Introduction
The litigation between Hospira, Inc. and Jiangsu Hengrui Medicine Co., Ltd. is a significant case in the pharmaceutical industry, involving patent infringement claims related to dexmedetomidine hydrochloride products. Here, we will delve into the key aspects of this case, including the parties involved, the nature of the action, and the specific claims and defenses presented.
Parties Involved
- Hospira, Inc.: The plaintiff, a Delaware corporation with its principal place of business in Lake Forest, Illinois. Hospira is a well-known pharmaceutical company that develops and markets various medical products.
- Jiangsu Hengrui Medicine Co., Ltd.: The defendant, a Chinese corporation based in Lianyungang, Jiangsu, China. Hengrui is also a pharmaceutical company seeking to enter the U.S. market with generic versions of dexmedetomidine hydrochloride products[1].
Nature of the Action
This civil action is based on the Patent Laws of the United States, specifically 35 U.S.C. § 1 et seq. The dispute arises from Hengrui's submission of an Abbreviated New Drug Application (ANDA) No. 209065 to the U.S. Food and Drug Administration (FDA), seeking approval to market generic dexmedetomidine hydrochloride products before the expiration of patents held by Hospira[1].
Patents-in-Suit
Hospira alleges that Hengrui's ANDA infringes on several U.S. patents, including:
- U.S. Patent No. 8,455,527 (the “ʼ527 patent”)
- U.S. Patent No. 8,648,106 (the “ʼ106 patent”)
- U.S. Patent No. 9,320,712 (the “ʼ712 patent”)
- U.S. Patent No. 9,616,049 (the “ʼ049 patent”)[1].
These patents are listed in the FDA's Orange Book and cover Hospira's PRECEDEXTM product, including its premix formulation.
Hengrui's ANDA and Proposed Products
Hengrui's ANDA seeks approval for generic dexmedetomidine hydrochloride products in various concentrations:
- 80 mcg/20 mL
- 200 mcg/50 mL
- 400 mcg/100 mL
These products are collectively referred to as the "Proposed Hengrui Dexmedetomidine Products"[1].
Acts Giving Rise to the Action
Hospira alleges that Hengrui reviewed the patents-in-suit and commercial information regarding PRECEDEXTM before filing the ANDA. On December 18, 2017, Hengrui notified Hospira of its ANDA filing, which Hospira claims constitutes an act of infringement under 35 U.S.C. § 271(a), (b), and/or (c)[1].
Infringement Claims
Hospira contends that Hengrui's proposed products meet each limitation of at least one claim of the '527 patent. Additionally, Hospira argues that Hengrui's actions, including providing instructions for use in the proposed package insert, will induce and/or contribute to the direct infringement of the '527 patent by others. Hospira believes it will suffer irreparable harm if Hengrui is not enjoined from infringing the patents[1].
Awareness and Intent
Hospira alleges that Hengrui was aware of the existence of the '527 patent before filing the ANDA and took such action knowing it would constitute infringement. This awareness and intent are crucial elements in establishing willful infringement[1].
Comparison with Similar Cases
This case is part of a broader landscape of pharmaceutical patent litigation. For instance, in Hospira, Inc. v. Fresenius Kabi USA, LLC, Hospira's patents related to dexmedetomidine were challenged on grounds of obviousness. The court ultimately found that Fresenius Kabi had proven inherency by clear and convincing evidence, invalidating some of Hospira's patent claims[3].
Implications and Analysis
The litigation highlights the complexities and challenges in pharmaceutical patent law, particularly in the context of generic drug approvals. Here are some key implications:
Patent Protection and Generic Entry
The case underscores the importance of patent protection for innovative pharmaceutical companies like Hospira. Generic companies like Hengrui often seek to enter the market as soon as possible, which can lead to legal battles over patent validity and infringement.
Infringement and Intent
Hospira's allegations of willful infringement by Hengrui emphasize the need for generic companies to carefully review existing patents before filing ANDAs. The intent to infringe can significantly impact the outcome of such cases.
Regulatory Environment
The FDA's role in approving ANDAs and the Orange Book's listing of patents are critical in these disputes. Companies must navigate these regulatory frameworks carefully to avoid legal entanglements.
Key Takeaways
- Patent Infringement Claims: Hospira alleges that Hengrui's ANDA infringes on multiple patents related to dexmedetomidine hydrochloride products.
- Awareness and Intent: Hengrui's awareness of the patents and intent to infringe are central to Hospira's claims.
- Regulatory Framework: The case highlights the importance of the FDA's approval process and the Orange Book in pharmaceutical patent disputes.
- Broader Implications: The litigation reflects ongoing challenges in balancing innovation with generic competition in the pharmaceutical industry.
FAQs
What is the main issue in the litigation between Hospira and Hengrui?
The main issue is Hospira's allegation that Hengrui's ANDA for generic dexmedetomidine hydrochloride products infringes on several patents held by Hospira.
What are the specific patents involved in this case?
The patents involved include U.S. Patent Nos. 8,455,527, 8,648,106, 9,320,712, and 9,616,049.
What products is Hengrui seeking to market?
Hengrui is seeking to market generic dexmedetomidine hydrochloride products in concentrations of 80 mcg/20 mL, 200 mcg/50 mL, and 400 mcg/100 mL.
Why is Hospira claiming irreparable harm?
Hospira claims it will suffer irreparable harm if Hengrui is not enjoined from infringing the patents, as this could lead to significant market competition and financial losses.
What is the significance of Hengrui's awareness of the patents?
Hengrui's awareness of the patents and its intent to infringe are crucial in establishing willful infringement, which can lead to more severe penalties.
Cited Sources:
- Hospira, Inc. v. Jiangsu Hengrui Medicine Co., Ltd., Case 1:18-cv-00191-UNA, Document 1, Filed 02/01/18.
- Astellas US LLC v. Hospira, Inc., United States Court of Appeals for the Federal Circuit, Decided: December 30, 2022.
- Hospira, Inc. v. Fresenius Kabi USA, LLC, United States Court of Appeals for the Federal Circuit, 343 F. Supp. 3d 823 (N.D. Ill. 2018).
