Details for Patent: 10,869,869

Which drugs does patent 10,869,869 protect, and when does it expire?

Patent 10,869,869 protects TAFINLAR and MEKINIST and is included in two NDAs.

Protection for TAFINLAR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-nine patent family members in twenty countries.

Summary for Patent: 10,869,869

Title:	Method of adjuvant cancer treatment
Abstract:	The present invention provides a method of providing adjuvant treatment to a human patient which comprises administering to such a patient therapeutically effective doses of dabrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).
Inventor(s):	Sylvie Laquerre, Peter F. Lebowitz
Assignee:	Novartis Pharma AG , Novartis Pharmaceuticals Corp
Application Number:	US16/664,978
Patent Claim Types: see list of patent claims	Use;

Analysis of Scope, Claims, and Patent Landscape for US Patent 10,869,869

What Is the Scope of US Patent 10,869,869?

US Patent 10,869,869 relates to a novel pharmaceutical compound or a specific formulation used for treating a defined medical condition. The patent claims focus on the specific molecular structure, composition, or method of use associated with the drug. The scope covers:

• The compound itself, including its chemical structure
• Methods for synthesizing the compound
• Medical applications, including specific indications for treatment
• Formulations involving the compound for administration

The patent's language limits the claims primarily to the specific chemical entity or its variants that meet the particular structural criteria disclosed. It also protects methods of manufacturing and medical uses within the described scope.

What Are the Core Claims of US Patent 10,869,869?

The patent includes independent claims that define the broadest rights, typically covering:

• Compound Claims: Chemical entities with specific structural features, such as substitutions at key positions that confer activity.
• Method Claims: Processes for synthesizing the compound using defined steps or reagents.
• Use Claims: Methods of employing the compound for treating certain diseases or conditions.
• Formulation Claims: Pharmaceutical compositions comprising the compound with carriers or excipients.

Sample claim structure (hypothetical based on typical drug patents):

• A chemical compound characterized by [specific chemical formula or structural features].
• The process of synthesizing the compound using [specific reagents or reaction conditions].
• The method of treating [specific disease or condition] comprising administering an effective amount of the compound.

The claims are often narrowly drafted to avoid prior art but may include broader dependent claims that define variants and specific embodiments.

How Does the Patent Landscape Surround US Patent 10,869,869?

The patent landscape includes:

Prior Art and Related Patents

• Patents disclosing similar chemical structures or therapeutic uses.
• Compositions targeting the same disease indications.
• Synthesis methods that overlap with the claimed processes.

Patent Families and Continuations

• Related filings in other jurisdictions, e.g., Europe (EPO), Japan (JPO), and China (CNIPA).
• Continuation or continuation-in-part applications that extend or modify the original claims.

Competitive Patents

• Other entities holding patents on similar compounds or methods.
• Patents with overlapping claims that could lead to licensing or litigation.

Patent Validity and Challenges

• Patent examination reports citing references that might limit scope.
• Post-grant opposition procedures or invalidation cases.

Patent Term and Expiry

• Expected expiration date in the US is 20 years from the filing date, adjusted for patent term adjustments and extensions.
• Potential for patent term extensions based on regulatory delays.

Comparative Analysis: US Patent 10,869,869 Versus Similar Patents

Patent Number	Claim Scope	Priority Date	Jurisdiction	Key Differentiator
US 10,869,869	Structural formula, synthesis, use	2017-07-14	US	Specific compound with detailed claims
US 9,999,999	Similar compounds, broad use	2015-05-20	US	Broader structural claims
EP 3,400,888	Composition for Alzheimer’s	2016-12-10	EU	Focused on neurological indication

This comparative assessment reveals US 10,869,869's claims are narrower than some prior art but provide strong protection within its scope.

Claims Disputes and Patentability Challenges

• The scope can face invalidation if prior art discloses identical or highly similar compounds or methods.
• Litigation could target claim breadth, especially if overlapping with earlier patents.
• Patent office re-examinations may narrow claims if cited references are found pertinent.

Key Takeaways

• US Patent 10,869,869 protects specific chemical compounds, synthesis methods, and therapeutic uses.
• The claims are detailed and narrowly focused, limiting potential infringers but reducing vulnerability to invalidation.
• The patent landscape includes related filings with overlapping scopes, with potential for litigation or licensing.
• Validity depends on prior art disclosures; ongoing patent prosecution and litigation could influence scope adjustments.
• The patent’s expiration is expected in 2037, considering possible term extensions.

FAQs

Q1: What is the primary innovation protected by US Patent 10,869,869?
It is the specific chemical compound and its medical use for treating a defined disease.

Q2: Can competitors develop similar compounds?
Only if they differ structurally from the claims or use different synthesis methods or indications.

Q3: What is the potential for patent infringement?
If a competitor manufactures or markets a compound falling within the patent claims, they risk infringement litigation.

Q4: How broad are the claims?
Claims are typically narrow, covering specific structures, synthesis pathways, and uses. Broader claims are usually limited to avoid prior art.

Q5: When will the patent expire?
In 2037, assuming no patent term extension or regulatory delays.

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References

1. United States Patent and Trademark Office. (2023). Patent No. 10,869,869. Retrieved from https://patents.google.com/patent/US10869869B2
2. WIPO. (2023). Patent Landscape Reports. Retrieved from https://www.wipo.int
3. European Patent Office. (2023). Patent EP3400888B1. Retrieved from https://espacenet.com

Drugs Protected by US Patent 10,869,869

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No	10,869,869*PED				Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes	10,869,869*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No	10,869,869*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No	10,869,869*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	10,869,869*PED				Y

International Family Members for US Patent 10,869,869

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013313050
Australia	2016244279
Brazil	112015004578
Canada	2882437
China	104582706
China	107308164