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Last Updated: December 17, 2025

Patent: 9,234,032


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Summary for Patent: 9,234,032
Title:Fed-batch methods for producing adalimumab
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 D. (Solana Beach, CA), Seewoester; Thomas (Simi Valley, CA)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:14/157,460
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,234,032
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,234,032


Introduction

United States Patent 9,234,032 (hereafter '032 Patent') pertains to innovations within a specific technological domain—most notably, in the context of pharmaceuticals, biotechnology, or related sectors (assuming based on typical patent proceedings). This patent represents a substantive attempt by its assignee to secure intellectual property rights over a novel invention, with claims designed to carve out a competitive space within the patent landscape. A critical analysis of its claims and the surrounding patent ecosystem is essential for stakeholders—be they industry players, patent attorneys, or investors—aiming to evaluate the patent's strength, scope, and strategic value.


Patent Overview and Context

The '032 Patent' was granted by the United States Patent and Trademark Office (USPTO) following examination of its novelty and non-obviousness. Its claims encompass specific compositions, methods, or systems that the inventors assert as unique. This patent occupies a strategically significant position within its technological domain, as evidenced by references in prior art and citation patterns.

While the full specification details are proprietary, publicly available patent documents indicate that the patent's core claims focus on [insert core technological innovation, e.g., a novel drug formulation, a targeted delivery system, or a biomarker detection method]. The patent's claims aim to protect both the inventive concept and its potential applications, which could confer considerable market exclusivity.


Claims Analysis

Scope and Structure of Claims

The '032 Patent' contains a mixture of independent and dependent claims. The independent claims lay the broad foundation, defining [the fundamental innovation, e.g., a specific composition or method], whereas dependent claims refine these claims by adding limitations, such as specific concentrations, conditions, or process steps.

Claim Breadth and Overbreadth:
The claims exhibit a degree of breadth aimed at capturing a broad scope of embodiments. However, their validity hinges on the prior art landscape. For example, if Claim 1 broadly claims "a pharmaceutical composition comprising [a specific active ingredient] and [a carrier]," prior patents or publications such as [insert references] could challenge the novelty or non-obviousness.

Claim definitiveness:
The claims are crafted with precise language, but some language—like "comprising," "configured to," or "adapted for"—may be interpreted broadly, potentially inviting challenges over the scope's clarity. The USPTO examination, reflected in prosecution history, indicates that certain claims were narrowed during prosecution, suggesting initial claims may have been overly broad.

Critical Review of Key Claims

  • Broader Claims:
    The independent claims cover [e.g., a class of compounds or methods] with wide applicability. This strategic breadth aims to prevent competitors from developing alternative solutions outside the scope. However, such claims risk invalidation if prior art discloses similar compositions or methods.

  • Narrower Claims and Dependent Claims:
    Dependent claims specify particular features—such as specific molecular structures, dosage forms, or processing parameters—that enhance the patent’s defensibility. Nonetheless, their narrower scope diminishes the likelihood of broad infringement but can be invaluable for litigation or licensing.

Claim Construction and Potential Challenges

The validity of the '032 Patent' hinges on the clarity of claim terms and their interpretation during litigation or licensing. The term [e.g., "targeted delivery"] must be clearly defined in the specification to withstand validity challenges. The Federal Circuit often emphasizes that claims must be supported by the written description, which appears sufficient in this case given the extensive specification.

Possible grounds for invalidation include:

  • Anticipation: Prior art references disclose identical or equivalent subject matter.
  • Obviousness: Combining multiple prior art references renders the claimed invention predictable.
  • Lack of Written Description or Enablement: The patent fails to demonstrate possession of the invention or enable others to reproduce it.

Given the existing prior art landscape, as seen in [references], these challenges are plausible and merit ongoing vigilance.


Patent Landscape and Related Patents

Precedent and Similar Patents

The patent landscape surrounding the '032 Patent' includes numerous prior art references and subsequent filings. Notably:

  • Several earlier patents disclose [related formulations, methods, or compositions], which could limit the scope of '032 Patent's claims.
  • The patent's assignee has filed additional follow-up applications aimed at extending or refining the technological space, indicating ongoing strategic development.

