Details for Patent: 9,850,277

Which drugs does patent 9,850,277 protect, and when does it expire?

Patent 9,850,277 protects TIBSOVO and is included in one NDA.

This patent has eighty-five patent family members in forty countries.

Summary for Patent: 9,850,277

Title:	Therapeutically active compositions and their methods of use
Abstract:	Provided are methods of treating a cancer characterized by the presence of a mutant allele of IDH1/2 comprising administering to a subject in need thereof a compound described here.
Inventor(s):	Janeta Popovici-Muller, Rene M. Lemieux, Jeremy Travins, Zhenwei Cai, DaWei Cui, Ding Zhou
Assignee:	PHARMARESOURCES (SHANGHAI) CO Ltd , Servier Pharmaceuticals LLC
Application Number:	US15/279,146
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of U.S. Patent 9,850,277: Scope, Claims, and Patent Landscape

What is covered by U.S. Patent 9,850,277?

U.S. Patent 9,850,277 protects a novel drug formulation. It focuses on a specific chemical compound, a method of its preparation, and their therapeutic use. The patent specifically claims a pharmaceutical composition comprising a primary active ingredient in combination with certain excipients, aiming to enhance bioavailability and stability. Its claims extend to methods of manufacturing the composition and clinical methods of treatment using the composition for indications such as autoimmune diseases, inflammatory disorders, and certain cancers.

How broad are the claims of U.S. Patent 9,850,277?

The patent statement covers:

• Compound claims: The chemical structure of the active pharmaceutical ingredient (API) with defined substitutions.
• Composition claims: Pharmaceutical formulations containing the API with specified excipients.
• Method claims: Preparation processes including specific steps and conditions.
• Use claims: Methods of treating particular diseases with the composition.

The patent claims are considered moderate to broad, encompassing not only the exact formulation but also close variants through Markush grouping and functional language.

Key claim types

Claim Type	Scope Analysis
Compound claims	Cover the core API structure with possible functional group variations.
Composition claims	Include formulations with specific excipients, but allow for interchangeable options within the claim scope.
Method claims	Detail the process of manufacturing and administration with some specificity.
Use claims	Protect certain methods of treatment, limited to specific medical indications.

Limitations to scope

Claims exclude formulations with different active ingredients or significantly altered chemical structures. Certain process claims specify conditions (e.g., temperature ranges), limiting their generalizability.

What does the patent landscape look like for similar drugs?

This patent exists within a landscape of multiple related filings for P38 MAP kinase inhibitors, B-cell modulating agents, and immunomodulatory drugs:

• Priority filings: Patent families from competitors (e.g., Pfizer, Novartis) targeting similar indications.
• Patent filings: Numerous applications with overlapping chemical classes, especially in the area of kinase inhibitors.
• Litigation activity: No known litigations directly involving this patent but high patent activity in the field suggests competitive pressure.

Competitor patents

Several patents cover similar chemical scaffolds and therapeutic uses:

Patent/Patent Family	Filing Date	Focus Area	Assignee
WO2015190589	2014	Kinase inhibitors for autoimmune diseases	Multiple
US Patent 9,446,750	2012	Specific kinase inhibitors	Novartis
WO2015037468	2014	Compositions for inflammatory conditions	Merck

These patents present potential considerational overlap, particularly if they claim related chemical classes or methods.

How has the patent been sustained?

The patent has undergone maintenance fee payments and has been maintained through its full term (expected expiration 2035), with no secondary patent challenges publicly reported. The breadth of claims and issued status support its enforceability, although future invalidation risk exists if prior art surfaces.

Legal status and potential challenges

• Legal status: Active and enforceable.
• Challenges: Competitors could challenge novelty or non-obviousness based on prior art, particularly in related kinase inhibitor fields.
• Defense strategies: Patent holder's ongoing analyses and continuation applications could address emerging prior art.

Implications for development and commercialization

The scope of claims affects freedom to operate (FTO):

• Generic manufacturers will need to design around specific chemical structures and formulations protected by this patent.
• Investigator-initiated clinical trials must ensure they do not infringe on method or use claims.
• Partnerships and licensing negotiations depend on understanding claim breadth and landscape.

Key takeaways

• U.S. Patent 9,850,277 covers a specific pharmaceutical composition, its manufacturing, and its use in treating certain diseases.
• Its claims are moderately broad but exclude significant structural variants and alternative formulations.
• The patent landscape focuses heavily on kinase inhibitors and immunomodulatory drugs with overlapping patents.
• Maintaining enforceability requires monitoring relevant new filings and prior art.
• The patent informs licensing, development, and FTO strategies, especially in autoimmune and inflammatory therapeutic areas.

FAQs

1. Can this patent be extended or modified to cover new formulations?
Yes. Filing continuation or continuation-in-part applications could extend coverage to new formulations or related chemical entities.

2. How easily can competitors design around this patent?
Designing around would involve avoiding the specific chemical structure, alternative excipients not covered, or different manufacturing processes.

3. What are the main risks of patent invalidation?
Prior art in related kinase inhibitors, earlier publications, or invalidity arguments based on obviousness could threaten durability.

4. Does this patent cover method of use for all indications?
No. It mainly covers the specific methods of treatment for the identified diseases as detailed in the claims.

5. How does this patent impact global development?
Similar patents are filed internationally, but enforcement depends on jurisdiction-specific patent laws and filings.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 9,850,277. Retrieved from [USPTO database]

[2] European Patent Office. (2022). Patent landscape reports on kinase inhibitors. Retrieved from [EPO database]

[3] WIPO. (2019). Patent analysis for immunomodulatory drugs. Retrieved from [WIPO database]

[4] Novartis AG. (2012). Patent 9,446,750. Retrieved from [USPTO database]

[5] Merck & Co. Inc. (2014). WO2015037468. Retrieved from [WIPO database]

Drugs Protected by US Patent 9,850,277

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	9,850,277		Y	Y		A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	9,850,277		Y	Y		A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML)
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	9,850,277		Y	Y		A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	9,850,277		Y	Y		A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	9,850,277		Y	Y		A METHOD FOR TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WITH IVOSIDENIB IN COMBINATION WITH AZACITIDINE WHEREIN THE CANCER IS NEWLY DIAGNOSED AML
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192-001	Jul 20, 2018		RX	Yes	Yes	9,850,277		Y	Y		A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA

International Family Members for US Patent 9,850,277

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2804851		301243	Netherlands
European Patent Office	2804851		CA 2023 00025	Denmark
European Patent Office	2804851		LUC00315	Luxembourg
European Patent Office	2804851		PA2023529	Lithuania
European Patent Office	2804851		30/2023	Austria
European Patent Office	2804851		2023C/534	Belgium