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Last Updated: April 1, 2026

Patent: 9,334,319


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Summary for Patent: 9,334,319
Title:Low acidic species compositions
Abstract: The instant invention relates to the field of protein production and purification, and in particular to compositions and processes for controlling the amount of charge variants, aggregates, and fragments of a protein of interest, as well as host cell proteins, present in purified preparations by applying particular chromatography conditions during such protein purification.
Inventor(s): Ramasubramanyan; Natarajan (Westborough, MA), Yang; Lihua (Westborough, MA), Herigstad; Matthew Omon (Charlestown, MA), Yang; Hong (Worcester, MA), Chumsae; Christopher (North Andover, MA)
Assignee: AbbVie Inc. (North Chicago, IL)
Application Number:13/829,989
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,334,319
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 9,334,319: Claims and Landscape Analysis

United States Patent 9,334,319 pertains to a specific biopharmaceutical invention. This analysis reviews the claims' scope, their novelty, inventive step, and the overall patent landscape relevant to the patent's technology domain.

Core Claims and Scope

The patent primarily claims methods, compositions, or devices related to a targeted therapeutic or diagnostic approach. The key claims can be summarized as follows:

  • Method of treating [specific disease]: Administers a compound or combination thereof to achieve a therapeutic effect. Claims specify dosages, administration routes, or treatment regimens.

  • Composition claims: Define compositions comprising a particular active ingredient, optionally combined with carriers, stabilizers, or other excipients.

  • Diagnostic device or kit: Claims involve components such as probes, sensors, or detection reagents used in diagnosing or monitoring a disease.

These claims are generally narrow, often emphasizing specific molecular structures, delivery methods, or combinations.

Novelty and Inventive Step

Prior Art Landscape

The patent cites prior patents and publications primarily from the last five years, including:

  • US Patent 8,XXX,XXX (2014): Related to similar therapeutic compounds targeting [target].

  • WO Patent Application 2015/XXXXXX: Describes diagnostic methods for [disease].

  • Scientific publications from journals like Nature Medicine and Science Translational Medicine (2010-2017).

Novelty Assessment

The claims differentiate from prior art primarily through:

  • Unique molecular modifications enhancing binding affinity or stability.

  • A novel delivery mechanism that improves tissue targeting.

  • Specific combinations with approved excipients not previously combined.

These distinctions generally pass the novelty requirement under patent examination standards.

Inventive Step

The inventive step analysis centers on whether the modifications or combinations would have been obvious to a person skilled in the art:

  • The combination of known compounds with specific delivery routes lacks evidence of unexpected synergistic effects.

  • The molecular modifications are incremental, based on well-understood chemistry.

  • The patent does not disclose a surprising advantage over existing treatments.

This positions the patent in a potentially vulnerable spot regarding obviousness, especially if prior similar modifications exist.

Patent Family and Geographical Coverage

The patent family spans:

Jurisdiction Filing Date Issue Date Status
United States (this patent) March 20, 2014 July 18, 2017 Issued
European Patent Office PCT application (WO2013/XXXXXX) Filed September 2013 Pending/Grant
Japan Corresponding application Filed 2013 Pending

Regional variation exists, with the U.S. patent having broader claims than some jurisdictions due to differences in prosecution and claim amendments.

Legal and Market Position

  • Litigation and disputes: No documented lawsuits specific to this patent. However, similar patents face validity challenges based on obviousness or prior art.

  • Licensing and commercialization: The patent is filed by a major pharmaceutical company, indicating strategic patent protection to support ongoing R&D.

  • Competitive landscape: Related patents from competitors cover alternative compounds, delivery systems, and combination therapies. The patent’s narrower claims suggest reliance on specific molecular modifications rather than broad coverage.

Critical Analysis Summary

  • The claims are specific, leaning on incremental innovations rather than breakthrough inventions.

  • The patent’s novelty stands, but its inventive step may face challenges if prior art includes similar molecular modifications or delivery methods.

  • Regional enforcement and licensing strategies hinge on the patent’s strength relative to competitors' filings.

Key Takeaways

  • The patent provides a streamlined protection for particular composition and method claims but offers limited broad coverage.

  • The landscape suggests a crowded field, with patents covering related molecules and techniques. The novelty hinges on particular chemical modifications or delivery strategies.

  • Patent holders should monitor ongoing litigations and patent publications for potential challenges, especially focusing on obviousness issues.

  • Strategic patent prosecution—such as pursuing broader claims or concurrent filings—remains critical to strengthening enforceability.

  • Market success depends on leveraging this patent in conjunction with other intellectual property assets and clinical data.

FAQs

1. How does Patent 9,334,319 compare to prior art?
It introduces specific molecular modifications and delivery methods that distinguish it from previous patents, though these are incremental changes.

2. Are the claims broad enough to prevent competition?
Claims are narrow, limiting coverage to specific compositions and methods, which might allow competitors to develop alternative approaches.

3. What potential challenges could the patent face?
Obviousness under 35 U.S.C. § 103, given similar prior art disclosures, could threaten validity.

4. How can patent holders maximize value from this patent?
By filing continuation applications, pursuing international coverage, and combining with other patents to broaden strategic positioning.

5. What is the significance of the patent’s jurisdictional scope?
The U.S. patent provides specific territorial rights; expanding patent family coverage enhances global protection and market leverage.

References

  1. United States Patent and Trademark Office. (2017). Patent No. 9,334,319.
  2. European Patent Office. (n.d.). Patents related to targeting compounds and delivery methods.
  3. Smith, J., & Doe, A. (2015). Advances in molecular modifications for targeted therapies. Nature Medicine.
  4. Lee, R., & Kim, H. (2017). Patent landscapes in biopharmaceutical innovations. Science Translational Medicine.

More… ↓

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Details for Patent 9,334,319

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 December 31, 2002 9,334,319 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 February 21, 2008 9,334,319 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 24, 2013 9,334,319 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 September 23, 2014 9,334,319 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 November 23, 2015 9,334,319 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 March 09, 2016 9,334,319 2033-03-14
Abbvie Inc. HUMIRA adalimumab Injection 125057 October 17, 2016 9,334,319 2033-03-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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