Details for Patent: 8,828,956

Which drugs does patent 8,828,956 protect, and when does it expire?

Patent 8,828,956 protects AMVUTTRA, GIVLAARI, LEQVIO, and OXLUMO, and is included in four NDAs.

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

Summary for Patent: 8,828,956

Title:	Carbohydrate conjugates as delivery agents for oligonucleotides
Abstract:	The present invention provides iRNA agents comprising at least one subunit of the formula (I): ##STR00001## wherein: A and B are each independently for each occurrence O, N(R.sup.N) or S; X and Y are each independently for each occurrence H, OH, a hydroxyl protecting group, a phosphate group, a phosphodiester group, an activated phosphate group, an activated phosphite group, a phosphoramidite, a solid support, --P(Z')(Z'')O-nucleoside, --P(Z')(Z'')O-oligonucleotide, a lipid, a PEG, a steroid, a lipophile, a polymer, --P(Z')(Z'')O-Linker-OP(Z''')(Z'''')O-oligonucleotide, a nucleotide, an oligonucleotide, --P(Z')(Z'')-formula (I), --P(Z')(Z'')-- or -Linker-R; R is L.sup.G, -Linker-L.sup.G, or has the structure shown below: ##STR00002## L.sup.G is independently for each occurrence a carbohydrate, e.g., monosaccharide, disaccharide, trisaccharide, tetrasaccharide, oligosaccharide, polysaccharide; R.sup.N is independently for each occurrence H, methyl, ethyl, propyl, isopropyl, butyl, or benzyl; and Z', Z'', Z''' and Z'''' are each independently for each occurrence O or S.
Inventor(s):	Manoharan; Muthiah (Cambridge, MA), Rajeev; Kallanthottathil G. (Cambridge, MA), Jayaprakash; Narayanannair K. (Cambridge, MA), Maier; Martin (Cambridge, MA)
Assignee:	Alnylam Pharmaceuticals, Inc. (Cambridge, MA)
Application Number:	13/693,478
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

United States Patent 8,828,956: A Detailed Analysis of Scope and Claims

Introduction

United States Patent 8,828,956, titled "Carbohydrate conjugates as delivery agents for oligonucleotides," is a significant patent in the field of biotechnology, particularly in the area of RNA interference (RNAi) and oligonucleotide delivery. This patent, assigned to Alnylam Pharmaceuticals, Inc., represents a crucial advancement in the delivery of therapeutic oligonucleotides.

Background and Context

The patent is part of a series of continuations and divisions, tracing back to the original application filed on December 14, 2011. It builds upon earlier patents and provisional applications, reflecting the ongoing research and development in this field[1][4].

Invention Overview

The patent describes carbohydrate conjugates designed to deliver oligonucleotides, such as small interfering RNA (siRNA) and microRNA, into cells. These conjugates are engineered to enhance the stability, cellular uptake, and efficacy of oligonucleotides, which are crucial for therapeutic applications[1][4].

Claims and Scope

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims specify the structure and composition of the carbohydrate conjugates, including the types of carbohydrates and oligonucleotides used, as well as the methods for their preparation and use[1][4].

Dependent Claims

Dependent claims further detail the specific embodiments of the invention, such as the types of linkers, the number of carbohydrate moieties, and the specific oligonucleotide sequences. These claims provide a narrower scope within the broader framework of the independent claims[1][4].

Patent Scope Metrics

Claim Length and Count

Research on patent scope suggests that the length and count of claims can be indicative of the patent's breadth and complexity. For US 8,828,956, the claims are detailed and numerous, reflecting the intricate nature of the technology. Narrower claims at publication are often associated with a higher probability of grant and a shorter examination process, which was the case here[3].

Examination Process

The patent underwent a rigorous examination process, which is evident from the multiple continuations and divisions. The examination process tends to narrow the scope of patent claims, ensuring that the granted patent is well-defined and not overly broad. This process aligns with the findings that longer examination durations result in more significant scope adjustments[3].

Prior Art and References

The patent cites several prior art documents, including earlier patents by the same inventors and other relevant publications. These references highlight the evolutionary nature of the technology and the contributions of the current invention to the existing body of knowledge[1].

Assignee and Inventors

The patent is assigned to Alnylam Pharmaceuticals, Inc., a company at the forefront of RNAi therapeutics. The inventors, including Muthiah Manoharan, Kallanthottathil G. Rajeev, Jayaprakash Nair, and Martin Maier, are renowned for their work in this field[1].

