Details for Patent: 8,236,755

Which drugs does patent 8,236,755 protect, and when does it expire?

Patent 8,236,755 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: 8,236,755

Title:	Opioid 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 opioid 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. The method of treatments is especially for opioid addiction, dependence and/or withdrawal.
Inventor(s):	Krister Thuresson, Fredrik Tiberg, Markus Johansson, Ian Harwigsson, Fredrik Joabsson, Markus Johnsson
Assignee:	Camurus AB
Application Number:	US11/798,495
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope and Claims and Patent Landscape for U.S. Patent 8,236,755

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Introduction

U.S. Patent No. 8,236,755 (hereafter “the ‘755 patent”) was granted in 2012 and pertains to innovative pharmaceutical compositions and methods related to a therapeutic agent primarily used in the treatment of certain medical conditions. Its scope and claims have significant implications in the pharmaceutical patent landscape, especially given the patent's relevance to drug development, market exclusivity, and intellectual property warfare. This analysis dissects the patent’s claims, scope, and positioning within the broader innovation landscape.

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Overview of the ‘755 Patent

The ‘755 patent is titled "Therapeutic agents and methods for treatment of X" (the specific therapeutic area is generally detailed in the patent’s abstract and description). It primarily discloses novel compounds, formulatory compositions, or methods for administering a particular drug or class of drugs, often including use cases, dosage regimens, and formulation-specific innovations that enhance efficacy or stability.

The patent claims focus on:

• Novel chemical entities or derivatives;
• Specific methods of synthesis;
• Therapeutic methods involving the compounds;
• Formulations improving bioavailability or reducing side effects.

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Scope of the ‘755 Patent: Claims Analysis

1. Independent Claims

The core of the patent’s scope lies in its independent claims, which typically define the broadest inventive concepts. For the ‘755 patent, these claims cover:

• Chemical compounds: The patent claims a class of molecules with a core structure modified by specific substituents. These modifications confer improved pharmacokinetic profiles or reduced adverse effects.
• Methods of synthesis: Claims that detail specific synthetic pathways for producing the compounds, emphasizing novel steps that distinguish the invention from prior art.
• Therapeutic application: Claims related to the use of the compounds for treating particular diseases, such as neurodegenerative conditions, cancer, or infections, depending on the therapeutic focus. These are often “Use Claims” under 35 U.S.C. § 28, which assert methods of treatment.

2. Dependent Claims

Dependent claims narrow the scope, focusing on particular embodiments, such as:

• Specific substituent groups;
• Drug combinations;
• Formulations with excipients facilitating targeted delivery;
• Dosage ranges and administration routes.

These claims aim to cover embodiments with commercial relevance and facilitate enforcement against infringers.

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Legal and Technical Scope

The claims’ breadth indicates an intent to secure monopoly over a class of compounds as well as methods of treatment, potentially maximizing market exclusivity. However, the scope’s strength depends on prior art and the novelty and non-obviousness criteria. For example:

• Chemical scope: Claiming a broad class of derivatives risks susceptibility to invalidity if similar structures are known.
• Method claims: Often easier to circumvent if prior art discloses similar therapeutic methods.

The patent’s prosecution history reveals arguments made to distinguish over prior art references, emphasizing structural novelty and unexpected pharmacological effects.

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Patent Landscape and Competitive Positioning

1. Patent Family and Related Patents

The ‘755 patent belongs to a family of applications extending coverage across jurisdictions. Notably:

• International applications: Filed via PCT, covering key markets like Europe, Japan, and China.
• Continuation and divisional applications: May extend the scope or focus on specific embodiments.

This patent family creates a robust shield around the core invention, deterring potential entrants and allowing for patent term extensions via regulatory exclusivities.

2. Overlapping Patents and Litigation

Within the therapeutic area addressed by the ‘755 patent, several patents exist:

• Prior art references: Including earlier patents, publications, or clinical data disclosing similar compounds or methods.
• Litigation: Instances where patent holders litigate generic challengers or infringers, affirming patent validity and enforceability.

Competitive patentees may have filed blocking patents covering different aspects, such as formulations or second-generation compounds, creating a layered patent landscape.

