Details for Patent: 7,855,211

Which drugs does patent 7,855,211 protect, and when does it expire?

Patent 7,855,211 protects VERZENIO and is included in one NDA.

This patent has fifty-one patent family members in forty-five countries.

Summary for Patent: 7,855,211

Title:	Protein kinase inhibitors
Abstract:	The present invention provides a compound of formula (I): ##STR00001## or a pharmaceutically acceptable salt thereof which is useful in the treatment of cell proliferative diseases.
Inventor(s):	Coates; David A (Indianapolis, IN), Gelbert; Lawrence Mark (Indianapolis, IN), Knobeloch; John M. (Indianapolis, IN), De Dios Magana; Alfonso (Carmel, IN), De Prado Gonzalez; Ana (Madrid, ES), Filadelfa Del Prado Catalina; Miriam (Madrid, ES), Garcia Paredes; Maria Cristina (Madrid, ES), Martin De La Nava; Eva Maria (Madrid, ES), Martin Ortega Finger; Maria Dolores (Madrid, ES), Martinez Perez; Jose Antonio (Madrid, ES), Mateo Herranz; Ana Isabel (Madrid, ES), Perez Martinez; Carlos (Madrid, ES), Sanchez Martinez; Concepcion (Madrid, ES)
Assignee:	Eli Lilly and Company (Indianapolis, IN)
Application Number:	12/637,789
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound;

Analyzing the Scope and Claims of United States Patent 7,855,211: A Detailed Overview

Introduction

United States Patent 7,855,211, assigned to Eli Lilly and Company, is a significant patent in the pharmaceutical industry, particularly for the drug VERZENIO (abemaciclib). This patent is crucial for understanding the exclusive rights granted to the patent holder and the implications for the drug's market presence.

Background of VERZENIO

VERZENIO (abemaciclib) is a kinase inhibitor used in the treatment of advanced or metastatic breast cancer, especially in patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. The FDA approved VERZENIO on September 28, 2017[1].

Patent Overview

Patent Assignment and Exclusivity

The U.S. Patent and Trademark Office (USPTO) granted Patent 7,855,211 to Eli Lilly and Company. This patent assigns exclusive legal rights to the patent holder, protecting the proprietary chemical formulation, including the drug's brand name, trademark, product dosage form, ingredient formulation, and manufacturing process[2].

Patent Expiration Date

The patent is set to expire on September 28, 2031. This date is critical as it marks the end of the exclusive rights granted to Eli Lilly and Company, after which generic versions of the drug could potentially enter the market[2].

Scope and Claims of the Patent

Chemical Formulation

The patent covers piperazine-pyridine-pyrimidine based benzimidazole derivatives and salts thereof, which are the active ingredients in VERZENIO. These compounds are specifically formulated to inhibit kinases, which are enzymes involved in the signaling pathways that regulate cell division and growth[4].

Pharmaceutical Formulation

The patent includes claims for pharmaceutical formulations comprising these benzimidazole derivatives. This encompasses various dosage forms and the manufacturing processes involved in producing the drug. The formulation is designed to ensure the stability, efficacy, and safety of the drug when administered to patients[4].

Regulatory Review Period and Patent Term Extension

Determination of Regulatory Review Period

The FDA determined the regulatory review period for VERZENIO to be 2,907 days, with 2,760 days during the testing phase and 147 days during the approval phase. This period is crucial for calculating the potential patent term extension[1].

Patent Term Extension Application

Eli Lilly and Company applied for a patent term extension, seeking 652 days of extension. The USPTO applies several statutory limitations to calculate the actual period for patent extension, which may differ from the requested duration[1].

Patent Landscape and Exclusivity

Drug Patents vs. Exclusivity

While the patent itself provides exclusive rights for 20 years from the date of filing, the FDA can grant additional exclusivity periods. These periods can range from 180 days to seven years, depending on the circumstances, and may run concurrently with the patent term[2].

Current Market Status

As of the current date, there is no therapeutically equivalent generic version of VERZENIO available in the United States. This maintains Eli Lilly and Company's exclusive market position for the drug until the patent expires or generic equivalents are approved[2].

