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Last Updated: December 24, 2024

Details for Patent: 10,478,500

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Which drugs does patent 10,478,500 protect, and when does it expire?

Patent 10,478,500 protects OXLUMO and is included in one NDA.

This patent has sixty-two patent family members in forty countries.

Summary for Patent: 10,478,500

Title:	Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression
Abstract:	The invention relates to RNAi agents, e.g. double-stranded RNAi agents, targeting the HAO1 gene, and method of using such RNAi agents to inhibit expression of HAO1 and methods of treating subjects having, e.g., PH1. Described herein are double-stranded RNAi agents which inhibit the expression of a HA01 gene in a cell, such as a cell within a subject, e.g., a mammal, such as a human having a HAO1 associated disorder, and uses of such double-stranded RNAi agents. In certain aspects of the invention, substantially all of the nucleotides of an iRNA of the invention are modified.
Inventor(s):	Querbes; William (Boston, MA), Fitzgerald; Kevin (Brookline, MA), Bettencourt; Brian (Groton, MA), Liebow; Abigail (Somerville, MA), Erbe; David V. (Arlington, MA)
Assignee:	Alnylam Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	15/517,471
Patent Claim Types: see list of patent claims	Use; Composition; Compound;
Patent landscape, scope, and claims:	United States Patent 10,478,500: A Detailed Analysis Overview of the Patent The United States Patent 10,478,500, titled "Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression," was issued on November 19, 2019. This patent is assigned to Alnylam Pharmaceuticals, Inc., and Dicerna Pharmaceuticals, Inc.[2][4]. Inventors and Assignees The patent was invented by a team that includes William Querbes, Kevin Fitzgerald, Brian Bettencourt, Abigail Liebow, and David V. Erbe. The assignees are Alnylam Pharmaceuticals, Inc., and Dicerna Pharmaceuticals, Inc.[2][4]. Patent Scope Subject Matter The patent pertains to compounds, compositions, and methods useful for reducing Glycolate Oxidase (HAO1) target RNA and protein levels. This is achieved through the use of double-stranded RNA interference (RNAi) agents, specifically Dicer substrate siRNA (DsiRNA) agents[2][4]. Claims The patent includes multiple claims that define the scope of the invention. Here are some key aspects: RNAi Agents: The patent claims cover RNAi agents, including DsiRNA agents, designed to target the HAO1 gene. Compositions: The claims include compositions comprising these RNAi agents, which are formulated for delivery and efficacy. Methods: The patent covers methods of using these RNAi agents to inhibit HAO1 gene expression and treat subjects with conditions such as Primary Hyperoxaluria Type 1 (PH1)[2][4]. Technical Details RNAi Mechanism The RNAi agents described in the patent work by targeting the HAO1 mRNA, leading to its degradation and subsequent reduction in HAO1 protein levels. This mechanism is crucial for treating diseases associated with elevated HAO1 activity[4]. Delivery Methods The patent also discusses methods for delivering these RNAi agents, including formulations that enhance stability and cellular uptake. This often involves conjugating the RNAi agents with delivery agents to improve their therapeutic efficacy[2][4]. Patent Expiration Dates The patent is set to expire on December 26, 2034. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holders, after which the technology could become more widely available[2]. Related Patents and Continuations Family of Patents This patent is part of a family of patents related to RNAi technology and HAO1 inhibition. Other patents, such as US Patent 11,446,380 and US Patent 9,828,606, also cover similar technologies and methods, ensuring a broad protection landscape for the inventors[2][4]. Continuations and Divisionals The patent landscape includes various continuations and divisional patents that further refine and expand the original claims. These additional patents help in maintaining a robust intellectual property portfolio around the RNAi technology[2]. Impact on Treatment Therapeutic Applications The invention has significant therapeutic implications, particularly for treating PH1 and other conditions associated with elevated HAO1 activity. By inhibiting HAO1 gene expression, these RNAi agents can reduce the symptoms and complications of these diseases[2][4]. Clinical Significance The development of these RNAi agents represents a major advancement in the treatment of genetic disorders. It highlights the potential of RNAi technology in precision medicine, offering targeted and effective therapeutic options where traditional treatments may be limited[4]. Legal and Regulatory Aspects Patent Litigation Patents like US 10,478,500 are often subject to litigation, as seen in cases involving other RNAi technologies. For instance, Alnylam Pharmaceuticals has been involved in patent disputes related to its LNP technology used in mRNA vaccines[1]. Regulatory Approvals The approval and regulatory process for these RNAi agents involve rigorous clinical trials and safety evaluations. The FDA grants exclusivity periods, which can run concurrently with patent protection, ensuring that the innovator company has sufficient time to recoup its investment in research and development[2]. Key Takeaways RNAi Technology: The patent covers advanced RNAi technology targeting the HAO1 gene. Therapeutic Applications: It has significant implications for treating PH1 and other related conditions. Patent Expiration: The patent expires on December 26, 2034. Related Patents: Part of a broader family of patents protecting RNAi technology. Clinical Significance: Represents a major advancement in precision medicine. FAQs What is the primary focus of US Patent 10,478,500? The primary focus is on compositions and methods for inhibiting HAO1 gene expression using RNAi agents. Who are the assignees of this patent? The assignees are Alnylam Pharmaceuticals, Inc., and Dicerna Pharmaceuticals, Inc. What is the expiration date of this patent? The patent is set to expire on December 26, 2034. What conditions can be treated using the technology described in this patent? The technology is particularly useful for treating Primary Hyperoxaluria Type 1 (PH1) and other conditions associated with elevated HAO1 activity. How does the RNAi mechanism work in this patent? The RNAi agents target the HAO1 mRNA, leading to its degradation and subsequent reduction in HAO1 protein levels. Cited Sources Alnylam document - Case 1:99-mc-09999 Document 260 Filed 03/16/22. Drugs.com - Generic Oxlumo Availability. Hoover Institution - Patent Claims and Patent Scope. Google Patents - US10478500B2 - Compositions and methods for inhibition of HAO1 (Hydroxyacid Oxidase 1 (Glycolate Oxidase)) gene expression. More… ↓ ⤷ Subscribe

Drugs Protected by US Patent 10,478,500

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y	Y		TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Foreign Priority and PCT Information for Patent: 10,478,500

PCT Information
PCT Filed	October 09, 2015	PCT Application Number:	PCT/US2015/054881
PCT Publication Date:	April 14, 2016	PCT Publication Number:	WO2016/057893

International Family Members for US Patent 10,478,500

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3204015	⤷ Subscribe	301167	Netherlands	⤷ Subscribe
European Patent Office	3204015	⤷ Subscribe	PA2022004	Lithuania	⤷ Subscribe
European Patent Office	3204015	⤷ Subscribe	CA 2022 00011	Denmark	⤷ Subscribe
European Patent Office	3204015	⤷ Subscribe	2022C/509	Belgium	⤷ Subscribe
European Patent Office	3204015	⤷ Subscribe	LUC00252	Luxembourg	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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