Details for Patent: 10,420,735

Which drugs does patent 10,420,735 protect, and when does it expire?

Patent 10,420,735 protects NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,420,735

Title:	Norepinephrine compositions and methods therefor
Abstract:	The inventive subject matter is directed to compositions and methods for ready-to-inject norepinephrine compositions with improved stability. Most preferably, compositions presented herein are substantially antioxidant free and exhibit less than 10% isomerization of R-norepinephrine and exhibit less than 5% degradation of total norepinephrine.
Inventor(s):	Hingorani Tushar, Akasapu Prem Sagar, Soppimath Kumaresh
Assignee:	NEVAKAR INC.
Application Number:	US16163480
Patent Claim Types: see list of patent claims

Understanding the Scope and Claims of United States Patent 10,420,735

Introduction

The United States Patent 10,420,735, titled "Norepinephrine Compositions and Methods Therefor," is a critical patent in the pharmaceutical industry, particularly in the development and manufacture of stable, ready-to-inject norepinephrine formulations. This analysis delves into the scope, claims, and the broader patent landscape surrounding this patent.

Background

The '735 patent, along with other related patents (10,471,026, 10,568,850, 10,646,458, and 11,602,508), addresses the need for improved stable, low-concentration, ready-to-inject, and antioxidant-free norepinephrine formulations. These patents share a common specification and are owned by Nevakar Injectables, Inc.[1][2].

Patent Scope

The scope of the '735 patent is defined by its claims, which outline the specific inventions and methods protected under the patent. Here are some key aspects:

Claims Overview

The patent includes multiple claims, with Claim 1 being exemplary:

• "A method of treating hypotension, comprising: administering a ready-to-administer norepinephrine composition at an initial dose per minute; wherein the norepinephrine composition is substantially free of antioxidants; and wherein the norepinephrine or a salt thereof in the norepinephrine composition comprises at least about 90% R-isomer of norepinephrine after storage at 25±2° C. and 60±5% relative humidity, over at least three months as determined by HPLC."[1][2].

Key Claim Terms

• Chelating Agent: A crucial term in the claims, which has been a subject of dispute in the litigation between Nevakar and Baxter. The court has adopted a construction that a chelating agent must be "a separate chemical compound, added to the composition," and it should have "at least two donor groups that form a ring structure with a metal ion."[1].

Antioxidant-Free Composition

The patent emphasizes the importance of compositions that are substantially free of antioxidants, which is a significant innovation in the field of norepinephrine formulations[1][4].

Claim Construction and Litigation

The '735 patent has been at the center of a patent infringement dispute between Nevakar Injectables, Inc., and Baxter Healthcare Corp. Here are some key points from the litigation:

Dispute Over Claim Terms

The parties have disputed the construction of several claim terms, particularly the term "chelating agent." The court's decision favored Baxter's proposed construction, which requires the chelating agent to be a separate chemical compound with specific properties[1].

Infringement Allegations

Nevakar alleges that Baxter's Norepinephrine Bitartrate in 5% Dextrose Injection products infringe the claims of the '735 patent, among others. Baxter, in turn, seeks a declaratory judgment that its products do not infringe these patents[1][2].

Patent Landscape

The '735 patent operates within a complex patent landscape, influenced by several factors:

Patent Scope Metrics

Research suggests that patent scope can be measured using metrics such as independent claim length and independent claim count. These metrics indicate that narrower claims are often associated with a higher probability of grant and a shorter examination process[3].

Importance of Claim Scope

Getting the claim scope right is crucial in patent applications. While broader claims may offer broader protection, they are more difficult to get granted and easier to invalidate. The claim scope must be anchored to the embodiments in the disclosure to avoid invalidation grounds such as the abstract idea exception[5].

Industry Impact

The '735 patent has significant implications for the pharmaceutical industry:

Innovation in Norepinephrine Formulations

The patent addresses a critical need for stable, ready-to-inject norepinephrine compositions, which is a significant innovation in the treatment of hypotension. This innovation can improve patient care and treatment outcomes[1][4].

Litigation and Market Competition

The ongoing litigation between Nevakar and Baxter highlights the competitive nature of the pharmaceutical industry. The outcome of this litigation can impact market competition and the availability of these critical medications[1][2].

Expert Insights

Industry experts emphasize the importance of precise claim drafting to avoid legal challenges. As noted by legal experts, "a broad claim is not only more difficult to get granted but also easier to get invalidated"[5].

Statistics and Trends

• Patent Examination Process: Studies show that the examination process tends to narrow the scope of patent claims, and this narrowing is more significant when the duration of examination is longer[3].
• Patent Maintenance: Narrower claims are associated with higher maintenance payments and forward citations, indicating their relevance and impact[3].

Conclusion

The United States Patent 10,420,735 is a pivotal patent in the pharmaceutical industry, particularly in the development of stable norepinephrine formulations. Understanding its scope, claims, and the surrounding patent landscape is essential for navigating the complex legal and competitive environment of pharmaceutical innovation.

Key Takeaways

• Precise Claim Construction: The '735 patent highlights the importance of precise claim construction to avoid legal disputes.
• Innovation in Norepinephrine Formulations: The patent addresses a critical need for stable, ready-to-inject norepinephrine compositions.
• Litigation Impact: The ongoing litigation between Nevakar and Baxter underscores the competitive and legal challenges in the pharmaceutical industry.
• Patent Scope Metrics: Narrower claims are often associated with a higher probability of grant and a shorter examination process.
• Industry Impact: The patent has significant implications for patient care and treatment outcomes in hypotension.

Frequently Asked Questions (FAQs)

Q1: What is the main subject of the '735 patent? The '735 patent is directed to compositions and methods for ready-to-inject norepinephrine formulations with improved stability.

Q2: What is the significance of the term "chelating agent" in the '735 patent? The term "chelating agent" is crucial and has been a subject of dispute, requiring it to be a separate chemical compound with specific properties.

Q3: Who are the parties involved in the litigation over the '735 patent? The parties involved are Nevakar Injectables, Inc., and Baxter Healthcare Corp.

Q4: What are the implications of the '735 patent for the pharmaceutical industry? The patent has significant implications for innovation in norepinephrine formulations, patient care, and market competition.

Q5: Why is precise claim construction important in patent applications? Precise claim construction is important to avoid legal disputes and to ensure that the claims are not overly broad, which can lead to invalidation.

Cited Sources

1. Baxter Healthcare Corp. v. Nevakar Injectables Inc. - Casetext
2. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE NEVAKAR INJECTABLES, INC., Plaintiff, v. BAXTER HEALTHCARE CORP., Defendant. - Insight.RPXCorp
3. Patent Claims and Patent Scope - SSRN
4. US10420735B2 - Norepinephrine compositions and methods therefor - Patents.Google
5. The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law

Drugs Protected by US Patent 10,420,735

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-001	Oct 6, 2022		RX	Yes	Yes	10,420,735		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-002	Oct 6, 2022		RX	Yes	Yes	10,420,735		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION
Long Grove Pharms	NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE	norepinephrine bitartrate	SOLUTION;INTRAVENOUS	214628-003	Oct 6, 2022		RX	Yes	Yes	10,420,735		Y			INDICATED TO RAISE BLOOD PRESSURE IN ADULT PATIENTS WITH SEVERE, ACUTE HYPOTENSION

International Family Members for US Patent 10,420,735

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3051467
World Intellectual Property Organization (WIPO)	2018140894