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Last Updated: March 13, 2025

Patent: 10,259,877


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Summary for Patent: 10,259,877
Title:Methods for treating or preventing migraine headache
Abstract:The present invention relates to methods of migraine prophylaxis using anti-CGRP receptor antibodies or binding fragments. In particular, methods for preventing or reducing the occurrence of migraine headache in a patient in need thereof comprising administering to the patient an anti-CGRP receptor or binding fragment according to specific dosage regimens are disclosed. Pharmaceutical compositions and administration devices comprising anti-CGRP receptor antibodies or binding fragments for use in the methods are also described.
Inventor(s):Sun Hong, Dunayevich Eduardo, Lenz Robert A., Vargas Gabriel
Assignee:AMGEN INC.
Application Number:US15136736
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive Analysis of the Claims and Patent Landscape for United States Patent 10,259,877

Introduction

Patent analysis is a crucial step in understanding the intellectual property landscape, particularly for businesses and inventors looking to protect their innovations or navigate the competitive market. This article will delve into a comprehensive and critical analysis of the claims and the patent landscape for United States Patent 10,259,877, focusing on key aspects such as claim construction, patent quality, and the broader patent landscape.

Understanding Patent Claims

Claim Construction and Interpretation

Patent claims are the heart of a patent, defining the scope of the invention and the rights granted to the patent holder. The construction and interpretation of claims are critical in determining the validity and enforceability of a patent. As highlighted in the case of Nature Simulation Systems Inc. v. Autodesk, Inc., the judicial role is to construe the claim as a matter of law, considering the intrinsic record of the patent document, including the words of the claims, the specification, the prosecution history, and sometimes extrinsic evidence[2].

For United States Patent 10,259,877, it is essential to analyze the claims in the context of the specification and prosecution history to understand their scope and boundaries. This involves identifying any ambiguities or indefiniteness issues, which could impact the patent's validity.

Clarity and Precision

The clarity and precision of patent claims are paramount. According to Section 112(b) of the U.S. Patent Act, claims must be "particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention"[2]. The Supreme Court has emphasized that claims must be precise enough to afford clear notice of what is claimed, thereby informing the public of what is still open to them[2].

Patent Quality and Examination

Definition of Patent Quality

The quality of a patent is a multifaceted concept that includes meeting statutory requirements for novelty, clarity, and other criteria. The U.S. Patent and Trademark Office (USPTO) has been working to improve patent quality through initiatives such as the Enhanced Patent Quality Initiative. However, there is a need for a consistent definition of patent quality articulated in agency documents and guidance[4].

For a patent like 10,259,877, evaluating its quality involves assessing whether it meets these statutory requirements and whether it would be upheld if challenged in a lawsuit.

Examination Process

The examination process at the USPTO is crucial in ensuring that patents meet the required standards. The USPTO has increased the time available for certain art units to perform thorough examinations, recognizing that different technology areas may require more time for searching and evaluation[4].

Understanding the examination process and any challenges faced during the prosecution of 10,259,877 can provide insights into the patent's strength and potential vulnerabilities.

Patent Landscape and Family Searching

Patent Family and Related Patents

Patent family searching is essential for understanding the scope and coverage of related patents. This involves analyzing the initial set of claims presented in the patent application and any amendments or narrowing of claims that occurred during the prosecution process. Claims within a patent family may differ due to interactions between the applicant and the patent office[3].

For 10,259,877, identifying related patents within its family can help in understanding the broader intellectual property landscape and potential licensing or litigation issues.

Multi-Jurisdiction Filing and Complexity

Patent family searching is complicated by multi-jurisdiction filing, inconsistencies in indexing across databases, language barriers, and the scientific sophistication of the innovation. These complexities must be navigated to make informed decisions about seeking licenses, challenging patent validity, or allocating resources to R&D initiatives[3].

Export Control and Deemed Export Requirements

EAR and Foreign Filing Requirements

For patents that involve technology subject to the Export Administration Regulations (EAR), it is crucial to understand the nexus between export and deemed export requirements. Technology included in a patent application may require a license from the Bureau of Industry and Security (BIS) prior to export or reexport, especially if it involves foreign nationals or foreign filing[1].

For 10,259,877, determining whether the technology is subject to the EAR and if any export or deemed export licenses are required is vital to comply with regulatory requirements.

Inter Partes Review and Patent Challenges

PTAB and Administrative Challenges

The Leahy-Smith America Invents Act (AIA) introduced significant changes to U.S. patent law, including the creation of the Patent Trial and Appeal Board (PTAB). PTAB hears administrative challenges to the validity of patents, such as inter partes review. Understanding these processes is crucial for patent holders and challengers alike[5].

For 10,259,877, being aware of the potential for PTAB challenges and the criteria used to determine patentability, such as the Alice/Mayo test for ineligible subject matter, is essential for maintaining the patent's validity.

Key Takeaways

  • Claim Construction: Analyze claims in the context of the specification and prosecution history to ensure clarity and precision.
  • Patent Quality: Evaluate the patent against statutory requirements and USPTO guidelines for quality.
  • Patent Landscape: Conduct thorough patent family searching to understand related patents and potential licensing or litigation issues.
  • Export Control: Determine if the technology is subject to EAR and comply with export and deemed export requirements.
  • Administrative Challenges: Be prepared for potential PTAB challenges and understand the criteria for patentability.

FAQs

What is the importance of claim construction in patent analysis?

Claim construction is crucial as it defines the scope of the invention and the rights granted to the patent holder. It helps in determining the validity and enforceability of a patent.

How does the USPTO ensure patent quality?

The USPTO ensures patent quality through initiatives like the Enhanced Patent Quality Initiative, consistent definitions articulated in agency documents, and increased examination time for certain technology areas.

What are the challenges in patent family searching?

Patent family searching is complicated by multi-jurisdiction filing, inconsistencies in indexing, language barriers, and the scientific sophistication of the innovation.

What are the implications of EAR on patent applications?

Technology included in a patent application may require a license from BIS prior to export or reexport, especially if it involves foreign nationals or foreign filing.

How does PTAB impact patent validity?

PTAB hears administrative challenges to the validity of patents, such as inter partes review, and uses criteria like the Alice/Mayo test to determine patentability.

Sources

  1. BIS - nexus between export and deemed export requirements under the EAR and the foreign filing requirement.
  2. UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT - Nature Simulation Systems Inc. v. Autodesk, Inc..
  3. CAS.org - Advanced patent searching techniques.
  4. GAO - Intellectual Property: Patent Office Should Define Quality, Reassess Incentives.
  5. Congressional Research Service - The Patent Trial and Appeal Board and Inter Partes Review.

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Details for Patent 10,259,877

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 May 17, 2018 10,259,877 2036-04-22
Amgen Inc. AIMOVIG erenumab-aooe Injection 761077 March 11, 2019 10,259,877 2036-04-22
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
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