Details for Patent: 9,119,771

Which drugs does patent 9,119,771 protect, and when does it expire?

Patent 9,119,771 protects QUZYTTIR and is included in one NDA.

This patent has five patent family members in five countries.

Summary for Patent: 9,119,771

Title:	Non-sedating antihistamine injection formulations and methods of use thereof
Abstract:	Described herein are injectable compositions containing non-sedating or second and third generation antihistamines such as cetirizine/levocetirizine and methods of use thereof. Specifically, methods of treating acute allergic reactions including anaphylaxis with the compositions are disclosed. In certain embodiments, the injectable compositions are bioequivalent to currently marketed oral dosage forms. In other embodiments, the non-sedating or second and third generation antihistamine injectable formulations are therapeutically equivalent to diphenhydramine injectable formulations and/or are more effective than placebo. In other embodiments, a non-sedating antihistamine injectable composition is delivered by an autoinjector.
Inventor(s):	Du; Jie (Lansdale, PA)
Assignee:	JDP THERAPEUTICS, INC. (Lansdale, PA)
Application Number:	13/559,954
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

United States Patent 9,119,771: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,119,771, titled "Non-sedating antihistamine injection formulations," is a significant patent in the pharmaceutical field, particularly in the area of allergy treatments. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background and Invention Overview

The patent, granted on August 25, 2015, describes injectable compositions containing non-sedating or second and third generation antihistamines, such as cetirizine and levocetirizine. These formulations are designed to provide rapid relief from allergic reactions without the sedative side effects associated with first-generation antihistamines[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:

Claims

• The patent includes multiple claims that cover various aspects of the injectable compositions, including the specific antihistamines used, the formulation components, and the methods of administration.
• Claim 1, for example, describes an injectable composition comprising a non-sedating antihistamine, a solvent, and optionally, one or more additives such as preservatives or stabilizers[5].

Dependent Claims

• Dependent claims further specify the types of antihistamines, solvents, and additives that can be used in the composition. For instance, claim 2 specifies that the non-sedating antihistamine is cetirizine or levocetirizine[5].

Patent Claims Analysis

To understand the breadth of protection, it is crucial to analyze the patent claims in detail.

Independent Claims

• Independent claims are the broadest claims in the patent and define the core invention. In this case, claim 1 sets the foundation for all other claims by describing the basic components of the injectable composition.

Dependent Claims

• Dependent claims narrow down the scope by adding specific limitations. These claims help to ensure that the patent covers various embodiments of the invention while avoiding overly broad claims that might be challenged.

Patent Landscape

The patent landscape surrounding US 9,119,771 involves several key aspects:

Related Patents

• Other patents related to antihistamine formulations and injectable compositions are part of this landscape. For example, patents covering different types of antihistamines or alternative delivery methods (e.g., oral or topical) could be relevant[4].

Competitors and Market Players

• Companies involved in the development and marketing of antihistamine products are key players in this landscape. Pharmaceutical companies like Johnson & Johnson, Pfizer, and others that produce allergy medications could be impacted by this patent.

International Patent Filings

• The global patent landscape is also important. Filings in other countries, such as Europe, Japan, and China, would indicate the international reach of this invention and potential competition or collaborations[4].

Legal and Regulatory Considerations

The legal and regulatory environment is crucial for understanding the patent's validity and enforceability.

Obviousness-Type Double Patenting (ODP)

• As seen in cases like In re Cellect LLC, ODP can be a significant issue if multiple patents from the same family have overlapping claims. Ensuring that the claims of US 9,119,771 do not overlap with other related patents is essential to avoid ODP issues[1].

Patent Term Adjustment (PTA)

• The patent term adjustment, as governed by 35 U.S.C. § 154(b), could affect the duration of the patent. Any delays during the prosecution process that are attributable to the USPTO could result in an extension of the patent term[1].

Economic and Market Impact

The economic and market impact of this patent is substantial.

Market Demand

• The demand for non-sedating antihistamines is high, given the prevalence of allergies and the need for effective, non-drowsy treatments. This patent could provide a competitive edge in the market.

Revenue Potential

• The revenue potential for injectable antihistamine formulations is significant. With the patent in place, the holder can exclude others from making, using, or selling similar compositions, thereby protecting market share and revenue.

Research and Development

Continued research and development in this area are critical for maintaining a competitive edge.

Patent Claims Research Dataset

• Utilizing datasets like the USPTO's Patent Claims Research Dataset can provide insights into patent scope and trends. This dataset contains detailed information on claims from US patents and can help in understanding the broader patent landscape[3].

Collaborations and Licensing

• Collaborations with other pharmaceutical companies or research institutions can lead to further innovations and broader market reach. Licensing agreements can also be a viable strategy to monetize the patent.

Challenges and Opportunities

There are several challenges and opportunities associated with this patent.

Challenges

• One of the main challenges is the potential for generic or biosimilar competition once the patent expires. Additionally, regulatory changes or new technologies could impact the market position of this invention.

Opportunities

• Opportunities include expanding the product line to cover other types of allergies or developing new delivery methods. International expansion and strategic partnerships can also enhance the patent's value.

Key Takeaways

• Scope and Claims: The patent covers injectable compositions containing non-sedating antihistamines like cetirizine and levocetirizine, with specific claims defining the components and methods of administration.
• Patent Landscape: The landscape includes related patents, competitors, and international filings, which are crucial for understanding the patent's position and potential challenges.
• Legal and Regulatory: Ensuring compliance with ODP and PTA regulations is vital for maintaining the patent's validity and term.
• Economic and Market Impact: The patent has significant market demand and revenue potential, but also faces challenges from generic competition and regulatory changes.
• Research and Development: Continued R&D and strategic collaborations are essential for maintaining a competitive edge.

FAQs

What is the main invention covered by US 9,119,771?

The main invention is an injectable composition containing non-sedating antihistamines like cetirizine and levocetirizine.

How does the patent protect the invention?

The patent protects the invention through a series of claims that define the specific components and methods of administration of the injectable composition.

What are the potential challenges to this patent?

Potential challenges include generic or biosimilar competition, regulatory changes, and new technologies that could impact the market position of this invention.

How can the patent holder monetize this invention?

The patent holder can monetize the invention through sales, licensing agreements, and strategic partnerships.

What is the significance of ODP in this context?

ODP is significant because it prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of PTA or other adjustments[1].

Cited Sources

1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
2. U.S. Patent Small Claims Court, Administrative Conference of the United States.
3. Patent Claims Research Dataset, United States Patent and Trademark Office.
4. Search for Patents, United States Patent and Trademark Office.
5. US9119771B2 - Non-sedating antihistamine injection formulations, Google Patents.

Drugs Protected by US Patent 9,119,771

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Jdp	QUZYTTIR	cetirizine hydrochloride	SOLUTION;INTRAVENOUS	211415-001	Oct 4, 2019		RX	Yes	Yes						TREATMENT OF ACUTE URTICARIA

International Family Members for US Patent 9,119,771

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010266103
Canada	2803987
European Patent Office	2477634
Spain	2616703
World Intellectual Property Organization (WIPO)	2011003074