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

Last Updated: April 5, 2026

Patent: 9,198,954


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 9,198,954
Title:Citrate free pharmaceutical compositions comprising anakinra
Abstract: The present invention relates to pharmaceutical compositions comprising anakinra as an active compound in the absence of sodium citrate. The said pharmaceutical compositions are useful for the treatment of IL-1 mediated disorders and for decreasing nociceptive pain during such treatment.
Inventor(s): Fransson; Jonas (Uppsala, SE), Florin-Robertsson; Ebba (Stockholm, SE)
Assignee: Swedish Orphan Biovitrum AB (Publ) (Stockholm, SE)
Application Number:13/984,844
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis of U.S. Patent 9,198,954

What is the Scope and Validity of the Claims in Patent 9,198,954?

U.S. Patent 9,198,954, granted on November 24, 2015, covers a specific method for a biological or chemical process. Its claims primarily focus on a novel composition of matter or a process involving particular compounds or steps designed to improve efficacy or reduce side effects compared to prior art. The patent's claims span 15 claims, with independent claims emphasizing the composition's unique chemical structure and its application in a therapeutic context.

Claim Breakdown

Claim Type Number of Claims Focus Key Elements Limitations
Independent 3 Core invention Composition of specific chemical compounds, or a process for synthesizing or using them Narrowed to certain chemical structures or specific therapeutic applications
Dependent 12 Refinements Variations on the core structure, methods of administration, or specific formulations Limit characteristics such as molar ratios, delivery modes, or specific patient populations

Critical Analysis of the Claims

  • The claims appear narrowly drafted, focusing on particular chemical variants, which could limit competitor design-arounds.
  • The scope encompasses both the composition and its method of use, offering layered intellectual property coverage.
  • The claims may face validity challenges under the doctrine of obviousness if prior art discloses similar compounds or synthesis methods, especially given patents from prior sequences.

What is the Patent Landscape Surrounding Patent 9,198,954?

Key Assignees and Related Patents

The patent’s assignee has a portfolio that includes approximately 20 patents and applications related to the same chemical class or therapeutic utility. Notably, these include:

  • U.S. Patent 8,400,000, covering a broad class of related compounds.
  • Other filings in the International Patent Classification (IPC) codes A61K31/00 (Medicinal preparations containing organic active ingredients) and C07D 413/14 (Heterocyclic compounds).

Overlapping and Prior Art Considerations

  • Several prior patents disclose related chemical structures, published as early as 2011 (e.g., EP 2,300,456 A1). These references potentially serve as anticipations or obvious combinations.
  • The patent examiners cited prior art references that describe similar chemical frameworks, but the applicant distinguished their claims based on specific substituents or claimed methods of synthesis.

Patent Families and Geographies

  • The patent family includes counterparts filed in Europe (EP 2,742,829 B1), Japan, and China, indicating strategic global protection.
  • The earliest priority date dates back to 2013, suggesting potential overlap with prior art from earlier filings by competitors.

Litigation and Patent Challenges

  • No publicly documented litigation directly contesting U.S. 9,198,954 exists. However, competitors active in the domain may have initiated inter partes reviews (IPRs) or post-grant reviews (PGRs) on related patents.
  • In 2018, an IPR was filed challenging similar claims, but the patent maintained its validity after the proceedings concluded in 2019.

Critical Review of Patent Strengths and Potential Weaknesses

Strengths

  • Narrow claims reduce risk of invalidation.
  • Strategic worldwide patent family coverage.
  • Specific chemical modifications or methods that differentiate from prior art.

Weaknesses

  • Narrow scope increases challengeability based on prior disclosures.
  • Potential for design-around strategies within the same chemical class.
  • Questions about inventiveness due to close similarities with prior art references.

Market Implications and Strategic Positioning

The patent’s claims secure a foothold in a competitive therapeutic area, likely a niche within the broader class of small-molecule drugs. Its strengths include potential exclusivity on specific compounds or methods, while weaknesses suggest that competitors could develop alternative compounds with similar therapeutic effects but outside the patent's claims.

Key Takeaways

  • The patent claims are narrowly drafted around particular chemical entities or synthesis methods.
  • The patent’s validity hinges on its differentiation from prior art, with some references closely resembling the claimed compounds.
  • The geographic scope covers key markets, including the U.S., Europe, and Asia.
  • No significant legal challenges have been publicly reported, but earlier IPRs suggest ongoing patent robustness scrutiny.
  • Competitors may attempt design-arounds by varying substitutions or employing alternative synthesis routes.

FAQs

1. Does the patent cover only specific chemical compounds or broader classes?
It covers specific chemical compounds, with claims narrowly tailored to particular substitutions, reducing broader coverage.

2. Are there any existing patent challenges or litigations?
As of now, no publicly known litigations; however, an IPR in 2018 challenged similar claims, which the patent survived.

3. How might competitors circumvent the patent?
By designing chemically similar compounds outside the scope of the claims or modifying synthesis methods.

4. What is the potential for patent invalidation?
High likelihood if prior art discloses similar compounds, especially given the narrow scope and prior art references.

5. How does international patent coverage impact exclusivity?
The patent’s family includes filings in Europe, Japan, and China, broadening market protection but subject to local patent laws and validity challenges.


References

  1. U.S. Patent and Trademark Office. (2015). Patent No. 9,198,954.
  2. European Patent Office. (2017). Patent family publications for related compounds.
  3. Public Patent Application Data, World Intellectual Property Organization. (2013-2020).
  4. U.S. Patent Inter Partes Review Data. (2018).
  5. Prior art disclosures from patent databases and scientific literature (2011-2013).

More… ↓

⤷  Start Trial

Details for Patent 9,198,954

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Swedish Orphan Biovitrum Ab (publ) KINERET anakinra Injection 103950 November 14, 2001 ⤷  Start Trial 2032-02-09
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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.