Details for Patent: 8,962,630

Which drugs does patent 8,962,630 protect, and when does it expire?

Patent 8,962,630 protects KISQALI and KISQALI FEMARA CO-PACK (COPACKAGED) and is included in two NDAs.

This patent has sixty-one patent family members in forty-eight countries.

Summary for Patent: 8,962,630

Title:	Pyrrolopyrimidine compounds and their uses
Abstract:	The disclosed compounds relate to treatments and therapies for protein kinase-associated disorders. There is also a need for compounds useful in the treatment or prevention or amelioration of one or more symptoms of cancer, transplant rejections, and autoimmune diseases. Furthermore, there is a need for methods for modulating the activity of protein kinases, such as CDK1, CDK2, CDK4, CDK5, CDK6, CDK7, CDK8 and CDK9, using the compounds provided herein.
Inventor(s):	Brain; Christopher Thomas (Cambridge, MA), Sung; Moo Je (Cambridge, MA), Lagu; Bharat (Acton, MA)
Assignee:	Novartis AG (Basel, CH)
Application Number:	13/786,955
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,962,630
Patent Claim Types: see list of patent claims	Use;

Analyzing the Scope and Claims of United States Patent 8,962,630

Introduction

United States Patent 8,962,630, assigned to Novartis AG and Astex Therapeutics Limited, is a significant patent in the pharmaceutical industry, particularly in the treatment of protein kinase-associated disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Publication Number and Details

• The patent number is US 8,962,630 B2, with a publication date and other relevant details available through the USPTO database[5].

Invention Description The patent pertains to pyrrolopyrimidine compounds and their uses, specifically in treatments and therapies for protein kinase-associated disorders. These compounds are designed to inhibit specific kinases, which are enzymes involved in various cellular processes, including those related to cancer and other diseases[4].

Scope of the Patent

Claims and Coverage The patent includes multiple claims that define the scope of the invention. Here are some key aspects:

• Compound Claims: The patent claims specific pyrrolopyrimidine compounds, including their structural formulas and methods of synthesis. These claims are crucial as they define the exact chemical entities that are protected under the patent[4].

• Method Claims: In addition to the compounds themselves, the patent also claims methods of using these compounds for treating various diseases, such as cancer. These method claims are important as they protect the therapeutic applications of the compounds[4].

• Use Claims: The patent further includes claims related to the use of these compounds in combination with other therapeutic agents, which expands the scope of protection to include potential combination therapies[4].

Claim Analysis

Claim Types and Significance

• Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 might describe the general structure of the pyrrolopyrimidine compounds[4].

• Dependent Claims: These claims are narrower and depend on the independent claims. They often specify particular aspects of the compounds or methods, such as specific substituents or dosages.

• Claim Charts and Coverage: To analyze the coverage of these claims, tools like Claim Charts can be used. These charts help in visualizing the scope of each claim and identifying any gaps in coverage. This is particularly useful for determining whether a particular product or method falls within the protected scope of the patent[3].

Patent Landscape

Competitive Analysis

• Related Patents: The patent landscape includes other patents related to protein kinase inhibitors. Analyzing these patents can help in understanding the competitive environment and identifying potential infringement risks or opportunities for collaboration[1].

• Patent Family: The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including all related applications filed at participating IP Offices. This helps in understanding the global protection strategy for the patented compounds[1].

Intellectual Property Rights and Enforcement

Ownership and Assignments

• The patent is assigned to Novartis AG and Astex Therapeutics Limited. Any changes in ownership or assignments can be tracked through the Patent Assignment Search website provided by the USPTO[1].

Regulatory Considerations

Patent Term Extension

• The patent holders have applied for patent term extension under 35 U.S.C. 156, which is relevant for human drug products. This extension is crucial for maintaining market exclusivity for the drug product, KISQALI, which is claimed by the patents[5].

Practical Applications and Impact

Therapeutic Uses

• The pyrrolopyrimidine compounds protected under this patent are used in the treatment of various diseases, including cancer. The therapeutic efficacy and safety of these compounds have been a focus of clinical trials and regulatory approvals[4].

Future Directions and Opportunities

Research and Development

• The scope concepts and claim coverage analysis can help in identifying future design opportunities and potential gaps in the current patent portfolio. This can guide further research and development efforts to expand the therapeutic applications of these compounds[3].

Key Takeaways

• Patent Scope: The patent covers specific pyrrolopyrimidine compounds and their therapeutic uses.
• Claim Analysis: Detailed claim analysis using tools like Claim Charts is essential for understanding the coverage and identifying gaps.
• Patent Landscape: The patent is part of a broader landscape of protein kinase inhibitors, and analyzing related patents is crucial for competitive strategy.
• Regulatory Considerations: Patent term extension applications are important for maintaining market exclusivity.
• Future Directions: Continuous analysis of scope concepts and claim coverage can guide future R&D efforts.

FAQs

1. What is the main subject of United States Patent 8,962,630?

   • The main subject is pyrrolopyrimidine compounds and their uses in treating protein kinase-associated disorders.

2. Who are the assignees of this patent?

   • The patent is assigned to Novartis AG and Astex Therapeutics Limited.

3. What is the significance of the patent term extension application for this patent?

   • The patent term extension application is significant for maintaining market exclusivity for the drug product KISQALI.

4. How can Claim Charts help in analyzing the patent?

   • Claim Charts help in visualizing the scope of each claim and identifying any gaps in coverage, making it easier to determine if a particular product or method falls within the protected scope.

5. Where can one find detailed information about the patent assignments and changes in ownership?

   • Detailed information about patent assignments and changes in ownership can be found through the Patent Assignment Search website provided by the USPTO.

Sources

1. USPTO - Search for patents
   • https://www.uspto.gov/patents/search
2. USA.gov - U.S. Patent and Trademark Office (USPTO)
   • https://www.usa.gov/agencies/u-s-patent-and-trademark-office
3. Schwegman - Patent Analytics
   • https://www.slwip.com/services/patent-analytics/
4. Google Patents - US8962630B2
   • https://patents.google.com/patent/US8962630B2/en
5. Regulations.gov - FEB 0 6 2018
   • https://downloads.regulations.gov/FDA-2018-E-0068-0002/attachment_1.pdf

Drugs Protected by US Patent 8,962,630

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes						IN COMBINATION WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY FOR TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER-2)-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes						IN COMBINATION WITH FULVESTRANT FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE BASED THERAPY OR FOLLOWING DISEASE PROGRESSION ON ENDOCRINE THERAPY
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes						IN COMBINATION WITH AN AROMATASE INHIBITOR FOR THE TREATMENT OF PRE/PERIMENOPAUSAL OR POSTMENOPAUSAL WOMEN WITH HR-POSITIVE, HER2-NEGATIVE ADVANCED OR METASTATIC BREAST CANCER, AS INITIAL ENDOCRINE-BASED THERAPY
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes						IN COMBINATION WITH AN AROMATASE INHIBITOR FOR THE ADJUVANT TREATMENT OF ADULTS WITH HORMONE RECEPTOR (HR)-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-NEGATIVE STAGE II AND III EARLY BREAST CANCER AT HIGH RISK OF RECURRENCE
Novartis	KISQALI	ribociclib succinate	TABLET;ORAL	209092-001	Mar 13, 2017		RX	Yes	Yes						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

International Family Members for US Patent 8,962,630

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2331547		300909	Netherlands
European Patent Office	2331547		PA2017039	Lithuania
European Patent Office	2331547		CR 2017 00060	Denmark
European Patent Office	2331547		122017000102	Germany
European Patent Office	2331547		LUC00048	Luxembourg