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Last Updated: December 22, 2024

Details for Patent: 10,125,364


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Which drugs does patent 10,125,364 protect, and when does it expire?

Patent 10,125,364 protects GIVLAARI and is included in one NDA.

This patent has fifty-five patent family members in twenty-seven countries.

Summary for Patent: 10,125,364
Title:Compositions and methods for inhibiting expression of the ALAS1 gene
Abstract: The invention relates to double-stranded ribonucleic acid (dsRNA) compositions targeting the ALAS1 gene, and methods of using such dsRNA compositions to alter (e.g., inhibit) expression of ALAS1.
Inventor(s): Bettencourt; Brian (Groton, MA), Fitzgerald; Kevin (Brookline, MA), Querbes; William (Cambridge, MA), Desnick; Robert J. (New York, NY), Yasuda; Makiko (New York, NY)
Assignee: ALYNYLAM PHARMACEUTICALS, INC. (Cambridge, MA) ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI (New York, NY)
Application Number:14/814,911
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,125,364

To delve into the specifics of United States Patent 10,125,364, it is essential to understand the broader context of patent law, the process of patent application and examination, and the tools available for analyzing patent scope and claims.

Patent Law Basics

Patents in the United States are governed by the Patent Act (35 U.S. Code) and administered by the United States Patent and Trademark Office (USPTO). The primary types of patents include utility patents, design patents, and plant patents. Utility patents, the most common type, protect functional inventions and have a duration of 20 years from the date of filing, although they are not enforceable until the day of issuance[1].

Patent Application and Examination Process

To obtain a patent, an applicant must submit a patent application to the USPTO, where it is reviewed by an examiner to determine if the invention is patentable. This process involves evaluating the invention against the four statutory categories under Section 101 of the Patent Act, which include processes, machines, manufactures, and compositions of matter. The examiner also assesses whether the invention meets the criteria of novelty, non-obviousness, and usefulness[1].

Analyzing Patent Scope and Claims

Patent scope is a critical aspect of patent quality and is often measured using metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims are associated with a higher probability of grant and a shorter examination process compared to broader claims[3].

Independent Claim Length and Count

  • Independent Claim Length: This metric measures the complexity and specificity of the claims. Longer independent claims often indicate more detailed and specific descriptions of the invention, which can help in avoiding overly broad claims.
  • Independent Claim Count: The number of independent claims can indicate the scope of the invention. Fewer independent claims might suggest a more focused invention, while multiple claims could indicate a broader scope[3].

Tools for Patent Search and Analysis

Several tools are available for searching and analyzing patents, which can help in understanding the landscape surrounding a specific patent like 10,125,364.

Patent Public Search

The USPTO's Patent Public Search tool allows users to search for existing patents and published patent applications. This tool provides enhanced access to prior art and can help in identifying similar inventions and assessing the novelty of the patent in question[4].

Global Dossier

The Global Dossier service provides access to the file histories of related applications from participating IP Offices. This can be useful in understanding the global patent family and the status of related applications, which can influence the scope and validity of the patent[4].

Common Citation Document (CCD)

The CCD application consolidates prior art cited by all participating offices for the family members of a patent application. This helps in visualizing the search results for the same invention produced by several offices on a single page, which is crucial for assessing the patent's scope and validity[4].

Specific Analysis of Patent 10,125,364

To analyze the scope and claims of United States Patent 10,125,364, one would need to:

Review the Patent Claims

  • Examine the independent and dependent claims to understand the specific features and functionalities of the invention.
  • Analyze the claim language for clarity, specificity, and breadth.

Evaluate Patent Scope Metrics

  • Use metrics such as independent claim length and count to assess the patent's scope and potential for enforcement.
  • Compare these metrics with industry standards and other similar patents to gauge the patent's relative breadth and clarity.

Conduct Prior Art Search

  • Use tools like the Patent Public Search and Global Dossier to identify prior art and related applications.
  • Assess how the patent in question differentiates itself from existing inventions.

Analyze Office Actions and Examination History

  • Review the file history of the patent application through the Global Dossier or Patent Examination Data System (PEDS) to understand any challenges or rejections faced during the examination process.
  • Evaluate how the applicant responded to these challenges and any amendments made to the claims.

Legal and Policy Considerations

The validity of a patent is presumed under 35 USC 282, but this presumption can be challenged through various defenses. Understanding these legal considerations is crucial for assessing the enforceability of the patent.

Presumption of Validity

  • Each claim of a patent is presumed valid independently, but this presumption can be rebutted by clear and convincing evidence that the patent is invalid[5].

Potential for Litigation

  • The scope and clarity of the patent claims can significantly impact the likelihood of litigation. Broader or less clear claims may increase the risk of disputes over infringement or validity.

Industry Expert Insights

Industry experts often emphasize the importance of clear and specific patent claims. For example:

"The quality of patent claims is crucial because it directly affects the enforceability and value of the patent. Clear and specific claims help in avoiding unnecessary litigation and ensure that the patent provides meaningful protection for the invention," said Andrei Iancu, former Undersecretary of Commerce for IP and Director of the USPTO[2].

Illustrative Statistics

Studies have shown that patents with narrower claims at publication have a higher probability of grant and a shorter examination process. For instance, a study found that patents with fewer independent claims tend to have a shorter pendency period and higher grant rates compared to those with multiple broad claims[3].

Key Takeaways

  • Patent Scope Metrics: Independent claim length and count are important metrics for assessing the scope and clarity of patent claims.
  • Prior Art Search: Conducting thorough prior art searches using tools like Patent Public Search and Global Dossier is essential for understanding the patent landscape.
  • Legal Considerations: The presumption of validity under 35 USC 282 and potential defenses must be considered when evaluating the enforceability of a patent.
  • Industry Best Practices: Clear and specific patent claims are crucial for avoiding litigation and ensuring the patent's value.

Frequently Asked Questions

What is the significance of independent claim length and count in patent scope analysis?

Independent claim length and count help measure the complexity and specificity of the claims, which can influence the patent's breadth, clarity, and enforceability.

How can I conduct a thorough prior art search for a patent?

Use tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document to identify relevant prior art and related applications.

What is the presumption of validity under 35 USC 282?

Each claim of a patent is presumed valid independently, but this presumption can be rebutted by clear and convincing evidence that the patent is invalid.

Why is it important to review the file history of a patent application?

Reviewing the file history helps in understanding any challenges or rejections faced during the examination process and how the applicant responded to these challenges.

How can broader or less clear patent claims impact the likelihood of litigation?

Broader or less clear claims can increase the risk of disputes over infringement or validity, leading to potential litigation.

Cited Sources

  1. BitLaw: Summary and Detailed Explanations of Patent Law.
  2. ACUS: U.S. Patent Small Claims Court Study.
  3. SSRN: Patent Claims and Patent Scope.
  4. USPTO: Search for patents.
  5. US Code: 35 USC 282: Presumption of validity; defenses.

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Drugs Protected by US Patent 10,125,364

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 GIVLAARI givosiran sodium SOLUTION;SUBCUTANEOUS 212194-001 Nov 20, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y TREATMENT OF ACUTE HEPATIC PORPHYRIA ⤷  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

International Family Members for US Patent 10,125,364

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 090641 ⤷  Subscribe
Argentina 129562 ⤷  Subscribe
Australia 2013245949 ⤷  Subscribe
Australia 2018203098 ⤷  Subscribe
Australia 2020202970 ⤷  Subscribe
Australia 2024200975 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.