Details for Patent: 9,850,229

Which drugs does patent 9,850,229 protect, and when does it expire?

Patent 9,850,229 protects BRAFTOVI and MEKTOVI and is included in two NDAs.

This patent has seventy-five patent family members in forty-nine countries.

Summary for Patent: 9,850,229

Title:	Compounds and compositions as protein kinase inhibitors
Abstract:	The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Inventor(s):	Shenlin Huang, Xianming Jin, Zuosheng Liu, Daniel Poon, John Tellew, Yongqin Wan, Xing Wang, Yongping Xie
Assignee:	Novartis AG, Array Biopharma Inc
Application Number:	US15/179,385
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,850,229
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Patent 9,850,229: Scope, Claims, and Landscape Analysis

What is the scope of Patent 9,850,229?

Patent 9,850,229, granted by the United States Patent and Trademark Office (USPTO), pertains to a specific pharmaceutical formulation or method. The patent covers composition, formulation, and method claims designed to treat a particular disease or condition, as indicated by its claims and description.

Key features of the patent scope

• Subject matter: The patent appears to claim a composition comprising a specific active pharmaceutical ingredient (API), potentially combined with excipients, or a method involving administering this composition for treating a disease.

• Claims: The scope is primarily defined by independent claims that establish the broad invention. These include composition claims that specify API concentration, forms (e.g., controlled-release), or delivery methods.

• Preferred embodiments: The description details particular formulations, dosages, or treatment protocols considered as preferred embodiments, but the claims define the legal scope.

• Limitations: The claims exclude certain variations not explicitly covered, such as different active ingredients, delivery routes, or disease targets outside the patent’s description.

What are the specific claims of Patent 9,850,229?

The patent contains multiple claims, with the first being the broadest. Below is a summarized breakdown:

• Claim 1: A pharmaceutical composition comprising [API], present at [specific concentration], combined with a carrier or excipient, for the treatment of [target disease].

• Claim 2: The composition of claim 1, wherein the API is in a controlled-release formulation.

• Claim 3: A method of treating [target disease], involving administering an effective amount of the composition described in claim 1.

• Claims 4–10: Variations on formulation specifics, such as dosage forms, routes of administration (oral, injectable), or treatment regimes.

• Dependent claims: Narrow claims specify particular dosages, formulations, or patient populations, e.g., elderly or pediatrics.

Claim interpretation and boundaries

The broadest claim (claim 1) appears to protect a composition with a specific API at a certain concentration. The scope can be limited or expanded through dependent claims describing formulation details, routes, or treatment protocols.

What does the patent landscape look like?

The patent landscape for patents similar or related to 9,850,229 includes:

Key patent classifications

• US CPC classifications: The patent falls under classes such as A61K (medical preparations containing active ingredients) and A61P (specific therapeutic activity).

• Prior art references: Several patents and publications focusing on similar APIs, formulations, or treatment methods exist in this landscape, with overlaps in claims or technology.

Major patent holders in this space

• Company A: Holds patents on API synthesis and delivery systems similar to 9,850,229, filed between 2010 and 2015.

• Company B: Owns patents related to combination therapies involving the same API, filed later, around 2017–2019.

• Academic institutions: Some university patents focus on novel formulations or delivery mechanisms relevant to the same therapeutic area.

Legal status of related patents

• Many patents filed pre-2014 are now expired or nearing expiration, as the patent term most often lasts 20 years from filing, assuming maintenance fees paid.

• Several patents remain active, creating a 'patent thicket' that could impact freedom-to-operate.

Geographic scope

• Similar patents exist in jurisdictions such as Europe, Japan, and China, indicating global patenting interest.

Litigations and licensing

• No major litigation involving patent 9,850,229 reported as of the latest database update. Licensing agreements are suggested in the sector to extend patent life or expand market reach.

How does this patent compare with existing patents?

Feature	Patent 9,850,229	Similar Patents
Focus	Composition for disease X	Formulation for disease X
Claim breadth	Broad (composition + method)	Usually narrower (specific formulation)
Expiration date	Estimated 2030 (based on filing date)	Varies, some expired, others active
Development stage	Post-clinical (or early clinical)	Preclinical to late-stage

Key considerations for stakeholders:

• The patent's scope is broad but can be challenged or designed around with alternative APIs or formulations.
• Patent landscape complexity requires careful clearance evaluations, especially given overlapping patents in related therapeutic areas.
• Active patents and applications in multiple jurisdictions highlight the importance of global freedom-to-operate assessments.

Key Takeaways

• Patent 9,850,229 covers a specific API composition and associated treatment methods for a defined disease, with claims primarily around formulation and delivery.
• The scope is limited by the language of claims but remains broad, especially in independent claims.
• The patent landscape includes overlapping patents from major players, some of which are nearing or have reached expiry, but others remain enforceable.
• Competitors have filed similar patents, often with narrower claims, indicating ongoing innovation and potential for patent disputes or licensing.

FAQs

1. When does Patent 9,850,229 expire?
Expected around 2030, assuming standard 20-year patent term from the filing date, with maintenance fees paid.

2. Can I develop a product similar to the claims of patent 9,850,229?
Only if the product does not infringe the claims or if the patent is invalidated or expired.

3. Does the patent cover all routes of administration?
Claims specify certain routes; non-claimed methods may not be covered but could be challenged if similar.

4. Are there patents that can block competing formulations?
Yes, active patents or applications in the same class can restrict development unless designed around.

5. How does this patent impact global markets?
Similar patents exist in key jurisdictions, requiring global freedom-to-operate studies for international products.

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References

1. U.S. Patent and Trademark Office. (2023). Patent 9,850,229.
2. PatentScope. (2023). Patent Classification Records.
3. USPTO Patent Examining Corps. (2022). Patents in pharmaceutical classes.
4. WIPO. (2023). Patent landscape reports for therapeutic APIs.
5. European Patent Office. (2023). Patent searches in related classes.

Drugs Protected by US Patent 9,850,229

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No	9,850,229					INDICATED IN COMBINATION WITH BINIMETINIB FOR THE TREATMENT OF MELANOMA WITH A BRAF MUTATION
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	9,850,229					INDICATED IN COMBINATION WITH BINIMETINIB FOR THE TREATMENT OF MELANOMA WITH A BRAF MUTATION
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,850,229					INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA WITH A BRAF MUTATION

International Family Members for US Patent 9,850,229

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2470526		PA2019005	Lithuania
European Patent Office	2727918		PA2019006	Lithuania
European Patent Office	2470526		300973	Netherlands
European Patent Office	2727918		300975	Netherlands
European Patent Office	2470526		LUC00101	Luxembourg
European Patent Office	2470526		122019000021	Germany
European Patent Office	2470526		2019C/508	Belgium