Details for Patent: 10,005,761

Which drugs does patent 10,005,761 protect, and when does it expire?

Patent 10,005,761 protects BRAFTOVI and MEKTOVI and is included in two NDAs.

This patent has seventy-nine patent family members in forty-nine countries.

Summary for Patent: 10,005,761

Title:	Compounds and compositions as protein kinase inhibitors
Abstract:	The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.
Inventor(s):	Huang; Shenlin (San Diego, CA), Jin; Xianming (San Ramon, CA), Liu; Zuosheng (San Diego, CA), Poon; Daniel (Piedmont, CA), Tellew; John (La Jolla, CA), Wan; Yongqin (Irvine, CA), Wang; Xing (San Diego, CA), Xie; Yongping (San Diego, CA)
Assignee:	Array BioPharma Inc. (Boulder, CO)
Application Number:	15/070,905
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,005,761
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 10,005,761

Introduction

United States Patent 10,005,761, titled "Compounds and compositions as protein kinase inhibitors," is a significant patent in the field of pharmaceuticals, particularly in the development of therapeutic agents. This patent, issued to Array BioPharma, Inc., covers novel compounds, pharmaceutical compositions, and methods for treating various diseases using these compounds.

Patent Overview

The patent, US10005761B2, was granted on June 26, 2018, and is classified under the category of compounds and compositions as protein kinase inhibitors. Here is a brief overview of the patent:

Publication Number and Authority

• Publication Number: US10005761B2
• Authority: United States Patent and Trademark Office (USPTO)[4].

Claims and Scope

The patent includes multiple claims that define the scope of the invention.

Independent Claims

Independent claims are crucial as they define the broadest scope of the invention. For US10005761B2, the independent claims typically cover the novel compounds, their pharmaceutical compositions, and the methods of using these compounds for therapeutic purposes.

• Compound Claims: These claims specify the chemical structures of the novel compounds, including their molecular formulas and structural representations. For example, the patent describes compounds such as those with the chemical structure NC1=NC=CC(C2=CN([7*])N=C2C2=C([5*])C(CS([4*])(=O)=O)=[Y]C([3*])=C2[2*])=N1[4].

• Composition Claims: These claims cover the pharmaceutical compositions that include the novel compounds, often in combination with other ingredients such as carriers, excipients, and solvents.

• Method Claims: These claims outline the methods of using the compounds and compositions for treating diseases, such as cancer and other disorders associated with protein kinase activity.

Dependent Claims

Dependent claims further narrow down the scope of the independent claims by adding additional limitations. These claims often specify particular aspects of the compounds, compositions, or methods, such as specific dosages, administration routes, or patient populations.

Patent Landscape

Understanding the patent landscape is essential for assessing the novelty, non-obviousness, and potential infringement risks associated with the patent.

Prior Art

The patent cites several prior art references, including other patents and scientific literature, which were considered during the examination process. These references help in understanding the state of the art at the time of the patent application and how the claimed invention differs from existing knowledge[4].

Global Dossier and IP5 Offices

The patent is part of a global dossier, which means it is linked to related applications filed at other IP5 Offices (the United States, Japan, Korea, China, and Europe). This allows for a unified view of the patent family and access to citation data, office actions, and other relevant documents across these jurisdictions[1].

Citation Data

The Common Citation Document (CCD) application consolidates prior art citations from all participating IP5 Offices, providing a single point of access to citation data related to the patent family. This helps in understanding how different patent offices have evaluated the prior art for this invention[1].

Legal and Litigation Aspects

Patents are often subject to legal challenges and litigation, which can impact their validity and enforceability.

Claim Construction

In patent litigation, claim construction is a critical step where the court interprets the meaning of the claim terms. For example, in a recent case involving Array BioPharma, Inc., the court had to construe terms such as "simultaneously" and "concurrently" to determine the scope of the claims[2].

Validity and Infringement

The validity of the patent can be challenged on grounds such as lack of novelty, non-obviousness, or indefiniteness. Defendants may argue that the claims are overly broad or lack sufficient clarity, as seen in various patent disputes[2][3].

Metrics for Measuring Patent Scope

Research has shown that metrics such as independent claim length and independent claim count can be used to measure patent scope. These metrics can indicate the breadth and clarity of the claims, which are crucial for patent quality and the likelihood of grant and maintenance[3].

Practical Implications

For businesses and researchers, understanding the scope and claims of this patent is vital for several reasons:

• Innovation and R&D: Knowing the boundaries of what is patented helps in designing new compounds and methods that do not infringe on existing patents.
• Licensing and Collaboration: Companies may need to license this patent or collaborate with the patent holder to use the patented technology.
• Litigation Risk: Understanding the patent landscape and claim construction can help in assessing and mitigating litigation risks.

Key Takeaways

• Novel Compounds: The patent covers novel compounds with specific chemical structures and their pharmaceutical compositions.
• Therapeutic Methods: The methods of using these compounds for treating diseases are also claimed.
• Global Dossier: The patent is part of a global dossier, providing unified access to related applications and citation data.
• Legal Considerations: Claim construction and validity challenges are critical aspects in patent litigation.
• Metrics for Scope: Independent claim length and count can be used to measure patent scope and quality.

FAQs

1. What is the main subject of United States Patent 10,005,761?

   • The main subject is compounds and compositions as protein kinase inhibitors, along with methods for their therapeutic use.

2. How can one access the file histories of related applications for this patent?

   • Through the Global Dossier service, which provides access to the file histories of related applications from participating IP Offices[1].

3. What metrics can be used to measure the scope of a patent like US10005761B2?

   • Metrics such as independent claim length and independent claim count can be used to measure patent scope and quality[3].

4. Why is claim construction important in patent litigation?

   • Claim construction is crucial as it determines the meaning and scope of the claim terms, which can impact the validity and enforceability of the patent[2].

5. Where can one find prior art citations related to this patent?

   • Prior art citations can be found through the Common Citation Document (CCD) application, which consolidates citation data from participating IP5 Offices[1].

Sources

1. USPTO - Search for patents
2. District of Delaware - Memorandum Opinion
3. SSRN - Patent Claims and Patent Scope
4. Google Patents - US10005761B2

Drugs Protected by US Patent 10,005,761

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No	10,005,761					TREATMENT OF MELANOMA
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	10,005,761					TREATMENT OF MELANOMA
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	10,005,761					BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	10,005,761					BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	10,005,761					BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	10,005,761					BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB AND MFOLFOX6, FOR THE TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	10,005,761					INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA

International Family Members for US Patent 10,005,761

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2470526		PA2019005	Lithuania
European Patent Office	2727918		PA2019006	Lithuania
European Patent Office	2470526		300973	Netherlands
European Patent Office	2727918		300975	Netherlands
European Patent Office	2470526		LUC00101	Luxembourg
European Patent Office	2470526		122019000021	Germany
European Patent Office	2470526		2019C/508	Belgium