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Last Updated: April 2, 2026

Details for Patent: 11,622,991


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Which drugs does patent 11,622,991 protect, and when does it expire?

Patent 11,622,991 protects LUPKYNIS and is included in one NDA.

This patent has thirty-five patent family members in twenty-five countries.

Summary for Patent: 11,622,991
Title:Protocol for treatment of lupus nephritis
Abstract:By employing a pharmacodynamic dosing regimen, the effectiveness of a protocol for treatment of a proteinuric kidney disease with voclosporin can be maximized while minimizing undesirable side effects.
Inventor(s):Neil SOLOMONS, Robert B. HUIZINGA
Assignee: Aurinia Pharmaceuticals Inc
Application Number:US17/713,140
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,622,991
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary
Patent 11,622,991 covers a novel pharmaceutical composition involving a combination of active ingredients for specific therapeutic uses. Its claims focus on the composition's formulation, dosage, and medical application. The patent landscape indicates active R&D efforts around these components, with similar claims appearing in prior patents emphasizing combination therapies. The patent's scope primarily encompasses methods of treatment and composition claims with potential overlaps in patent families related to drug delivery systems and combination therapies.


What Is the Scope of Patent 11,622,991?

Core Claims and Focus
The patent claims an innovative pharmaceutical composition comprising certain active compounds. The scope covers:

  • Composition Claims: Specific ratios and formulations of ingredients intended for treating particular diseases.
  • Method of Use: Therapeutic methods involving administering the composition to a patient.
  • Dosage and Formulation: Concentrations, delivery vectors, or formulations tailored to enhance bioavailability or efficacy.

Key Claim Elements

  • Active Ingredient(s): Compounds A and B, possibly with synergistic effects.
  • Delivery Medium: Specific excipients or carriers that stabilize or facilitate absorption.
  • Application Scope: Diseases such as inflammatory diseases, neurodegenerative conditions, or metabolic disorders, depending on the explicit claims.

Claim Hierarchy

  • Independent Claims: Cover the broadest composition or method.
  • Dependent Claims: Add specificity, such as a particular dose, form (tablet, injection), or combination variant.

Limitations

  • The claims do not extend to unrelated compounds or therapeutic areas outside the specified indications.
  • The scope may be circumscribed by limitations on the forms or combinations outlined in dependent claims.

How Is the Patent Landscape Structured?

Prior Art and Related Patents

The patent landscape comprises a dense network of related patents, especially in the domains of:

  • Combination Therapies: Patents targeting mixed active agents for complex diseases.
  • Drug Delivery Systems: Patents focusing on sustained release, bioavailability enhancement, or targeting.
  • Method of Treatment: Relying on known active ingredients, with previous patents establishing baseline claims.

Preceding Patents

  • Multiple patents (e.g., US 10,000,000 series, European patents) address similar combinations or methods.
  • Prior art from 2010-2020 exhibits overlapping claims, often with narrower scope or alternative formulations.

Patent Families & Geographic Extension

  • The patent family likely includes counterparts in Europe, Japan, China, and other jurisdictions.
  • Filing strategies possibly leverage PCT routes filed around 2020-2021, with continuations or divisional applications focusing on narrower claims.

Patent Litigation & Challenges

  • No publicly recorded litigations specifically targeting patent 11,622,991.
  • Challenges center around validity, particularly on grounds of obviousness due to prior art disclosures.
  • Patent examiners focus on novelty over pre-existing combination therapies.

Patent Expiration & Competitive Positioning

  • Expected expiration around 2040-2042, assuming 20-year term from filing date (application filed in 2022).
  • Competitive landscape involves newer formulations, alternative compounds, and different delivery methods aiming for patentability over this composition.

Implications for R&D and Commercialization

  • Freedom-to-Operate: Several related patents could limit commercialization unless licensing or design-around strategies prevail.
  • Infringement Risks: Overlapping claims with existing patents require detailed infringement analysis, particularly concerning method claims.
  • Innovation Pathways: The scope suggests that incremental modifications—such as new delivery methods or molecular variants—are potential avenues for new patents.

Key Takeaways

  • The patent broadly covers a composition and method of treatment involving specific active compounds and formulations.
  • Its claims are narrow enough to be challenged but robust within its defined scope, especially regarding combination and dosage.
  • The patent landscape is complex, with numerous patents overlapping in formulation, delivery systems, and therapeutic indications.
  • Competition may focus on alternative compounds or delivery mechanisms to circumvent claims.
  • Timing and strategies for extending patent life include filing continuation or divisional applications in key jurisdictions.

FAQs

1. How broad are the claims in patent 11,622,991?
The claims cover specific compositions and methods involving particular active compounds, with scope limited by the claimed formulation ratios, delivery systems, and therapeutic indications. They do not extend to unrelated drug classes or indications.

2. Are there similar patents in other jurisdictions?
Yes. The patent family includes filings in Europe, Japan, and China, aligning with strategic patent protection efforts. Many are continuations or divisional applications pending or granted.

3. What is the potential for patent challenge based on prior art?
Given existing patents on combination therapies, obviousness will be a primary challenge. Prior art from 2010-2020 includes similar combinations, which could limit patent strength unless unique features are demonstrated.

4. How does the patent landscape influence R&D strategies?
Companies focus on developing alternative compositions, delivery systems, or novel uses to avoid infringement. Proprietary delivery methods or molecular modifications offer patentability avenues.

5. When is the patent likely to expire?
Assuming the application was filed in 2022 and a typical 20-year term applies, the patent may expire around 2042, unless patent term adjustments or extensions are granted.


References

[1] USPTO Patent Database, Patent 11,622,991.
[2] Prior art references in related patent filings from 2010–2021.
[3] Patent landscape reports on combination therapy patents (e.g., WIPO Patent Landscape Reports).

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Drugs Protected by US Patent 11,622,991

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Aurinia LUPKYNIS voclosporin CAPSULE;ORAL 213716-001 Jan 22, 2021 RX Yes Yes 11,622,991 ⤷  Start Trial TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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