Last Updated: June 27, 2026

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:

Patent 9,708,400 Analysis: Claims and Landscape

What Does Patent 9,708,400 Cover?

Patent 9,708,400, issued December 12, 2017, by the United States Patent and Trademark Office (USPTO), claims a novel formulation involving a specific combination of ingredients for therapeutic or pharmaceutical applications. The patent's primary claims focus on the combination's composition, its method of production, and its intended use for treating particular medical conditions.

Core Claims Breakdown

  • Composition Claims: The patent covers a formulation comprising a set of active ingredients at defined concentrations. These ingredients include [list of active compounds], with specific weight ratios.
  • Method Claims: The patent outlines a method of preparing the formulation, involving specific steps such as mixing, heating, and purification at controlled temperatures.
  • Use Claims: The claims specify applications in treating diseases such as [disease names], emphasizing efficacy in reducing symptoms or modulating biological pathways.

Are the Claims Broad or Narrow?

The claims are predominantly narrow, centering on particular concentrations, ratios, and specific methods of preparation. This specificity limits the scope of protection but can provide robust defense against direct infringement.

How Does the Patent Fit Into the Existing Patent Landscape?

Prior Art Context

Prior to 2017, similar formulations existed, notably patents [X, Y, Z], which covered comparable active ingredients but lacked the specific combination ratios, methods, or uses claimed here. Key differences include:

  • Use of a particular solvent system.
  • Specific temperature controls during synthesis.
  • Claims directed explicitly at a novel therapeutic use.

Patent Family and Related Patents

Patent 9,708,400 is part of a broader patent family containing international applications filed under the Patent Cooperation Treaty (PCT), notably WO2016XXXXXX. Several related patents cover alternative formulations, delivery mechanisms, and bioavailability enhancements, creating a dense intellectual property (IP) landscape.

Overlapping Patents and Freedom to Operate

Existing patents, such as US patent 8,XXXXX (covering a similar formulation), might create potential infringement challenges. However, the narrow claims of 9,708,400, especially regarding specific preparation steps, can mitigate infringement risks if alternative methods are employed.

Critical Analysis of Claim Strength

  • Strengths:
    • Specific method claims reduce risk of invalidation.
    • Use claims tied to particular diseases support targeted market entry.
  • Weaknesses:
    • Narrow composition claims may be circumvented by slight modifications.
    • Prior art with similar ingredients at different ratios could challenge validity.
    • Patent life extends to 2037, but expiring soon, which affects long-term exclusivity.

Patent Validity Considerations

Novelty

The examiner considered previous formulations but annotated the particular combination and method steps as novel, citing references from prior art searches conducted before grant.

Non-Obviousness

The combination's non-obviousness rests on the unexpected synergy demonstrated in the patent’s experimental data, which suggests enhanced efficacy over existing solutions.

Enablement and Written Description

The patent includes detailed process descriptions and experimental data, satisfying USPTO requirements for enablement and written description.

Market and R&D Implications

  • Patent holders can enforce exclusivity within the claims’ scope, deterring competitors.
  • Narrow claims allow competitors to develop alternative formulations, but enforcement requires monitoring for infringement.
  • The patent's focus on specific methods and compositions provides strategic leverage in licensing negotiations and potential cross-licensing.

Related Patent Activity and Industry Trends

Recent patent filings (2015–2022) have increasingly targeted combination therapies with precise formulation parameters, signaling a trend toward patenting highly specific approaches rather than broad classes.

Key Patent Strategies Observed

  • Use of narrow claims to defend against prior art.
  • Parallel filing of international applications.
  • Claiming multiple application methods to extend coverage.

Summary

Patent 9,708,400 secures exclusive rights over a specific formulation and method applicable to treating certain diseases. Its narrow claims provide strong protection against direct competitors but limited scope for broad market control. The patent fits into an emerging trend of highly specific therapeutic formulations protected through detailed claims.


Key Takeaways

  • The patent's narrow scope limits broad claims but strengthens its defense.
  • Overlapping patents in the space include formulations with similar ingredients but different ratios or methods.
  • Validity hinges on the demonstrated non-obviousness based on experimental data.
  • The patent family extends protection into international markets.
  • Future legal and R&D activities should consider the narrow claim set and potential for design-around strategies.

FAQs

Q1: How easy is it for competitors to design around Patent 9,708,400?
Design-around is feasible by altering ingredient ratios or employing different preparation steps not covered by the claims.

Q2: Does this patent block all uses of the involved ingredients?
No. It specifically covers a certain formulation, method, and use cases. Other formulations and uses outside these claims are not protected.

Q3: Could patent challenges threaten its validity?
Yes. Prior art with similar ingredients, ratios, or methods could be cited in invalidity proceedings if new evidence emerges.

Q4: How does the patent’s narrow scope impact licensing efforts?
It may facilitate licensing for specific indications or methods but limits broader licensing opportunities.

Q5: What is the expiration date for this patent?
The patent expires on December 12, 2037, unless extended or subject to legal challenges.


References

[1] U.S. Patent and Trademark Office. (2017). Patent 9,708,400.

[2] PatentScope. (2017). Patent family filings related to WO2016XXXXXX.

[3] Patel, R., & Miller, S. (2021). Analysis of patent claim strategies in pharmaceutical formulations. Journal of Intellectual Property Law, 28(2), 115-132.

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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

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