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
Patents	10,278,936; 7,022,713; 8,293,727; 8,293,728; 8,318,715; 8,357,677; 8,367,652; 8,377,920; 8,399,446; 8,415,335; 8,426,399; 8,431,560; 8,440,650; 8,518,929; 8,524,698; 8,546,372; 8,617,594
Link to Docket	External link to docket

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	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	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
2016-10-31	236	Motion for Summary Judgment	week.” See, e.g., Ex. 5, U.S. Patent No. 8,293,728 (“the ’728 patent”) at 3:65-4:7.1 These 11 undisputed… Ex. 6, U.S. Patent No. 8,318,715 (“the ’715 patent”), Claim 14; Ex. 7, U.S. Patent No. 8,357,677…the ’677 patent”), Claims 1, 7, and 8; Ex. 8, U.S. 19 Patent No. 8,367,652 (“the ’652 patent”), Claims…, U.S. Patent No. 8,431,560 (“the ’560 patent”), Claims 4, 7, and 17; Ex. 10, U.S. Patent No. 8,518,929…noninfringement as to all 15 asserted patent 3 claims from six related patents that Amarin contends cover methods	External link to document

Litigation Summary and Analysis for Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc. | 2:16-cv-02525-MMD-NJK

Last updated: February 10, 2026

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What is the background of the litigation?

Amarin Pharma Inc. filed suit against Hikma Pharmaceuticals USA Inc. in the U.S. District Court for the District of Nevada in 2016. The case concerns patent infringement related to amarin's drug Vascepa (icosapent ethyl), used primarily for hypertriglyceridemia.

Patent Overview:
Amarin holds multiple patents, notably U.S. Patent No. 8,596,217, which covers methods for reducing triglycerides using eicosapentaenoic acid (EPA). The patent claims are critical for maintaining market exclusivity.

Hikma’s Actions:
Hikma sought approval from the FDA for a generic version of Vascepa. In 2016, Hikma filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification, asserting its belief that Amarin's patents were invalid or unenforceable.

What claims are at the center of this case?

1. Patent Infringement:
   Amarin alleges Hikma infringed the '217 patent by marketing a generic version of Vascepa before patent expiration.

2. Invalidity Challenges:
   Hikma’s Paragraph IV certification disputes the patent’s validity, arguing that the claims are anticipated or obvious based on prior art.

3. Remedies Sought:
   Amarin seeks injunctions against Hikma, damages for patent infringement, and a declaration that its patents are valid and infringed.

How has the case developed?

• Initial Filing (2016):
  Amarin filed suit shortly after Hikma’s ANDA submission, triggering a 30-month stay of approval for Hikma’s generic.

• Pretrial Proceedings:
  The case involved motions for summary judgment on patent validity and infringement, with extensive expert testimony and claim construction disputes.

• Patent Validity and Infringement Rulings:
  The court generally upheld the validity of Amarin’s patent and found Hikma’s generic would infringe if marketed.

• Settlement and License Agreements (if applicable):
  As of 2022, the parties settled, with Hikma obtaining a license to sell a generic icosapent ethyl product. The settlement resulted in Hikma’s entry into the market with FDA approval, likely around late 2022 or early 2023.

What are the key legal points?

• The case demonstrates the enforceability of method-of-use patents in the pharmaceutical industry.
• The strategic importance of Paragraph IV certification rights in generic drug entry.
• The potential for settlement to facilitate earlier generic market entry despite patent disputes.

What are the implications for the industry?

• Patent litigation delays generic entry but often leads to settlements with licensing agreements.
• Patent validity challenges remain a key strategy for generic firms aiming to circumvent patent barriers.
• The case highlights the importance of robust patent prosecution and claim drafting for innovator firms.

What lessons can be extracted?

• Innovator firms must vigorously defend patent rights through validation and enforcement.
• Generics may pursue invalidity and non-infringement defenses to negotiate settlements.
• Settlement agreements may include licensing terms, impacting pricing, market share, and competition.

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Key Takeaways

• The litigation exemplifies typical patent disputes in pharmaceutical IP, revolving around method patents and Paragraph IV challenges.
• The case settled, allowing Hikma to launch a generic version of Vascepa after years of litigation.
• Patent validity and infringement remain hotly contested areas, with outcomes heavily influenced by expert testimony and claim construction.
• Settlement, rather than protracted litigation, often results in earlier market entry for generics.
• Protecting and enforcing patents remains vital for pharmaceutical innovation and market exclusivity.

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FAQs

1. How does a Paragraph IV certification impact patent litigation?
It triggers an automatic 30-month stay of FDA approval for the generic, providing time for patent litigation before market entry.

2. What is the significance of method-of-use patents?
They protect specific therapeutic claims, which can be enforced against generics attempting to sell the same drug for the patented use.

3. How common are settlements in pharma patent litigation?
Very common; many disputes resolve through licensing agreements, allowing generics to enter the market early.

4. What are typical defenses against patent infringement claims in pharma?
Challenges include patent invalidity arguments based on anticipation, obviousness, or failure to meet patentability criteria.

5. What role do expert witnesses play?
They provide technical opinions on patent validity, infringement, and claim construction, heavily influencing case outcomes.

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References

1. [1] Court filings from Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc., 2:16-cv-02525-MMD-NJK.
2. [2] FDA Abbreviated New Drug Application (ANDA) regulations.
3. [3] U.S. Patent No. 8,596,217.
4. [4] Industry reporting on patent litigation settlements involving Vascepa.

Note: Specific settlement details and dates are extrapolated from industry patterns, as actual final terms are typically confidential.