Litigation Details for Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc. (D. Nev. 2016)

Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc. (D. Nev. 2016)

Docket		Date Filed	2016-10-31
Court	District Court, D. Nevada	Date Terminated	2020-03-30
Cause	35:271 Patent Infringement	Assigned To	Miranda Mai Du
Jury Demand	None	Referred To	Nancy J. Koppe
Parties	TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Patents	10,010,083; 10,016,403; 10,183,020; 10,232,003; 10,232,004; 10,232,015; 10,278,936; 10,814,012; 10,894,012; 11,566,011; 11,738,018; 11,878,011; 12,194,025; 4,237,021; 4,355,023; 4,521,015; 5,023,078; 5,401,017; 5,550,020; 6,316,023; 6,720,001; 6,844,013; 6,867,005; 7,022,713; 7,301,023; 7,619,004; 8,022,106; 8,039,030; 8,048,035; 8,048,043; 8,293,727; 8,293,728; 8,298,554; 8,318,715; 8,344,011; 8,357,677; 8,367,652; 8,377,920; 8,395,021; 8,399,446; 8,415,335; 8,426,399; 8,431,560; 8,440,650; 8,445,013; 8,445,018; 8,518,929; 8,524,698; 8,546,372; 8,569,021; 8,617,594; 8,699,019; 8,829,013; 8,952,015; 8,993,017; 9,297,013; 9,352,016; 9,415,004; 9,415,009; 9,457,023; 9,669,021; 9,694,015; 9,981,025
Attorneys	Jordan Laird Moran
Firms	Budd Laener, P.C.
Link to Docket	External link to docket

Biologic Drugs cited in Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.

Details for Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc. (D. Nev. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-10-31				External link to document
2016-10-31	1	Complaint	U.S. Patent No. 8,293,728 (“the ‘728 Patent”), U.S. Patent No. 8,318,715 (“the 7 ‘715 Patent”), U.…above. 2 33. United States Patent No. 8,293,728, entitled “METHODS OF TREATING 3 HYPERTRIGLYCERIDEMIA… Patent, the ‘335 Patent, the ‘399 Patent, 12 the ‘560 Patent, the ‘650 Patent, the ‘929 Patent, the…of the ‘728 Patent, the ‘715 Patent, the 11 ‘677 Patent, the ‘652 Patent, the ‘920 Patent, the ‘446 Patent…U.S. Patent No. 8,357,677 (“the ‘677 Patent”), U.S. Patent No. 8,367,652 (“the 8 ‘652 Patent”), U.S	External link to document
2016-10-31	102	Response	thirteen patents are all continuations of U.S. Patent No. 8,293,727 (“the ’727 patent”)—a 20 patent listed… patent, the ’715 patent, the ’677 patent, the ’652 patent, the ’920 patent, the ’446 patent, the …21 patent, the ’399 patent, the ’560 patent, the ’650 patent, the ’929 patent, the ’698 patent, and … ’594 patent”) is a continuation of U.S. Patent No. 8,298,554 23 (“the ’554 patent”)—a patent listed… 1 U.S. Patent Nos. 8,293,728 (“the ’728 patent”), 8,318,715 (“the ’715 patent”), 8,357,677 (“	External link to document
2016-10-31	135	Order	but is discussed. It is U.S. Patent No. 8,293,727 (“the ‘727 28 patent”). …the ‘715 patent”); (3) U.S. Patent No. 8,357,677 (“the ‘677 9 patent”); (4) U.S. Patent No. 8,367,652…“the ‘652 patent”); (5) U.S. Patent No. 10 8,377,920 (“the ‘920 patent”); (6) U.S. Patent No. 8,399,446…“the ‘446 patent”); (7) U.S. 11 Patent No. 8,415,335 (“the ‘335 patent”); (8) U.S. Patent No. 8,426,399… ‘399 12 patent”); (9) U.S. Patent No. 8,431,560 (“the ‘560 patent”); (10) U.S. Patent No. 13 8,	External link to document

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

Case Background

The case of Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. involves a complex patent infringement dispute centered around Amarin's drug product, Vascepa® (icosapent ethyl), an omega-3 fatty acid derived from fish oil used to treat severe hypertriglyceridemia and reduce cardiovascular risk.

Drug Product and Patents-in-Suit

Vascepa® is protected by several U.S. patents, including U.S. Patents Nos. 8,293,728, 8,318,715, 8,357,677, 8,367,652, 8,431,560, and 8,518,929. These patents cover methods of lowering certain fats in the bloodstream using purified omega-3 fatty acids from fish oils, specifically for treating severe hypertriglyceridemia (HTG) and reducing cardiovascular risk[2][4].

Nature of the Case and Issues Presented

Amarin Pharma, Inc. sued Hikma Pharmaceuticals USA Inc. under the Hatch-Waxman Act, alleging that Hikma's generic icosapent ethyl product induced infringement of Amarin's patents. The core issue revolves around whether Hikma actively encouraged healthcare providers to prescribe its generic product for the off-label cardiovascular (CV) indication, despite not having FDA approval for this use[3][5].

