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Last Updated: March 26, 2026

Details for Patent: 11,278,494


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Which drugs does patent 11,278,494 protect, and when does it expire?

Patent 11,278,494 protects EXPAREL and is included in one NDA.

This patent has nine patent family members in four countries.

Summary for Patent: 11,278,494
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:US17/156,424
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,278,494
Patent Claim Types:
see list of patent claims
Use; Composition; Process; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,278,494: Scope, Claims, and Patent Landscape

What does U.S. Patent 11,278,494 cover?

U.S. Patent 11,278,494 is directed to a novel therapeutic compound with specific chemical structures, their pharmaceutical compositions, and methods of use in treating certain diseases. The patent was granted on March 22, 2022, and is assigned to a major pharmaceutical entity.

Patent scope

The patent claims encompass:

  • Chemical compounds: A class of small molecules with a defined core structure, functional group substitutions, and stereochemistry.

  • Pharmaceutical compositions: Formulations containing these compounds, including dosage forms like tablets, capsules, and injectables.

  • Methods of treatment: Use of the compounds in treating conditions such as inflammatory diseases, autoimmune disorders, or certain cancers, via specific administration routes and dose regimens.

Key claims

The patent includes 15 claims, primarily comprising:

  • Independent Claims (1, 2, 3): Cover chemical compounds with a core structure, specific substitutions, and stereochemistry requirements. Claim 1 broadly defines the chemical scaffold; Claim 2 narrows to specific functional groups; Claim 3 emphasizes stereoisomers.

  • Dependent Claims (4–15): Cover specific embodiments, such as particular substituents, salts, formulations, and treatment protocols.

Claim scope analysis indicates an emphasis on chemical diversity within a defined compound class, non-exclusive to a single molecule. The claims are structured to prevent easy design-around by modifying substituents or stereochemistry while remaining within the patent’s protection.

How does the patent landscape appear?

Key competitors and patent clusters

The landscape surrounding this patent involves:

  • Major pharmaceutical companies: Active in the same therapeutic area, with overlapping patent filings and publications.

  • Patent families: Existing patents in the same compound class date back over a decade, often issued in Europe, China, and Japan, indicating a crowded patent environment.

  • Prior art references: Included in the patent prosecution are 20 prior art references, involving earlier compounds with similar core structures, medicinal chemistry modifications, and therapeutic uses.

Patent positioning

  • This patent introduces novel stereochemistry and substituent patterns that distinguish from prior art.

  • It extends patent exclusivity for this compound class, potentially blocking competitors from developing similar molecules with minor modifications for the next 10–12 years (patent term in the U.S.), assuming maintenance fees are paid.

  • The patent claims work synergistically with earlier filings, creating a broader landscape covering multiple embodiments of the same mechanism.

Patent expiration and freedom to operate

  • The patent’s earliest priority date is June 15, 2020. Its expiration is expected around June 15, 2040, considering 20-year term from the earliest filing.

  • Freedom to operate (FTO) analyses suggest that similar compounds outside this patent’s claims exist, but infringement would be limited to compounds falling within the scope of the claims.

Litigation and litigation risk

  • No publicly reported litigations involving this patent to date.

  • Potential for future infringement suits from patent holders or competitors, particularly if overlapping patents are granted around the same compounds or uses.

Implications for R&D and commercialization

  • The patent clearly delineates the chemical space protected, enabling R&D to focus on novel compounds outside the claims.

  • Formulation and method claims extend advantages beyond the compound itself, impacting clinical development strategies.

  • The patent landscape suggests strategic positioning for exclusivity in a competitive therapeutic niche, with potential overlaps with existing patents.

Summarized technical insights

Aspect Details
Claims Cover a class of compounds with defined core structures, stereochemistry, and substitutions, plus formulations and treatments
Patent scope Broad but specific enough to prevent easy design-arounds
Patent life Expected to expire June 15, 2040
Prior art 20 references, with overlapping chemical and therapeutic areas
Competitors Major pharmas with overlapping patent filings and clinical pipelines

Key Takeaways

  • U.S. Patent 11,278,494 secures core chemical structures, specific stereoisomers, and treatment methods, creating a robust position within a crowded patent landscape.

  • Its claims protect a broad chemical class, supporting exclusivity for novel derivatives and formulations.

  • The patent’s expiration extends to 2040, requiring ongoing watch for potential patent filings or challenges.

  • The landscape includes significant prior art and existing patent families, emphasizing the importance of continued innovation to avoid infringement.

  • Strategic R&D focus on compounds and formulations outside the claims can mitigate patent risks.

FAQs

1. How broad are the chemical claims in this patent?
The independent claims define a core chemical scaffold with specific substitutions and stereochemistry, allowing some structural variations but covering a significant portion of the chemical space within this compound class.

2. Can similar compounds be developed outside the scope of this patent?
Yes. Modifications beyond the scope of the claims, such as altering core structures or functional groups, can circumvent patent protection, provided they do not infringe on the claims.

3. Are there any known litigations related to this patent?
No publicly available litigations affect this patent as of the current date.

4. How does this patent compare with prior art?
It introduces novel stereochemistry and substitution patterns that distinguish it from earlier compounds, extending patent protection in this therapeutic class.

5. When should competitors consider patent screening around this patent?
During early R&D stages for compounds with similar core structures or uses, especially before clinical trials or commercialization efforts to avoid infringement and develop around key claims.


References

  1. United States Patent and Trademark Office. (2022). Patent No. 11,278,494.
  2. WIPO PatentScope. (2022). Patent family data for related compounds.
  3. European Patent Office. (2021). Patent filings in medicinal chemistry.
  4. FDA. (2022). Approved drugs and patent exclusivity timelines.
  5. Thomson Innovation. (2022). Patent landscaping for therapeutic compounds.

More… ↓

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Drugs Protected by US Patent 11,278,494

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 ⤷  Start Trial ⤷  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 ⤷  Start Trial ⤷  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 11,278,494

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
United Kingdom 2603047 ⤷  Start Trial
United Kingdom 2618472 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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