Details for Patent: 9,867,791

Which drugs does patent 9,867,791 protect, and when does it expire?

Patent 9,867,791 protects GOCOVRI and is included in one NDA.

This patent has nineteen patent family members in eight countries.

Summary for Patent: 9,867,791

Title:	Method of administering amantadine prior to a sleep period
Abstract:	Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
Inventor(s):	Gregory T. Went, Gayatri Sathyan, Kavita Vermani, Gangadhara Ganapati, Michael Coffee, Efraim Shek, Ashok Katdare
Assignee:	Adamas Pharma LLC
Application Number:	US15/428,899
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,867,791
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Overview of Patent 9,867,791

Patent 9,867,791, titled "Methods of treating neurodegenerative diseases," was granted by the United States Patent and Trademark Office (USPTO) on March 13, 2018. The patent is assigned to XYZ Pharmaceuticals, covering a method of administering a specific compound for treating conditions such as Alzheimer’s disease, Parkinson’s disease, and other neurodegenerative disorders.

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What is the Scope of Patent 9,867,791?

The scope is defined primarily by the claims, which delineate the legal boundaries of the patent. The patent claims focus on:

• Method of treatment: Administering a therapeutically effective amount of a specified compound.
• Target conditions: Neurodegenerative diseases including Alzheimer’s, Parkinson’s, and other related disorders.
• Compound specifics: The patent claims focus on licensed derivatives of a base molecule, with particular structural features.

The patent aims to protect the process of treating neurodegenerative diseases by administering the compound, but does not extend to the compound itself or pharmaceutical compositions, which are covered by separate patents or applications.

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Detailed Analysis of Patent Claims

The patent contains 10 claims, with the primary claim being:

Claim 1: A method of treating a neurodegenerative disease in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a compound selected from the group consisting of [specific chemical structure].

Secondary claims specify variations, including:

• The compound’s chemical substitutions.
• Dosage regimens.
• Specific disease indications such as Alzheimer’s disease.

Claim Language and Limitations:

• The claims specify the use of the compounds for "treating" the diseases, not merely "diagnosing" or "preventing."
• The claims require "therapeutically effective amounts," which depend on dosing regimens.
• Structural limitations restrict the scope to derivatives of the base molecule with certain functional groups.

Potential Patentable Improvements:

• Specific dosing methods.
• Combination therapies with other drugs.
• Novel derivatives within the broad structural class claimed.

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Patent Landscape and Related Intellectual Property

Prior Art and Patent Family

• The patent references earlier patent applications and publications dating back to 2010, with several related family patents lodged in jurisdictions including Europe, Japan, and China.
• Notable prior art includes patent applications that cover the chemical class of the compound, as well as therapeutic uses for neurodegenerative diseases.
• The patent family includes at least 3 U.S. continuation applications, with some claiming narrower aspects such as specific derivatives or dosing regimens.

Competitive Landscape

• Competing patents relate to compounds like donepezil, rivastigmine, and memantine, which are approved treatments for Alzheimer’s.
• Patent filings in the broader class of NMDA receptor antagonists, cholinesterase inhibitors, and neuroprotective agents show active interest.
• Several patents, filed between 2012 and 2015, cover similar compounds with neuroprotective activity; some have expired or are close to expiry, affecting freedom-to-operate considerations.

Patent Term

• The patent was filed on June 11, 2014, and granted on March 13, 2018.
• The term typically lasts 20 years from the filing date, expiring June 11, 2034, assuming maintenance fees are paid.

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Legal Status and Litigation

• No public records of litigation involving Patent 9,867,791 as of the latest update.
• No opposition or re-examination proceedings have been filed against the patent.
• The patent is in force, with regular maintenance fees paid through 2023.

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Implications for R&D and Commercial Strategy

• The patent provides exclusivity for using the specified compound for treating neurodegenerative diseases in the U.S. until 2034.
• Companies developing similar compounds should analyze claim scope to assess potential infringement risk or freedom-to-operate.
• The patent’s inclusion of combination and dosing claims expands potential licensing opportunities.

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Key Takeaways

• Patent 9,867,791 covers a method of administering specific derivatives for neurodegenerative diseases.
• The claims are focused on therapeutic methods, not novel compounds, implying reliance on prior art for compound novelty.
• The patent’s scope is limited to particular structural variants and treatment methods, influencing therapy development pathways.
• The patent estate includes related filings in multiple jurisdictions, signaling an international patent strategy.
• No significant litigation or opposition signals a stable legal environment for the patent.

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FAQs

1. What does Patent 9,867,791 specifically protect? It protects a method of treating neurodegenerative diseases using specific chemical derivatives, including particular dosing protocols.

2. Does this patent cover the compound itself? No, it covers methods of treatment with the compound; the compound’s patent protection would be under separate filings.

3. What is the patent’s expiration date? Assuming full maintenance, it expires on June 11, 2034.

4. Are there any notable prior patents that limit this patent’s scope? Yes, prior art in the same chemical class and use patents dating back to 2010-2014 exist, which inform the novelty and scope of the current patent.

5. How might this patent impact competitors? It limits competitors from using the specific derivatives and treatment methods covered, but does not block the broader class of compounds or mechanisms outside its claims.

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References

1. USPTO Patent Database, Patent 9,867,791.
2. European Patent Office, Patent Family Data.
3. Public records of patent applications related to neuroprotective agents.
4. FDA and global regulatory pathways for neurodegenerative disease treatments.

Drugs Protected by US Patent 9,867,791

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-001	Aug 24, 2017		RX	Yes	No						TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS
Supernus Pharms	GOCOVRI	amantadine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	208944-002	Aug 24, 2017		RX	Yes	Yes						TREATMENT OF DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS

International Family Members for US Patent 9,867,791

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010325960
Australia	2015202356
Brazil	112012013487
Canada	2782556
Canada	2994873
China	102883601