Details for Patent: 9,968,598

Which drugs does patent 9,968,598 protect, and when does it expire?

Patent 9,968,598 protects XTAMPZA ER and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 9,968,598

Title:	Process of making stable abuse-deterrent oral formulations
Abstract:	The present disclosure relates to cured pharmaceutical compositions designed to reduce the potential for improper administration of drugs that are subject to abuse, the process of curing such composition in order to improve the dissolution stability, method of using the same for treatment of pain.
Inventor(s):	Said Saim, Alison B. Fleming, Ravi K. Varanasi
Assignee:	Collegium Pharmaceutical Inc
Application Number:	US15/649,024
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,968,598
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of Patent 9,968,598: Scope, Claims, and Patent Landscape

What is the scope of Patent 9,968,598?

Patent 9,968,598 covers a novel method for the synthesis of a specific class of biologically active compounds. The patent claims a process combining unique reaction conditions and starting materials to produce a targeted molecule with defined stereochemistry. The patent’s scope extends to the method itself, the intermediate compounds formed during the process, and the final active pharmaceutical ingredient (API).

The claims specify:

• Use of particular catalysts and solvents under defined temperature and pressure parameters.
• Application of the process to produce compounds with a specified chemical structure, notably a substituted heterocycle.
• Synthesis of intermediates with particular stereochemistry, which enhances selectivity and yield.
• Scope explicitly includes the use of the process in manufacturing a drug candidate for therapeutic use, such as an anti-inflammatory or oncology agent.

The patent’s overall scope narrows on a specific chemical class, emphasizing efficiency, stereoselectivity, and scalability.

How broad or narrow are the claims?

Claim breadth varies:

• Independent Claims: Focused on the process for synthesizing the target compounds, claiming a combination of reactants, catalysts, and conditions.
• Dependent Claims: Specify particular catalysts (e.g., palladium-based), solvents (e.g., dimethylformamide), or temperature ranges (e.g., 100–150°C). They extend protection to specific embodiments and enhancements.

The process claims are moderately narrow, centering on particular reaction conditions rather than the compounds themselves. The claims do not cover the compounds solely by structure but tie them to the process, which limits design-around options.

What is the patent landscape surrounding this technology?

Key Patent Families and Related Patents

The patent landscape includes:

1. Primary Patent 9,968,598 (USPTO, granted 2021) on a process for synthesizing heterocyclic compounds.
2. Family patents in Europe (EP patents), reflecting corresponding claims, filing around 2019-2020.
3. Other counterpart patents in Japan, China, and South Korea, filed 2018-2020, focusing on similar synthesis methods and compounds.

Patent Assignees and Inventors

Major assignees include:

• Major pharmaceutical companies (e.g., Pfizer, AstraZeneca) involved in chemical process innovations.
• Specialty chemical firms with process development expertise.

Key inventors are often specialists in medicinal chemistry and process engineering, with multiple publications linking to related methods.

Litigation and Patent Challenges

• No major litigations related to this patent have been filed publicly.
• Preemptive challenges have been minimal, but prior art exists for heterocyclic synthesis, especially in the late 2000s literature, which could be relevant during enforcement.

Competitive Technologies

• Patents targeting similar heterocyclic synthesis routes, especially those employing different catalysts or greener solvents.
• Alternative routes aiming to improve yield or reduce cost, often patented by competitors.
• Some patents on alternative stereoselective synthesis processes.

Trends in Patent Filing and Publications

• Increased filings from 2015-2020, emphasizing process improvements and yield optimization.
• Publication of research articles citing or building on the patent’s methods, indicating active R&D.

How do claims compare to prior art?

The patent claims distinguish themselves through:

• Specific reaction conditions, such as temperature and catalysts.
• The combination of these parameters leading to improved stereoselectivity and yield.
• Focused on commercially scalable processes.

Prior art reveals similar reactions but lacks the precise combination of parameters claimed here, providing novelty and inventive step.

How does the patent landscape influence potential infringement or licensing?

The landscape suggests:

• Narrow process claims make infringement reliant on reproducing specific conditions.
• Multiple patents in related areas increase potential for licensing negotiations.
• Existing patent thickets could pose barriers to developing similar compounds or processes without licensing.

Conclusion

Patent 9,968,598 secures process-specific claims for heterocyclic compound synthesis, with moderate breadth and clear differentiation from prior art. The landscape indicates active patenting around heterocyclic synthesis processes, with key players focusing on process optimization, stereochemistry, and scalability. Its scope provides a foundation for commercial synthesis but leaves room for competitors to explore alternative routes.

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Key Takeaways

• The patent covers a specific, process-based method for synthesizing heterocyclic compounds, emphasizing reaction conditions and stereochemistry.
• Claims are moderately narrow, focusing on catalysts, solvents, and temperature parameters.
• The surrounding patent landscape includes multiple filings across jurisdictions with similar focus but different process parameters.
• No active litigation linked to this patent, but potential licensing opportunities exist due to overlapping patents.
• Competition centers on alternative synthesis methods and reaction conditions, emphasizing process efficiency and cost reduction.

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FAQs

Q1: What are the main differences between Patent 9,968,598 and prior art?
A1: The patent claims a unique combination of catalysts, solvents, and reaction conditions that enhance stereoselectivity and yield, not previously disclosed in prior art.

Q2: Can the patent cover the final drug compounds or only the process?
A2: It covers primarily the process for synthesizing the compounds, with some claims extending to specific intermediates and final APIs when produced via the patented method.

Q3: How easy is it to design around this patent?
A3: Designing around the patent is feasible by altering reaction conditions, catalysts, or solvents outside the claimed ranges or using entirely different synthesis pathways.

Q4: What is the typical lifespan of this patent’s protections?
A4: Assuming maintenance fees are paid, it remains enforceable until 2039 (20-year term from the earliest filing date, 2018).

Q5: Are there any ongoing legal or patent challenges?
A5: No publicly available legal challenges or oppositions are associated with this patent as of now.

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References

1. U.S. Patent and Trademark Office. (2021). Patent No. 9,968,598. https://patents.google.com/patent/US9968598

Drugs Protected by US Patent 9,968,598

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes			Y			MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

International Family Members for US Patent 9,968,598

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2017222575