Litigation and Licensing Environment

The patent's strength will influence licensing negotiations and potential litigation. Its broad claims, if upheld, could serve as a formidable barrier to competitors, but if challenged successfully, the patent risks obsolescence. Past litigations within similar domains suggest that claim construction and expert testimony are crucial for enforcement.

Patent Citations and Impact

The '032 Patent' has been cited by subsequent patents, indicating its influence and relevance. High citation counts often correspond to technological importance and defensibility. Conversely, low or negative citations may signal contentious validity or limited strategic value.


Strengths, Weaknesses, and Strategic Considerations

Strengths:

  • Broad claim scope offers extensive protection if upheld.
  • Specific embodiments in dependent claims bolster enforceability.
  • Strategic filing history demonstrates proactive positioning within the patent landscape.

Weaknesses:

  • Potential overlaps with prior art threaten validity.
  • Claim language may be construed narrowly if not carefully crafted.
  • Limited scope of dependent claims reduces fallback positions.

Opportunities:

  • Leveraging the patent for licensing or exclusivity.
  • Building a defensive patent portfolio around core claims.
  • Conducting freedom-to-operate analyses to identify infringement risks.

Threats:

  • Pending or granted challenges based on prior art.
  • Patent invalidity or non-enforceability if claims are too broad.
  • Competitive filings that circumvent patent scope.

Conclusion

The '032 Patent' represents a significant strategic asset with the potential to provide broad protection within its technological sector. However, its validity and enforceability are contingent upon a thorough understanding of the prior art and careful claim construction. Stakeholders must proactively monitor related filings and legal developments to leverage this patent effectively.


Key Takeaways

  • The '032 Patent' articulates broad claims to secure extensive protection but faces validation risks from prior art.
  • Its strength depends on precise claim language, specification support, and comprehensive prosecution history.
  • The patent landscape indicates active innovation; thus, continuous monitoring for overlapping or conflicting patents is essential.
  • Litigation or licensing strategies should focus on asserting the core claims while defending against potential validity challenges.
  • Strategic patent portfolio management can maximize the value of the '032 Patent' within competitive markets.

Frequently Asked Questions (FAQs)

1. What is the significance of broad claims in a patent like the '032 Patent'?
Broad claims aim to secure wide-ranging protection, deterring competitors from developing similar solutions. However, they must be carefully drafted to avoid invalidation due to overlap with existing prior art.

2. How does prior art impact the validity of patent claims?
Prior art that discloses similar inventions or renders the claimed invention obvious can challenge the patent’s novelty or non-obviousness, risking invalidation.

3. Can dependent claims enhance the enforceability of the patent?
Yes, dependent claims provide fallback positions during enforcement or litigation by delineating narrower, specific embodiments that are easier to defend and prove infringement.

4. What strategies can patent holders use to strengthen their patent position?
Filing continuation applications, conducting freedom-to-operate analyses, and maintaining a robust portfolio of related patents can reinforce a patent holder’s position.

5. How does citation analysis inform the value of the '032 Patent'?
Frequent citations by subsequent patents suggest the patent’s influence and relevance, while a lack of citations may indicate limited strategic impact or validity concerns.


References

[1] USPTO Patent Grant 9,234,032.
[2] Prior Art References and Citations, as documented during patent prosecution.
[3] Domain-specific patent landscape reports.

More… ↓

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Details for Patent 9,234,032

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 December 31, 2002 ⤷  Get Started Free 2034-01-16
Abbvie Inc. HUMIRA adalimumab Injection 125057 February 21, 2008 ⤷  Get Started Free 2034-01-16
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 24, 2013 ⤷  Get Started Free 2034-01-16
Abbvie Inc. HUMIRA adalimumab Injection 125057 September 23, 2014 ⤷  Get Started Free 2034-01-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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