Details for Patent: 8,071,623

Which drugs does patent 8,071,623 protect, and when does it expire?

Patent 8,071,623 protects ZEJULA and AKEEGA and is included in three NDAs.

This patent has eighty-one patent family members in forty-nine countries.

Summary for Patent: 8,071,623

Title:	Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors
Abstract:	The present invention relates to compounds of formula I: ##STR00001## and pharmaceutically acceptable salts, stereoisomers or tautomers thereof which are inhibitors of poly (ADP-ribose) polymerase (PARP) and thus useful for the treatment of cancer, inflammatory diseases, reperfusion injuries, ischemic conditions, stroke, renal failure, cardiovascular diseases, vascular diseases other than cardiovascular diseases, diabetes, neurodegenerative diseases, retroviral infection, retinal damage or skin senescence and UV-induced skin damage, and as chemo- and/or radiosensitizers for cancer treatment.
Inventor(s):	Jones; Philip (Rome, IT), Ontoria Ontoria; Jesus Maria (Rome, IT), Scarpelli; Rita (Rome, IT), Schultz-Fademrecht; Carsten (Rome, IT)
Assignee:	Instituto di Ricerche di Biologia Molecolare P. Angeletti SpA (Rome, unknown)
Application Number:	12/006,993
Patent Claim Types: see list of patent claims	Composition; Compound;

Detailed Analysis of the Scope and Claims of United States Patent 8,071,623

Introduction

United States Patent 8,071,623, issued on December 6, 2011, is a significant patent in the field of pharmaceuticals, particularly for the treatment of cancers using poly(ADP-ribose) polymerase (PARP) inhibitors. This patent is associated with the drug ZEJULA (niraparib), which has been approved for various cancer treatments.

Inventors and Assignees

The patent was invented by Philip Jones, Jesus Maria Ontoria, Rita Scarpelli, and Carsten Schultz-Fademrecht, and it is assigned to Instituto di Ricerche di Biologia Molecolare P. Angeletti SpA, though it has been transferred to MSD Italia S.r.l., a subsidiary of Merck & Co., Inc.[1][4].

Background of the Invention

The patent relates to amide substituted indazoles that act as inhibitors of the PARP enzyme. These compounds are useful in treating tumors with specific defects in DNA-repair pathways and can enhance the effects of certain DNA-damaging agents such as anticancer agents and radiotherapy. Additionally, they have potential uses in reducing cell necrosis in conditions like stroke and myocardial infarction, and in down-regulating inflammation and tissue injury[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention. Here are some key aspects:

• Claims 1-3 and 5-9: These claims specifically cover the active ingredient niraparib and compositions containing it, which are part of the approved product ZEJULA[1].
• Compound Specifications: The patent details specific amide substituted indazoles that inhibit PARP activity, which is crucial for their therapeutic effects[4].

Patent Scope and Breadth

The scope of the patent is defined by its claims, which are narrowed down during the patent examination process to ensure clarity and validity. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Regulatory Review and Patent Term Extension

The patent has undergone a regulatory review period before the commercial marketing of ZEJULA. This review period is a critical factor in the extension of the patent term under 35 U.S.C. § 156. The patent term has been extended to March 27, 2031, due to the regulatory review period[1].

Patent Term and Expiration

The original expiration date of the patent was March 23, 2030, but it has been extended by 370 days to March 27, 2031, due to the regulatory review period and patent term adjustment provisions[1].

Related Patents and Patent Landscape

Several other patents are related to niraparib and its uses:

• Patent 11,091,459: Covers compositions comprising niraparib, particularly certain solid forms, with an expiration date of March 27, 2038[2].
• Patent 11,207,311: Discloses methods of treating prostate cancer using niraparib, with an expiration date of July 28, 2037[2].
• Other Patents: There are several other patents related to niraparib, including those covering different aspects of its use and formulation, all with varying expiration dates[2].

Impact on Innovation and Licensing

The breadth and clarity of patent claims can significantly impact innovation and licensing. Broader claims can lead to increased licensing and litigation costs, potentially diminishing the incentives for innovation. However, the claims in U.S. Patent 8,071,623 have been carefully defined to ensure validity and clarity, which is crucial for maintaining a positive innovation environment[3].

Commercial and Therapeutic Significance

ZEJULA, the product associated with this patent, has been approved for the treatment of various cancers, including ovarian cancer. The therapeutic significance of PARP inhibitors like niraparib lies in their ability to target tumors with specific DNA-repair defects, making them highly effective in certain cancer treatments[4].

Legal and Regulatory Aspects

The patent extension under 35 U.S.C. § 156 is based on the regulatory review period for ZEJULA. This extension ensures that the patent holder has adequate time to recoup their investment in the drug's development and regulatory approval process[1].

Conclusion

United States Patent 8,071,623 is a pivotal patent in the field of cancer treatment, particularly for PARP inhibitors. The patent's scope, claims, and regulatory aspects are well-defined, ensuring clarity and validity. The extension of the patent term due to regulatory review highlights the complex interplay between patent law and regulatory approval processes.

Key Takeaways

• Inventors and Assignees: Philip Jones, Jesus Maria Ontoria, Rita Scarpelli, and Carsten Schultz-Fademrecht; assigned to Instituto di Ricerche di Biologia Molecolare P. Angeletti SpA.
• Claims: Cover niraparib and compositions containing it.
• Patent Scope: Defined by specific claims related to PARP inhibitors.
• Regulatory Review: Extended patent term to March 27, 2031.
• Related Patents: Several patents cover different aspects of niraparib use and formulation.
• Therapeutic Significance: Crucial for treating cancers with specific DNA-repair defects.

FAQs

1. What is the main subject of United States Patent 8,071,623?

   • The main subject is amide substituted indazoles that act as inhibitors of the PARP enzyme.

2. Who are the inventors of this patent?

   • Philip Jones, Jesus Maria Ontoria, Rita Scarpelli, and Carsten Schultz-Fademrecht.

3. What is the associated drug with this patent?

   • ZEJULA (niraparib).

4. Why was the patent term extended?

   • Due to the regulatory review period under 35 U.S.C. § 156.

5. What is the current expiration date of the patent?

   • March 27, 2031.

Cited Sources

1. Application for Extension of Patent Term Under 35 U.S.C. § 156 for U.S. 8,071,623 - Regulations.gov
2. Generic Akeega Availability - Drugs.com
3. Patent Claims and Patent Scope - SSRN
4. United States Patent 8,071,623 - Google Patents

Drugs Protected by US Patent 8,071,623

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No			Y	Y
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No			Y	Y
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes			Y	Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No			Y	Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: 8,071,623

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0700432.8	Jan 10, 2007

International Family Members for US Patent 8,071,623

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2109608		CA 2018 00017	Denmark
European Patent Office	2109608		300937	Netherlands
European Patent Office	2109608		PA2018009	Lithuania
European Patent Office	2109608		122018000048	Germany
European Patent Office	2109608		LUC00072	Luxembourg
European Patent Office	2109608		2018C/017	Belgium
European Patent Office	2109608		1890020-9	Sweden