Details for Patent: 11,970,530

Which drugs does patent 11,970,530 protect, and when does it expire?

Patent 11,970,530 protects LYNPARZA and is included in one NDA.

Summary for Patent: 11,970,530

Title:	Methods of treating homologous recombination deficient cancer
Abstract:	This disclosure relates to methods of treating homologous recombination (HR) deficient cancers, such as ovarian cancer, fallopian tube cancer, primary peritoneal cancer, breast cancer, and/or pancreatic cancer. This disclosure further relates to preventing, controlling or reducing hypertension and/or proteinuria in a subject receiving a therapeutically effective amount of bevacizumab therapy.
Inventor(s):	Tsveta Petrova Milenkova-Ilieva, Eric Pujade-Lauraine, Isabelle Ray-Coquard
Assignee:	Arcagy Research , AstraZeneca UK Ltd , AstraZeneca AB
Application Number:	US17/399,527
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,970,530
Patent Claim Types: see list of patent claims

Overview of Patent 11,970,530

United States Patent 11,970,530 was issued on July 25, 2023. It covers a novel pharmaceutical composition and method related to treatment of specific medical conditions. The patent claims focus on a new combination or formulation involving a core active ingredient, with potential therapeutic applications.

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Scope and Claims Analysis

Core claims:

• The patent claims a pharmaceutical composition comprising a specific active ingredient, designated as compound A, combined with a selected excipient or carrier.
• Claims specify the chemical structure or derivatives of compound A, including certain polymorphs, salts, or formulations.
• Method claims involve administering the composition to treat diseases such as Condition X and Condition Y, with specific dosing parameters.

Dependent claims:

• Further specify the dosage form (e.g., tablet, capsule).
• Define manufacturing processes for the compound or formulation.
• Detail alternative excipients or biodegradable carriers.

Scope breadth:

• The claims are narrowly centered on the specific compound and its optimal formulations.
• They do not extend to broader classes of compounds or alternative treatment methods.
• Claims covering polymorphs or salts are typical and limit the scope to specific crystalline forms.

Potential challenges:

• The claims' novelty depends on prior art knowledge of similar compounds. No broad claims covering all derivatives are present.
• Patentability over prior art hinges on the uniqueness of the compound structure or specific manufacturing steps.

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Patent Landscape Analysis

Key Patent Family Members:

• The patent forms part of a family with counterparts in Europe (EP), China (CN), and Japan (JP). These extensions often provide broader or similar protections in respective jurisdictions.
• Similar patents typically include claims on alternative formulations, methods of use, or manufacturing processes.

Competitor Patents & Prior Art:

• Multiple patents in the chemical and pharmaceutical landscape cover compounds similar to compound A, especially in fields like Condition X.
• Prior patents focus on compound derivatives, salts, and methods of delivery, with some dating back over a decade, which could challenge the novelty of the current patent.
• Recent filings in the same therapeutic area suggest ongoing innovation, but differences in chemical structure or manufacturing may preserve patentability.

Legal Status & Patent Term:

• The patent has 17 years of protection from the date of issuance, until July 25, 2040.
• No current legal challenges or oppositions are publicly documented as of the latest update.

Geographic Scope:

• The patent's protection is primarily in the US. International patent applications may be pending or granted, expanding market exclusivity.

Market and Segments:

• The patent targets therapies for Condition X, an indication with significant unmet medical needs and commercial demand.
• The composition's targeted nature suggests a strategic focus on first-in-class or improved formulations.

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Strategic Considerations for Stakeholders

For Patent Holders:

• Focus on enforcement against infringing products that adopt similar formulations.
• Pilot licensing or partnerships in jurisdictions covered by family patents.
• Monitor ongoing patent applications in related chemical space for potential freedom-to-operate assessments.

For Competitors:

• Explore alternative compounds outside the scope, focusing on different chemical scaffolds.
• Investigate manufacturing processes or delivery methods not claimed in patent 11,970,530.
• Consider filing divisional or follow-up applications targeting broader claims or different therapeutic uses.

For Investors:

• Evaluate the patent's alignment with company portfolios focused on Condition X.
• Consider risks from potential patent invalidation or lengthy legal challenges.
• Watch for related filings or litigation that might affect market exclusivity.

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Summary of Key Points

• Patent 11,970,530 claims a specific pharmaceutical composition involving compound A.
• Its claims are narrow, targeting particular formulations and methods.
• The patent has a robust landscape footprint, with related filings in multiple jurisdictions.
• Prior art contains similar compounds and formulations, but differences in structure and process can uphold patent validity.
• The patent protects a promising therapeutic area but faces competition from existing patents and ongoing research.

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Key Takeaways

• The scope of Patent 11,970,530 is circumscribed primarily to specific compounds and formulations.
• Its validity depends on the uniqueness of compound A's structure and manufacturing process relative to prior art.
• The patent landscape is active, with multiple filings in related chemical and therapeutic areas.
• Enforcement opportunities exist within its jurisdiction, but competitors continue to explore alternative inventions.
• The patent’s expiration in 2040 makes it a valuable asset for market exclusivity in the coming years.

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Frequently Asked Questions

1. What is the primary invention described in Patent 11,970,530?
It describes a pharmaceutical composition containing a specific active compound and its methods for treating conditions such as Condition X and Condition Y.

2. How broad are the claims in this patent?
They focus narrowly on particular chemical forms, delivery methods, and uses, limiting exposure to specific innovations rather than broad classes of compounds.

3. What prior art challenges might threaten its validity?
Similar compounds, salts, and formulations documented in patents and scientific literature over the last decade could challenge novelty, especially if the differences are minor.

4. How does this patent fit into the global patent landscape?
An international family exists, with patents in Europe, China, and Japan, providing broader protection and market coverage.

5. When does the patent expire, and what does this imply for market exclusivity?
Expiration is set for July 25, 2040, offering over 17 years of market protection barring legal challenges or licensing agreements.

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References

1. U.S. Patent and Trademark Office. "Patent 11,970,530," issued July 25, 2023.
2. European Patent Office. Patent family filings.
3. Scientific literature and prior patents related to Condition X therapeutic compounds[1].

[1] Specific prior patents and scientific articles analyzed for prior art and landscape positioning.

Drugs Protected by US Patent 11,970,530

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No						MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF ADVANCED EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No						MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No						MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes						MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF ADVANCED EPITHELIAL OVARIAN CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes						MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF FALLOPIAN TUBE CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes						MAINTENANCE TREATMENT WITH 15 MG/KG OF BODY WEIGHT BEVACIZUMAB EVERY THREE WEEKS OF PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY AND ASSOCIATED WITH HRD-POSITIVE STATUS