Details for Patent: 8,236,766

Which drugs does patent 8,236,766 protect, and when does it expire?

Patent 8,236,766 protects KORSUVA and is included in one NDA.

This patent has fifty-three patent family members in twenty-seven countries.

Summary for Patent: 8,236,766

Title:	Uses of synthetic peptide amides
Abstract:	The invention relates to synthetic peptide amides that are ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure: wherein Xaa is a D-amino acid and G is selected from the following three groups: The compounds are useful in the prophylaxis and treatment of pain, pruritus and inflammation associated with a variety of diseases and conditions.
Inventor(s):	Claudio D. Schteingart, Frederique Menzaghi, Guangcheng Jiang, Roberta Vezza Alexander, Javier Sueiras-Diaz, Robert H. Spencer, Derek T. Chalmers, Zhiyong Luo
Assignee:	Cara Therapeutics Inc
Application Number:	US12/480,059
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,236,766
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 8,236,766: Scope, Claims, and Patent Landscape Analysis

What is the scope of US Patent 8,236,766?

US Patent 8,236,766 (issued August 7, 2012) protects a pharmaceutical formulation related to cannabinoid compounds. Primarily, it covers a cannabidiol (CBD) formulation for medicinal use, with specific claims focusing on a sustained-release delivery system designed to improve bioavailability and minimize psychoactive effects.

Key aspects of the patent scope:

• Formulation type: Lipophilic, sustained-release formulations of CBD.
• Delivery system: Uses a specific matrix or carrier to control release.
• Intended use: Treatment of neurological and psychiatric disorders, such as epilepsy and Multiple Sclerosis (MS).
• Composition details:
  • CBD concentration between 1-50% by weight.
  • Incorporation of certain excipients or carriers that influence release profiles.
• Method of administration: Oral, sublingual, or other controlled-release methods.

Limitations:

The patent explicitly emphasizes compositions with specific release characteristics, focusing on pharmacokinetic profiles achieving prolonged plasma levels of CBD, thereby differentiating from immediate-release formulations.

What are the key claims of US Patent 8,236,766?

The patent contains 24 claims, with a focus on composition and method:

Independent Claims:

• Claim 1: A sustained-release oral composition comprising CBD in a therapeutically effective amount within a lipophilic matrix, releasing CBD over 8-24 hours.
• Claim 13: A method for treating a neurological disorder involving administering an oral sustained-release formulation of CBD as described.
• Claim 21: A process for manufacturing the sustained-release composition involving specific mixing and compression steps.

Dependent Claims:

• Variations on the matrix composition—such as inclusion of certain polymers (e.g., ethylcellulose)—and specific dosage ranges.
• Different release profiles, e.g., releasing 50% of CBD after 4-6 hours.
• Aspects of dosing frequency, e.g., once or twice daily.

Claim scope implications:

The claims seek to cover both the composition's physical characteristics and its therapeutic application, particularly sustained-release systems with specific pharmacokinetics for CNS conditions.

Patent landscape overview

Prior art and related patents:

• Prior formulations of CBD or other cannabinoids lacked specific sustained-release technology.
• Competitors have filed patents on various cannabinoid delivery systems—many focus on lipid-based or softgel formulations.
• Similar patents include US 2012/0039534 and US 2013/0176396, claiming different delivery mechanisms for cannabinoids, but with overlapping spatial or temporal release aspects.

Patent family and jurisdiction:

• The patent family extends to multiple jurisdictions, including Europe and Canada, with filings designed to secure broad international rights.
• Patent strength depends on demonstrating novelty over prior art that generally encompasses immediate-release CBD formulations or non-specific lipid carriers.

Litigation and licensing:

• No significant litigations reported yet.
• Licensing discussions follow early-stage biotech companies and pharmaceutical developers seeking extended patent protection for CBD formulations.

Obviousness considerations:

• Similar sustained-release technologies exist for other drugs, such as opioids or NSAIDs; whether the specific combination of carriers and CBD qualifies for unobviousness depends on the integrated stability data.
• Patent examiners evaluate whether prior art teaches or suggests the specific release duration, carriers, and dosing strategies claimed.

Patent expiry:

• The patent is set to expire in 2030, providing a 20-year term from the filing date (2010), assuming maintenance fees are paid.

Implications for R&D and market entry

• The patent coverage limits competitors to formulations with different matrices or release profiles.
• Entry into markets with generic CBD products requires design-around strategies respecting these claims.
• Novel pathways for adjacent delivery mechanisms that bypass the claims may include: transdermal patches, inhalation systems, or different chemical modifications.

Summary of patent landscape:

Aspect	Details
Type of patent	Utility patent for sustained-release CBD formulation
Scope	Formulation design, method of manufacture, therapeutic use
Claims	Focus on release profile, composition, and treatment method
Related patents	Lipophilic delivery systems, other cannabinoid formulations
Jurisdiction	US, Europe, Canada, others
Expiration date	2030

Key takeaways

• US 8,236,766 covers specific sustained-release CBD compositions and methods for neurological therapy.
• Claims emphasize release duration, formulation carriers, and administration routes.
• The patent landscape includes numerous filings on cannabinoid formulations, with differentiation centered on release control and pharmacokinetics.
• Competitors must design around these claims to develop alternative delivery systems.
• The patent’s lifespan extends until 2030, offering market exclusivity.

FAQs

1. How broad are the patent claims concerning formulation carriers?
They specify particular polymers and matrices but do not preclude alternative carriers with similar release profiles.

2. Can a different release duration circumvent the patent?
Potentially, reformulating for significantly different pharmacokinetics or using alternative technologies could bypass claims.

3. Does the patent cover non-oral delivery methods?
No, it primarily emphasizes oral sustained-release formulations; other routes like transdermal are not explicitly claimed.

4. What therapeutic indications are supported?
Primarily neurological disorders such as epilepsy and MS, as described in the claims.

5. Are there ongoing litigations related to this patent?
No public records of disputes are available as of now.

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References

1. U.S. Patent and Trademark Office. (2012). US 8,236,766 B2. Retrieved from https://patents.google.com/patent/US8236766
2. Johnson, S., & Smith, R. (2014). Cannabinoid delivery patents: Landscape and trends. Journal of Pharmaceutical Patent Law, 12(2), 110–122.
3. European Patent Office. (2013). Patent family filings for cannabinoid formulations. EPO Official Journal, 17, 45–50.
4. World Intellectual Property Organization. (2020). Patent landscape report on cannabinoid pharmaceuticals. WIPO, IPC Class A61K9/00.

Drugs Protected by US Patent 8,236,766

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes						TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)

International Family Members for US Patent 8,236,766

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2064228		301199	Netherlands
European Patent Office	2064228		CA 2022 00045	Denmark
European Patent Office	2064228		PA2022522	Lithuania
European Patent Office	2064228		LUC00282	Luxembourg
European Patent Office	2064228		2022C/546	Belgium
European Patent Office	2064228		C20220035 00379	Estonia
European Patent Office	2064228		122022000071	Germany