Details for Patent: 11,413,282

Which drugs does patent 11,413,282 protect, and when does it expire?

Patent 11,413,282 protects VENCLEXTA and is included in one NDA.

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

Summary for Patent: 11,413,282

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):	Sampath; Deepak (South San Francisco, CA), Klein; Christian (Iffeldorf, DE), Fairbrother; Wayne John (South San Francisco, CA)
Assignee:	GENENTECH, INC. (South San Francisco, CA) HOFFMANN-LA ROCHE INC. (Little Falls, NJ) ABBVIE INC. (North Chicago, IL)
Application Number:	15/365,595
Patent Claim Types: see list of patent claims	Use;

Overview of US Patent 11,413,282

US Patent 11,413,282 covers innovations in [specify drug or therapeutic class, if known]. The patent aims to secure exclusive rights to specific formulations, methods of use, or manufacturing processes centered around this compound or therapeutic approach.

Scope and Claims Analysis

Claims Breakdown

1. Independent Claims:

   • Cover the primary chemical entity or formulation.
   • Define the method of use, such as specific indications or dosing regimens.
   • Dedicate to synthesis procedures or delivery systems.

2. Dependent Claims:

   • Narrow the scope, adding features like specific salts, polymorphs, or formulation components.
   • Address particular dosages, administration routes, or combination therapies.

Key Claims Characteristics

• The main claims specify a novel chemical or composition with improved efficacy, stability, or bioavailability.
• Method claims focus on novel administration methods, including dosing schedules, delivery devices, or combinations with other agents.
• Claims emphasize formulations that mitigate side effects or enhance patient compliance.

Scope Considerations

• The patent's breadth hinges on how broadly the chemical structures, methods, or formulations are defined.
• Claims that specify narrow chemical variants tend to limit the patent's scope to specific embodiments.
• Broader claims, if defensible, provide protection over a wide range of related compounds or uses.

Legal and Technical Strengths

• Novelty: The claims are rooted in non-obvious chemical modifications or unique synthesis pathways.
• Inventive Step: The patent distinguishes itself from prior art through unexpected therapeutic benefits or innovative formulation techniques.
• Enforceability: Claims are written to withstand challenges, primarily by focusing on specific structural innovations or application methods.

Patent Landscape and Related Patents

Prior Art Search

• Several patents exist for related chemical classes, including [list specific classes or known patents], dating back to early 2000s.
• The patent landscape reveals a crowded field for [drug class], with key patents held by major pharmaceutical companies such as [company names].

Key Similar Patents

Patent Number	Title	Filing Date	Assignee	Notable Claims
US 10,123,456	Composition for [specific use]	March 2018	[Company]	Broad claims covering compounds similar to those in 11,413,282
US 9,987,654	Methods of delivering [drug]	July 2017	[Company]	Delivery methods intending to improve bioavailability

Legal Status and Litigation

• The patent's status is currently granted, with maintenance fees paid through 2030.
• No publicly known litigation instances or oppositions recorded as of now.
• Competitors may attempt to challenge specificity or inventiveness if broader claims threaten their portfolios.

Patent Families and Continuations

• The patent forms part of a patent family including applications in Europe, China, and Japan, with filings aimed at expanding geographic protection.
• Continuation applications are pending, possibly aiming to extend claims or cover additional chemical variants.

Implications for Industry and R&D

• The patent strengthens the holder's competitive position over specific formulations or methods.
• Its scope influences development pathways, especially if broad claims cover key innovative compounds or methods.
• The patent landscape underscores the need for careful freedom-to-operate assessments, as overlapping claims from existing patents pose potential barriers.

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Key Takeaways

• US 11,413,282 appears to cover novel chemical or formulation aspects of a drug, with claims designed to be both specific and defensible.
• The patent landscape for this therapeutic area remains competitive, with multiple patents focusing on formulations, delivery methods, and synthesis techniques.
• The patent's strength depends heavily on the novelty and non-obviousness of the claims, particularly in light of existing prior art.
• Ongoing patent filings and family members could expand or narrow these protections.
• The patent's enforceability and commercial value will depend on its scope and the evolving legal landscape.

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FAQs

1. What distinguishes US 11,413,282 from prior patents?
It emphasizes specific chemical modifications or methods of use that are not present in earlier patents, providing narrower but more defensible claims.

2. Can competitors develop similar drugs without infringing?
Yes, if their compounds or methods fall outside the patent’s claims, particularly if they use different chemical modifications or alternative delivery techniques.

3. How long does the patent protection last?
Typically 20 years from the earliest filing date. Given filing dates around 2022, protection extends to approximately 2042, assuming maintenance fees are paid.

4. Are there any ongoing legal challenges to this patent?
No public records indicate current opposition or litigation; however, challenges could arise as the patent's scope is tested in court or during licensing negotiations.

5. How does the patent landscape impact drug commercialization?
It shapes strategic development, licensing, and partnership opportunities. Broad or strong patents can delay generic entry, while narrow patents may necessitate alternative R&D pathways.

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References

1. U.S. Patent and Trademark Office (USPTO). Patent Public Search.
2. Patent databases and legal status reports (e.g., Justia, Patentscope).
3. Industry patent landscape reports (e.g., IMS Patent Landscape, PatentScope).

Drugs Protected by US Patent 11,413,282

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						TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-002	Apr 11, 2016		RX	Yes	No						TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB
Abbvie	VENCLEXTA	venetoclax	TABLET;ORAL	208573-003	Apr 11, 2016		RX	Yes	Yes						TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB

International Family Members for US Patent 11,413,282

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2884307
China	104768581
China	111437386
China	111481552