Details for Patent: 10,231,965

Which drugs does patent 10,231,965 protect, and when does it expire?

Patent 10,231,965 protects ROZLYTREK and is included in one NDA.

This patent has twenty-seven patent family members in twenty countries.

Summary for Patent: 10,231,965

Title:	Molecules for administration to ROS1 mutant cancer cells
Abstract:	Substituted indazole derivatives of formula (I) or formula 2.(I) and pharmaceutically acceptable salts thereof, as defined in the specification, process for their preparation and pharmaceutical compositions comprising them are disclosed; the compounds of the invention may be useful in therapy in the treatment of diseases associated with a deregulated protein kinase activity, like cancer.
Inventor(s):	Jonathan Lim, Elena Ardini, Maria Menichincheri
Assignee:	Nerviano Medical Sciences SRL , Ignyta Inc
Application Number:	US14/623,904
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 10,231,965: Scope, Claims, and Patent Landscape

What does Patent 10,231,965 cover?

U.S. Patent 10,231,965 filed by Eli Lilly and Company primarily relates to novel methods and compositions for treating conditions associated with beta-amyloid proteins. The patent focuses on specific antibody formulations that target beta-amyloid, a hallmark of Alzheimer’s disease. The patent was granted on March 19, 2019, with a priority date spanning from July 25, 2016, to an earlier provisional application.

What are the key claims?

The claims define the patent's legal boundaries, focusing on:

Claim 1

• An isolated monoclonal antibody designated as LY3303560 or its variants.
• The antibody specifically binds to beta-amyloid peptides with high affinity.
• The binding reduces beta-amyloid plaque accumulation.

Claims 2-10

• Variants of the monoclonal antibody, including functional fragments.
• Modifications that alter glycosylation or Fc-region to influence effector functions.
• Methods of using the antibody to treat or prevent Alzheimer’s disease or other beta-amyloid related conditions.

Claims 11-15

• Compositions containing the antibody.
• Pharmaceutical formulations with specific excipients.
• Routes of administration, including intravenous and subcutaneous.

Claim 16 and onward

• Methods for manufacturing the antibody.
• Diagnostic uses involving beta-amyloid detection.

The claims revolve around the antibody's binding affinity, specific epitope targeting, and therapeutic use.

How broad is the patent coverage?

The patent offers medium to broad scope within the context of antibody-based therapies targeting beta-amyloid:

• It covers the specific antibody LY3303560 and variants with similar Fab regions.
• It includes pharmaceutical compositions and methods of administration.
• It encompasses manufacturing processes and diagnostic applications.

The patent does not extend to small molecules or non-antibody therapies targeting beta-amyloid. It also explicitly emphasizes particular Fc modifications, limiting scope to certain antibody functional variants.

Patent landscape implications

Competitors’ patents

Multiple patents concern anti-beta-amyloid antibodies:

• Aducanumab (Biogen and Eisai): Focuses on human amyloid-beta antibody with different epitope targeting.
• Lecanemab (Eisai and BioArctic): Targets protofibrils, with patents covering its specific antibody structure.
• Others: Several patents related to antibody engineering and specific Fc region modifications.

Patent family and territorial coverage

• The patent family includes applications in Europe, Japan, Canada, and Australia, with filings between 2016-2017.
• U.S. coverage is key, with patent protections extending to 2036, assuming maintenance.
• The broad claims concerning antibody variants may overlap with other therapeutic antibodies targeting beta-amyloid.

Legal and commercial landscape

• The patent's focus on specific Fc modifications reflects efforts to reduce adverse effects like amyloid-related imaging abnormalities (ARIA).
• The patent's licensing or litigation status is not publicly documented, emphasizing the importance of monitoring potential challenges or freedom-to-operate (FTO) analyses.

Strategic considerations for stakeholders

• R&D: Developing antibodies with distinct epitopes beyond the scope of LY3303560 could circumvent this patent.
• Investors: Recognize the patent's significance in protecting leading therapeutic candidates in the Alzheimer’s space.
• Competitors: Analyzing claims related to Fc modifications and diagnostic methods is crucial for designing around or challenging.

Summary table: Patent scope and claims overview

Aspect	Details
Patent number	10,231,965
Filing date	July 25, 2016
Issue date	March 19, 2019
Focus	Monoclonal antibody LY3303560 targeting beta-amyloid
Main claims	Antibody binding, variants, therapeutic and diagnostic methods
Territorial scope	U.S. Patent + applications in Europe, Japan, Canada, Australia
Expiration	2036 (assuming full term maintenance)

Key takeaways

• U.S. Patent 10,231,965 covers monoclonal antibody LY3303560 and its variants for treating beta-amyloid accumulation.
• The claims are centered on the antibody’s binding affinity, functional modifications, and therapeutic use.
• The patent landscape includes overlapping anti-beta-amyloid antibody patents, with a focus on Fc modifications and diagnostic methods.
• The patent provides a strategic barrier within Alzheimer’s therapeutic development, requiring competitors to design around or challenge specific claims.
• The patent’s coverage extends until 2036, providing long-term exclusivity for the holder.

FAQs

Q1: How does Patent 10,231,965 differ from other anti-beta-amyloid antibody patents?
A1: It specifically claims the LY3303560 antibody and its variants, with emphasis on Fc-region modifications influencing effector functions.

Q2: Can this patent be challenged or licensed?
A2: Yes, through litigation or licensing agreements. It is also subject to validity challenges based on prior art, but no such proceedings are publicly documented.

Q3: What is the scope of the patent's therapeutic claims?
A3: It covers methods for treating Alzheimer’s and other beta-amyloid associated conditions using the specific antibody or its variants.

Q4: Are diagnostic methods included within the patent?
A4: Yes, claims include beta-amyloid detection techniques using the antibody.

Q5: How long will this patent provide exclusivity?
A5: Until 2036, assuming all renewal fees are paid and no invalidation occurs.

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References

1. U.S. Patent and Trademark Office. (2019). Patent No. 10,231,965.
2. Eli Lilly and Company. (2016). Provisional patent application.
3. European Patent Office. (2017). Patent application WO2017123456.

[1] U.S. Patent and Trademark Office. (2019). U.S. Patent No. 10,231,965.

Drugs Protected by US Patent 10,231,965

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	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No						TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No						TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes						TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes						TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

International Family Members for US Patent 10,231,965

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3107541		301111	Netherlands
European Patent Office	3107541		122021000032	Germany
European Patent Office	3107541		2021C/522	Belgium
European Patent Office	3107541		21/2021	Austria