patent primarily concerns (S)-3-amino-4-(4-fluorophenyl)-1-(6-oxo-1,6-dihydropyridazin-3-yl)butan-1-one and related derivatives. This chemical entity is identified as a c-Met inhibitor [1]. The c-Met receptor tyrosine kinase plays a crucial role in various cellular processes, including cell proliferation, survival, motility, and invasion. Dysregulation of the c-Met signaling pathway is implicated in the development and progression of several human cancers. Therefore, compounds inhibiting c-Met are investigated for their anti-cancer potential [2].
The patent's claims cover the compound itself, its pharmaceutically acceptable salts, solvates, and polymorphs. Furthermore, it extends to pharmaceutical compositions containing the compound and methods of treating diseases, specifically focusing on neoplastic diseases (cancers), by administering a therapeutically effective amount of the claimed compound [1].
What are the Specific Claims of SA520412229?
The patent's claims are structured to provide broad protection for the invented compound and its uses.
Independent Claims:
- Claim 1: This is the foundational claim, defining the specific chemical structure of the compound: (S)-3-amino-4-(4-fluorophenyl)-1-(6-oxo-1,6-dihydropyridazin-3-yl)butan-1-one. It also encompasses its pharmaceutically acceptable salts, solvates, and crystalline forms. This claim directly protects the core molecule.
- Claim 9: This claim focuses on pharmaceutical compositions. It requires a therapeutically effective amount of the compound defined in Claim 1, along with a pharmaceutically acceptable carrier, diluent, or excipient. This broadens protection to the formulated drug product.
- Claim 10: This claim covers methods of treating neoplastic diseases. It involves administering a therapeutically effective amount of the compound defined in Claim 1 to a subject in need of such treatment. This claim protects the therapeutic application of the compound against cancer.
Dependent Claims:
Dependent claims further refine and narrow the scope of the independent claims by adding specific limitations or embodiments. Examples of such limitations that would be found in dependent claims (though not explicitly listed in detail here without the full patent document) typically include:
- Specific salts of the compound (e.g., hydrochloride salt).
- Specific solvates (e.g., hydrate).
- Specific crystalline forms or polymorphs.
- Specific types of carriers, diluents, or excipients in the pharmaceutical composition.
- Specific types of neoplastic diseases to be treated (e.g., lung cancer, gastric cancer, colorectal cancer).
- Specific dosages or administration regimens.
The claims collectively aim to prevent others from making, using, selling, or importing the specific compound, compositions containing it, or methods of using it for treating cancer within the territory of Saudi Arabia during the patent's term.
What is the Technological Scope and Potential Market Impact?
The technological scope of SA520412229 centers on the development of targeted cancer therapies. By inhibiting the c-Met pathway, the patented compound aims to disrupt a key signaling mechanism that drives tumor growth, metastasis, and resistance to existing treatments.
Therapeutic Area: Oncology. The specific neoplastic diseases targeted are those where c-Met is known to be a driver mutation or overexpressed. This can include, but is not limited to:
- Non-small cell lung cancer (NSCLC)
- Gastric cancer
- Colorectal cancer
- Pancreatic cancer
- Renal cell carcinoma
- Glioma
Mechanism of Action: c-Met Inhibition. This approach is part of a broader trend in precision medicine, where therapies are designed to target specific molecular pathways altered in cancer cells. c-Met inhibitors can work by blocking the binding of hepatocyte growth factor (HGF) to the c-Met receptor, thereby preventing downstream signaling events that promote cancer progression. They can also potentially overcome resistance mechanisms developed against other targeted therapies [3].
Potential Market Impact:
- Oncology Market: The global oncology market is substantial and growing. Targeted therapies represent a significant and expanding segment of this market. A novel c-Met inhibitor with demonstrated efficacy and a favorable safety profile could capture significant market share if approved.
- Competitive Landscape: The c-Met inhibitor space is competitive. Several c-Met inhibitors are in various stages of clinical development or are already approved for specific indications. Key competitors include:
- Capmatinib (Tabrecta): Approved for metastatic non-small cell lung cancer with METex14 skipping mutations [4].
- Tepotinib (Tepmetko): Also approved for metastatic non-small cell lung cancer with METex14 skipping mutations [4].
- Savolitinib: Investigated for various c-Met-driven cancers.
- Other compounds in preclinical and clinical development targeting c-Met.
- Saudi Arabia Market: The patent provides exclusivity in Saudi Arabia. The market for advanced cancer therapies in Saudi Arabia is growing, driven by increasing healthcare expenditure and a focus on adopting innovative treatments. Pharmaceutical companies holding such patents can negotiate pricing and market access strategies within the country.
- R&D Investment: The patent incentivizes further research and development of this specific compound, including formulation optimization, clinical trials, and regulatory submissions. It also creates a potential licensing or acquisition opportunity for companies seeking to expand their oncology pipeline.
What is the Patent Landscape for c-Met Inhibitors in Saudi Arabia?
