Details for Patent: 9,314,464

Which drugs does patent 9,314,464 protect, and when does it expire?

Patent 9,314,464 protects BRAFTOVI and MEKTOVI and is included in two NDAs.

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

Summary for Patent: 9,314,464

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:	Novartis AG (Basel, CH)
Application Number:	13/931,111
Patent Claim Types: see list of patent claims	Use;

Understanding the Scope and Claims of United States Patent 9,314,464

Introduction

United States Patent 9,314,464, hereafter referred to as the '464 patent, is a significant intellectual property asset in the pharmaceutical sector. This patent is part of a broader portfolio related to specific pharmaceutical compounds and their applications. Here, we will delve into the details of the patent, its claims, and the surrounding patent landscape.

Patent Overview

The '464 patent, titled "Pharmaceutical Compositions and Methods of Use," is associated with Array Biopharma, Inc. and pertains to specific pharmaceutical compositions, particularly those involving encorafenib, a kinase inhibitor used in cancer treatment.

Claims of the '464 Patent

The claims of the '464 patent define the invention to which the patentee is entitled the right to exclude. Here are some key aspects of the claims:

Composition Claims

• The patent includes claims related to specific pharmaceutical compositions containing encorafenib, often in combination with other active ingredients. These compositions are designed for the treatment of various cancers, such as melanoma and colorectal cancer[5].

Method Claims

• The patent also claims methods of treating cancer using these compositions. These methods typically involve administering the pharmaceutical composition to a patient in need of such treatment[5].

Dosage and Administration

• The claims specify particular dosages and administration regimens for the pharmaceutical compositions. This includes details on the frequency and amount of the drug to be administered[5].

Legal Standards for Claim Construction

The construction of patent claims is a critical aspect of patent law. The Federal Circuit has established that "the claims of a patent define the invention to which the patentee is entitled the right to exclude"[2].

• Claim Construction: The court's role in claim construction is to determine the meaning of the claims based on the patent specification, the prosecution history, and other relevant evidence. There is no "magic formula or catechism" for conducting claim construction, emphasizing the need for a nuanced and context-specific approach[2].

Patent Landscape

The '464 patent operates within a complex and dynamic patent landscape, particularly in the pharmaceutical sector.

Global Patent Filings

• The global patent landscape has seen significant growth, with total patent applications exceeding 3.5 million in 2023, marking the fourth consecutive year of growth. This trend indicates a high level of innovation and competition in various sectors, including pharmaceuticals[3].

Pharmaceutical Patent Trends

• The pharmaceutical industry is characterized by intense patent activity. Patents like the '464 patent are crucial for protecting intellectual property related to new drugs and treatments. The trend of increasing patent filings suggests a continuous effort to innovate and secure exclusive rights for new pharmaceutical compositions and methods[3].

Expiration Dates and Generic Challenges

• The '464 patent, along with other related patents, has specific expiration dates. For instance, the Orange Book lists the expiration date for the '464 patent as July 4, 2031. As patents approach their expiration dates, generic manufacturers often challenge their validity or seek to market generic versions, which can lead to litigation and further shape the patent landscape[5].

Litigation and Enforcement

Patents in the pharmaceutical sector are frequently involved in litigation, particularly as generic manufacturers seek to enter the market.

Infringement and Validity Challenges

• The '464 patent has been subject to challenges, including allegations of invalidity and non-infringement. For example, generic manufacturers may submit Abbreviated New Drug Applications (ANDAs) with Paragraph IV certifications, alleging that the patent is invalid, unenforceable, or not infringed by their generic products[5].

Court Decisions and Precedents

• Court decisions play a crucial role in defining the scope and enforceability of patents. In cases involving the '464 patent, courts have to construe the claims and determine their validity and enforceability based on the evidence presented. These decisions can set precedents that influence future patent litigation[2][5].

Economic and Strategic Value

The economic and strategic value of patents like the '464 patent cannot be overstated.

Patent Valuation

• Patents can be highly valuable, with prices ranging widely. For instance, the mean price per patent document can be as high as $483,924, and significant deals have involved millions of dollars. The value of a patent like the '464 patent would be determined by its market impact, the exclusivity it provides, and the revenue it generates[1].

Licensing and Collaboration

• Patents can also serve as strategic assets for licensing and collaboration. Companies may license their patents to other firms, generating revenue and fostering innovation through collaborative efforts. This is particularly common in the pharmaceutical industry, where partnerships can accelerate drug development and market entry[1].

Key Takeaways

• Patent Claims: The '464 patent includes specific claims related to pharmaceutical compositions and methods of use, particularly involving encorafenib.
• Legal Standards: Claim construction is critical and follows established legal standards that consider the patent specification, prosecution history, and other evidence.
• Patent Landscape: The patent operates within a dynamic global patent landscape marked by increasing filings and intense competition in the pharmaceutical sector.
• Litigation and Enforcement: Patents are frequently involved in litigation, especially as generic manufacturers challenge their validity and enforceability.
• Economic and Strategic Value: Patents like the '464 patent hold significant economic and strategic value, influencing market dynamics and innovation.

FAQs

1. What is the '464 patent related to?

   • The '464 patent is related to specific pharmaceutical compositions, particularly those involving encorafenib, a kinase inhibitor used in cancer treatment.

2. How are patent claims constructed?

   • Patent claims are constructed based on the patent specification, the prosecution history, and other relevant evidence, following established legal standards.

3. What is the current trend in global patent filings?

   • Global patent filings have shown strong growth, with total applications exceeding 3.5 million in 2023, marking the fourth consecutive year of growth.

4. Why are patents in the pharmaceutical sector frequently involved in litigation?

   • Patents in the pharmaceutical sector are frequently involved in litigation as generic manufacturers challenge their validity and enforceability, especially as patents approach their expiration dates.

5. How are the economic and strategic values of patents determined?

   • The economic and strategic values of patents are determined by their market impact, the exclusivity they provide, and the revenue they generate, as well as their potential for licensing and collaboration.

Sources

1. The Value of a Patent - Perpetual Motion Patents
2. ARRAY BIOPHARMA, INC., Plaintiff - District of Delaware
3. Global Patent Filing Slowdown? - TPI International
4. SNIPR TECHNOLOGIES LIMITED v. ROCKEFELLER UNIVERSITY - CAFC
5. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - Insight.RPXcorp.com

Drugs Protected by US Patent 9,314,464

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						TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes						TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes						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						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						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

International Family Members for US Patent 9,314,464

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