Detailed Analysis of the Scope and Claims of United States Patent 10,434,103
Introduction
The United States Patent 10,434,103, titled "Crystal of 3,5-disubstituted benzene alkynyl compound," is a significant patent in the field of pharmaceuticals, particularly for its application in antitumor agents. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Objectives
The patent, issued on October 8, 2019, and assigned to Taiho Pharmaceutical Co., Ltd., aims to provide a crystal form of a 3,5-disubstituted benzene alkynyl compound. This compound is identified as a potential antitumor agent, highlighting its importance in medical and veterinary science[1][4].
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, the patent claims cover the crystal form of the 3,5-disubstituted benzene alkynyl compound, including its preparation methods and uses.
Claim Types
The patent includes various types of claims, such as:
- Composition of Matter Claims: These claims cover the specific chemical structure of the 3,5-disubstituted benzene alkynyl compound and its crystal form.
- Method of Preparation Claims: These claims detail the processes used to synthesize and crystallize the compound.
- Use Claims: These claims specify the therapeutic uses of the compound, particularly as an antitumor agent[1][4].
Claim Specificity and Breadth
The breadth and specificity of patent claims are crucial in determining the scope of protection. For pharmaceutical patents, broader claims can provide more comprehensive protection but must be supported by a detailed and enabling disclosure in the patent application.
Written Description Requirement
The patent claims must satisfy the written description requirement under 35 U.S.C. § 112(a), which mandates that the specification must describe the invention in "such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same"[3].
Genus Claims
In the pharmaceutical and biotechnology industries, genus claims are common. These claims cover a class of compounds rather than specific embodiments. However, the Federal Circuit has taken a rigid stance on genus claims, making it challenging to obtain valuable patent protection for drugs and biologics. The claims in this patent must be carefully drafted to ensure they are commensurate with the disclosure and enablement provided in the application[3].
Patent Landscape
The patent landscape surrounding US 10,434,103 includes several related patents and applications.
Related Patents
- Patent 9,108,973: This patent, also assigned to Taiho Pharmaceutical Co., Ltd., covers a 3,5-disubstituted alkynylbenzene compound and its salt. It was issued on August 18, 2015, and is related to the same class of compounds as the subject patent[5].
- Other Related Applications: The Global Dossier service provided by the USPTO can help identify related applications and patent families across different IP offices, which is useful for understanding the broader patent landscape[2].
Patent Classification
The patent is classified under various categories in the International Patent Classification (IPC) system:
- A61K31/00: Medicinal preparations containing organic active ingredients.
- A61K31/33: Heterocyclic compounds.
- A61K31/395: Heterocyclic compounds having nitrogen as a ring hetero atom.
- A61K31/505: Pyrimidines; Hydrogenated pyrimidines[1][4].
Patent Expiration and Generic Availability
The patent is set to expire on February 23, 2033. Until then, there will be no generic version of the drug available in the United States, as generic versions require the expiration of the original patent[5].
Practical Implications
The protection offered by this patent is significant for Taiho Pharmaceutical Co., Ltd., as it prevents others from manufacturing, using, or selling the same crystal form of the 3,5-disubstituted benzene alkynyl compound without permission. This exclusivity is crucial for the commercial success of the drug and for recouping the investment in research and development.
Competitive Landscape
The exclusivity period allows Taiho Pharmaceutical Co., Ltd. to maintain a competitive edge in the market. However, the rigid stance on genus claims by the Federal Circuit may impact the ability to secure broad protection for future pharmaceutical inventions[3].
Key Takeaways
- Scope of Protection: The patent covers the crystal form of a 3,5-disubstituted benzene alkynyl compound, its preparation methods, and its use as an antitumor agent.
- Claim Specificity: The claims must be supported by a detailed and enabling disclosure to satisfy the written description requirement.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and applications, particularly those assigned to Taiho Pharmaceutical Co., Ltd.
- Patent Expiration: The patent will expire on February 23, 2033, after which generic versions may become available.
- Competitive Edge: The exclusivity period is crucial for maintaining a competitive edge in the pharmaceutical market.
FAQs
What is the main subject of United States Patent 10,434,103?
The main subject of this patent is the crystal form of a 3,5-disubstituted benzene alkynyl compound, which is useful as an antitumor agent.
Who is the assignee of this patent?
The assignee of this patent is Taiho Pharmaceutical Co., Ltd.
What is the expiration date of this patent?
The patent is set to expire on February 23, 2033.
Are there any related patents to US 10,434,103?
Yes, there are related patents, such as Patent 9,108,973, which covers a 3,5-disubstituted alkynylbenzene compound and its salt.
What are the implications of the Federal Circuit's stance on genus claims for pharmaceutical patents?
The Federal Circuit's rigid stance on genus claims makes it challenging to obtain valuable patent protection for drugs and biologics, as the claims must be commensurate with the disclosure and enablement provided in the application.
How does the patent classification system categorize this patent?
The patent is classified under A61K31/00, A61K31/33, A61K31/395, and A61K31/505, among other categories.
Sources
- Google Patents - Crystal of 3,5-disubstituted benzene alkynyl compound
- USPTO - Search for patents
- DigitalCommons@NYLS - Eviscerating Patent Scope
- Google Patents - Crystal of 3,5-disubstituted benzene alkynyl compound (French version)
- Drugs.com - Generic Lytgobi Availability