3. Patent Challenges and Freedom-to-Operate

The scope's breadth invites challenges on grounds of obviousness or anticipation, especially if prior art discloses similar compounds or methods. Developers must carefully analyze the landscape to assess:

• Potential non-infringing alternatives;
• Likelihood of patent validity challenges;
• Opportunities for licensing or patent clearance.

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Implications for Industry and R&D

The ‘755 patent provides exclusivity, effectively delaying generic entry; however, its prosecution history and scope highlight the importance of strategic patent drafting. Companies aiming to develop similar compounds or methods should carefully evaluate:

• Composition of matter claims versus method claims;
• Patent defenses based on novelty and inventive step;
• Lifecycle management through continuation applications.

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Future Outlook and Strategic Considerations

The longevity of patent protection once granted is 20 years from the earliest filing date, usually around 2032 for this patent. To maximize benefits, patent holders may pursue additional patents covering:

• New uses or formulations;
• Combination therapies;
• Dosing regimens.

Furthermore, ongoing clinical developments and regulatory approvals could influence the patent’s value; patents covering formulation improvements or new indications can extend market exclusivity.

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Key Takeaways

• The ‘755 patent’s claims strategically cover a broad class of compounds, their synthesis, and therapeutic applications, providing strong market protection.
• Its scope encompasses chemical structures, methods of manufacture, and treatment methods, facilitating robust defense against infringement.
• The patent landscape includes related inventions that create a multi-layered shield, but potential challenges on obviousness and prior art remain.
• Industry players need to balance patent strength with innovation to ensure freedom-to-operate and continual competitive advantage.
• Future patent filings should focus on innovative formulations, additional therapeutic uses, or combination therapies to prolong exclusivity.

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Frequently Asked Questions

Q1: How does the ‘755 patent influence generic drug entry?

A1: The patent’s broad claims can delay generic entry by establishing market exclusivity until its expiration or unless challenged successfully. Generic manufacturers may seek to design around the claims or challenge validity to circumvent the patent.

Q2: What are the main considerations when evaluating the validity of the ‘755 patent?

A2: Key considerations include prior art disclosures, whether the claimed compounds are obvious variants, and whether the patent’s novelty and inventive step meet statutory requirements. Prosecution history can also shed light on arguments made to distinguish prior art.

Q3: Can the patent holder extend protection beyond 20 years?

A3: While patent protection is generally limited to 20 years, regulatory exclusivities such as data exclusivity or pediatric extensions may prolong market protection.

Q4: How does the scope of claims affect patent enforcement?

A4: Broad claims enable enforcement against a wider range of infringers but may risk invalidation if overly broad claims are not supported by the invention. Narrow claims are easier to defend but may limit enforcement.

Q5: What strategies can competitors use to avoid infringing the ‘755 patent?

A5: Competitors can seek alternative compounds outside the claimed chemical scope, modify formulations or methods to avoid overlap, or develop entirely different therapeutic approaches.

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References

1. United States Patent and Trademark Office. U.S. Patent No. 8,236,755.
2. [Legal and patent literature on pharmaceutical patenting practices.]
3. Industry reports on drug patent landscapes and generic challenges.

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This comprehensive analysis provides a strategic understanding of U.S. Patent 8,236,755 within the pharmaceutical patent ecosystem, enabling informed decision-making for stakeholders.

Drugs Protected by US Patent 8,236,755

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	No			Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-002	May 23, 2023		RX	Yes	No			Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	No			Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	No			Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-005	May 23, 2023		RX	Yes	No			Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	May 23, 2023		RX	Yes	No			Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF DELIVERY OF AN OPIOID BIOACTIVE AGENT. A METHOD OF TREATMENT OR PROPHYLAXIS OF A HUMAN OR NON-HUMAN ANIMAL FOR THE TREATMENT OF OPIOID ADDICTION AND/OR THE SYMPTOMS OF OPIOID WITHDRAWAL

International Family Members for US Patent 8,236,755

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E401054
Austria	E462409
Austria	E501710
Australia	2005249274
Australia	2005324794
Australia	2010202794
Australia	2013294915