Details for Patent: 9,370,582

Which drugs does patent 9,370,582 protect, and when does it expire?

Patent 9,370,582 protects LEQVIO and is included in one NDA.

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

Summary for Patent: 9,370,582

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), Nair; Jayaprakash (Cambridge, MA), Maier; Martin (Cambridge, MA)
Assignee:	ALNYLAM PHARMACEUTICALS, INC. (Cambridge, MA)
Application Number:	14/329,557
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Understanding the Scope and Claims of U.S. Patents: A Detailed Analysis

Introduction

Patents are a cornerstone of innovation, providing inventors and companies with exclusive rights to their inventions. In the United States, the U.S. Patent and Trademark Office (USPTO) is responsible for granting these rights. This article delves into the scope and claims of U.S. patents, using the context of U.S. Patent 9,370,582 as a case study, and explores the broader patent landscape.

The Role of the USPTO

The USPTO plays a crucial role in the patent system, overseeing the granting of patents and ensuring that inventions meet the criteria of novelty, non-obviousness, and usefulness[1].

Patent Claims and Scope

Patent claims define the scope of the invention and are critical in determining what is protected by the patent. The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014, highlighting the complexity and variability of patent claims[3].

Claim Construction

Claim construction is a legal process that determines the meaning of the terms used in patent claims. This process is crucial as it affects the validity and enforceability of the patent. The Federal Circuit has emphasized that claim construction is a question of law, subject to de novo review on appeal[2].

Patent Scope Measurements

The USPTO has developed measures to analyze the scope of patents, including claim-level and document-level statistics. These measures help in understanding the breadth and depth of patent protection. For instance, the Patent Claims Research Dataset includes newly-developed measures of patent scope, such as the number of claims and the dependency relationship between claims[3].

Technology Areas and Patent Trends

Patents are classified into various technology areas, which help in analyzing trends in patenting. The USPTO uses the World Intellectual Property Organization (WIPO) classification system, which includes 35 technical fields. For example, electrical engineering and mechanical engineering patents made up about 60% of USPTO patents in 2018, with a significant increase in electrical engineering patents driven by information and communication technologies (ICT)[1].

U.S. Patent 9,370,582: A Case Study

While specific details of U.S. Patent 9,370,582 are not provided here, a general analysis can be applied based on common practices.

Claim Analysis

To understand the scope of U.S. Patent 9,370,582, one must analyze its claims. This involves identifying the independent and dependent claims, understanding the claim language, and determining the breadth of protection. Claim construction, as mentioned earlier, is a critical step in this process.

Technological Field

Identifying the technological field in which the patent is classified is essential. This could be one of the 35 WIPO technical fields, such as electrical engineering or mechanical engineering. The classification helps in understanding the broader context and trends within that field.

Patent Eligibility

The patent eligibility of U.S. Patent 9,370,582 would be determined based on the criteria of novelty, non-obviousness, and usefulness. Recent updates, such as the 2024 USPTO guidance on AI patents, provide additional clarity on patent eligibility for complex technologies like AI[4].

Industry and R&D Trends

The patent landscape is heavily influenced by industry trends and R&D investments. For instance, firms in the computer and electronics manufacturing industry received a significant number of patents in 2017, reflecting their high R&D expenditures[1].

High R&D Industries

High R&D industries tend to have high rates of patenting. The computer systems design and related services industry, for example, shows relatively high levels of U.S. patenting, even though other industries may outspend them in domestic R&D[1].

Legal and Policy Considerations

The legal and policy framework surrounding patents is complex and evolving.

Small Claims Patent Court

There have been discussions and studies on the feasibility of a small claims patent court to address the needs of smaller inventors and companies. The Administrative Conference of the United States (ACUS) has conducted extensive research on this topic, engaging with various stakeholders to understand the legal, policy, and practical considerations[5].

AI Patent Guidance

The USPTO's 2024 guidance update on AI patents aims to clarify the process for determining the patent eligibility of AI-related inventions. This guidance includes examples of patent-eligible and ineligible claims, helping practitioners to draft claims that avoid common rejections[4].

Key Takeaways

• Patent Claims: The scope of a patent is defined by its claims, which must be carefully constructed and analyzed.
• Technology Areas: Patents are classified into various technology areas, which help in understanding trends and the broader context.
• Industry Trends: High R&D industries tend to have high rates of patenting, reflecting their innovation activities.
• Legal Framework: The legal framework, including claim construction and patent eligibility, is crucial in determining the validity and enforceability of patents.
• Policy Updates: Recent updates, such as the 2024 USPTO guidance on AI patents, provide clarity and tools for practitioners.

FAQs

What is the role of the USPTO in the patent system?

The USPTO is responsible for granting patents and ensuring that inventions meet the criteria of novelty, non-obviousness, and usefulness.

How are patent claims constructed and analyzed?

Patent claims are constructed through a legal process that determines the meaning of the terms used. This process involves claim construction, which is subject to de novo review on appeal.

What are the main technology areas for USPTO patents?

The main technology areas include electrical engineering, mechanical engineering, and other fields such as instruments and chemistry, with electrical engineering patents showing significant growth driven by ICT.

How does the USPTO classify patents technologically?

The USPTO uses the World Intellectual Property Organization (WIPO) classification system, which includes 35 technical fields.

What is the significance of the 2024 USPTO guidance on AI patents?

The guidance aims to refine and clarify the process for determining the patent eligibility of AI-related inventions, providing examples and tools for practitioners to evaluate and draft patent claims.

Sources

1. National Science Foundation, "Invention: U.S. and Comparative Global Trends," January 15, 2020.
2. United States Court of Appeals for the Federal Circuit, "VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC.," September 16, 2024.
3. U.S. Patent and Trademark Office, "Patent Claims Research Dataset," August 28, 2017.
4. Mintz, "Understanding the 2024 USPTO Guidance Update on AI Patent," July 25, 2024.
5. Administrative Conference of the United States, "U.S. Patent Small Claims Court," accessed December 20, 2024.

Drugs Protected by US Patent 9,370,582

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	LEQVIO	inclisiran sodium	SOLUTION;SUBCUTANEOUS	214012-001	Dec 22, 2021		RX	Yes	Yes			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

International Family Members for US Patent 9,370,582

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008333811
Australia	2008340354
Australia	2008340355