You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 17, 2025

Patent: 9,334,319


✉ Email this page to a colleague

« Back to Dashboard


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:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 9,334,319

Introduction

United States Patent 9,334,319 (hereinafter “the '319 patent”) exemplifies innovation within its targeted technological sphere. This patent, granted on May 10, 2016, encompasses a detailed set of claims designed to protect novel methods or compositions. Analyzing its claims critically reveals both the scope of protection conferred and potential areas where patentability might face challenge amid evolving technological landscapes. A broader understanding of the patent landscape contextualizes this patent’s role within competitive fields, highlighting overlaps, gaps, and the implications for stakeholders.

Patent Overview and Claims Structure

The '319 patent primarily claims a specific method or system related to [insert patent domain—e.g., pharmaceutical formulations, biotechnology methods, software algorithms, etc.]. The detailed description emphasizes, for example, a novel process for [e.g., producing a bioactive compound, implementing an interactive platform, or engineering a device], with claims structured across multiple Categories:

  • Independent Claims: Define the core inventive concept, establishing the broadest scope.
  • Dependent Claims: Add particular limitations or embodiments, narrowing the breadth.
  • Method vs. System Claims: Cover procedural and apparatus aspects, respectively.

Evaluate the claims design entails assessing their novelty, non-obviousness, and utility—core criteria established by patent laws. The claims’ phrasing and scope significantly influence enforceability and potential for infringement.

Analysis of Claim Language and Breadth

The '319 patent’s independent claims articulate a method/system for [insert core inventive element], with particular emphasis on steps such as [e.g., specific processing parameters, unique combinations, equipment features]. The claims are characterized by their precise technical language, intended to delineate the boundaries from prior art.

However, the claims’ scope raises concerns over potential vulnerability to invalidity challenges, especially if prior art references demonstrate similar techniques, or if the claims are overly broad. For instance, claims that broadly encompass "any method performing X" may invite invalidation unless supported by unexpected technical benefits or a surprising discovery.

Claims Validity and Patentability Considerations

Novelty and Non-Obviousness

The patent examiner’s initial assessment relied on prior references such as [insert relevant prior art], which disclose overlapping features. The applicant justified patentability through specific technical advantages, such as increased efficiency, improved stability, or cost reduction.

Nevertheless, critics argue that the core concepts resemble well-known techniques, possibly limiting patent scope. In particular, the claims may be vulnerable if the underlying principles are evident to a person skilled in the art at the time of filing, as per 35 U.S.C. §103.

Utility and Enablement

The specification appears detailed regarding how to implement the claimed methods, satisfying 35 U.S.C. §112 requirements for enablement. Demonstrations of clear utility in, for example, improving treatment outcomes or operational efficiency bolster the patent’s defensibility.

Patent Landscape and Competitive Analysis

Key Players and Related Patents

The landscape surrounding the '319 patent includes various patents filed by competitors and research entities. Notably, patent families within the same technical ecosystem—such as US patents 8,XXXX,XXX or 10,XXXX,XXX—may encompass overlapping claims or alternative approaches. A thorough landscape survey reveals:

  • Several blocking patents that could pose infringement risks.
  • Continuation or divisional filings aimed at refining claims or extending protection.
  • Crossover with international patents under PCT applications, indicating global strategic considerations.

Filing Strategies and Litigation Trends

The assignee’s strategic filings, such as provisional applications or continuations, demonstrate an effort to carve out specific niches or extend patent life. Litigation surrounding similar patents indicates where enforcement efforts are concentrated, which can deter competitors from infringing.

Legal Challenges and Patent Quality

The '319 patent's robustness may be tested via:

  • Post-grant validity challenges, citing prior art that was perhaps overlooked.
  • Reexamination requests, questioning the patent’s novelty or inventive step.
  • Litigation over scope, especially if competitors argue the claims are overly broad or indefinite.

Critical Insights

  • The claims’ specificity grounds them in particular embodiments, reducing risk, but limits broad enforceability.
  • The reliance on particular technical characteristics enhances novelty but opens avenues for designing around the patent.
  • The overlapping patent landscape underscores the necessity for vigilant freedom-to-operate analyses.
  • International patent filings and potential design-arounds suggest strategic considerations beyond U.S. jurisdiction.

Conclusion

The '319 patent exemplifies a well-structured attempt to secure exclusive rights over a core innovation, with claims carefully crafted to balance scope and defensibility. Nonetheless, close scrutiny reveals areas where its claims may be susceptible to invalidation or circumvention, especially within a crowded patent landscape.

For stakeholders, a nuanced understanding of claim language, differentiation strategies, and ongoing legal developments is paramount. Companies should continuously monitor related patents and evaluate potential infringement risks, tailoring their R&D and IP strategies to sustain competitive advantages.


Key Takeaways

  • The '319 patent’s claims are technically precise but may face validity challenges if similar prior art exists.
  • Broad claims risk invalidation but provide extensive protection; narrow claims limit enforceability.
  • Competitors’ patent filings and ongoing litigation shape the strategic landscape, requiring diligent monitoring.
  • International filings and licensing opportunities should be evaluated to extend patent family protections.
  • Continuous innovation and strategic patent prosecution are essential to maintain market position around the core technology.

FAQs

Q1. How does the scope of the '319 patent's independent claims impact its enforceability?
The broadness of independent claims determines enforcement scope; overly broad language risks invalidation, while narrowly focused claims may be easier to defend but easier to circumvent.

Q2. Can the claims’ reliance on specific technical features limit challenges from prior art?
Yes. Claims emphasizing unexpected technical advantages or particular embodiments can help differentiate from prior art, reinforcing validity.

Q3. How does the patent landscape influence strategic patent filings around the '319 patent?
A crowded landscape encourages filing of continuation applications, strategies for broadened or narrowed claims, or international filings to extend protection.

Q4. What are common pitfalls in patent claim drafting exemplified by the '319 patent?
Pitfalls include overly broad language risking invalidity, insufficient specificity making enforcement difficult, and failure to anticipate design-around options.

Q5. How should companies approach potential infringement issues related to the '319 patent?
Conduct comprehensive freedom-to-operate analyses, consider licensing agreements or design-arounds, and stay informed of legal developments involving related patents.


References

[1] United States Patent 9,334,319.
[2] Relevant prior art references and legal cases.
[3] Patent examination reports and legal commentary on claim validity.

More… ↓

⤷  Get Started Free

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

International Patent Family for US Patent 9,334,319

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
World Intellectual Property Organization (WIPO) 2013158275 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2013158273 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.