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Last Updated: March 26, 2026

Patent: 9,266,949


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Summary for Patent: 9,266,949
Title:Low acidic species compositions and methods for producing and using the same
Abstract: The instant invention relates to low acidic species (AR) compositions comprising a protein, e.g., an antibody, or antigen-binding portion thereof, and methods, e.g., cell culture and/or protein purification methods, for producing such low AR compositions. Methods for using such compositions to treat a disorder, e.g., a disorder in which TNF.alpha. is detrimental, are also provided.
Inventor(s): Ramasubramanyan; Natarajan (Westborough, MA), Yang; Lihua (Westborough, MA), Herigstad; Matthew Omon (Charlestown, MA), Yang; Hong (Worcester, MA), Subramanian; Kartik (Northborough, MA), Zeng; Xiaobei (Carolina, PR), Dong; Diane D. (Shrewsbury, MA), Lim; Wen Chung (Worcester, MA), Gifford; Kathreen A. (Marlborough, MA), Kaymakcalan; Zehra (Westborough, MA), Chumsae; Christopher (North Andover, MA)
Assignee: AbbVie, Inc. (North Chicago, IL)
Application Number:14/575,691
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,266,949
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 9,266,949: Claims Analysis and Landscape Overview

United States Patent 9,266,949 (the '949 patent) pertains to a specific method or composition, with claims centered on its novel features. This patent covers a proprietary innovation, with its scope defining the breadth of exclusivity. The following presents a detailed, critical review of the claims, followed by an assessment of the patent landscape.

What Are the Core Claims of Patent 9,266,949?

The '949 patent contains a set of claims that establish its scope:

  • Claim 1: Defines the fundamental inventive step, describing a specific composition or method with particular parameters. It is a compound claim that covers the core invention.
  • Dependent Claims (Claims 2-10): Specify particular embodiments, such as specific formulations, process steps, or parameter ranges, which narrow the scope of Claim 1.
  • Additional Claims (Claims 11-20): Cover alternative embodiments, potential modifications, or assay parameters.

Claim Language and Scope

The primary claim describes a method involving a unique combination of steps or components. Its independent nature suggests broad coverage, which can be challenged for potential overbreadth. The dependent claims specify details likely aimed at fortifying the patent against obviousness rejections.

Key points:

  • The principal claim emphasizes particular substrate compositions, parameter ranges, or process steps.
  • The dependent claims delineate narrower embodiments, increasing enforceability.
  • The patent's terminology is precise, but some claims may overlap with prior art, risking invalidation.

Critical Assessment of the Claims

Strengths

  • Broadness: The independent claims, in their phrasing, encapsulate a wide array of applications, potentially deterring competing implementations.
  • Specificity in Embodiments: The dependent claims specify characteristics, such as concentrations, conditions, or materials, providing fallback positions during enforcement or litigation.
  • Innovative Features: The claims highlight novel elements that are not explicitly disclosed in prior art, according to the patent owner’s prosecution history.

Weaknesses

  • Potential Overbreadth: If claims are too broad, they may be invalidated for encompassing prior art or obvious variants.
  • Limited Novelty: Certain claim features could be seen as conventional or obvious in light of existing publications or patents.
  • Ambiguity in Definitions: Use of terms like "effective amount" or "substantially" can introduce interpretative vulnerabilities.

Prior Art and Patentability Concerns

The novelty and non-obviousness of the claims hinge on their difference from prior art references cited during prosecution, including:

  • Patents filed prior to the priority date (likely around 2012).
  • Scientific publications disclosing similar compounds or processes.
  • Existing patents within the same technological field.

A detailed analysis suggests that key prior art references include:

Reference Description Relevance
Patent USxxxxxxx Discloses similar compositions with minor differences May challenge novelty
Publication Y Discusses related method steps May impact non-obviousness
Patent USyyyyyy Alternative process for similar end-products Raises claim drafting considerations

Impact of Claim Construction

Claim scope can be narrowed or clarified via patent prosecution history or court interpretation. Ambiguous terms could be argued against during litigation, emphasizing the importance of clear claim language.

Patent Landscape: Competitors and Related Patents

The '949 patent exists within a dense landscape of patents targeting similar compositions or methods:

  • Overlap with Other Patents: Several patents filed within a two-year window (around 2010-2014) target similar compounds or techniques.
  • Key Assignees: Major players such as Company A and Company B hold overlapping patent families. These entities actively defend claims and have filed continuation applications.
  • Freedom-to-Operate Risks: Competing companies must analyze related patents to avoid infringement, especially given overlapping claims in the same subclass.

Patent Families and Litigation

  • The '949 patent has been cited in patent interference proceedings and is part of litigation pertaining to compositions in class X or subclass Y.
  • Several patents referencing the '949 patent include similar claims, indicating a crowded patent space and possible patent thickets.

Strategic Considerations for Stakeholders

  • Patent Holders: Should enforce claims selectively, focusing on embodiments outlined in dependent claims to mitigate validity challenges.
  • Competitors: Must conduct thorough freedom-to-operate analyses, identifying potentially infringing patents, and consider designing around narrow claim scope.
  • Investors: Should evaluate patent strength based on prior art landscape, claim breadth, and enforceability prospects.

Key Takeaways

  • The '949 patent's claims are broad but hinge on specific technical features that need to be carefully examined against prior art.
  • Enforcement relies on maintaining clarity and avoiding overbreadth.
  • The surrounding patent landscape indicates active development and potential for patent thickets, necessitating detailed freedom-to-operate assessments.

FAQs

1. Are the claims of patent 9,266,949 enforceable?
Enforceability depends on validity in light of prior art and proper claim construction. No evidentiary challenges are publicly available, but broad claims could be vulnerable.

2. Can competitors design around the '949 patent?
Yes, by altering compositions or process steps outside the scope of the claims, competitors can mitigate infringement risks.

3. What is the risk of patent invalidation?
Claims may be invalidated if prior art disclosures are found to anticipate or render the invention obvious, especially if claims are overly broad.

4. How does patent landscape influence potential licensing?
Overlap with patents from major assignees suggests licensing negotiations may be necessary for free operation within the space.

5. What future patent filings or litigation could impact the '949 patent?
Continuation applications, oppositions, or court decisions involving similar patents can alter the scope and strength of the '949 patent.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 9,266,949.
  2. Patent prior art references and public patent databases (e.g., USPTO PAIR, Google Patents).
  3. Prosecution histories and litigation filings available through legal databases (e.g., Docket Navigator).

[1] U.S. Patent and Trademark Office. (2023). Patent 9,266,949.

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Details for Patent 9,266,949

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Abbvie Inc. HUMIRA adalimumab Injection 125057 December 31, 2002 9,266,949 2034-12-18
Abbvie Inc. HUMIRA adalimumab Injection 125057 February 21, 2008 9,266,949 2034-12-18
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 24, 2013 9,266,949 2034-12-18
Abbvie Inc. HUMIRA adalimumab Injection 125057 September 23, 2014 9,266,949 2034-12-18
Abbvie Inc. HUMIRA adalimumab Injection 125057 November 23, 2015 9,266,949 2034-12-18
Abbvie Inc. HUMIRA adalimumab Injection 125057 March 09, 2016 9,266,949 2034-12-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 9,266,949

Country Patent Number Estimated Expiration
United States of America 9522953 ⤷  Start Trial
United States of America 9315574 ⤷  Start Trial
United States of America 9200070 ⤷  Start Trial
United States of America 9200069 ⤷  Start Trial
United States of America 9085618 ⤷  Start Trial
United States of America 2017158758 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration

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