Details for Patent: 10,925,835

Which drugs does patent 10,925,835 protect, and when does it expire?

Patent 10,925,835 protects CONSENSI and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,925,835

Title:	Celecoxib and amlodipine formulation and method of making the same
Abstract:	Provided herein is a celecoxib and amlodipine composition and method of making the same. The composition contains granules containing celecoxib. The amlodipine is incorporated into the composition as an extragranulate.
Inventor(s):	Efrati; Yitshak Itsik (Modiin, IL)
Assignee:	DEXCEL LTD. (Or-Akiva, IL) KITOV PHARMACEUTICALS (Tel Aviv, IL)
Application Number:	17/006,959
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Understanding the Scope and Claims of United States Patent 10,925,835

Introduction

The United States Patent 10,925,835, hereafter referred to as the '835 patent, is a significant intellectual property asset in the pharmaceutical sector. To delve into its scope and claims, it is essential to analyze the patent's context, its claims, and the broader patent landscape.

Background of the Patent

The '835 patent, titled "Celecoxib and Amlodipine Formulation and Method of Making the Same," was issued on February 23, 2021, to Kitov and Dexcel Pharma Limited as co-assignees of the inventor Yitshak I. Efrati. This patent is owned by Purple Biotech, which has exclusive rights to assert it[5].

Patent Claims

Independent Claims

The '835 patent includes several independent claims that define the scope of the invention. These claims typically outline the novel and non-obvious aspects of the invention, such as the specific formulation and method of making the Celecoxib and Amlodipine combination.

• Claim 1: This claim usually sets the broadest scope of the invention, describing the combination of Celecoxib and Amlodipine in a specific formulation. For example, it might specify the ratio of the two active ingredients, the type of excipients used, and the method of preparation.
• Subsequent Claims: These claims narrow down the scope by adding specific limitations or additional features. For instance, Claim 2 might specify a particular method of manufacturing, while Claim 3 could detail a specific dosage form (e.g., tablets, capsules).

Dependent Claims

Dependent claims build upon the independent claims by adding further limitations or features. These claims help to protect various aspects of the invention and can be used to defend against potential infringement.

• Claim 4: This might depend on Claim 1 and add a specific step in the manufacturing process, such as a particular mixing or coating technique.
• Claim 5: This could depend on Claim 2 and specify a particular packaging or storage condition for the formulation.

Subject Matter Eligibility

Given the recent updates in patent law, particularly the 2024 USPTO guidance on AI and software-related patents, it is crucial to ensure that the claims of the '835 patent meet the criteria for subject matter eligibility.

• Practical Applications: The claims must integrate abstract ideas into practical applications. For example, if the patent claims involve a method of treating a specific condition using the Celecoxib and Amlodipine formulation, it must demonstrate how this method provides concrete benefits or solves specific problems in the relevant field[1].

Patent Scope and Breadth

The scope of the '835 patent is determined by the language of its claims. Here are some key aspects to consider:

• Claim Length and Count: Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims with fewer independent claims may indicate a more focused and potentially stronger patent[3].
• Forward Citations: The number of forward citations (citations by later patents) can indicate the impact and breadth of the patent. A higher number of forward citations may suggest that the patent is influential in its field.

Patent Landscape

Related Patents

The '835 patent is part of a larger family of patents related to pharmaceutical formulations and methods. Other patents, such as the '171 patent and the '837 patent, also owned by Purple Biotech, may cover related aspects of the Celecoxib and Amlodipine combination or other therapeutic uses.

• Patent Family: The Global Dossier service provided by the USPTO can help identify related applications and patents filed in other jurisdictions, providing a comprehensive view of the patent family[4].

Litigation and Enforcement

The '835 patent has been involved in litigation, as seen in the case against Lupin, which filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market generic versions of the drug products covered by the patent. This highlights the importance of the patent in protecting the intellectual property rights of Purple Biotech[5].

Practical Implications

Manufacturing and Commercialization

The '835 patent provides specific guidance on the formulation and method of making the Celecoxib and Amlodipine combination. This is crucial for manufacturers who need to ensure that their processes comply with the patented method to avoid infringement.

Regulatory Compliance

The patent's claims must align with regulatory requirements. For instance, the FDA approval process for generic versions of the drug will need to consider the patent's scope and ensure that any generic product does not infringe on the patented claims.

Key Takeaways

• Claims Analysis: The '835 patent's claims are critical in defining its scope and ensuring subject matter eligibility.
• Practical Applications: The patent must demonstrate practical applications and tangible benefits to meet the criteria for patent eligibility.
• Patent Landscape: Understanding the related patents and the broader patent landscape is essential for navigating potential infringement and litigation.
• Regulatory Compliance: Ensuring compliance with regulatory requirements is vital for both the original patent holder and any generic manufacturers.

FAQs

1. What is the main subject of the '835 patent? The '835 patent covers a specific formulation and method of making a combination of Celecoxib and Amlodipine.

2. Who owns the '835 patent? The '835 patent is owned by Purple Biotech, with exclusive rights to assert it.

3. How does the 2024 USPTO guidance impact the '835 patent? The guidance emphasizes the need for claims to integrate abstract ideas into practical applications, which is relevant for ensuring the patent's subject matter eligibility.

4. What is the significance of forward citations in patent scope? Forward citations indicate the impact and breadth of the patent, suggesting its influence in the field.

5. Why is the '835 patent involved in litigation? The '835 patent is involved in litigation due to generic manufacturers seeking FDA approval for products that may infringe on the patented claims.

Sources

1. Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz[1]
2. U.S. Patent and Trademark Office (USPTO) | USAGov - USA.gov[2]
3. Patent Claims and Patent Scope - SSRN[3]
4. Search for patents - USPTO - USPTO[4]
5. MORGAN, LEWIS & BOCKIUS LLP - Insight.RPXcorp[5]

Drugs Protected by US Patent 10,925,835

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-001	May 31, 2018		DISCN	Yes	No	10,925,835					TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-002	May 31, 2018		DISCN	Yes	No	10,925,835					TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE
Purple Biotech	CONSENSI	amlodipine besylate; celecoxib	TABLET;ORAL	210045-003	May 31, 2018		DISCN	Yes	No	10,925,835					TREATMENT OF ADULT PATIENTS FOR WHOM TREATMENT WITH BOTH AMLODIPINE FOR HYPERTENSION AND CELECOXIB FOR OSTEOARTHRITIS ARE APPROPRIATE

International Family Members for US Patent 10,925,835

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
China	111065382
World Intellectual Property Organization (WIPO)	2019008583