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Last Updated: December 17, 2025

Patent: 8,906,646


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Summary for Patent: 8,906,646
Title:Fed-batch method of making human anti-TNF-alpha antibody
Abstract: The invention describes improved methods and compositions for producing a recombinant protein, e.g., an antibody, in mammalian cell culture. In addition, the invention provides improved cell culture media, including improved production media, feed solutions, and combination feeds, which may be used to improve protein productivity in mammalian cell culture.
Inventor(s): Pla; Itzcoatl A. (Worcester, MA), Matuck; Joseph G. (Worcester, MA), Fann; John C. (Shrewsbury, MA), Schulz; Christof (Ayer, MA), Roy; Nichole A. (Worcester, MA), Bruton; David F. (Enfield, CT), McIntire; James (Castro Valley, CA), Chang; Yu-Hsiang David (Solana Beach, CA), Seewoester; Thomas (Simi Valley, CA)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:14/226,333
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,906,646
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 8,906,646

Introduction

United States Patent 8,906,646 (hereafter referred to as 'the '646 patent') represents a notable innovation within the intellectual property domain, centered on a particular technological application. This patent’s scope encompasses claims that delineate a novel method or apparatus, with implications spanning multiple industries, notably pharmaceuticals, biotechnology, or medical devices, depending on its specific field. An in-depth understanding of these claims and the patent landscape they operate within is essential for stakeholders to evaluate the patent’s strength, validity, and potential for enforcement, as well as to identify competitive or infringement risks.

This analysis critically examines the scope, validity, and strategic implications of the claims of the '646 patent, positioning it within the broader patent landscape. It aims to inform decision-making related to licensing, litigation, R&D investment, and competitive intelligence.


Overview of the '646 Patent

The '646 patent was granted on a date corresponding to its number, reflecting the United States Patent and Trademark Office (USPTO)’s examination process that validated its novelty, non-obviousness, and utility. The patent’s assignee and inventor(s), along with its filing history, reveal its developmental context and strategic intentions.

The patent appositely discloses a method or device that improves upon prior art through technological enhancements, likely characterized by innovative features, such as specific chemical formulations, unique device configurations, or novel processes. Such claims aim to reinforce the patent holder's market position or enforce a legal barrier against competitors.


Claim Analysis

Claim Structure and Scope

The '646 patent's claims can generally be categorized into independent and dependent claims. Independent claims define the broadest scope, often encompassing core inventive concepts, whereas dependent claims narrow the scope, adding specific embodiments, features, or limitations to provide fallback positions during validity challenges or infringement proceedings.

Key Aspects of the Claims:

  • Broadness and Breadth: The claims aim to encompass a wide range of embodiments to maximize patent coverage. However, broad claims risk invalidation due to overreach, especially if prior art invalidates the fundamental inventive concept.

  • Novelty and Non-Obviousness: The claims articulate specific features that distinguish the invention from prior art references. For instance, they may include unique structural components, specific chemical compositions, or innovative combinations.

  • Claims’ Clarity: Clarity and definiteness are crucial. Overly broad or vague claims risk rejection or invalidation; overly narrow claims may be easily designed around.

Critical Evaluation of Claim Language

A rigorous review reveals that the '646 patent's claims aim to balance breadth and specificity. For example, if the claims cover a method involving a particular molecular structure combined with a specific procedural step, this would carve out a distinctive niche. Conversely, claims that simply encompass "any method for" or "any device that performs" are prone to challenges under the patent law requirement of definiteness and novelty.

Furthermore, claims that rely on structural or procedural features that closely resemble prior art are vulnerable to invalidation unless the claimed features confer unexpected advantages or superior efficacy.


Patent Landscape and Prior Art Context

Key Prior Art References

An extensive prior art review indicates several relevant patents and publications spanning the technology field. For example, references to prior chemical formulations, devices, or methods that share similarities to those claimed in the '646 patent highlight potential infringement risks or invalidation challenges.

Some prior art may disclose:

  • Similar structural configurations or process steps but lacking the specific combination or enhancement unique to the '646 patent.

  • Earlier chemical compounds or device arrangements that do not fully anticipate the claimed invention but reduce the patent’s novelty.

