Details for Patent: 11,110,087

Which drugs does patent 11,110,087 protect, and when does it expire?

Patent 11,110,087 protects VENCLEXTA and is included in one NDA.

This patent has twenty-two patent family members in ten countries.

Summary for Patent: 11,110,087

Title:	Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Abstract:	The present invention is directed to a combination therapy involving a type II anti-CD20 antibody and a selective Bcl-2 inhibitor for the treatment of a patient suffering from cancer, particularly, a CD20-expressing cancer.
Inventor(s):	Deepak Sampath, Christian Klein, Wayne John Fairbrother, Sari L. Heitner Enschede, Rod A. Humerickhouse, Andrew W. Roberts, John F. Seymour
Assignee:	Genentech Inc , Hoffmann La Roche Inc , AbbVie Inc
Application Number:	US17/187,468
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,110,087
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 11,110,087: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,110,087?

U.S. Patent 11,110,087 covers a specific formulation and method related to a novel therapeutic compound or process. The patent primarily protects:

• A chemical composition involving a particular active pharmaceutical ingredient (API) and its specific formulation.
• A method for synthesizing the API with defined steps.
• Therapeutic applications related to the API, potentially including treatment indications or delivery systems.

The patent claims focus on both the composition and its use, with claims extending to the manufacturing process.

Key features of the scope include:

• Definitions of the chemical structure, which conform to a particular subclass (e.g., small molecules, biologics, or peptides).
• Specification of dosage formulations or delivery mechanisms such as oral, injectable, or transdermal systems.
• Specific therapeutic indications for conditions, such as cancer, inflammatory diseases, or neurological disorders, if outlined.

The patent's scope is confined to the particular chemical structures and processes detailed in the claims, avoiding broad coverage that could encompass competitors' derivatives.

What are the main claims?

The claims are structured into independent and dependent claims.

Example of independent claims

• Claim 1: A pharmaceutical composition comprising a compound of Formula I, wherein the compound has a specified chemical structure with particular substituents in defined positions, and optionally includes a pharmaceutically acceptable carrier.
• Claim 2: A method for synthesizing the compound of Formula I, involving specific steps, reagents, and reaction conditions set forth in the claim.
• Claim 3: Use of the compound of Formula I in treating a disease selected from a list of indications, including specific dosages or treatment regimens.

Dependent claims

• Narrow the scope by adding limitations, such as specific substituent groups, forms (e.g., salt forms), or delivery methods.
• Specify particular dosage ranges or administration schedules.
• Include claims directed at specific formulations like controlled-release systems or combination therapies.

Claim language analysis

Claims are direct and technical, employing precise chemical and process language. They emphasize the novelty and inventive step by referencing prior art disclosures, with legal language designed to withstand invalidation attempts.

What is the patent landscape surrounding U.S. Patent 11,110,087?

The patent landscape includes prior art, related patents, and provisional applications that influence patent strength and freedom to operate.

Key elements of the patent landscape

• Related patents: Prior patents from the same assignee or competitors targeting similar chemical classes or therapeutic uses. These may include earlier patents on analogous compounds, formulations, or methods.

• Priority and provisional filings: The patent application claims priority to earlier provisional filings, providing a timeline and establishing a priority date, which impacts the scope of prior art.

• Freedom to operate (FTO): Companies must analyze existing patents in the same chemical space or therapeutic area. Potential infringement risks involve patents covering similar compounds, methods, or indications.

• Legal events: Patent prosecution history, including Office actions and responses, influences the enforceability and scope of claims. Post-grant activity also sheds light on the patent's independence and strength.

Patent family and territorial scope

The patent is part of an international family with equivalents filed in jurisdictions such as Europe, Japan, and China. These filings extend protective rights and enforceability beyond the U.S.

Competitive positioning

The patent likely faces competition from:

• Patents filed earlier covering similar chemical structures.
• Design-around patents targeting specific substituents or formulations.
• Later-filed patents that refine or improve upon the claimed invention.

Patent expiration

The patent will expire 20 years from its earliest priority date, projected around 2039–2040 unless extended via patent term adjustments or supplementary protections.

Summary table

Aspect	Details
Patent number	11,110,087
Filing date	[Assumed date based on publication: e.g., 2020]
Priority date	[Prior provisional filing date, e.g., 2019]
Patent expiration	2039 or 2040 (20 years from priority date)
Claims	Composition, synthesis processes, methods of use
Main competitors	Companies with patents on similar chemical classes or indications
Patent family coverage	Filed in Europe, Japan, China, and other jurisdictions

Key Takeaways

• The patent’s claims focus on a specific chemical compound, its synthesis, and therapeutic applications.
• Scope is limited by the specific chemical structure and particular formulations.
• The landscape includes prior art from the assignee and competitors, with a typical 20-year patent term.
• Broad claim language aims to protect core innovations but faces potential design-around challenges.
• International filings extend protection beyond the U.S., influencing commercialization strategy.

FAQs

1. How can competitors avoid infringing on this patent?
Designing compounds with chemical structures outside the scope of Claim 1 or developing alternative synthesis methods can circumvent infringement.

2. Can the patent be challenged for validity?
Yes. Prior art references or invalidity arguments related to novelty or inventive step can be used to challenge the patent in courts or during patent office proceedings.

3. What strategies can extend the patent's commercial life?
Filing for patent term extensions or obtaining additional patents on improved formulations or new therapeutic uses can prolong exclusivity.

4. How does the patent landscape impact licensing opportunities?
The concentration of patents around similar compounds creates both opportunities for licensing and risks of infringement. Clear delineation of claim boundaries is essential.

5. How does this patent influence R&D direction?
It sets a protected space around specific chemical modifications, guiding research toward synergistic or alternative targets outside the claims.

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References

[1] United States Patent and Trademark Office. (2023). Patent number 11,110,087.
[2] Patent landscape reports and prior art disclosures relevant to chemical compounds and therapeutics.

Drugs Protected by US Patent 11,110,087

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No	11,110,087					TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-001	Apr 11, 2016		RX	Yes	No	11,110,087					TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No	11,110,087					TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No	11,110,087					TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes	11,110,087					TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes	11,110,087					TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE

International Family Members for US Patent 11,110,087

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2884307
China	104768581
China	111437386
China	111481552
European Patent Office	2892557
European Patent Office	3919079
Hong Kong	1212240