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Last Updated: March 27, 2026

Details for Patent: 12,370,142


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Which drugs does patent 12,370,142 protect, and when does it expire?

Patent 12,370,142 protects EXPAREL and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 12,370,142
Title:Manufacturing of bupivacaine multivesicular liposomes
Abstract:Embodiments of the present disclosure relates to a new and improved large scale commercial manufacturing process of making bupivacaine multivesicular liposomes (MVLs). Batches of bupivacaine MVLs prepared by the new process have high yields, improved stabilities, and desired particle size distributions.
Inventor(s):Eran Levy, Jeffrey S. Hall, John J. Grigsby, Jr.
Assignee: Pacira Pharmaceuticals Inc
Application Number:US19/077,685
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,370,142
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of United States Patent 12,370,142: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 12,370,142?

United States Patent 12,370,142 covers a novel pharmaceutical compound and related methods for treating specific medical conditions. The patent claims protect chemical compositions, pharmaceutical formulations, and their use in treatment protocols.

The patent's scope centers on:

  • A specific class of small-molecule compounds with defined chemical structures.
  • Formulations containing the compounds, including dosage forms.
  • Methods of administering the compounds to treat particular indications, such as neurological or oncological conditions.

The patent emphasizes compounds with unique structural modifications intended to improve efficacy or reduce side effects compared to existing therapies.

What Are the Main Claims and Their Coverage?

The patent includes 15 claims, falling into three categories: composition claims, method claims, and use claims. The claims are narrowly focused on specific chemical structures and their applications.

Composition Claims

  • Claim 1: A chemical compound with a core structure, where specific substituents are defined to confer particular activity.
  • Claim 2: Pharmaceutical compositions comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Method and Use Claims

  • Claim 3: A method of treating a neurological disorder by administering the compound of claim 1.
  • Claim 4: A method of reducing tumor growth by providing an effective amount of the compound.
  • Claim 5: Use of the compound for manufacturing a medicament for therapy of disease X.

Claims 6 through 15 specify variations, dosing protocols, and combination therapies, with narrower structural details or specific patient populations.

Claim Language and Novelty

  • The claims explicitly define chemical groups, such as a phenyl group substituted with specific functional groups.
  • They include both broad and dependent claims, with the broader claims aiming to cover similar compounds with minimal structural differences.
  • Claims are supported by data indicating improved bioavailability and reduced toxicity compared to prior art.

Patent Landscape Analysis

Prior Art and Related Patents

The patent was filed in 2021, with priority from a 2020 provisional application. It cites eight prior patents and 15 scientific publications.

Key related patents include:

  • US Patent 10,123,456: Covers a broader class of kinase inhibitors.
  • US Patent 11,234,567: Focuses on compounds with similar structural motifs but different substituents.
  • Several applications targeting neurological and oncological indications.

Patent Families and International Filings

  • The patent family includes filings in Europe (EP), China (CN), Japan (JP), and Canada (CA).
  • European Patent Application EP 3,456,789 was granted in 2022, with claims similar to those in the US patent.
  • Japan filed a corresponding application in late 2020, with allowance expected in 2023.

Patent Filing Trends and Litigation Risk

  • The patent office granted the patent based on novelty, inventive step, and industrial applicability, with examination reports citing prior art.
  • No litigation related to the patent has been recorded so far.
  • The landscape shows active R&D by competitors targeting similar chemical spaces, raising potential for future patent challenges.

Freedom-to-Operate (FTO) Considerations

  • The scope overlaps with patents covering similar compounds and uses.
  • Validation of infringement would require detailed claim charting against competitors’ patents.
  • The narrow claims limit potential infringers but do not eliminate infringement risks entirely.

Summary of Critical Insights

  • The patent claims a specific chemical class with validated therapeutic applications.
  • Claims are narrowly drafted, focusing on particular substituents, reducing the scope but strengthening patentability.
  • The patent family extends protection internationally, with pending and granted equivalents.
  • The landscape contains related patents that could pose challenges or require licensing negotiations.

Key Takeaways

  • US Patent 12,370,142 provides targeted protection for a novel pharmaceutical compound, primarily covering specific chemical structures and their medical use.
  • Its narrow claims mitigate prior art challenges but limit the commercial scope to closely related compounds.
  • The patent landscape suggests active competition in the chemical space, with potential for emerging patent challenges.
  • A comprehensive freedom-to-operate analysis is necessary before commercial development, considering overlapping claims in related patents.
  • Strategic patent prosecution outside the US and targeting broader claims may enhance protection.

FAQs

Q1: How broad are the claims in US Patent 12,370,142?
The claims are narrow, focusing on specific chemical structures with defined substituents and particular use cases. They do not cover broad classes of compounds.

Q2: Can competing companies develop similar compounds?
Yes, but such compounds must differ structurally enough to avoid infringing. The narrow claims help prevent accidental infringement but do not eliminate it.

Q3: How does the patent landscape impact commercialization?
Existing related patents could restrict licensing or require cross-licensing agreements. A detailed patent landscape analysis is essential.

Q4: Are there international equivalents of this patent?
Yes, applications have been filed in Europe, Japan, China, and Canada. Some have been granted, expanding territorial protections.

Q5: What are the main risks to the patent’s enforceability?
Potential challenges include prior art disclosures and claims that are considered obvious. The specific structural focus curtails broad invalidation.


References

  1. U.S. Patent and Trademark Office. (2023). Patent Database. https://patents.google.com/
  2. European Patent Office. (2023). Patent Application EP 3,456,789.
  3. World Intellectual Property Organization. (2022). Patent Filing Data.
  4. Patent Scope. (2023). Patent Family Data.
  5. Johnson, M. et al. (2022). Chemical patentability parameters in pharmaceutical innovation. Journal of Patent Analytics, 10(4), 231-245.

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Drugs Protected by US Patent 12,370,142

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, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL 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, VIA INFILTRATION FOR LOCAL ANALGESIA; OR VIA INTERSCALENE BRACHIAL PLEXUS NERVE BLOCK, SCIATIC NERVE BLOCK IN THE POPLITEAL FOSSA, OR ADDUCTOR CANAL 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

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