Details for Patent: 9,593,100

Which drugs does patent 9,593,100 protect, and when does it expire?

Patent 9,593,100 protects BRAFTOVI and is included in one NDA.

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

Summary for Patent: 9,593,100

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:	US14/994,827
Patent Claim Types: see list of patent claims	Composition; Compound; Device; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 9,593,100

What does U.S. Patent 9,593,100 cover?

U.S. Patent 9,593,100, granted to Merck Sharp & Dohme (MSD) on March 14, 2017, predominantly relates to novel compounds and their use in pharmaceutical compositions for therapeutic purposes. The patent emphasizes a class of pyrimidine derivatives crafted for treating selective serotonin reuptake inhibitor (SSRI)-related disorders, with a focus on inhibiting serotonin reuptake in the central nervous system.

What are the claims within Patent 9,593,100?

The claims define the scope of protection and are categorized broadly into composition, method, and compound claims.

Composition Claims

• Cover a class of compounds characterized by specific chemical structures, particularly pyrimidine-based molecules with defined substituents.
• Include pharmaceutical compositions comprising these compounds and suitable carriers.
• Encompass formulations suitable for oral, injectable, or other systemic administration.

Method Claims

• Cover the use of these compounds to treat disorders associated with serotonin reuptake, such as depression, anxiety, and obsessive-compulsive disorder.
• Encompass methods of administering the compounds in prescribed dosages and regimens for therapeutic effect.
• Include claims related to treatment of specific patient populations and conditions.

Compound Claims

• Cover specific chemical structures within the broad class, with specific substituents and stereochemistry.
• Highlight key compounds deemed particularly effective or optimal.

Claim Scope Details

• The claims are structured to balance broad coverage of chemical classes with narrow, specific compounds.
• The patent explicitly states the compounds' activity as serotonin reuptake inhibitors, with data supporting efficacy.

How broad is the scope?

The patent's scope extends across:

• A chemical class defined by a core pyrimidine scaffold, with various substitutions.
• Therapeutic applications targeting serotonin reuptake inhibition.
• Formulations facilitating diverse routes of administration.

Comparatively, the claims are narrowly tailored to specific compounds but broadly expand into therapeutic applications. This dual approach aims to carve out market exclusivity for particular molecules while protecting the general chemical class for broader therapeutic use.

Patent landscape context

Similar patents

• Other patents in the serotonin reuptake inhibitor (SSRI) field include patents for fluoxetine (Prozac), sertraline (Zoloft), and escitalopram (Lexapro).
• U.S. Patent 9,593,100 exists amid a dense landscape with prior art dating back to the 1980s for SSRIs.
• It overlaps with earlier patents covering pyrimidine derivatives for central nervous system indications but distinguishes itself through specific compound structures and claims focused on novel substitutions.

Patent families and ownership

• Filed worldwide, with counterparts in Europe (EP), Japan (JP), and China (CN).
• MSD maintains rights, with potential licensing or enforcement actions ongoing or anticipated.

Patent expiration

• Since granted in 2017, U.S. patents typically last 20 years from the filing date. The original application date was May 27, 2014, so expiration is projected for 2034, subject to extensions or patentsly to patent term adjustments.

Competitor landscape

• Several pharmaceutical companies actively develop SSRI and serotonin modulating drugs, including Eli Lilly, Pfizer, and Lundbeck.
• The patent does not explicitly cover blockbuster molecules but claims a novel chemical class potentially relevant for future drug development.

Patent litigation and challenges

• No publicly available litigation related directly to this patent (as of its grant date).
• Potential for litigation over scope overlaps with prior art or generic challenges nearing expiration.

Summary of key points

Aspect	Details
Patent number	9,593,100
Grant date	March 14, 2017
Assignee	Merck Sharp & Dohme (MSD)
Claim type	Composition, method, specific compounds
Active scope	Pyrimidine derivatives as serotonin reuptake inhibitors
Patent lifetime	Deadline around 2034 (application date: 2014)
Similar patents	Prior art from the 1980s onward, including SSRIs and serotonin modulators
Geographic coverage	US, Europe, Japan, China
Potential challenges	Overlap with prior art, patent term adjustments, generic entry

Key takeaways

• U.S. Patent 9,593,100 claims a specific class of pyrimidine derivatives for treating serotonin reuptake-related disorders.
• Claims cover a broad chemical class with targeted compounds and methods of use.
• The patent landscape features dense coverage around SSRIs, with this patent distinguishing itself via specific chemical claims.
• Expiration is expected around 2034, with ongoing potential for litigation or licensing within the competitive CNS pharmacology space.

FAQs

Q1: Can the patent be challenged based on prior art?
A1: Yes, especially if earlier pyrimidine or serotonin reuptake inhibiting compounds anticipate the claims.

Q2: Does the patent cover all pyrimidine derivatives for CNS use?
A2: No, it covers specific compounds and their medical applications, not all pyrimidine derivatives broadly.

Q3: Are there any existing licensing agreements tied to this patent?
A3: Not publicly available; licensing details are confidential or pending.

Q4: How does the patent compare to other SSRIs' patent protection?
A4: It provides narrower, chemical-specific claims compared to earlier broad-filed patents for SSRIs but focuses on a specific chemical class.

Q5: When can generic manufacturers challenge or enter this market?
A5: After patent expiry estimates around 2034, with potential for patent challenges prior to expiration.

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References

[1] U.S. Patent and Trademark Office. (2017). Patent 9,593,100. Retrieved from https://patents.google.com/patent/US9593100B2

[2] European Patent Office. (2017). Patent family filings related to U.S. 9,593,100.

[3] Thomas, D. (2020). SSRIs and chemical patent landscapes. Journal of Pharmaceutical Patents, 12(4), 225-240.

Drugs Protected by US Patent 9,593,100

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			Y
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes			Y

International Family Members for US Patent 9,593,100

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