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Last Updated: December 24, 2024

Details for Patent: 10,612,024


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Which drugs does patent 10,612,024 protect, and when does it expire?

Patent 10,612,024 protects AMVUTTRA and OXLUMO and is included in two NDAs.

This patent has thirty patent family members in eleven countries.

Summary for Patent: 10,612,024
Title:Modified double-stranded RNA agents
Abstract: One aspect of the present invention relates to double-stranded RNA (dsRNA) agent capable of inhibiting the expression of a target gene. The sense strand of the dsRNA agent comprises at least one thermally destabilizing nucleotide, and at least one said thermally destabilizing nucleotide occurring at a site opposite to the seed region (positions 2-8) of the antisense strand; and the antisense strand of the dsRNA agent comprises at least two modified nucleotides that provide the nucleotide a steric bulk that is less than or equal to the steric bulk of a 2'-OMe modification, wherein said modified nucleotides are separated by 11 nucleotides in length. Other aspects of the invention relates to pharmaceutical compositions comprising these dsRNA agents suitable for therapeutic use, and methods of inhibiting the expression of a target gene by administering these dsRNA agents, e.g., for the treatment of various disease conditions.
Inventor(s): Maier; Martin (Cambridge, MA), Foster; Don (Cambridge, MA), Milstein; Stuart (Cambridge, MA), Kuchimanchi; Satya (Cambridge, MA), Jadhav; Vasant (Cambridge, MA), Rajeev; Kallanthottathil (Cambridge, MA), Manoharan; Muthiah (Cambridge, MA), Parmar; Rubina (Cambridge, MA)
Assignee: ALNYLAM PHARMACEUTICALS, INC. (Cambridge, MA)
Application Number:16/272,721
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Delivery;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,612,024: A Comprehensive Analysis

Introduction

Patents are a crucial component of intellectual property law, providing inventors and companies with exclusive rights to their innovations. The United States Patent 10,612,024, like any other patent, has a specific scope and set of claims that define its boundaries and protections. This article delves into the details of this patent, exploring its claims, the patent landscape, and relevant legal considerations.

Patent Overview

Patent Number and Title

The United States Patent 10,612,024 is a specific patent that has been granted to an inventor or a company. While the exact title and details of this patent are not provided in the sources, understanding the general structure of a patent is essential.

Filing and Issuance Dates

The filing and issuance dates of a patent are critical in determining its validity and expiration. These dates also play a role in patent term adjustments and any potential terminal disclaimers[2].

Claims and Scope

Claim Structure

Patent claims are the heart of any patent, defining what is protected by the patent. Claims can be independent or dependent and must be clear, concise, and fully supported by the patent specification. The scope of a patent is often measured by metrics such as independent claim length and independent claim count, which can indicate the breadth and clarity of the patent[3].

Written Description Requirement

For a patent claim to be valid, it must meet the written description requirement under 35 U.S.C. § 112. This means the patent specification must provide sufficient detail to demonstrate that the inventor had possession of the claimed invention at the time of filing. Failure to meet this requirement can result in claims being invalidated, as seen in cases like Allergan USA, Inc. v. MSN Laboratories Private Ltd.[1][2].

Enablement Requirement

In addition to the written description, the enablement requirement under 35 U.S.C. § 112 must also be satisfied. This means the patent specification must provide enough information to enable a person of ordinary skill in the relevant field to make and use the invention without undue experimentation.

Patent Landscape

Related Patents and Continuations

Patents often have a complex landscape involving continuations, continuations-in-part, and divisional applications. These related patents can affect the validity and scope of the original patent. For example, in the case of Allergan USA, Inc. v. MSN Laboratories Private Ltd., the relationship between the '356 patent and its child patents (the '011 and '709 patents) was crucial in determining the validity of claim 40 under the doctrine of obviousness-type double patenting[2][4].

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that prevents the extension of patent term by filing multiple patents on the same invention. A later-filed, later-issued patent cannot be used as an ODP reference against an earlier-filed, earlier-issued patent if the earlier patent is the first to cover the claimed subject matter[4].

Legal Considerations

Inventorship

Determining the true and only inventors is a critical aspect of patent law. US patent law requires that the inventors listed on the patent application are those who conceived the idea and reduced it to practice. Incorrect inventorship can lead to patent invalidity[5].

Patent Term Adjustments (PTA)

PTA can extend the term of a patent due to delays in the prosecution process. However, these adjustments must be carefully considered to avoid unjustified extensions of patent term, as seen in cases where multiple related patents receive PTA, leading to potential ODP issues[1][4].

Case Law and Precedents

Allergan USA, Inc. v. MSN Laboratories Private Ltd.

This case highlights the importance of the written description requirement and the doctrine of ODP. The district court's decision to invalidate certain claims due to lack of written description and the appellate court's affirmation of the ODP analysis provide valuable insights into how these legal principles are applied[1][2].

Impact on Innovation

Patent Quality and Scope

The scope and quality of patents can significantly impact innovation. Broader, less clear patents can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. Narrower, clearer patents, on the other hand, are associated with a higher probability of grant and a shorter examination process[3].

Practical Implications

Strategic Patent Filings

Companies and inventors must strategically file patents to ensure they meet all legal requirements and maximize their protection. This includes careful drafting of claims, ensuring compliance with the written description and enablement requirements, and managing the patent landscape to avoid ODP issues.

Litigation and Enforcement

Understanding the scope and claims of a patent is crucial for litigation and enforcement. Patent holders must be able to defend their patents against challenges such as lack of written description or ODP, while also being aware of the potential for invalidation.

Key Takeaways

  • Clear and Concise Claims: Patent claims must be clear, concise, and fully supported by the patent specification.
  • Written Description and Enablement: These requirements are critical for the validity of patent claims.
  • Patent Landscape Management: Understanding the relationship between related patents is essential to avoid ODP and other validity issues.
  • Inventorship Accuracy: Correctly determining the true and only inventors is vital for patent validity.
  • Strategic Filings: Companies should strategically file patents to maximize protection and avoid legal challenges.

FAQs

Q: What is the significance of the written description requirement in patent law?

A: The written description requirement ensures that the patent specification provides sufficient detail to demonstrate that the inventor had possession of the claimed invention at the time of filing.

Q: How does obviousness-type double patenting (ODP) affect patent validity?

A: ODP prevents the extension of patent term by filing multiple patents on the same invention, ensuring that later-filed patents cannot be used to invalidate earlier-filed patents if the earlier patent is the first to cover the claimed subject matter.

Q: Why is accurate inventorship important in patent applications?

A: Accurate inventorship is crucial because incorrect inventorship can lead to patent invalidity. US patent law requires that only the true and only inventors be listed on the patent application.

Q: How do patent term adjustments (PTA) impact the patent term?

A: PTA can extend the term of a patent due to delays in the prosecution process, but these adjustments must be carefully managed to avoid unjustified extensions of patent term.

Q: What metrics can be used to measure patent scope?

A: Metrics such as independent claim length and independent claim count can be used to measure patent scope, indicating the breadth and clarity of the patent[3].

Sources

  1. Allergan U.S. v. MSN Labs. Private Ltd., No. 2024-1061 - Casetext
  2. ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - CAFC
  3. Patent Claims and Patent Scope - SSRN
  4. The Obviousness-Type Double Patenting Saga Continues - JD Supra
  5. Determining Inventorship for US Patent Applications - Oregon State University

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Drugs Protected by US Patent 10,612,024

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 ⤷  Subscribe ⤷  Subscribe Y Y AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS ⤷  Subscribe
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

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