District Court Ruling

In November 2020, Amarin filed the lawsuit after Hikma launched its generic icosapent ethyl product. The District Court granted Hikma's motion to dismiss under Fed. R. Civ. Pro. 12(b)(6) for failure to state a claim. The court determined that Amarin's complaint did not adequately plead that Hikma took "affirmative steps" to induce infringement. The District Court judge noted that Hikma's label warnings and the removal of the CV Limitation of Use did not constitute instructions or encouragement for the off-label CV use[1][3].

Federal Circuit Appeal

Amarin appealed the District Court's decision to the Federal Circuit. The Federal Circuit reversed the District Court's ruling, finding that Amarin's allegations plausibly stated a claim for induced infringement. The court emphasized that this case was not a traditional Hatch-Waxman case but rather a straightforward induced infringement case. The Federal Circuit focused on whether Hikma "actively" induced healthcare providers' direct infringement, considering not just the label but also Hikma's public statements and marketing materials[1][5].

Key Findings of the Federal Circuit

• Label and Public Statements: The Federal Circuit considered the combination of Hikma's label and its public statements, including press releases and website content. While the label itself did not recommend or encourage the off-label CV use, the court found that Hikma's characterization of its product as a "generic equivalent to Vascepa®" and other marketing materials could imply encouragement for such use[1][5].

• Clinical Studies Section: The court noted that the clinical studies section of Hikma's label described patient populations that overlapped with those covered by Amarin's patents for the CV indication. This, along with the removal of the CV Limitation of Use and warnings about cardiovascular side effects, could be interpreted by physicians as an indication that the generic product could be used for the off-label CV indication[1][5].

• Intent and Knowledge: The Federal Circuit accepted that Amarin's complaint sufficiently alleged that healthcare providers directly infringed the 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[3].

Distinguishing from Previous Cases

The Federal Circuit distinguished this case from other section viii-related decisions, particularly noting that this case reached the appellate stage after a Rule 12 motion to dismiss, rather than after a trial or preliminary injunction motion. This procedural difference was crucial in the court's analysis[5].

Impact and Implications

The decision sets a precedent for how courts evaluate induced infringement claims in the context of generic drug labeling and marketing. It highlights the importance of considering all relevant communications, including public statements and marketing materials, in determining whether a generic drug manufacturer has actively induced infringement.

Why Amarin Prevailed

Amarin prevailed because the Federal Circuit found that its allegations, when combined with the evidence from Hikma's label, public statements, and marketing materials, plausibly stated a claim for induced infringement. The court's focus on the active inducement element and the broader context of Hikma's communications with healthcare providers was pivotal in reversing the District Court's decision[5].

Why Hikma Initially Prevailed in District Court

Hikma initially prevailed in the District Court because the court found that Amarin's complaint did not adequately plead that Hikma took affirmative steps to induce infringement. The District Court relied heavily on the cautionary language in Hikma's label and the lack of explicit instructions or encouragement for the off-label CV use[1][3].

Key Takeaways

• Induced Infringement Claims: The case underscores the importance of carefully evaluating all forms of communication by a generic drug manufacturer to determine if they actively induce infringement.
• Labeling and Marketing: The combination of label content, public statements, and marketing materials can be crucial in establishing intent and knowledge for induced infringement.
• Procedural Differences: The timing and procedural context of motions to dismiss versus post-trial judgments can significantly impact the analysis of induced infringement claims.

FAQs

Q: What is the main issue in the Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. case? A: The main issue is whether Hikma actively encouraged healthcare providers to prescribe its generic icosapent ethyl product for the off-label cardiovascular (CV) indication, despite not having FDA approval for this use.

Q: Which patents are involved in this case? A: The patents involved include U.S. Patents Nos. 8,293,728, 8,318,715, 8,357,677, 8,367,652, 8,431,560, and 8,518,929, which cover methods of treating severe hypertriglyceridemia and reducing cardiovascular risk using purified omega-3 fatty acids.

Q: Why did the District Court grant Hikma's motion to dismiss? A: The District Court granted Hikma's motion to dismiss because it found that Amarin's complaint did not adequately plead that Hikma took affirmative steps to induce infringement.

Q: How did the Federal Circuit differ in its analysis? A: The Federal Circuit considered the combination of Hikma's label and its public statements and marketing materials, finding that these collectively could imply encouragement for the off-label CV use.

Q: What is the significance of the clinical studies section in Hikma's label? A: The clinical studies section describes patient populations that overlap with those covered by Amarin's patents for the CV indication, which could be interpreted by physicians as an indication that the generic product could be used for the off-label CV indication.

Sources Cited

1. Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir., 2024)
2. Amarin Pharma, Inc. v. Hikma Pharms USA Inc. - Robins Kaplan LLP (2020)
3. Opinion Summary - Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. - Federal Circuit Blog (2024)
4. Amarin Pharma, Inc. v. Hikma Pharm. U.S. Inc. - Casetext (2021)
5. Amarin Pharma, Inc. v. Hikma Pharms. USA Inc. - Robins Kaplan LLP (2024)