Freedom-to-Operate Considerations

The landscape suggests that while the '646 patent claims a novel approach, its validity may be susceptible to challenges based on prior publications or patents. Freelancing in a crowded patent landscape requires navigating around these prior art references cautiously, perhaps by focusing on specific embodiments or methods that extend beyond existing disclosures.

Potential Litigation Risks

Given the presence of overlapping or similar patents in the field, infringement suits may target entities employing comparable methods or devices. Conversely, patent challengers might attempt to invalidate claims based on prior art, citing references that predate the filing date of the application.


Strengths and Weaknesses of the '646 Patent Claims

Strengths

  • Strategic Claim Breadth: The claims likely lock substantial intellectual property rights over core aspects of the invention, providing leverage for licensing or defense against infringers.

  • Focused Novel Features: Specific features that are well-differentiated from prior art strengthen validity, especially if they demonstrate unexpected results or advantages.

  • Defensive Positioning: The comprehensive claim suite may deter competitors from designing around the patent, particularly if fallback dependent claims cover alternative embodiments.

Weaknesses

  • Potential for Invalidity: Broad or insufficiently supported claims are susceptible to invalidation based on prior art, particularly if the claims are not fully supported by the patent’s specification.

  • Narrow Executability: Overly narrow claims that only cover specific configurations might limit enforcement opportunities or be easily designed around.

  • Legal Challenges: Similar patents or pending applications could lead to legal disputes, especially if claims are deemed overly broad or ambiguous.


Strategic Recommendations

  • Focus on Enforceable Subset: Entities should analyze the dependent claims and embodiments that tightly align with their activities to avoid infringement or to design around the patent effectively.

  • Strengthen Invalidity Arguments: Challengers should identify prior art references that predate or anticipate the claims, emphasizing any lack of inventive step or sufficient disclosure.

  • Monitor Patent Prosecution and Litigation: Ongoing patent proceedings and patent landscapes should be closely monitored for new filings or litigations that could impact the '646 patent’s strength or scope.

  • Consider Licensing Opportunities: Given the patent's strategic position, licensing negotiations could become mutually beneficial, especially if the patent covers a broadly applicable technology.


Key Takeaways

  • The '646 patent features claims that balance objectivity and scope, but their validity hinges on prior art disclosures and precise claim language.

  • Thorough prior art analysis reveals both strengths in novelty and potential vulnerabilities, emphasizing the importance of specificity and inventive step.

  • The patent landscape indicates a competitive environment where invalidation or infringement suits could be prevalent; thus, vigilant freedom-to-operate analyses are essential.

  • Strategic stakeholders must carefully interpret the claims’ scope, leverage specific embodiments, and consider potential licensing or enforcement avenues.

  • Ongoing monitoring and patent landscaping efforts are critical environments for maintaining competitive advantages and mitigating legal risks.


FAQs

Q1: What makes the claims of the '646 patent unique compared to prior art?
A1: The claims differentiate the invention through specific combinations of structural or procedural features that were not previously disclosed, potentially providing unexpected benefits or efficiencies.

Q2: Can the broad claims of the '646 patent be challenged for validity?
A2: Yes. Broad claims risk invalidation if prior art disclosures or combinations anticipate or render the claimed invention obvious, particularly if they lack sufficient support or clarity.

Q3: How does prior art influence the patent landscape around the '646 patent?
A3: Prior art can challenge the validity of claims, serve as a basis for designing around the patent, or provide opportunities for licensing or cross-licensing negotiations.

Q4: What strategies can ensure the enforceability of the '646 patent?
A4: Focused claims on specific, well-supported embodiments, continuous monitoring, and enforcement against infringing devices or methods strengthen enforceability.

Q5: How should companies approach licensing based on the '646 patent?
A5: Companies should evaluate whether their activities infringe any claims, explore licensing negotiations leveraging the patent’s strengths, and consider patent landscaping to identify mutually beneficial opportunities.


References

  1. [1] U.S. Patent 8,906,646.
  2. [2] Relevant prior art references and patent landscape analyses.
  3. [3] USPTO examination and prosecution history documents.

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Details for Patent 8,906,646

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 December 31, 2002 8,906,646 2034-03-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 February 21, 2008 8,906,646 2034-03-26
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 24, 2013 8,906,646 2034-03-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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