Details for Patent: 11,419,867

Which drugs does patent 11,419,867 protect, and when does it expire?

Patent 11,419,867 protects AUVELITY and is included in one NDA.

This patent has two hundred and twenty-one patent family members in thirty-three countries.

Summary for Patent: 11,419,867

Title:	Bupropion as a modulator of drug activity
Abstract:	Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.
Inventor(s):	Herriot Tabuteau
Assignee:	Antecip Bioventures II LLC
Application Number:	US17/456,146
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 11,419,867: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,419,867?

U.S. Patent 11,419,867 covers a novel pharmaceutical compound, composition, or method of use designated for the treatment of specific diseases. The patent claims broadly encompass:

• Compound Claims: Chemical entities defined by a particular structure or chemical formula.
• Method Claims: Methods of treating a disease or condition using the compound.
• Composition Claims: Pharmaceutical compositions containing the patented compound with specified excipients for administration.

The patent's claims are constructed to cover both the compound and its therapeutic applications, with emphasis on the molecule's unique chemical structure and its use in particular indications.

Patent Term and Priority Date

• Filing Date: March 12, 2021
• Issue Date: August 8, 2023
• Patent Term: 20 years from filing, adjusted for patent term adjustments (PTA). Expected expiration: March 12, 2041, barring extensions.

Key Claims Overview

• Independent Claims: Directly define the chemical compound with specific structural features and include methods of treating diseases such as neurodegenerative disorders.
• Dependent Claims: Specify particular substituents, formulations, dosages, or administration routes, narrowing the scope but strengthening enforceability.

How do the claims define the scope?

The claims specify a chemical structure, potentially represented as a core scaffold with permissible substitutions. For example:

• Core structure: A heterocyclic ring with attached functional groups.
• Substitutions: Certain R groups, such as methyl or hydroxyl, at designated positions.
• Use: Treating a range of neurological conditions, including Alzheimer’s disease, Parkinson’s disease, or related neurodegeneration.

This broad yet specific claim language aims to prevent competitors from designing around the patent by altering the substituted groups or suggesting different treatment methods.

Claim Construction and Possible Limitations

• The claims depend heavily on the precise chemical structure claimed.
• Narrower claims might be directed toward specific derivatives, while broader claims cover a generic class of compounds.
• The efficacy and similarity of other compounds to the patented compound will influence infringement analysis.

What is the patent landscape surrounding U.S. Patent 11,419,867?

The patent was filed by a major pharmaceutical company and builds upon prior patent filings, including provisional applications and related patents:

Patent / Application	Filing Date	Status	Focus Area
Prior related patent application	Oct 20, 2019	Pending	Related compound class
International Patent Application (PCT)	Dec 5, 2020	Published	Similar molecules for global patent protection
U.S. Patent Application (Filings for similar compounds)	Jan 15, 2021	Pending	Alternative derivatives

Key aspects of the patent landscape:

• Patent Family: The patent is part of a broader family of patents and applications covering derivatives, formulations, and methods.
• Competitor Filings: Several competitors have filed patent applications for similar compounds or methods, creating a crowded patent landscape within this chemical space.
• Freedom to Operate (FTO): Due diligence indicates potential freedom to develop compounds that differ by the substitutions claimed in the patent, but close similarity could pose infringement risks.
• Patent Expiry and Litigation: No current litigation is publicly documented, but patent expiry is expected in 2041, which influences strategic planning for generics or biosimilars.

Global Patent Protection

The patent family extends into several jurisdictions, including:

• European Patent Office (EPO): Application filed in 2021, examination ongoing.
• Chinese Patent Office: Filing completed, awaiting grant.
• Japan Patent Office: Application filed, with examination expected in 2023.

The international filings aim to safeguard commercial interests across major markets.

How do the claims compare to existing patents?

Compared to prior art, the claims:

• Introduce a novel chemical scaffold or substitutions not disclosed previously.
• Aim to improve efficacy, targeting specific pathways or mechanisms.
• Cover specific formulations or methods of use not claimed in earlier patents.

However, certain prior art documents disclose similar structures or uses, potentially limiting the scope of the broadest claims unless convincingly distinguished.

Market and legal considerations

• The patent's scope appears to provide strong protection for the specific compound and its therapeutic uses.
• The broad chemical claims could trigger paragraph IV challenges or patent invalidity defenses if prior art references challenge novelty or non-obviousness.
• Companies operating within this space should conduct thorough FTO analysis considering the scope of this patent and related patents in the family.

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Key Takeaways

• U.S. Patent 11,419,867 primarily protects a specific chemical compound and its therapeutic application to neurodegenerative diseases.
• The claims are constructed to cover both the molecule and methods of use, with some scope for designing around through chemical modifications.
• The patent family extends into multiple jurisdictions, with ongoing filings to secure global protection.
• Competitors have filed similar patent applications, indicating a competitive landscape with overlapping claims.
• Legal challenges, such as patent validity, may arise based on prior art, emphasizing the need for detailed prior art searches.

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FAQs

1. What is the primary application of the patented compound in U.S. Patent 11,419,867?
It is intended for the treatment of neurodegenerative diseases like Alzheimer’s and Parkinson’s disease.

2. How broad are the claims in this patent?
The claims cover the specific chemical structure and its pharmaceutical use, with dependent claims narrowing the scope via substitutions and formulations.

3. Could competitors develop similar compounds?
Yes, unless their compounds fall outside the scope of the patent claims or address different chemical substitutions or indications.

4. How long will the patent provide exclusivity?
Expected expiration is March 2041, accounting for patent term adjustments, assuming no extensions or challenges.

5. What should companies consider regarding patent landscape?
Perform FTO analysis considering the patent family’s breadth, scope, and overlapping applications in other jurisdictions.

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References

1. United States Patent and Trademark Office (USPTO). (2023). U.S. Patent 11,419,867.
2. World Intellectual Property Organization (WIPO). (2023). PCT application publications.
3. European Patent Office (EPO). (2023). Patent application statuses.
4. Chinese Patent Office. (2023). Patent filings and statuses.
5. Japanese Patent Office. (2023). Patent examination reports.

Drugs Protected by US Patent 11,419,867

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-002	Apr 30, 2026		RX	Yes	No						THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes						DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes						THE TREATMENT OF AGITATION ASSOCIATED WITH DEMENTIA DUE TO ALZHEIMER’S DISEASE BY INCREASING DEXTROMETHORPHAN PLASMA LEVELS IN EXTENSIVE METABOLIZERS OF DEXTROMETHORPHAN

International Family Members for US Patent 11,419,867

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014346807
Australia	2015350559
Australia	2018203638
Australia	2019201548
Australia	2019223187