Impact on Innovation and Competition

Patent Scope and Quality

The scope and quality of patents, including Patent 7,855,211, are subject to scrutiny. Metrics such as independent claim length and independent claim count are used to measure patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process, which can impact the innovation landscape[3].

Litigation and Licensing

Broad or unclear patent claims can lead to increased litigation and licensing costs, potentially diminishing incentives for innovation. The examination process tends to narrow the scope of patent claims, which can affect the competitive landscape in the pharmaceutical industry[3].

Public Comment and Redetermination

Petitions for Redetermination

The FDA allows for public comments and petitions regarding the dates published for the regulatory review period. Any interested person can petition for a determination on whether the applicant for extension acted with due diligence during the regulatory review period. These petitions must comply with specific requirements and be submitted within the specified timeframe[1].

Key Takeaways

• Patent Exclusivity: Patent 7,855,211 grants exclusive rights to Eli Lilly and Company until September 28, 2031.
• Regulatory Review: The FDA determined a regulatory review period of 2,907 days, which is crucial for calculating the patent term extension.
• Market Impact: The absence of generic equivalents maintains Eli Lilly and Company's market exclusivity for VERZENIO.
• Innovation and Competition: The scope and quality of the patent can influence innovation and competition in the pharmaceutical industry.

FAQs

Q: What is the primary use of VERZENIO (abemaciclib)?

A: VERZENIO is used in the treatment of advanced or metastatic breast cancer, particularly in patients with disease progression following endocrine therapy and prior chemotherapy.

Q: When is the patent for VERZENIO set to expire?

A: The patent for VERZENIO is set to expire on September 28, 2031.

Q: Can generic versions of VERZENIO be marketed before the patent expires?

A: No, as of the current date, there are no therapeutically equivalent generic versions of VERZENIO available in the United States.

Q: How is the regulatory review period determined for patent term extension?

A: The FDA determines the regulatory review period based on the dates of the investigational new drug application, new drug application submission, and approval.

Q: What are the implications of broad or unclear patent claims?

A: Broad or unclear patent claims can lead to increased litigation and licensing costs, potentially diminishing incentives for innovation.

Sources

1. Federal Register/Vol. 88, No. 40/Wednesday, March 1, 2023/Notices - Federal Register.
2. Generic Verzenio Availability - Drugs.com.
3. Patent Claims and Patent Scope - Hoover Institution.
4. Innovations and Patent Trends in the Development of USFDA ... - MDPI.

Drugs Protected by US Patent 7,855,211

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y		AS MONOTHERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY AND PRIOR CHEMOTHERAPY IN THE METASTATIC SETTING
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y		IN COMBINATION WITH ENDOCRINE THERAPY (TAMOXIFEN OR AN AROMATASE INHIBITOR) FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE, NODE POSITIVE, EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y		IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-001	Sep 28, 2017		RX	Yes	No			Y	Y		IN COMBINATION WITH FULVESTRANT FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-002	Sep 28, 2017		RX	Yes	No			Y	Y		AS MONOTHERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING ENDOCRINE THERAPY AND PRIOR CHEMOTHERAPY IN THE METASTATIC SETTING
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-002	Sep 28, 2017		RX	Yes	No			Y	Y		IN COMBINATION WITH ENDOCRINE THERAPY (TAMOXIFEN OR AN AROMATASE INHIBITOR) FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH HR-POSITIVE, HER2-NEGATIVE, NODE POSITIVE, EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Eli Lilly And Co	VERZENIO	abemaciclib	TABLET;ORAL	208716-002	Sep 28, 2017		RX	Yes	No			Y	Y		IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR THE TREATMENT OF ADULT PATIENTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER

Foreign Priority and PCT Information for Patent: 7,855,211

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	08380343	Dec 22, 2008

International Family Members for US Patent 7,855,211

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2379528		300969	Netherlands
European Patent Office	2379528		PA2019004	Lithuania
European Patent Office	2379528		LUC00106	Luxembourg
European Patent Office	2379528		122019000010	Germany
European Patent Office	2379528		2019C/507	Belgium
European Patent Office	2379528		CA 2019 00008	Denmark
European Patent Office	2379528		CR 2019 00008	Denmark