Details for Patent: 8,835,443

Which drugs does patent 8,835,443 protect, and when does it expire?

Patent 8,835,443 protects TAFINLAR and MEKINIST and is included in four NDAs.

Protection for TAFINLAR has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty patent family members in twenty-eight countries.

Summary for Patent: 8,835,443

Title:	Pyrimidine compound and medical use thereof
Abstract:	The present invention relates to a pyrimidine compound or a pharmaceutically acceptable salt thereof represented by the following formula [I] ##STR00001## wherein each symbol is as defined in the specification and a method of therapeutically or prophylactically treating an undesirable cell proliferation, comprising administering such a compound. The compound of the present invention has superior activity in suppressing undesirable cell proliferation, particularly, an antitumor activity, and is useful as an antitumor agent for the prophylaxis or treatment of cancer, rheumatism, and the like. In addition, the compound of the present invention can be a more effective antitumor agent when used in combination with other antitumor agents such as an alkylating agent or metabolism antagonist.
Inventor(s):	Kawasaki; Hisashi (Takatsuki, JP), Abe; Hiroyuki (Takatsuki, JP), Hayakawa; Kazuhide (Takatsuki, JP), Iida; Tetsuya (Takatsuki, JP), Kikuchi; Shinichi (Takatsuki, JP), Yamaguchi; Takayuki (Takatsuki, JP), Nanayama; Toyomichi (Takatsuki, JP), Kurachi; Hironori (Takatsuki, JP), Tamaru; Masahiro (Takatsuki, JP), Hori; Yoshikazu (Takatsuki, JP), Takahashi; Mitsuru (Takatsuki, JP), Yoshida; Takayuki (Yokohama, JP), Sakai; Toshiyuki (Kyoto, JP)
Assignee:	Japan Tobacco Inc. (Tokyo, JP)
Application Number:	12/626,443
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope and Claims of United States Patent 8,835,443

Introduction

United States Patent 8,835,443, issued on September 16, 2014, is a significant patent in the pharmaceutical industry, particularly related to a pyrimidine compound and its medical use. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Patent 8,835,443 is assigned to Japan Tobacco Inc. and involves a pyrimidine compound or a pharmaceutically acceptable salt thereof. The invention is represented by a specific formula, which is crucial for its medical application[2][5].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are the key elements:

Chemical Structure

The patent describes a pyrimidine compound with a specific chemical structure. This structure is essential for the compound's pharmacological properties and its use in medical treatments[2][5].

Medical Use

The patent covers the medical use of the pyrimidine compound, including its application in treating various diseases. This could include cancer, given the context of similar compounds in the pharmaceutical industry[2][5].

Pharmaceutically Acceptable Salts

The patent also includes pharmaceutically acceptable salts of the pyrimidine compound, which are important for formulation and administration of the drug[2][5].

Claims of the Patent

The claims of the patent are the legal boundaries that define what is protected. Here are some key aspects:

Independent Claims

The independent claims are the broadest claims in the patent and define the core invention. For Patent 8,835,443, these claims would include the specific chemical structure of the pyrimidine compound and its medical use[4].

Dependent Claims

Dependent claims are narrower and build upon the independent claims. They might include specific formulations, methods of preparation, or particular medical applications of the compound[4].

Patent Expiration Date

The patent is set to expire on June 10, 2025. This expiration date is crucial for generic drug manufacturers, as it marks the time when they can legally produce and market generic versions of the drug[2][5].

Impact on Generic Drug Manufacturers

The expiration of Patent 8,835,443 will open up the market for generic versions of the drug. Generic manufacturers will be able to produce the pyrimidine compound without infringing on the original patent, potentially reducing costs and increasing accessibility for patients.

Broader Patent Landscape

Related Patents

Other patents in the same therapeutic area, such as those for cancer treatments, are also nearing expiration. For example, patents for drugs like Abiraterone Acetate and Niraparib Tosylate are set to expire in 2027, while patents for Belinostat and Bendamustine Hydrochloride will expire in 2026[1].

Patent Scope and Quality

The scope and quality of patents, including Patent 8,835,443, are subjects of ongoing debate. Metrics such as independent claim length and count are used to measure patent scope, with narrower claims often associated with a higher probability of grant and shorter examination processes[3].

Industry Implications

The expiration of Patent 8,835,443 and similar patents has significant implications for the pharmaceutical industry:

Competition and Innovation

Increased competition from generic drugs can drive innovation as companies seek to develop new and improved treatments. However, it also raises concerns about the financial incentives for innovation, as reduced revenue from patented drugs may impact research and development budgets.

Patient Access

The availability of generic drugs can improve patient access to essential medications by reducing costs. This is particularly important for life-saving treatments, where affordability can be a critical factor.

Key Takeaways

• Patent 8,835,443 covers a pyrimidine compound and its medical use, with a specific chemical structure and pharmaceutically acceptable salts.
• The patent expires on June 10, 2025, allowing for the production of generic versions thereafter.
• The broader patent landscape includes other expiring patents in the cancer treatment sector.
• The expiration of these patents will increase competition, potentially driving innovation and improving patient access to medications.

FAQs

Q: Who is the assignee of Patent 8,835,443? A: The assignee of Patent 8,835,443 is Japan Tobacco Inc.[2][5].

Q: What is the medical use of the pyrimidine compound described in the patent? A: The patent covers the medical use of the pyrimidine compound, though specific diseases are not detailed in the available sources. It is likely related to cancer treatment given the context of similar compounds[2][5].

Q: When does the patent expire? A: The patent expires on June 10, 2025[2][5].

Q: How does the expiration of this patent affect generic drug manufacturers? A: The expiration allows generic drug manufacturers to produce and market generic versions of the drug without infringing on the original patent, potentially reducing costs and increasing accessibility for patients.

Q: What are the broader implications of this patent expiration for the pharmaceutical industry? A: The expiration can increase competition, drive innovation, and improve patient access to medications by reducing costs. However, it may also impact the financial incentives for innovation in the industry.

Sources

1. GreyB, "Cancer Drug Patents Expiring 2024-2028".
2. Drugs.com, "Generic Tafinlar Availability".
3. Hoover Institution, "Patent Claims and Patent Scope".
4. Google Patents, "US8835443B2 - Pyrimidine compound and medical use thereof".
5. Drugs.com, "Generic Mekinist Availability".

Drugs Protected by US Patent 8,835,443

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	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No	8,835,443*PED				Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes	8,835,443*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513-001	Mar 16, 2023		RX	Yes	Yes	8,835,443*PED				Y
Novartis	TAFINLAR	dabrafenib mesylate	TABLET, FOR SUSPENSION;ORAL	217514-001	Mar 16, 2023		RX	Yes	Yes	8,835,443*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No	8,835,443*PED				Y
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No	8,835,443*PED				Y

Foreign Priority and PCT Information for Patent: 8,835,443

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2004-174770	Jun 11, 2004
Japan	2004-327111	Nov 10, 2004

International Family Members for US Patent 8,835,443

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1761528		C300701	Netherlands
European Patent Office	1761528		PA2014039	Lithuania
European Patent Office	1761528		CA 2014 00055	Denmark
European Patent Office	1761528		14C0083	France
European Patent Office	1761528		C20140036 00120	Estonia
European Patent Office	1761528		1490063-3	Sweden