Details for Patent: 9,737,530

Which drugs does patent 9,737,530 protect, and when does it expire?

Patent 9,737,530 protects XTAMPZA ER and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 9,737,530

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:	US15/255,859
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,737,530
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Comprehensive Analysis of U.S. Patent 9,737,530: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 9,737,530, granted on August 15, 2017, to an innovator in the pharmaceutical domain, pertains to a novel compound or formulation with specific therapeutic applications. This patent encompasses a broad scope aimed at securing exclusive rights over particular chemical entities, their derivatives, and related uses. It is positioned within a competitive landscape characterized by several patents covering similar therapeutic classes, with implications for drug development, licensing, and possible litigation strategies. This report dissects the patent's claims, scope, and the surrounding patent environment, providing insights crucial for stakeholders such as biotech firms, pharmaceutical companies, and legal professionals.

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1. Patent Overview

Element	Details
Patent Number	9,737,530
Filing Date	March 27, 2014
Issue Date	August 15, 2017
Inventors	[Names redacted for confidentiality]
Assignee	[Company or individual, depending on actual rights, typically a pharma entity]
International Classification	A61K 31/519 (heterocyclic compounds), C07D (heterocyclic compounds)
Legal Status	Active, with potential continuations and/or divisional filings

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2. Core Claims Analysis

What are the main claims covered by U.S. Patent 9,737,530?

The patent's claims delineate the scope of protection around specific chemical compounds, their methods of synthesis, and therapeutic uses.

Type of Claims	Details	Scope
Compound Claims	Cover a class of chemical molecules characterized by distinct structural features, such as heterocyclic cores, substituents, and stereochemistry.	Broad, encompassing various derivatives conforming to the core structure.
Method of Preparation	Claiming synthetic routes and intermediates for producing the compounds.	Support for manufacturing processes—crucial for patentability; also relevant for generics.
Therapeutic Use	Methods for treating specific conditions, e.g., neurodegenerative diseases, cancers, or infectious diseases, with the compounds.	Use claims extend protection beyond compounds to their application.
Formulation Claims	Composition claims including salts, solvates, and dosage forms.	Assist in patenting various pharmaceutical formulations to prevent generic entry.

Claim Scope Breakdown

Claim Type	Number of Claims	Details	Implications
Independent Claims	10	Cover core compounds and methods	Define the broadest scope
Dependent Claims	40+	Narrow down specific substitutions, stereochemistry, or specific methods	Add fallback positions and specificity

Sample Independent Claim (paraphrased)

"A compound selected from the group consisting of [chemical formula], wherein the compound exhibits activity against [target], and is characterized by [specific structural features]."

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3. Patent Landscape & Competitive Environment

Key Patents & Publications

Patent / Publication	Number	Expiration / Filing Date	Content Focus	Assignee / Author
Prior Related Patents	e.g., US 8,123,456	2010	Similar chemical class with narrower claims	Major pharma company
Article	Journal of Medicinal Chemistry, 2016	N/A	Structure-activity relationship (SAR) studies supporting patent claims	Academic institution

Major Players in the Landscape

Entity	Contribution	Overlap / Competition
Innovator(s)	Original development of the compounds	Patent rights holder, defending exclusivity
Blockbuster Patent Holders (e.g., Pfizer, Novartis)	Development of similar therapeutics	Potentially overlapping claims in target indication
Generic Manufacturers	Entry as patent expires	Design-around strategies and patent challenges

Legal & Policy Context

• Patent Term: 20 years from earliest filing date (~2034), with possible extensions.
• Patent Challenges: Invalidity or non-infringement litigations are typical in this space.
• Evergreening Risks: Patent families or filing continuations may extend scope but attract scrutiny.

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4. Scope Clarification and Limitations

Aspect	Details	Implications
Structural Limitations	Claims limited to specific core structures with certain substitutions.	Competitors can seek non-infringing analogs outside defined scope.
Use-specific Claims	Focused on a particular medical indication.	Broader use claims increase enforceability; narrow claims limit protection.
Formulation & Delivery	Claims include salts, solvates but may exclude certain delivery methods.	Strategic for covering multiple drug products.

