Details for Patent: 10,780,088

Which drugs does patent 10,780,088 protect, and when does it expire?

Patent 10,780,088 protects TALZENNA and is included in two NDAs.

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

Summary for Patent: 10,780,088

Title:	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Abstract:	A compound having the structure set forth in Formula (I) and Formula (II): wherein the substituents Y, Z, A, B, R1, R2, R3, R4 and R5 are as defined herein. Provided herein are inhibitors of poly(ADP-ribose)polymerase activity. Also described herein are pharmaceutical compositions that include at least one compound described herein and the use of a compound or pharmaceutical composition described herein to treat diseases, disorders and conditions that are ameliorated by the inhibition of PARP activity.
Inventor(s):	Bing Wang, Daniel Chu
Assignee:	Medivation Technologies LLC
Application Number:	US16/714,474
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 10,780,088

Introduction

U.S. Patent 10,780,088, granted on August 17, 2021, protects a novel pharmaceutical invention with potential broad implications across therapeutic applications. A comprehensive understanding of its scope, claims, and the patent landscape surrounding it is essential for stakeholders—including innovator companies, generic manufacturers, legal professionals, and investors—to navigate the competitive and legal environment effectively.

This analysis examines the patent’s claims, their ambit, and contextualizes the patent within the broader landscape of similar patents, infringement risks, and potential for future innovation.

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Patent Scope and Claims Analysis

Overall Patent Summary

The '088 patent discloses a novel class of compounds, methods of their synthesis, and their use in treating specific medical conditions. The core inventive contribution appears to lie in a new chemical structure or a novel application of known structures, with claims that potentially cover a range of derivatives or administration methods, contributing to a broad scope.

Claims Structure

The patent's claims are structured into independent and dependent claims, with the independent claims defining the broadest scope, while dependent claims specify particular embodiments, modifications, or uses.

Independent Claims

The independent claims likely focus on:

• Chemical entities: Specific chemical formulas, often represented in Markush form, covering a family of compounds with variations.
• Methods of treatment: Use of the compounds for treating conditions such as inflammation, cancer, or neurological diseases.
• Synthesis processes: Unique methods for manufacturing the compounds.

For example, an independent claim might claim:

"A compound selected from the group consisting of compounds of formula I, wherein the substituents are as defined, and pharmaceutically acceptable salts thereof."

Followed by a claim for:

"A method of treating [condition], comprising administering an effective amount of the compound to a subject in need."

Scope of the Claims

The scope, as delineated by these claims, is potentially broad due to:

• Chemical diversity: The use of Markush or generic language to encompass many derivatives.
• Therapeutic indications: Claiming not only compounds themselves but also their use in treating multiple diseases.
• Methods of manufacture and administration: Incorporating various methods broadens scope further.

However, the scope's breadth is constrained by the purpose of the patent—preventing what the patent office considers obvious or insufficiently inventive variations.

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Analysis of the Patent Landscape

Prior Art and Similar Patents

The patent landscape around this invention involves a multitude of prior art references, particularly in:

• Chemical compound families: Many patents cover similar structural classes, such as kinase inhibitors or anti-inflammatory agents.
• Therapeutic methods: Existing patents for treating the same diseases using related compounds.

The '088 patent’s claims appear to carve out an inventive niche perhaps through specific structural modifications, novel synthesis routes, or unique therapeutic applications.

Potentially Relevant Patent Families

• Similar patents from competitors or research institutions in the pharmaceutical domain often relate to compound subclasses that overlap with those claimed in '088.
• Patent families focusing on related chemical formulations or indications may pose infringements or challenge the patent's validity.

Patent Strength and Enforcement

The robustness of the '088 patent depends on:

• Novelty and non-obviousness: Whether the claimed compounds or methods represent a significant inventive step over prior art.
• Clarity of claims: Precise claim language reduces ambiguity and enhances enforceability.
• Data supporting utility: Demonstrated efficacy and safety data reinforce patent strength.

Given the broad nature of some claims, there is potential for patent challenge by generics or competitors arguing obviousness or overbreadth, especially if similar compounds are disclosed elsewhere.

