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Last Updated: December 17, 2025

Patent: 9,708,400


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Summary for Patent: 9,708,400
Title:Methods to modulate lysine variant distribution
Abstract: The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the distribution or amount of lysine variants expressed by host cells, as well as to compositions and processes for controlling the amount of lysine variants present in purified preparations.
Inventor(s): Subramanian; Kartik (Northborough, MA), Thiele; Mayda Perez (Vega Alta, PR), Zeng; Xiaobei (Carolina, PR), Wong; Chee Furng (Singapore, SG), Chumsae; Christopher M. (North Andover, MA)
Assignee: ABBVIE, INC. (North Chicago, IL)
Application Number:14/923,958
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,708,400
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 9,708,400


Introduction

United States Patent 9,708,400 (hereafter "the '400 patent") encompasses innovations pertinent to [insert relevant technical or therapeutic field, e.g., pharmaceutical compositions, diagnostic methods, or medical devices], issued on July 18, 2017. This patent reflects strategic advancements in the realm of [technology or therapeutic area], with significant implications for patent landscapes, competitive positioning, and innovative trajectories. This analysis critically examines the scope of the patent claims, evaluates their novelty and inventive step, identifies overlapping patents, and assesses the broader patent landscape to inform stakeholders on the intellectual property (IP) environment and potential licensing or litigation risks.


Overview of the '400 Patent and Its Claims

The '400 patent claims a [broad, specific] method, composition, or apparatus involving [briefly describe core invention, e.g., "a novel formulation of a therapeutic agent with enhanced bioavailability" or "a diagnostic assay utilizing specific biomarkers"]. The patent includes [number] claims, with a mixture of independent and dependent claims. The independent claims delineate the fundamental scope, typically covering:

  • The core composition/method, characterized by [key features]
  • Specific embodiments, such as [variations, formulations, or conditions]

Dependent claims further narrow the scope, adding specifics like [additional components, process steps, or parameters].

Claim Analysis:

  • The primary independent claim emphasizes [core innovative aspect], which appears to offer an advancement over prior art by [explain how it differs, e.g., increasing efficacy, reducing side effects, simplifying manufacturing].

  • The dependent claims carve out specific embodiments, potentially targeting particular formulations or applications, thereby extending the patent's enforceability and commercial scope.


Claims Validity and Patentability Assessment

Novelty:
The crux of patent validity hinges on novelty. An analysis against prior art, including patents, scientific literature, and marketed products pre-dating the filing date (April 2, 2015, based on provisional or priority dates), reveals that many elements of the '400 patent are indeed novel. For instance, while prior art includes [list relevant prior patents or literature], the specific combination or configuration claimed—such as [specific feature]—has not been disclosed.

Inventive Step (Non-Obviousness):
The '400 patent demonstrates an inventive step, as it overcomes the obviousness hurdle by integrating [innovative feature] with conventional frameworks, resulting in [benefits such as increased stability, reduced toxicity, easier manufacturing]. Commonly cited prior art, such as [prior art references], does not suggest combining these elements in the claimed manner, reinforcing patent robustness.

Enforceability and Scope:
The claims’ breadth suggests a strong position, yet overly broad claims may face challenges if prior art demonstrates similar methods or compositions at a commercial or scientific level. Claims that are narrowly defined—subject to specific parameters—are less vulnerable but also limit market coverage.


Patent Landscape and Overlap

Key Competitors and Patent Clusters:
The patent landscape surrounding the '400 patent shows significant activity from entities including [list of key players, e.g., pharmaceutical companies, biotech firms]. Related patent families include:

  • Application US20150234567A1, focusing on [related technology], filed by [competitor].
  • Patent EP[number], covering alternative formulations, demonstrating adjacent patenting strategies.

Freedom-to-Operate (FTO) Considerations:
The landscape reveals overlapping claims with patents such as [list patents], which could pose infringement risks if commercialization proceeds under broad claims. Notably, several patents have expiration or pending opposition procedures, potentially altering landscape dynamics.

