Litigation Details for Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (D. Del. 2020)

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (D. Del. 2020)

Docket		Date Filed	2020-11-30
Court	District Court, D. Delaware	Date Terminated	2023-09-19
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	Plaintiff	Referred To	Sherry R. Fallon
Parties	MOCHIDA PHARMACEUTICAL CO.,LTD.
Patents	10,568,861; 8,642,077; 9,700,537
Attorneys	Dominick T. Gattuso
Firms	Phillips, McLaughlin & Hall, P.A.
Link to Docket	External link to docket

Details for Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-11-30				External link to document
2020-11-30	1	Complaint	U.S. Patent Nos. 9,700,537 (“the ’537 patent”), 8,642,077 (the “’077 patent”), and 10,568,861 (the “… “’861 patent”) (collectively, the Asserted Patents”) under the Patent Laws of the United States, 35 …enforce its patents in federal court. 79. When the listed patent is a method-of-use patent, like … The Asserted Patents 37. On July 11, 2017, the United States Patent and Trademark Office… the ’537 patent is attached to this complaint as Exhibit C. 38. The ’537 patent is assigned	External link to document
2020-11-30	17	Amended Complaint	U.S. Patent Nos. 9,700,537 (“the ’537 patent”), 8,642,077 (the “’077 patent”), and 10,568,861 (the …composition and methods of using same), and 10,568,861 (Methods of reducing the risk of a cardiovascular…the “’861 patent”) (collectively, the “Asserted Patents”) under the Patent Laws of the United States, …enforce its patents in federal court. 95. When the listed patent is a method-of-use patent, like… The Asserted Patents 41. On July 11, 2017, the United States Patent and Trademark Office	External link to document
2020-11-30	20	Opening Brief in Support	U.S. Patent Nos. 9,700,537 (“the ’537 patent”), 8,642,077 (“the ’077 patent”), and 10,568,861 (“the…related patents. In fact, Amarin never asserted any of the patents-in-suit in its first patent infringement…the ’861 patent”) (collectively, “patents-in-suit”). Hikma moved to dismiss. D.I. 11. Amarin’s First … 994. Patents-in-suit. Amarin asserts induced infringement for three patents covering the CV…......................................10 U.S. Patent Nos. 9,700,537 ................................	External link to document
2020-11-30	103	Answer to Counterclaim	U.S. Patent Nos. 9,700,537 (the “’537 Patent”) 8,642,077 (the “’077 Patent”), and/or 10,568,861 (the…’537 Patent are invalid for failure to meet one or more of the requirements for patentability of Title…’077 Patent are invalid for failure to meet one or more of the requirements for patentability of Title…’861 Patent are invalid for failure to meet one or more of the requirements for patentability of Title…1338(a), in that the counterclaims arise under the Patent Laws of the United States, 35 U.S.C. § 100 et	External link to document
2020-11-30	108	Motion - Miscellaneous	claims against Hikma only as to U.S. Patent Nos. 9,700,537 and 10,568,861. Case 1:20-cv-01630-RGA-JLH Document…production or 1 Amarin no longer asserts U.S. Patent No. 8,642,077 against Hikma and seeks to appeal… 19 September 2023 1:20-cv-01630 830 Patent Plaintiff District Court, D. Delaware	External link to document
2020-11-30	123	Opening Brief in Support	against Hikma only as to U.S. Patent Nos. 9,700,537 and 10,568,861.” Id. …goals of “prompt resolution” and “patent certainty” in pharmaceutical patent disputes, which benefit litigants…Plaintiffs’ patents by encouraging the use of Hikma’s generic for the [allegedly patented] indication… of Plaintiffs’ patents for the [cardiovascular] indication” that Amarin’s patents allegedly cover…Plaintiffs’ patents by encouraging the use of Hikma’s generic for the [allegedly patented] indication	External link to document

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.: A Comprehensive Litigation Summary and Analysis

Introduction

The case of Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. is a significant milestone in the realm of pharmaceutical patent litigation, particularly concerning the use of "skinny labels" and induced infringement claims. Here, we delve into the details of the case, its procedural history, and the implications of the Federal Circuit's decision.

Background

Amarin Pharma, Inc. is the patent holder and manufacturer of Vascepa® (icosapent ethyl), an omega-3 fatty acid derived from fish oil, primarily used for treating severe hypertriglyceridemia and reducing cardiovascular risk. Hikma Pharmaceuticals USA Inc. sought to enter the market with a generic version of icosapent ethyl, leading to a series of legal battles.

First Wave of Litigation

The initial litigation involved Amarin's attempt to block Hikma's generic product through a patent infringement suit. However, Amarin lost this first wave of litigation when the court found Amarin's patents related to the severe hypertriglyceridemia (SH) indication to be invalid. Despite this, Amarin retained patent protection for the cardiovascular (CV) indication[2][3].

Second Wave of Litigation: Induced Infringement Claims

Following the first wave, Amarin launched a second wave of litigation, alleging that Hikma had induced infringement of Amarin's patents covering the CV indication. This claim was based on the argument that Hikma's actions encouraged healthcare providers to prescribe its generic icosapent ethyl product for the off-label CV indication, despite not having FDA approval for this use[2][3][5].

