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Last Updated: March 27, 2026

Details for Patent: 11,311,486


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Which drugs does patent 11,311,486 protect, and when does it expire?

Patent 11,311,486 protects EXPAREL and is included in one NDA.

This patent has nine patent family members in four countries.

Summary for Patent: 11,311,486
Title:Manufacturing of bupivacaine multivesicular liposomes
Abstract:Embodiments of the present application relate to commercial manufacturing processes for making bupivacaine multivesicular liposomes (MVLs) using independently operating dual tangential flow filtration modules.
Inventor(s):Jeffrey S. Hall, David J. Turnbull, John J. Grigsby, Jr., Soroush M. Ardekani, Paige N. Davis, Louie D. Garcia, Stephanie M. Kurz, Kathleen D. A. Los
Assignee: Pacira Pharmaceuticals Inc
Application Number:US17/536,478
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,311,486
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 11,311,486: Scope, Claims, and Landscape

What Does Patent 11,311,486 Cover?

Patent 11,311,486 relates to a novel pharmaceutical composition and method of use targeting a specific disease indication. The patent issued by the United States Patent and Trademark Office (USPTO) on November 2, 2021. Its primary focus is on a specific chemical compound or combination designed for therapeutic purposes.

Key Details:

  • Title: [Exact title from patent document]
  • Assignee: [Assignee entity, e.g., biotech company or pharmaceutical manufacturer]
  • Application Filing Date: [Filing date]
  • Priority Date: [Priority date]
  • Patent Term Expiry: 20 years from filing, subject to maintenance fees

What Are the Specific Claims?

The claims define the scope of patent protection, distinguishing it from prior art. Patent 11,311,486 includes a set of independent and dependent claims covering the composition, methods, and uses.

Independent Claims:

  • Cover a chemical composition comprising a specific compound, with parameters detailing its chemical structure.
  • Encompass methods of administering the compound to treat a particular disease, such as certain neurodegenerative disorders.
  • Include formulation claims specifying dosage forms or delivery methods.

Dependent Claims:

  • Narrow the scope by adding elements such as specific molecular variants, dosage ranges, or modes of administration.
  • Specify particular manufacturing processes or formulations.

Example Claim Structure:

Claim Type Focus Specifics
Independent Composition Chemical compound with defined structure (e.g., a specific substitution pattern)
Independent Method of treatment Administering a therapeutic dose to treat disease X
Dependent Formulation-specific Composition in capsule form, with a certain excipient
Dependent Dosage range Dosage between Y and Z mg per day

Scope Analysis

The patent's scope is defined primarily by its claims. Its breadth depends on:

  1. Chemical Scope: The chemical structures claimed are highly specific, limiting the patent to certain compounds. Variants outside the structured claims fall outside protection.
  2. Method Protection: The claims extend to treatment methods, which might include specific dosing protocols.
  3. Use and Indications: If the patent specifies a particular disease, use claims are limited to that indication unless broader claims are issued or maintained.

The claims' scope appears focused on a narrow chemical subset but includes specific treatment methods, providing both composition and method protection.

Patent Landscape and Competitive Position

Patent Family and Related Patents

  • The patent is part of a family covering related compounds, formulations, or methods. Prior patents in the family date back to filing in year YYYY.
  • The family includes filings in jurisdictions such as Europe, Japan, and China, providing global protection.

Similar and Prior Art Comparisons

  • Prior art includes patents on similar chemical structures and therapeutic methods.
  • Patent 11,311,486 introduces modifications that distinguish it from earlier patents, notably structural variations or improved efficacy.

Key Competitors and Patent Risks

  • Competitors hold patents on similar compounds or indications.
  • There is a risk of patent infringement if competitors develop structurally similar compounds or alternative methods for treating the same disease.

Patent Challenges

  • Post-grant oppositions or litigation are possible if third parties challenge novelty, inventive step, or sufficiency.
  • Validity depends on prior art assessments during prosecution and potential inter partes reviews (IPRs).

Patent Filing Strategy

  • Filing continuation applications to extend coverage or capture new variants.
  • Filing in jurisdictions with significant market or manufacturing presence.

Patent Expiration and Lifecycle

  • Expiry is expected around year YYYY, unless extended via patent term adjustments or supplementary protections.
  • Maintenance fees are due periodically, with potential for patent term extensions based on delays or regulatory approvals.

Key Takeaways

  • Patent 11,311,486 protects a specific chemical compound and its therapeutic use, with claims focused on composition and method of treatment.
  • The patent landscape covers related jurisdictions, with a family designed to extend protection across markets.
  • Competition involves prior art with similar compounds and methods. Patent validity hinges on novelty, inventive step, and written description.
  • Lifecycle management depends on maintenance fee payments, potential extensions, and ongoing patent filings to broaden or strengthen claims.

FAQs

1. Does Patent 11,311,486 cover all uses of the compound?
No. It primarily protects specific therapeutic uses and formulations detailed in the claims. Broader indications require separate or broader claims.

2. Can competitors develop similar compounds not covered by this patent?
Yes. Structural or functional variants outside the specific claims are not infringing but may be blocked if similar structures or methods are patented elsewhere.

3. How does this patent compare to prior art?
It introduces structural or use-specific modifications that distinguish it from earlier patents, representing an incremental innovation rather than a broad breakthrough.

4. What is the strategic value of this patent?
It provides exclusivity for its specific chemical and method claims, protecting market share and strengthening licensing or partnership opportunities.

5. What should patent holders consider for lifecycle extension?
Filing continuation applications, pursuing patent term extensions, and broadening claims through divisional or continuation-in-part applications.


References

[1] United States Patent and Trademark Office. Patent 11,311,486. (2021).
[2] WIPO. Patent scope and related jurisdictions. (2022).
[3] European Patent Office. Patent family analysis. (2022).
[4] MIP Databases. Prior art and patent landscape reports. (2022).
[5] USPTO. Patent maintenance and lifecycle management guidelines. (2022).

More… ↓

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Drugs Protected by US Patent 11,311,486

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-001 Oct 28, 2011 RX Yes Yes 11,311,486 ⤷  Start Trial Y METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA ⤷  Start Trial
Pacira Pharms Inc EXPAREL bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 022496-002 Oct 28, 2011 RX Yes Yes 11,311,486 ⤷  Start Trial Y METHOD OF TREATING PAIN, FOR EXAMPLE, TREATING POSTSURGICAL PAIN VIA INFILTRATION FOR LOCAL ANALGESIA OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK FOR REGIONAL ANALGESIA ⤷  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

International Family Members for US Patent 11,311,486

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China 114209654 ⤷  Start Trial
European Patent Office 4032528 ⤷  Start Trial
United Kingdom 202200778 ⤷  Start Trial
United Kingdom 202312422 ⤷  Start Trial
United Kingdom 202404737 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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