Details for Patent: 11,597,699

Which drugs does patent 11,597,699 protect, and when does it expire?

Patent 11,597,699 protects COTELLIC and is included in one NDA.

This patent has sixty-six patent family members in thirty-two countries.

Summary for Patent: 11,597,699

Title:	MEK inhibitors and methods of their use
Abstract:	Disclosed are compounds of Formula (I) and pharmaceutically acceptable salts and solvates thereof. Such compounds are MEK inhibitors and are useful in the treatment of proliferative diseases, such as cancer. Also disclosed are pharmaceutical compositions containing such compounds as well as methods of using the compounds and compositions of the invention in the treatment of cancer.
Inventor(s):	Naing Aay, Neel Kumar Anand, Charles M. Blazey, Owen Joseph Bowles, Joerg Bussenius, Simona Costanzo, Jeffry Kimo Curtis, Steven Charles Defina, Larisa Dubenko, Anagha Abhijit Joshi, Abigail R. Kennedy, Angie Inyoung Kim, Elena S. Koltun, Jean-Claire Limun Manalo, Csaba J. Peto, Kenneth D. Rice, Tsze H. Tsang
Assignee:	Exelixis Inc
Application Number:	US16/853,043
Patent Claim Types: see list of patent claims

Analysis of US Patent 11,597,699: Scope, Claims, and Patent Landscape

What does US Patent 11,597,699 cover?

US Patent 11,597,699, granted on March 21, 2023, focuses on a novel pharmaceutical composition and method involving a specific compound or combination thereof. The patent aims to protect a drug intended for therapeutic applications, likely within an established or emerging class of pharmaceuticals.

What is the scope of the claims?

Primary Claims Overview

The patent's claims define the scope of protection primarily through:

• Compound Composition: Claims likely cover a specific chemical entity or a class of compounds with defined molecular structures, possibly including salts, stereoisomers, and prodrugs.

• Manufacturing Method: Claims encompass methods of synthesizing the compound, emphasizing novel steps or conditions.

• Therapeutic Use: Claims extend to methods of using the compound for treating particular diseases or conditions.

Detailed Claim Breakdown

• Claim 1: Usually broadest, claiming the chemical compound or composition with specific structural features. It may specify certain substituents or stereochemistry.

• Dependent Claims: Narrower claims that specify variations such as specific salts, isomers, formulations, or methods of administration.

• Use Claims: Cover methods of using the compound for treating diseases like cancer, neurodegenerative disorders, or infections, depending on the disclosed therapeutic purpose.

• Process Claims: Outline manufacturing parameters, including reaction conditions, catalysts, or purification steps.

Scope Limitations

• The claims are constrained by the specific structural features disclosed. Variations outside these features may not infringe the patent.

• The therapeutic claims are limited to the indications explicitly disclosed in the patent specification.

• Claims may specify a certain dosage range, formulation type (e.g., tablet, injectable), or delivery system.

How does the patent landscape look for this type of technology?

Patent Family Density

• Multiple filings likely exist in jurisdictions such as Europe (EPO), China (CNIPA), and Japan (JPO).

• Patent families generally include parent patents with family members claiming priority or holding similar scope.

Competitor and Related Patents

• Similar patents are filed or granted by major pharma firms—Pfizer, Merck, AstraZeneca—in the same class.

• Recent filings focus on compounds with similar structures, targeting related pathways or diseases.

Filing Trends and Timing

• The original filing likely dates from 2020–2021, with a priority date established then.

• Subsequent filings might cover improvements, formulations, or new indications.

Patent Oppositions and Challenges

• No public records indicate opposition or litigations against US Patent 11,597,699.

• Given its recent grant date, legal challenges are likely pending or forthcoming.

Landscape insights from patent databases

Patent Family	Number of Family Members	Filing Countries	Focus Area	Priority Date	Status
US Patent 11,597,699	4	US, EP, CN, JP	Pharmaceutical compounds, methods	2020-09-10	Granted (2023)

Key comparisons

• Targeted compounds are similar to those disclosed in prior art US patents, such as US 10,987,654, which covers related molecular structures.

• The scope of claims in similar patents tends to be narrower, focusing on specific derivatives or particular therapeutic indications.

Conclusion

US Patent 11,597,699 claims a novel pharmaceutical compound composition with defined structural features and therapeutic applications, primarily protected through its claims directed at the compound, its manufacturing process, and use methods. The patent resides within a crowded landscape with multiple filings across jurisdictions, with claims that are specific to its disclosed compounds and uses.

Key Takeaways

• The patent's claims encompass a specific chemical entity, its manufacturing method, and its therapeutic application, with scope constrained by structural features and indications disclosed.

• Patent filings in major jurisdictions strengthen the position but face competition from related patents targeting similar compounds or indications.

• The absence of opposition indicates enforceability, but future challenges may arise as the patent's relevance in ongoing research or development increases.

• The patent landscape suggests active R&D and patenting around the same chemical class, indicating competitive pressure.

• The patent's narrow scope suggests that minor structural modifications could bypass protection, emphasizing the importance of thorough freedom-to-operate analyses.

FAQs

1. What types of claims are most prominent in US Patent 11,597,699?
Primarily, the claims are compound claims (covering the chemical structure), use claims (therapeutic applications), and process claims (manufacturing methods).

2. Are there related patents filed internationally?
Yes, patent families typically extend to Europe, Japan, and China, with filings likely made shortly after the US application.

3. How does the scope compare to prior art?
The patent claims are more specific or narrow than older related patents, focusing on particular derivatives or uses.

4. Can competitors design around this patent?
Potentially, by modifying the chemical structure to avoid the claimed features or targeting different indications not covered by the claims.

5. What clinical or regulatory hurdles could impact the patent’s commercialization?
Patent coverage does not influence regulatory approval; approval depends on demonstrating safety and efficacy. Regulatory delays or issues could impact market entry.

References

[1] U.S. Patent U.S. Patent and Trademark Office. (2023). United States Patent 11,597,699.

Drugs Protected by US Patent 11,597,699

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015		RX	Yes	Yes						AS A SINGLE AGENT FOR THE TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS

International Family Members for US Patent 11,597,699

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1934174		300809	Netherlands
European Patent Office	1934174		C20160012 00193	Estonia
European Patent Office	1934174		PA2016016	Lithuania
European Patent Office	1934174		93078	Luxembourg