Commercial and Therapeutic Implications

The carbohydrate conjugates described in this patent have significant commercial and therapeutic implications. They offer improved delivery mechanisms for oligonucleotides, enhancing the potential for RNAi-based therapies to treat a variety of diseases. This technology is crucial for advancing the field of precision medicine[1][4].

Patent Term and Extensions

The patent term for US 8,828,956 has been subject to extensions under 35 U.S.C. § 156, reflecting the regulatory approval process for the therapeutic applications of the invention. Such extensions are common for patents related to pharmaceuticals and biologics[5].

Litigation and Licensing

Given the importance of this patent, it is likely to be a focal point for licensing agreements and potential litigation. The clarity and specificity of the claims are critical in avoiding disputes and ensuring that the patent holder's rights are protected[3].

Industry Impact

The invention described in US 8,828,956 has a substantial impact on the biotechnology and pharmaceutical industries. It sets a precedent for the development of similar delivery agents and underscores the importance of intellectual property in driving innovation in these fields.

"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity."[3]

Key Takeaways

• Invention Details: The patent describes carbohydrate conjugates for delivering oligonucleotides, enhancing their stability and cellular uptake.
• Claims and Scope: The patent includes detailed independent and dependent claims defining the structure and use of these conjugates.
• Examination Process: The patent underwent a rigorous examination process, resulting in well-defined claims.
• Commercial Implications: The technology has significant commercial and therapeutic potential, particularly in RNAi-based therapies.
• Patent Term and Extensions: The patent term has been extended under regulatory provisions.
• Industry Impact: The invention influences the development of similar delivery agents and underscores the importance of intellectual property in biotechnology.

Frequently Asked Questions (FAQs)

Q: What is the main subject of United States Patent 8,828,956? A: The main subject is carbohydrate conjugates designed as delivery agents for oligonucleotides.

Q: Who is the assignee of this patent? A: The patent is assigned to Alnylam Pharmaceuticals, Inc.

Q: What is the significance of the examination process for this patent? A: The examination process ensured that the claims were well-defined and not overly broad, aligning with best practices in patent examination.

Q: How does this patent impact the biotechnology industry? A: It sets a precedent for the development of similar delivery agents and highlights the importance of intellectual property in driving innovation.

Q: Are there any extensions to the patent term? A: Yes, the patent term has been extended under 35 U.S.C. § 156 due to regulatory approval processes.

Cited Sources

1. United States Patent and Trademark Office. Carbohydrate Conjugates as Delivery Agents for Oligonucleotides. US Patent 10,806,791 B2, October 20, 2020.
2. Unified Patents Portal. US-8828956-B2.
3. Hoover Institution. Patent Claims and Patent Scope. Working Paper Series No. 16001, August 18, 2016.
4. Google Patents. US8828956B2 - Carbohydrate conjugates as delivery agents for oligonucleotides.
5. Regulations.gov. Untitled. FDA-2022-E-3112-0001, February 15, 2022.

Drugs Protected by US Patent 8,828,956

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	AMVUTTRA	vutrisiran sodium	SOLUTION;SUBCUTANEOUS	215515-001	Jun 13, 2022		RX	Yes	Yes	8,828,956		Y	Y		AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
Alnylam Pharms Inc	GIVLAARI	givosiran sodium	SOLUTION;SUBCUTANEOUS	212194-001	Nov 20, 2019		RX	Yes	Yes	8,828,956		Y	Y		TREATMENT OF ACUTE HEPATIC PORPHYRIA
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes	8,828,956		Y	Y		AS AN ADJUNCT TO DIET AND STATIN THERAPY FOR THE TREATMENT OF ADULTS WITH PRIMARY HYPERLIPIDEMIA, INCLUDING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH), BY INHIBITING EXPRESSION OF THE PCSK9 GENE
Alnylam Pharms Inc	OXLUMO	lumasiran sodium	SOLUTION;SUBCUTANEOUS	214103-001	Nov 23, 2020		RX	Yes	Yes	8,828,956		Y	Y		TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1)

International Family Members for US Patent 8,828,956

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008333811
Australia	2008340354
Australia	2008340355
Canada	2708153
Canada	2708171
Canada	2708173