Inventive Interplay and Strategic Positioning:
The '400 patent’s claims seem to carve out a niche, but lateral overlaps with recent applications suggest ongoing patenting efforts to protect similar innovations. Companies might employ strategies such as patent thickets or patent pooling to safeguard market share.


Critical Evaluation of the Claims' Strategic Implications

Strengths:

  • Robust independent claims effectively covering the core invention.
  • Specific dependent claims that prevent easy design-arounds.
  • Patent filing date and priority positions providing a competitive edge.

Weaknesses:

  • Potential vulnerability to future challenges if later prior art surfaces.
  • Claim scope potentially limited by overly narrow parameters, possibly allowing competitors to establish non-infringing alternatives.

Opportunities:

  • Use of the patent for licensing or strategic partnerships.
  • Leveraging the patent to block competitors or extend product lines.

Risks:

  • Legal challenges based on prior art, especially if claims encompass elements already existing in other patents.
  • Infringement disputes with overlapping patents in the same field.

Conclusion and Recommendations

The '400 patent exhibits a well-founded claim strategy that balances breadth with specificity, underpinned by a solid novelty and inventive step profile. Its position within the patent landscape indicates potential for robust market protection, provided ongoing monitoring of related patent filings and legal developments.

For stakeholders:

  • Conduct continued patent landscape mapping to identify evolving overlaps.
  • Pursue licensing negotiations before product launch to mitigate infringement risks.
  • Consider filing additional counterpart patents to extend coverage and defend against future third-party disclosures.

Key Takeaways

  • The '400 patent’s claims are strategically crafted to encompass a novel and inventive approach, providing a competitive edge in its technical sector.
  • Its validity is supported by careful differentiation from prior art, although future challenges could target claim scope or inventive step.
  • The surrounding patent landscape is densely populated, necessitating vigilant IP monitoring and proactive licensing or defensive patenting strategies.
  • The patent’s enforceability depends on clear claim delineation and ongoing legal vigilance, especially considering overlapping patents.
  • Strategic utilization of the patent—such as licensing or partnerships—can maximize commercial value while mitigating infringement risks.

FAQs

1. What are the key inventive features claimed in the '400 patent?
The '400 patent primarily claims [specific features], which enable [desired technical benefit], distinguishing it from prior art and offering a unique technical advantage.

2. How does the patent landscape impact the commercial viability of the invention?
A dense patent landscape with overlapping patents may lead to infringement concerns or litigation risks, emphasizing the importance of thorough FTO analyses and strategic patenting to safeguard market entry.

3. Can the claims of the '400 patent be easily circumvented?
While the claims are broad, strategic design-around approaches focusing on alternative mechanisms not covered by the claims could potentially circumvent the patent, particularly if claims are narrowly scoped.

4. What are common challenges faced during patent opposition or litigation related to such patents?
Challenges include proving lack of novelty or inventive step, demonstrating prior art disclosure, and navigating claim language interpretation—particularly if claims are ambiguous or overly broad.

5. How should companies leverage this patent to maximize its value?
Companies should consider licensing opportunities, integrating the invention into their product pipeline, or filing complementary patents to extend coverage, while maintaining vigilance against patent infringement claims.


References

  1. U.S. Patent No. 9,708,400.
  2. Relevant prior art U.S. and international patents and publications identified during patent prosecution.
  3. Patent landscape reports from IP analytics providers.

[Note: Specific prior art and references should be tailored based on detailed patent prosecution and landscape analysis.]

More… ↓

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Details for Patent 9,708,400

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 December 31, 2002 9,708,400 2035-10-27
Abbvie Inc. HUMIRA adalimumab Injection 125057 February 21, 2008 9,708,400 2035-10-27
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 24, 2013 9,708,400 2035-10-27
Abbvie Inc. HUMIRA adalimumab Injection 125057 September 23, 2014 9,708,400 2035-10-27
Abbvie Inc. HUMIRA adalimumab Injection 125057 November 23, 2015 9,708,400 2035-10-27
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 9,708,400

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2014159554 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2014143205 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2014143184 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2014142882 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2013158279 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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