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Last Updated: December 22, 2024

Patent: 11,066,458


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Summary for Patent: 11,066,458
Title:VEGF antagonist formulations suitable for intravitreal administration
Abstract:Ophthalmic formulations of a vascular endothelial growth factor (VEGF)-specific fusion protein antagonist are provided suitable for intravitreal administration to the eye. The ophthalmic formulations include a stable liquid formulation and a lyophilizable formulation. Preferably, the protein antagonist has an amino acid sequence of SEQ ID NO:4.
Inventor(s):Furfine Eric, Dix Daniel, Graham Kenneth, Frye Kelly
Assignee:REGENERON PHARMACEUTICALS, INC.
Application Number:US16582486
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Understanding the Claims and Patent Landscape of United States Patent 11,066,458

Introduction

When analyzing the claims and patent landscape of a specific patent, such as United States Patent 11,066,458, it is crucial to delve into the intricacies of patent law, the structure of the patent itself, and the broader legal and competitive context. Here, we will provide a comprehensive and critical analysis of the key aspects involved.

Overview of Patent 11,066,458

To begin, it is essential to understand the subject matter of the patent. While the specific details of U.S. Patent 11,066,458 are not provided in the sources, we can infer general principles from similar patents and patent litigation cases.

Structure of a Patent

Components of a Patent

A nonprovisional patent application, like the one for U.S. Patent 11,066,458, must include several key components:

  • Claims: These define the scope of the invention and are critical for determining infringement and validity[4].
  • Abstract: A brief summary of the invention.
  • Description: A detailed explanation of the invention.
  • Oath or Declaration: A statement by the inventor attesting to their role in the invention.
  • Drawings: Visual representations of the invention, if applicable[4].

Claims Analysis

Types of Claims

Patent claims can be categorized into several types:

  • Independent Claims: Standalone claims that define the invention without reference to other claims.
  • Dependent Claims: Claims that refer back to and further limit an independent claim[4].
  • Product Claims: Claims that cover the physical product itself.
  • Process Claims: Claims that cover the method of making or using the product[4].

Claim Construction

The process of interpreting the meaning of patent claims is known as claim construction. This is often a contentious issue in patent litigation, as the interpretation can significantly affect the scope of protection and potential infringement. Courts may use various tools, including the patent specification and prosecution history, to determine the meaning of claim terms[1].

Patent Infringement and Validity

Infringement

Patent infringement occurs when a party makes, uses, sells, or imports a product or process that falls within the scope of the claims of an issued patent. In the context of U.S. Patent 11,066,458, any analysis would need to determine whether the accused product or process infringes any of the claims. This often involves a detailed comparison of the accused product against the claim language[5].

Validity

The validity of a patent can be challenged on several grounds, including:

  • Anticipation: Whether the invention was previously known or described.
  • Obviousness: Whether the invention would have been obvious to a person of ordinary skill in the relevant field.
  • Lack of Written Description: Whether the patent specification adequately describes the invention.
  • Lack of Enablement: Whether the patent specification enables a person of ordinary skill to make and use the invention.
  • Indefiniteness: Whether the claims are clear and definite[1][5].

Patent Landscape and Litigation

Patent Litigation Process

In cases involving U.S. Patent 11,066,458, the litigation process might follow a similar pattern to other patent disputes:

  • Pre-Litigation Exchanges: Parties may engage in negotiations and exchanges of detailed statements regarding the patents in question, as mandated by 42 U.S.C. § 262(l)[5].
  • Claim Construction: The court may hold a Markman hearing to construe the meaning of disputed claim terms.
  • Infringement and Validity Determinations: The court will determine whether the accused product infringes the claims and whether the claims are valid.

Recent Cases and Precedents

Recent cases involving Regeneron Pharmaceuticals, such as the disputes over Eylea® (aflibercept), highlight the complexity and rigor involved in patent litigation. These cases often involve multiple patents, detailed claim constructions, and challenges to validity and infringement[1][3][5].

Strategic Considerations

Patent Portfolio Management

Companies must manage their patent portfolios strategically, ensuring that their patents are robust and defensible. This includes:

  • Broad and Narrow Claims: Balancing broad claims for maximum protection with narrow claims to avoid invalidation[4].
  • Claim Variations: Using multiple claim types to cover different aspects of the invention[4].

Competitive Landscape

Understanding the competitive landscape is crucial. Companies must monitor competitors' patent filings and litigation activities to anticipate potential challenges and opportunities.

Key Takeaways

  • Detailed Claims Analysis: Understanding the types and scope of claims is essential for determining infringement and validity.
  • Claim Construction: The interpretation of claim terms can significantly impact the outcome of patent litigation.
  • Patent Litigation Process: Pre-litigation exchanges, claim construction, and determinations of infringement and validity are critical steps.
  • Strategic Patent Management: Managing a patent portfolio requires balancing broad and narrow claims and monitoring the competitive landscape.

FAQs

What are the key components of a nonprovisional patent application?

A nonprovisional patent application must include claims, an abstract, a description, an oath or declaration, and in most cases, drawings[4].

How is patent infringement determined?

Patent infringement is determined by comparing the accused product or process against the claim language of the issued patent to see if it falls within the scope of the claims[5].

What are the common grounds for challenging the validity of a patent?

Common grounds include anticipation, obviousness, lack of written description, lack of enablement, and indefiniteness[1][5].

Why is claim construction important in patent litigation?

Claim construction is crucial because it determines the meaning of the claim terms, which can significantly affect the scope of protection and potential infringement[1].

How do companies manage their patent portfolios strategically?

Companies manage their patent portfolios by balancing broad and narrow claims, using multiple claim types, and monitoring the competitive landscape[4].

Sources

  1. Regeneron Pharm. v. Mylan Pharm., CIVIL 1:22-CV-61 (KLEEH)
  2. Regeneron Pharmaceuticals Inc. Form 10K
  3. IN RE: AFLIBERCEPT PATENT LITIGATION (2024) | FindLaw
  4. WIPO Patent Drafting Manual: Second edition
  5. Regeneron Pharmaceuticals, Inc. v. Celltrion, Inc., No. 24-cv-00053-TSK

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Details for Patent 11,066,458

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Regeneron Pharmaceuticals, Inc. EYLEA aflibercept Injection 125387 November 18, 2011 ⤷  Subscribe 2039-09-25
Regeneron Pharmaceuticals, Inc. EYLEA aflibercept Injection 125387 August 16, 2018 ⤷  Subscribe 2039-09-25
Regeneron Pharmaceuticals, Inc. EYLEA HD aflibercept Injection 761355 August 18, 2023 ⤷  Subscribe 2039-09-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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