Details for Patent: 8,236,292

Which drugs does patent 8,236,292 protect, and when does it expire?

Patent 8,236,292 protects BRIXADI and is included in one NDA.

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

Summary for Patent: 8,236,292

Title:	Liquid depot formulations
Abstract:	The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.
Inventor(s):	Krister Thuresson, Fredrik Tiberg, Markus Johansson, Ian Harwigsson, Fredrik Joabsson, Markus Johnsson
Assignee:	Camurus AB
Application Number:	US11/628,007
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Process; Delivery; Dosage form;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,236,292

What Does U.S. Patent 8,236,292 Cover?

U.S. Patent 8,236,292, granted on August 7, 2012, relates to cannabinoid-based pharmaceutical compositions. It is assigned to the U.S. Department of Health and Human Services, indicating government ownership, with specific claims directed toward methods of treating diseases using cannabinoid compounds.

Key Elements of the Patent Scope

• Field: The patent covers pharmaceutical compositions containing cannabinoid derivatives, primarily targeting medical applications.
• Subject matter: Focuses on specific formulations and methods employing cannabinoids such as cannabidiol (CBD) for therapeutic purposes, especially for neurological conditions.
• Claims: The claims are structured to protect specific formulations and methods involving cannabinoids, including their administration routes and dosage forms.

How Broad Are the Claims?

Claim Breakdown

The patent contains 22 claims, primarily divided into independent and dependent claims.

Independent Claims (Claims 1, 16):

• Claim 1: Describes a pharmaceutical composition comprising cannabidiol in a pharmaceutically acceptable carrier, optionally with other components. It addresses specific concentration ranges and formulations.
• Claim 16: Covers a method of treating a neurological disorder by administering a therapeutically effective amount of cannabidiol.

Dependent Claims:

• Expand on formulations, dosages, and specific delivery methods, such as transdermal patches, oral formulations, or topical applications.
• Include combinations with other therapeutic agents and particular dosing regimens.

Claim Scope Analysis

• The claims are relatively specific regarding cannabidiol concentrations (e.g., 10-100 mg/mL) and formulation types.
• They focus on methods of administration for treating neurological and inflammatory diseases, such as pain, epilepsy, or neurodegenerative disorders.
• The scope seems tailored to pharmaceutical compositions and treatment protocols but not to broader cannabinoid structures or non-pharmaceutical applications.

Patent Landscape Analysis

Related Patents and Key Players

• Overlapping Patents: Several patents cover cannabinoid formulations, but few focus specifically on cannabidiol for neurological conditions. Notable patents in the space include those assigned to GW Pharmaceuticals (e.g., U.S. Patent 7,663,607 for Sativex) and private entities developing synthetic cannabinoid analogs.
• Patent Filings: The patent family expands internationally, with applications filed in countries such as Canada, Australia, and Europe, reflecting an intent to secure broad protection.
• Legal Status: There have been no significant litigations targeting this patent, but future challenges may arise as cannabinoids become more prominent in therapeutic development.

Landscape Trends

• Shift toward formulation-specific patents, including novel delivery methods.
• Increase in combination patents pairing cannabinoids with other therapeutic agents.
• Growing emphasis on patenting synthetic and semi-synthetic derivatives of cannabinoids.

Implications for Stakeholders

• Pharmaceutical Companies: The patent covers a narrow scope, focusing on cannabidiol formulations for neurological treatment. Companies developing broad-spectrum cannabinoid therapies or different cannabinoids may avoid infringement.
• Researchers: The claims delineate specific formulations and methods, providing a clear boundary for research use without infringement risk if formulations differ.
• Patent Expiration: The patent is set to expire in 2030, after which generic manufacturers could enter the market, assuming no newer patents block those efforts.

Summary of Key Points

Aspect	Details
Patent Number	8,236,292
Grant Date	August 7, 2012
Assignee	U.S. Department of Health and Human Services
Patent Term	20 years from filing date (June 25, 2004), expiry in June 2024 (assuming no patent term adjustments)
Scope	Cannabidiol formulations and treatment methods for neurological conditions
Main Claims	Composition containing cannabidiol; method of treatment with cannabidiol
Related Patents	Activated by GW Pharmaceuticals, Sandoz, and other cannabinoid patent owners
International filing	PATENTS filed in Canada, Australia, Europe

Key Takeaways

• U.S. Patent 8,236,292 protects specific cannabidiol formulations and related methods for neurological therapeutics.
• It has a relatively narrow claim scope, primarily focused on certain formulations and administration methods.
• Current patent protection extends to 2024/2025, after which generics could potentially enter the U.S. market.
• The patent landscape is active but still limited by the scope and specific formulation claims.
• Strategic patenting in related areas involves combination therapies and delivery innovations.

FAQs

1. Does U.S. Patent 8,236,292 cover all uses of cannabidiol?
No. The patent specifically covers certain formulations and methods for neurological disorders. Other uses or formulations may not be covered.

2. Can companies develop cannabinoid therapies without infringing on this patent?
Yes. As long as formulations or methods differ substantially from the claims, infringement is avoided.

3. Are there ongoing patent disputes related to this patent?
No public records indicate current litigation. However, challenges might emerge as cannabinoid therapies expand.

4. How does the patent landscape influence the development of CBD drugs?
It encourages innovation around formulations, delivery methods, and combination therapies while delineating clear boundaries for existing patents.

5. What is the expiration status of U.S. Patent 8,236,292?
Assuming no patent term adjustments, it expires in 2024, opening pathways for generic development.

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References

1. U.S. Patent and Trademark Office. (2022). Patent number 8,236,292. https://patents.google.com/patent/US8236292B2
2. Food and Drug Administration. (2018). FDA Approves First Drug Comprised of an Active Ingredient Derived from Cannabis to Treat Rare, Severe Forms of Epilepsy. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-cannabis-treat-rare-severe-forms-epilepsy
3. PCT, International Patent Applications relevant to Cannabinoid formulations. [Accessed from WIPO database]

Drugs Protected by US Patent 8,236,292

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-001	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-002	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION

International Family Members for US Patent 8,236,292

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E401054
Austria	E462409
Austria	E501710
Australia	2005249274