District Court Ruling

The District Court of Delaware granted Hikma's motion to dismiss Amarin's complaint under Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. The court determined that Amarin's complaint failed to allege facts showing that Hikma had taken "affirmative steps" to induce infringement. The court noted that Hikma's label, which included warnings of potential cardiovascular side effects but did not recommend the CV indication, was not sufficient to establish inducement[1][3][5].

Federal Circuit Appeal

Amarin appealed the District Court's decision to the Federal Circuit. The Federal Circuit reversed the District Court's judgment, finding that Amarin's allegations, when taken together, plausibly stated a claim for induced infringement. The court considered not only Hikma's label but also its public statements and marketing materials. Specifically, the court noted that Hikma's press releases consistently referred to its product as a "generic equivalent to Vascepa®" and that the removal of the CV Limitation of Use from Hikma's label, combined with warnings about cardiovascular side effects, could communicate to physicians that the product could be used for the off-label CV indication[1][3][5].

Key Points of the Federal Circuit's Decision

• Label and Public Statements: The Federal Circuit emphasized that while Hikma's label alone did not recommend or encourage the off-label use, the combination of the label and Hikma's public statements and marketing materials did plausibly suggest such use[1][3][5].
• Intent and Knowledge: The court accepted that healthcare providers directly infringed Amarin's patents by prescribing Hikma's product for the off-label CV indication and that Hikma had the requisite intent and knowledge to induce this infringement[1][3].
• Skinny Labels: The case highlights the complexities surrounding "skinny labels," where a generic drug's label omits certain indications to avoid patent infringement. The Federal Circuit's decision suggests that even with a skinny label, a generic manufacturer can still be liable for induced infringement if other communications imply off-label use[5].

Hikma’s Petition for Rehearing En Banc

Following the Federal Circuit's decision, Hikma filed a petition for rehearing en banc, arguing that the panel erred in allowing inducement claims to proceed without explicit statements encouraging the claimed methods. Hikma contended that the decision rested on a theory of "passive inducement" rather than active encouragement[5].

Implications and Takeaways

• Monitoring Generic Communications: The decision provides a new enforcement tool for patent owners, who are now advised to monitor generics' advertising and written communications for any implications of off-label use[5].
• Litigation Strategy: The case illustrates a two-step strategy by pharmaceutical companies to maintain market exclusivity and delay generic entry. Despite losing both waves of litigation, Amarin's actions have delayed Hikma's entry into the market, resulting in significant financial benefits for Amarin[2].
• Skinny Labels and Induced Infringement: The Federal Circuit's decision clarifies that even with a skinny label, generic manufacturers can be held liable for induced infringement if their overall communications suggest off-label use[5].

Statistics and Financial Impact

• The delays caused by these litigations can result in billions of dollars in added drug costs. For instance, Vascepa® earns Amarin roughly $580 million per year, making the prolonged litigation period highly profitable despite the lack of a meritorious patent case[2].

Quotes from Industry Experts

"The Amarin decision provides a new enforcement tool in their arsenal. Patent owners are encouraged to monitor generics’ advertising and other written communications for statements that indicate or imply the possibility of off-label use."

• DLA Piper Insights[5]

Key Takeaways

• The Federal Circuit's decision in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. highlights the importance of considering both labels and public statements in induced infringement claims.
• Generic manufacturers must be cautious in their communications to avoid implying off-label use.
• The case underscores the strategic use of patent litigation to delay generic entry and maintain market exclusivity.
• The financial implications of such litigation can be significant, affecting both the pharmaceutical companies and the broader healthcare market.

FAQs

Q: What is the main issue in the Amarin v. Hikma case? A: The main issue is whether Hikma's actions, including its label and public statements, induced healthcare providers to prescribe its generic icosapent ethyl product for the off-label cardiovascular (CV) indication.

Q: What is a "skinny label" in the context of pharmaceuticals? A: A "skinny label" refers to a generic drug label that omits certain indications to avoid patent infringement, while still being approved for other uses.

Q: How did the Federal Circuit rule in the Amarin v. Hikma case? A: The Federal Circuit reversed the District Court's decision, finding that Amarin's allegations, including Hikma's label and public statements, plausibly stated a claim for induced infringement.

Q: What are the implications of the Federal Circuit's decision for generic manufacturers? A: The decision implies that generic manufacturers must be careful in their communications to avoid any implication of off-label use, as this could lead to induced infringement claims.

Q: How has the litigation affected the market entry of Hikma's generic product? A: The litigation has delayed Hikma's entry into the market, allowing Amarin to maintain its market exclusivity and earn significant profits from Vascepa®.

Cited Sources:

1. JDSupra - Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2024)
2. NYU Journal of Intellectual Property and Entertainment Law - Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin v. Hikma Type Litigation
3. Federal Circuit Blog - Opinion Summary - Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc.
4. DrugPatentWatch - Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (D. Del. 2020)
5. DLA Piper Insights - Amarin v. Hikma: Defining the limits of protection that skinny labels afford