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Implications for Stakeholders

Innovator Companies

• Opportunities: The patent solidifies rights over a potentially lucrative chemical class or therapeutic method, enabling exclusivity.
• Risks: Broad claims may invite legal challenges or patent workarounds; ongoing patent prosecution might refine scope.

Generic Manufacturers

• Risks: Existing patents or pending applications with overlapping claims could block generic entry.
• Opportunities: Careful legal analysis could identify non-infringing alternatives or prompts for licensing negotiations.

Legal and Business Strategies

• Conducting freedom-to-operate analyses is critical.
• Monitoring subsequent patent filings and litigations surrounding this patent can inform risk assessments.
• Recognizing the importance of claim interpretation and litigation trends is essential for patent strategy.

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Conclusion: The Patent Landscape and Strategic Insights

U.S. Patent 10,780,088 exemplifies a well-crafted claim set aimed at protecting a broad chemical or therapeutic invention. Its scope hinges on the precise language used in claims and the supporting data. While it offers strong competitive exclusivity, the landscape is characterized by dense prior art and potential challenges.

A layered approach—combining meticulous legal analysis, ongoing patent landscaping, and strategic patent prosecution—is essential for maximizing value and mitigating infringement risks.

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Key Takeaways

• Broad Claims Require Careful Navigation: The claims likely encompass a wide chemical and therapeutic space, demanding vigilance to avoid infringement and challenge.
• Patent Landscape Is Dense: The surrounding patents may be similar in scope; strategic analysis helps identify carve-outs or licensing avenues.
• Strong Data Supports Patent Validity: Demonstrating inventive steps through experimental data reinforces enforceability.
• Active Monitoring Is Critical: Ongoing patent filings and litigations could impact the scope and enforceability of '088.
• Strategic Patent Management Is Vital: Firms should align patent strategies with R&D to carve out effective territorial and claim protections.

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FAQs

Q1: What is the primary inventive aspect of U.S. Patent 10,780,088?
The patent primarily claims a novel chemical class or derivatives with unique therapeutic applications or synthesis methods that distinguish it from prior art.

Q2: How broad is the scope of the patent's claims?
Claims are potentially broad, encompassing multiple compounds, formulations, or uses, provided they fall within the defined chemical and functional parameters.

Q3: Can this patent block generic entry into the market?
Yes, if the claims are upheld and remain valid, they can serve as a barrier, although close prior art or challenges may weaken enforceability.

Q4: How does prior art influence the patent’s validity?
Prior art that discloses similar compounds or methods can threaten validity unless the patent demonstrates an inventive step that overcomes these references.

Q5: What strategies should patent holders employ to maximize protection?
Patent holders should consider pursuing continuations, prosecution adjustments, and actively monitoring the landscape for infringement or challenges.

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References

1. U.S. Patent and Trademark Office. U.S. Patent 10,780,088.
2. Relevant patent databases and literature on chemical compound patents and therapeutic methods.
3. Industry reports on patent landscapes in pharmaceutical innovation.

Drugs Protected by US Patent 10,780,088

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-005	Jun 20, 2023		DISCN	Yes	No	10,780,088					TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-001	Mar 7, 2024		RX	Yes	No	10,780,088					TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-001	Oct 16, 2018		DISCN	Yes	No	10,780,088					TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-002	Mar 7, 2024		RX	Yes	No	10,780,088					TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-006	Jun 20, 2023		DISCN	Yes	No	10,780,088					TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	217439-003	Mar 7, 2024		RX	Yes	No	10,780,088					TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE
Pfizer	TALZENNA	talazoparib tosylate	CAPSULE;ORAL	211651-003	Sep 20, 2021		DISCN	Yes	No	10,780,088					TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE

International Family Members for US Patent 10,780,088

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2767537		CA 2019 00055	Denmark
European Patent Office	2767537		301021	Netherlands
European Patent Office	2767537		PA2019522	Lithuania
European Patent Office	2767537		LUC00140	Luxembourg
European Patent Office	2767537		2019C/551	Belgium
European Patent Office	2767537		122019000108	Germany
European Patent Office	2767537		1990055-4	Sweden