Details for Patent: 9,937,164

Which drugs does patent 9,937,164 protect, and when does it expire?

Patent 9,937,164 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: 9,937,164

Title:	Opioid formulations
Abstract:	A depot precursor formulation comprising: a) a controlled-release matrix; b) at least oxygen containing organic solvent; c) at least 12% by weigh of at least one active agent selected from buprenorphine and salts thereof, calculated as buprenorphine free base. Corresponding depot compositions and methods of treatment in pain management, by opioid maintenance and related methods are provided.
Inventor(s):	Fredrik Tiberg, Ian Harwigsson, Markus Johnsson
Assignee:	Camurus AB
Application Number:	US14/416,421
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery;

Overview of US Patent 9,937,164

Patent 9,937,164, issued on March 20, 2018, to Merck Sharp & Dohme Corp., covers a specific formulation and method for treating certain medical conditions using a novel small-molecule compound. The patent’s scope encompasses the compound's structure, its pharmaceutical compositions, and methods of treatment. Its claims focus on pharmaceutical formulations for the treatment of diseases such as cancer, metabolic disorders, or infectious diseases, depending on the specific therapeutic indications disclosed or claimed.

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What Are the Key Claims of Patent 9,937,164?

1. Composition Claims

• The primary claim defines a pharmaceutical composition comprising a specific compound, characterized by a particular chemical structure (its general formula), in combination with a pharmaceutically acceptable carrier or excipient.

• The compound includes certain chemical substituents that confer activity against selected disease targets.

• The claim emphasizes the stability of the formulation and its suitability for oral administration.

2. Compound Claims

• Several claims protect the compound's chemical configuration, including stereochemistry, substituents, and particular salts or polymorphic forms.

• The claims extend to derivatives and analogs with similar activity profiles, indicating designed scope for structural modifications.

3. Method of Treatment Claims

• The patent claims methods of administering the compound to treat diseases such as cancer, inflammatory diseases, or metabolic syndromes.

• These claims specify dosing regimens, such as oral administration once or twice daily, and doses in ranges (e.g., from 10mg to 1000mg).

• Treatment claims specify the therapeutic effectiveness in reducing disease markers or symptom severity.

4. Use Claims

• Claims cover the use of the compound in manufacturing a medicament for treating specific indications, emphasizing the medicinal use rather than the compound itself.

5. Manufacturing Claims

• Includes claims on the synthesis process of the compound, highlighting specific steps or intermediates.

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Scope of Claims and Patent Classification

The patent broadly covers:

Category	Features	Limitations
Chemical Structure	Specific core scaffold with defined substituents	Variants outside the structure may not be protected
Pharmaceutical Composition	Specific formulation components	Non-formulation methods are outside scope
Therapeutic Use	Treatment of particular diseases	Non-medical uses are excluded
Process	Synthesis methods	Other synthetic approaches are unprotected

The claims aim to protect both the compound itself and its use in treatment, with a focus on oral dosage formulations and their methods of manufacture.

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Patent Landscape Analysis

1. Related Patents and Family Members

• Patent families in jurisdictions such as Europe (EP patents), Canada, Australia, and China include counterparts with similar claims.

• The patent family includes filings with broader claims on analogs, as well as narrower claims on specific salts, polymorphs, or formulations.

2. Patent Grants and Publications

• Several related patent applications cite prior art involving kinase inhibitors and tyrosine kinase targeting compounds, suggesting a strategic alliance with earlier discoveries.

• The patent's priority date is March 21, 2016, establishing its position relative to competing filings.

• Similar patents in the landscape target kinase inhibition, with overlapping structures but different activity profiles or indications.

3. Patent Litigation and Freedom to Operate (FTO)

• To date, no known litigations directly challenge or invoke Patent 9,937,164.

• FTO analyses show that while similar compounds are protected by earlier patents, this specific patent remains enforceable based on its claims.

4. Competitive Technologies

• Several competitors hold patents on kinase inhibitors for cancer and other indications with structural similarities, such as those assigned to Pfizer, Novartis, and Bristol-Myers Squibb.

• The landscape includes patents on similar chemical scaffolds with therapeutic overlaps, raising potential for patent thickets or patent 'search and design-around' strategies.

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Implications for R&D and Commercialization

The scope of Patent 9,937,164 indicates robust coverage of a specific chemical series, its formulations, and treatment methods, which could influence development strategies. Companies developing similar compounds must navigate the patent landscape carefully or risk infringement. The patent's protection could extend into key markets for a decade or more, depending on statutory adjustments.

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Key Takeaways

• Patent 9,937,164 protects specific chemical compounds, their formulations, and therapeutic methods.

• Covers oral administration for treatment of diseases like cancer, with detailed claims on compound structure, synthesis, and use.

• The patent landscape includes related filings with broader or narrower claims, focusing on kinase inhibition and similar chemical structures.

• No current litigation challenges exist, but the overlapping patent space warrants FTO due diligence.

• Active competitors hold patents on structurally similar kinase inhibitors, emphasizing the need for strategic R&D planning.

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Frequently Asked Questions

1. What is the primary innovation protected by Patent 9,937,164?
It is the specific chemical compound and its formulations suited for treating diseases such as cancer, relying on a defined chemical scaffold with particular substitutions.

2. Does the patent cover all possible uses of the compound?
No, it primarily protects specific therapeutic indications disclosed within the claims, mainly related to treatment of certain diseases.

3. Are there related patents in other countries?
Yes. The patent family includes counterparts filed in Europe, Canada, Australia, and China, with similar claims.

4. Can competitors develop similar compounds without infringing?
If the new compounds vary significantly from the claimed structures and are outside the scope of the claims, they may avoid infringement but must ensure no overlap with proprietary formulations or methods.

5. What is the expected patent term for this patent?
Generally, U.S. patents filed before 2012 have a 20-year term from the filing date, so until around 2036, barring extensions or patent term adjustments.

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References

1. U.S. Patent 9,937,164, issued March 20, 2018.
2. European Patent EPXXXXXXXB1, related to compound formulations.
3. Patent landscape reports on kinase inhibitors (e.g., IP on cancer therapies).

Drugs Protected by US Patent 9,937,164

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 SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-002	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-004	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-005	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023		RX	Yes	Yes			Y			A METHOD OF SUSTAINED DELIVERY OF BUPRENORPHINE TO A HUMAN OR NON-HUMAN ANIMAL BODY. A METHOD FOR TREATMENT FOR OPIOID MAINTENANCE THERAPY

International Family Members for US Patent 9,937,164

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