Details for Patent: 10,278,969

Which drugs does patent 10,278,969 protect, and when does it expire?

Patent 10,278,969 protects TRUSELTIQ and is included in one NDA.

This patent has forty-four patent family members in thirty-three countries.

Summary for Patent: 10,278,969

Title:	Pharmaceutical dosage forms
Abstract:	The present invention relates to solid pharmaceutical dosage forms comprising the drug substance 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)-ph- enylamino]-pyrimidin-4-yl}-1-methyl-urea or any pharmaceutically acceptable salt thereof. It further relates to processes of making said solid pharmaceutical dosage forms.
Inventor(s):	Ribeiro; Suzie (Basel, CH)
Assignee:	Novartis AG (Basel, CH)
Application Number:	15/102,378
Patent Claim Types: see list of patent claims	Compound; Dosage form;

Understanding the Scope and Claims of a U.S. Patent: A Detailed Analysis

Introduction to U.S. Patents

Patents are a crucial component of intellectual property law, providing inventors with exclusive rights to their inventions. In the United States, the patent laws are codified in Title 35 of the U.S. Code, outlining what constitutes patentable subject matter and the application process[1].

What is Patentable Subject Matter?

To be patentable, an invention must be new, useful, and non-obvious. This includes processes, machines, manufactures, or compositions of matter, as well as any new and useful improvements thereof[1].

The Patent Application Process

The patent application process involves several key steps:

Filing the Application

• An applicant can file either a provisional or non-provisional patent application. A provisional application provides temporary protection and allows the applicant to file a non-provisional application within one year[2].
• The non-provisional application must include a detailed specification, claims, and an abstract. The specification should be clear and concise, enabling any person skilled in the art to make and use the invention[1].

Patent Prosecution

• After filing, the application is reviewed by a patent examiner who checks for compliance with legal requirements and conducts a prior art search to determine if the invention is novel, useful, and non-obvious.
• If the examiner rejects the application, the applicant must respond to the Office Action, addressing each rejection or objection. This process can involve multiple rounds of amendments and responses[1][5].

Patent Claims

Definition and Importance

• Patent claims are the legal definition of the inventor's protectable invention. They must particularly point out and distinctly claim the subject matter of the invention[1][5].

Metrics for Measuring Patent Scope

• The scope of patent claims can be measured using metrics such as independent claim length and independent claim count. Narrower claims are often associated with a higher probability of grant and a shorter examination process[3].

Example: United States Patent 10,278,969

To illustrate the concepts of patent scope and claims, let's consider a hypothetical analysis of United States Patent 10,278,969, though the specific details of this patent are not provided here.

Reading the Patent Specification

• The patent specification would include a title, background of the invention, a summary of the invention, a detailed description, claims, and an abstract. This information helps in understanding the invention's scope and how it is differentiated from prior art[1].

Analyzing the Claims

• The claims section is critical as it defines the legal boundaries of the invention. Each claim must be clear and distinct, pointing out the novel and non-obvious aspects of the invention.
• Independent claims are particularly important as they define the broadest scope of the invention. Dependent claims further narrow down the scope by adding additional limitations[1][3].

Prior Art and Novelty

• The patent examiner's prior art search is crucial in determining the novelty and non-obviousness of the invention. The applicant must demonstrate how their invention differs from existing technology[1][5].

Patent Landscape and Competitiveness

Types of Patents

• Patents can be categorized into utility patents, design patents, and plant patents. Utility patents, which are the most common, protect functional aspects of an invention, while design patents protect the visual or ornamental design[2].

Global Competitiveness

• Patents play a significant role in global competitiveness. They provide a competitive edge by allowing inventors to exclude others from making, using, or selling their inventions. This can be particularly important in fields like biotechnology and computer science, where innovation is rapid and highly valued[4].

Maintenance and Expiration

Maintenance Fees

• To keep a utility patent in force, maintenance fees must be paid at 3.5, 7.5, and 11.5 years after the issue date. Failure to pay these fees results in the patent expiring[1].

Expiration and Public Domain

• Patents generally expire 20 years from the filing date of the non-provisional application. Once a patent expires, the invention enters the public domain, and others can freely use, make, and sell the invention[1].

Infringement and Enforcement

Unauthorized Use

• The unauthorized making, using, offering to sell, or selling of a patented invention during its term is considered infringement. Patent owners can seek damages and injunctions in federal court to enforce their rights[1].

March-In Rights

• In cases where federal funding is involved, march-in rights allow federal agencies to access and use the patented invention if the contractor or patent grantee fails to achieve practical application or meet public use requirements[4].

Key Takeaways

• Patentable Subject Matter: Inventions must be new, useful, and non-obvious to be patentable.
• Application Process: Includes filing a provisional or non-provisional application, followed by patent prosecution.
• Patent Claims: Define the legal boundaries of the invention and must be clear and distinct.
• Maintenance and Expiration: Patents require maintenance fees and generally expire after 20 years.
• Infringement: Unauthorized use of a patented invention can lead to legal action.

FAQs

Q: What are the main types of patents in the United States?

• The main types are utility patents, design patents, and plant patents[2].

Q: How long does it typically take for a patent application to be processed?

• The average processing time for a U.S. utility patent application is about three years, though it can be longer for certain fields like biotech and computer science[5].

Q: What happens if a patent application is rejected?

• The applicant must respond to the Office Action, addressing each rejection or objection, and may need to amend the claims[1][5].

Q: Why are maintenance fees important for patents?

• Maintenance fees are necessary to keep a utility patent in force beyond 4, 8, and 12 years after the issue date[1].

Q: What are march-in rights in the context of patents?

• March-in rights allow federal agencies to access and use patented inventions funded by federal grants if the contractor or patent grantee fails to achieve practical application or meet public use requirements[4].

Sources

1. The Maryland People's Law Library - Patents
2. SBIR - THE U.S. PATENT APPLICATION PROCESS
3. Hoover Institution - Patent Claims and Patent Scope
4. CSIS - March-In Rights and U.S. Global Competitiveness
5. Penn State Office of Technology Transfer - Legal Protections

Drugs Protected by US Patent 10,278,969

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-001	May 28, 2021		DISCN	Yes	No			Y
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 10,278,969

PCT Information
PCT Filed	December 11, 2014	PCT Application Number:	PCT/IB2014/066820
PCT Publication Date:	June 18, 2015	PCT Publication Number:	WO2015/087283

International Family Members for US Patent 10,278,969

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	098716
Australia	2014362999
Canada	2930055
Chile	2016001436
China	105813635
China	116942629
Cyprus	1122063