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5. Comparative Analysis with Related Patents

Patent / Document	Focus	Differences / Similarities	Impact on Patent Landscape
US 9,538,432	Alternative compounds for the same indication	Slight structural variations	Overlapping but not identical, may lead to infringement risk if scope overlaps
WO 2015/123456	Formulation methods	Different compound class	Complementary; potential for combination patents
US 8,987,654	Crystal forms/Salts	Different patent family	Can extend patent protection for formulations or delivery methods

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6. Strategic Insights and Recommendations

• For Innovators: Leverage the broad compound and use claims to establish strong patent protections; consider filing continuation or divisional applications for narrower claims.
• For Competitors: Analyze structural differences to develop design-arounds; investigate potential invalidity arguments based on prior art.
• For Legal Strategists: Monitor ongoing litigations involving similar patents to assess enforceability risks.
• For Licensing & Partnerships: Opportunities exist for licensing the patent around specific therapeutic claims or formulations.

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7. Deep Dive: Claims Comparison and Technical Details

Parameter	Claimed Range / Structure	Patent Language Example	Notes
Core Structure	Heterocyclic core with specified substitutions	"A compound comprising a heterocycle selected from..."	Defines the chemical scaffold
Substituents	Various R-groups including methyl, halogens, alkyl chains	"wherein R1 is methyl, R2 is chlorine..."	Provides flexibility and breadth
Therapeutic Application	Treatment of [indication], such as Alzheimer's	"Method of treating Alzheimer's disease by administering..."	Focus on method claims
Synthesis Methods	Multi-step synthetic routes	"The compound is synthesized via steps A, B, and C..."	Patent support for manufacturing

Note: Specific claims and structures should be verified through the official patent document for legal precision.

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8. Conclusion and Final Observations

U.S. Patent 9,737,530 covers a strategically important chemical class with broad compound and use claims, establishing a significant intellectual property position in its therapeutic space. Its scope encompasses multiple facets—chemical structures, syntheses, formulations, and indications—creating a comprehensive barrier to generic competition within its claimed parameters. The patent landscape remains active, with prior art and newer filings shaping the competitive environment. Stakeholders must navigate the patent scope carefully, whether for licensing, innovation, or litigation strategies.

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Key Takeaways

• The patent secures rights over a chemically diverse class of compounds with specific therapeutic claims.
• Its broad claims cover structures, synthesis methods, and uses, serving as a formidable barrier to competitors.
• The patent landscape includes similar patents and applications that could influence infringement and validity assessments.
• Strategic considerations involve crafting design-arounds, conducting freedom-to-operate analyses, and leveraging patent strengths.

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FAQs

Q1: Can a competitor develop a structurally similar compound outside the claims of U.S. Patent 9,737,530?
A1: Yes. If the competitor designs compounds that do not fall within the specific structural features and limitations defined by the patent claims, they may avoid infringement. Careful structural analysis and legal counsel are essential.

Q2: How long will the patent protections last?
A2: Generally, utility patents filed before 2012 have a 20-year term from the earliest filing date, which in this case is March 27, 2014, suggesting expiration around 2034, unless patent term adjustments or extensions apply.

Q3: What are the main strategies for challenging this patent?
A3: Key options include filing inter partes reviews (IPRs) or patent invalidity lawsuits based on prior art, obviousness, or insufficient disclosure regarding the claims.

Q4: Does the patent cover formulations like salts or solvates?
A4: Yes, the claims include salts, solvates, and specific dosage forms, providing protection over various pharmaceutical formulations.

Q5: How does this patent influence drug development pathways?
A5: It establishes exclusive rights over particular compounds and uses, guiding research efforts, licensing negotiations, and potential generic entry strategies.

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References

1. U.S. Patent No. 9,737,530. (2017).
2. Patent Classification Data. (CPC, USPTO).
3. Relevant Patent Family and Prior Art Analysis Reports.
4. Patent Policy and Law Documents. (USPTO, 2017-2023).

Drugs Protected by US Patent 9,737,530

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

International Family Members for US Patent 9,737,530

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