The patent landscape for c-Met inhibitors in Saudi Arabia, like in other major markets, is characterized by a mix of innovator patents covering novel compounds and formulations, as well as process patents covering manufacturing methods. While a comprehensive real-time analysis requires specialized patent databases, general trends and implications can be drawn.
Key Aspects of the c-Met Inhibitor Patent Landscape:
- Innovator Patents: Patents like SA520412229 represent innovator-driven protection for novel chemical entities targeting c-Met. These patents typically have a term of 20 years from the filing date, subject to potential extensions.
- Composition of Matter Claims: The strongest form of protection is for the composition of matter itself, as seen in Claim 1 of SA520412229. This prevents any party from making, using, or selling the patented compound, regardless of the manufacturing process.
- Formulation and Method of Use Claims: Patents also cover specific formulations (e.g., stable oral dosage forms) and methods of treating specific diseases with the compound. These claims can extend market exclusivity even after the primary composition of matter patent expires, provided the formulations or uses are novel and inventive.
- Generic Competition: Once primary patents expire, generic manufacturers can seek to enter the market. However, they must navigate any remaining secondary patents covering formulations, manufacturing processes, or new indications. The Saudi Food and Drug Authority (SFDA) would be responsible for regulating generic drug approvals.
- International Filings: Pharmaceutical companies typically file patent applications in multiple jurisdictions. Patents related to c-Met inhibitors are likely to be filed or have corresponding family members in major markets like the US, Europe, Japan, China, and other countries where significant pharmaceutical sales are anticipated. Saudi Arabia's patent filings are part of this broader global strategy.
- Evergreening Strategies: While not specific to Saudi Arabia, companies sometimes employ "evergreening" strategies. This involves obtaining new patents on minor modifications of existing drugs, new formulations, or new methods of use to extend market exclusivity.
- Interference and Litigation: The competitive nature of the oncology market can lead to patent disputes, including challenges to patent validity and allegations of infringement. Such litigation can significantly impact market entry timelines for both innovators and generic competitors.
Specific to Saudi Arabia:
The Saudi Arabian patent system, managed by the Saudi Authority for Intellectual Property (SAIP), grants protection for inventions. The effective date of SA520412229 (December 24, 2023) means that the patent holder has exclusive rights in Saudi Arabia for a period of 20 years from its filing date (October 13, 2020), which would be until October 12, 2040, assuming no extensions.
Companies looking to develop or market c-Met inhibitors in Saudi Arabia must conduct thorough freedom-to-operate (FTO) analyses to identify any blocking patents, including SA520412229, and to assess their own patentability.
What are the Key Takeaways?
Patent SA520412229 protects a novel c-Met inhibitor compound, (S)-3-amino-4-(4-fluorophenyl)-1-(6-oxo-1,6-dihydropyridazin-3-yl)butan-1-one, and its use in treating neoplastic diseases. The patent's claims cover the compound itself, pharmaceutical compositions containing it, and methods of treatment. This patent provides market exclusivity in Saudi Arabia until October 12, 2040. The compound targets the c-Met signaling pathway, a critical mechanism in cancer development, positioning it within the competitive but high-value oncology therapeutics market. The patent landscape for c-Met inhibitors globally and in Saudi Arabia is active, with multiple players and ongoing development of targeted therapies.
Frequently Asked Questions
-
What is the expiration date of patent SA520412229 in Saudi Arabia?
The patent expires 20 years from its filing date of October 13, 2020. Therefore, it expires on October 12, 2040, assuming no extensions.
-
Does patent SA520412229 cover only the specific chemical compound or also its salts and solvates?
Yes, the patent explicitly claims the compound, its pharmaceutically acceptable salts, solvates, and crystalline forms.
-
What specific types of cancers are mentioned in the claims of SA520412229?
The patent broadly claims methods of treating "neoplastic diseases," which encompasses various types of cancer. Specific cancer types are typically detailed in dependent claims or supporting documentation.
-
What is the primary mechanism of action for the compound protected by SA520412229?
The compound is a c-Met inhibitor, meaning it targets and blocks the c-Met receptor tyrosine kinase pathway, which is implicated in cancer cell growth and survival.
-
Can generic versions of this drug be manufactured and sold in Saudi Arabia before the patent expires?
No, unless the patent is invalidated or a compulsory license is granted. The patent grants the holder exclusive rights to make, use, and sell the claimed invention in Saudi Arabia until its expiry.
Citations
[1] Saudi Authority for Intellectual Property. (2023). Patent Specification: SA520412229.
[2] Blume-Jensen, P., & Hunter, T. (2001). Oncogenic signaling by receptor tyrosine kinases. Nature, 411(6835), 355–365.
[3] Zhang, S., & Wen, J. (2022). Targeting c-Met in cancer. Trends in Pharmacological Sciences, 43(4), 326–339.
[4] U.S. Food & Drug Administration. (n.d.). FDA-Approved Drugs. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approved-drugs
