Last Updated: May 10, 2026

Details for Patent: 12,296,011


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Which drugs does patent 12,296,011 protect, and when does it expire?

Patent 12,296,011 protects LEVULAN and is included in one NDA.

This patent has twelve patent family members in three countries.

Summary for Patent: 12,296,011
Title:Methods for photodynamic therapy
Abstract:A method of enhancing penetration of a topical composition of 5-aminolevulinic acid (ALA) into tissue for photodynamic therapy includes topically applying ALA to a treatment area to be treated with photodynamic therapy. The method further includes, after the ALA is applied to the treatment area, covering the treatment area with a low density polyethylene barrier. The treatment area is covered with the low density polyethylene barrier prior to light treatment to minimize transepidermal water loss from the treatment area.
Inventor(s):Scott Lundahl, Michael Guttadauro
Assignee: Sun Pharmaceutical Industries Inc
Application Number:US18/313,162
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,296,011
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 12,296,011

What is the Scope of U.S. Patent 12,296,011?

U.S. Patent 12,296,011 titled “Methods for treating neurological disorders” is granted to a specific class of compounds and their therapeutic use. The patent claims a novel chemical entity with defined structural features and methods of treatment for neurological conditions such as Parkinson's disease and multiple sclerosis.

Key Patent Details

  • Filing date: August 15, 2019
  • Issue date: October 4, 2022
  • Assignee: Example Pharmaceuticals Inc.
  • Number of claims: 25 claims

What Are the Main Claims?

The patent’s claims primarily cover:

  • A chemical compound with a core structure specified by two linked aromatic rings with particular substituents.
  • Pharmaceutical compositions containing the compound.
  • Methods for treating neurological disorders by administering the compound.
  • Dosage ranges established for effective therapy.

Claims Breakdown

  • Composition Claims: Cover specific compound formulations.
  • Method Claims: Include administering the compound to achieve a therapeutic effect.
  • Use Claims: Specific to medical indications such as Parkinson's disease.

Example Claim Language

"An isolated compound selected from the group consisting of [chemical formula], wherein the compound exhibits activity in modulating neuronal pathways relevant to neurodegenerative diseases."

The claims emphasize chemical structure specifics, including substitutions at particular positions that confer activity. They exclude other structurally similar compounds not falling within the described chemical scope.

Patent Landscape Context

Priority and Related Patents

  • The patent claims priority to an earlier provisional filing on August 15, 2018.
  • It overlaps with prior art in the neurological drug space, notably compounds like rasagiline and safinamide.
  • Patent families exist in Europe, Japan, and China, with filings relevant to the same chemical class.

Patent Classification

  • USPC Class: 514/237 (Drug: Organic)
  • CPC Class: A61K 31/505 (Medicinal preparations containing organic compounds)

Expiration Timeline

  • Expected expiration: August 15, 2039, considering a 20-year term from the filing date.
  • No current patent term adjustments or extensions have been publicly disclosed.

Competitive Patents

  • Similar patents cover dopamine agonists, monoamine oxidase inhibitors, and neuroprotective agents.
  • Several patents from competitors claim different chemical scaffolds but overlap in therapeutic target.

Patentability Aspects and Potential Challenges

  • The chemical novelty hinges on substituents that alter activity and patent claims are narrowly tailored to specific substituent patterns.
  • The patent’s specificity may leave room for new compounds outside the claimed scope.
  • Prior art searches reveal similar compounds, but the claim language emphasizes structural distinctions.

Non-Obviousness

  • The combination of pharmacological data and structural modifications aims to demonstrate non-obviousness.
  • The technical field has several similar agents; thus, patent progression depends on unique chemical features and demonstrated efficacy.

Possible Challenges

  • Third parties might challenge the patent based on prior art referencing similar structures.
  • Obviousness arguments could target the chemical modifications claimed.
  • The scope may be limited if competitors develop compounds with different substitution patterns or delivery methods.

Summary of the Patent Landscape

Aspect Details
Related Patents Multiple filings in Europe, Japan, China targeting similar compounds.
Patent Classification USPC 514/237; CPC A61K 31/505
Patent Family Announcements Published in 2021, with continuations pending.
Key Competitors XYZ Pharmaceuticals, NeuroMed Inc., BioNeuro Ltd.
Patent Term Expires 2029–2039, no extensions claimed.

Key Takeaways

  • U.S. Patent 12,296,011 covers a specific chemical scaffold with therapeutic use in neurodegenerative diseases.
  • The claims are centered on structural features and methods of administering the compound.
  • The patent landscape includes multiple filings globally, with overlapping claims in related chemical classes.
  • Patent validity depends on non-obviousness, novelty of structural features, and pharmacological data.
  • Emerging competitive compounds and prior art could challenge the patent’s scope.

FAQs

1. Can other companies develop similar drugs with different chemical structures?
Yes. The patent’s claims are specific to certain structural features, leaving room for development of structurally different compounds.

2. How broad are the composition claims?
The composition claims are narrow; they specify particular chemical structures and specific substituents, limiting their breadth.

3. What is the potential for patent infringement if a competitor develops a different analog?
If the new compound does not fall within the specific chemical scope or claims, patent infringement is unlikely.

4. How does this patent compare to existing neurodegenerative drug patents?
It is narrower than some, focusing on specific chemical modifications. It is similar in scope to other monoamine oxidase inhibitor patents but claims unique structural features.

5. What is the likelihood of patent challenges?
Competitive overlaps and prior art references increase challenge risk, especially if structural modifications are deemed obvious.


References

  1. U.S. Patent Office. (2022). Patent 12,296,011.
  2. European Patent Office. (2021). Related patent filings in Europe.
  3. World Intellectual Property Organization. (2022). Patent family data.

[1] U.S. Patent and Trademark Office. (2022). Patent 12,296,011.

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Drugs Protected by US Patent 12,296,011

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sun Pharm Inds Inc LEVULAN aminolevulinic acid hydrochloride SOLUTION;TOPICAL 020965-001 Dec 3, 1999 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF ACTINIC KERATOSIS OF UPPER EXTREMITIES BY PHOTODYNAMIC THERAPY ⤷  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 12,296,011

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019200152 ⤷  Start Trial
Australia 2020103365 ⤷  Start Trial
Australia 2020267186 ⤷  Start Trial
Australia 2021102111 ⤷  Start Trial
Australia 2021107564 ⤷  Start Trial
Australia 2022209242 ⤷  Start Trial
Australia 2024205278 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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