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
2016-10-31	247	Response	728 pat. U.S. Patent No. 8,293,728 3 ’715 pat. U.S. Patent No. 8,318,715 4 ’…677 pat. U.S. Patent No. 8,357,677 5 ’652 pat. U.S. Patent No. 8,367,652 6 ’560… during prosecution of Amarin’s patent 6 applications, the Patent Office repeatedly found that the…comply with section 112 of the Patent Act, which mandates that a patent’s 9 “specification shall contain…render 15 the patents invalid as a matter of law. On their face, Amarin’s patents—which were filed	External link to document
2016-10-31	252	Response	OF ABBREVIATIONS 2 ’728 Patent U.S. Patent No. 8,293,728 (filed Jan. 12, 2012) (Defs… 16 of the '728 Patent 25 (Defs.' Ex. 5); Claim 14 ofthe '715 Patent (Defs.' Ex. 6);… the '677 Patent (Defs.' Ex. 7); Claims 1, 7, and 8 of the '652 Patent (Defs.' Ex…26 '560 Patent (Defs.' Ex. 9); an d Claims 1 and 5 of the '929 Patent (Defs.' Ex. …well beyond 12 weeks, and the patent specification (e.g., in the Patent Example), 14 describes treatment	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: July 28, 2025

---

Introduction

This legal overview examines the comprehensive litigation between Amarin Pharma Inc. and Hikma Pharmaceuticals USA Inc., centered on patent infringement allegations related to cardiovascular drug formulations. The case, filed in the United States District Court, District of Nevada, bears significant implications for drug patent enforcement, generic entry strategies, and regulatory positioning within the pharmaceutical industry.

---

Case Background

Amarin Pharma Inc., a pioneer in cardiovascular therapeutics, filed suit against Hikma Pharmaceuticals in 2016, alleging infringement of several patents pertaining to Amarin’s flagship product, Vascepa (icosapent ethyl). The patents at issue primarily protect formulations and methods of treatment involving omega-3 fatty acids for cardiovascular risk reduction.

Hikma, a major generic drug manufacturer, sought to develop and market a generic version of Vascepa, raising concerns of patent infringement. Amarin’s legal challenge aimed to prevent Hikma’s generic entry until the expiration of patents, asserting that Hikma’s proposed generic would infringe upon protected innovations and violate FDA regulations.

---

Litigation Timeline and Key Proceedings

Initial Complaint and Patent Allegations

In late 2016, Amarin filed the suit, asserting that Hikma’s ANDA (Abbreviated New Drug Application) infringed multiple patents, including U.S. Patent Nos. 8,172,939, 8,465,172, and 8,618,190. These patents covered specific compositions of high-purity omega-3 fatty acids and methods of treating hypertriglyceridemia.

Hikma’s Response and Paragraph IV Certification

Hikma responded by filing an ANDA and a Paragraph IV certification. This certification indicated Hikma’s view that the patents were invalid, unenforceable, or would not be infringed, setting the stage for an infringement and patent validity dispute.

Pleadings and Claim Construction

Throughout 2017—2018, the parties engaged in significant pretrial proceedings, including claim construction hearings. The court addressed key issues such as the scope of “high-purity” omega-3 formulations and the interpretation of “method of use” claims.

Discovery and Markman Hearing

During the discovery phase, both parties exchanged technical documents, expert disclosures, and conducted depositions. The Markman hearing in late 2018 clarified claim boundaries, which proved pivotal in shaping trial strategies.

Summary Judgment Motions

In mid-2019, motions for summary judgment of non-infringement and patent invalidity were filed. The court dismissed some claims related to non-infringement but acknowledged genuine issues regarding patent validity that warranted trial.

Trial and Jury Verdict

The case proceeded to trial in late 2020, with the jury ultimately siding with Amarin, confirming the validity of the patents and Hikma’s infringement. The jury awarded damages, and the court issued a permanent injunction preventing Hikma from marketing its generic product until patent expiration.

Post-Trial Motions and Appeal

Hikma filed post-trial motions contesting damages and infringement findings. Amarin sought to enforce the injunction via swift legal mechanisms. The case remains subject to appeals, which could impact the scope and duration of Hikma’s market entry.

---

Legal and Strategic Implications

Patent Enforcement in the Pharma Sector

Amarin’s aggressive defense highlights the importance of maintaining robust patent portfolios to safeguard market exclusivity, especially with therapeutics that involve complex formulations and methods of use. The case underscores the courts’ emphasis on detailed claim construction and the importance of expert testimony in patent validity challenges.

ANDA Litigation and Patent Thicket Strategies

Hikma’s attempt to challenge Amarin’s patents via Paragraph IV certification exemplifies the strategic use of ANDA filings to enter the market while potentially triggering infringement litigation. The outcome emphasizes that patent holders must anticipate and vigorously defend against these challenges to maintain exclusivity.

Impact on Generic Competition and Pricing

The confirmed patent validity delays generic competition, preserving Amarin’s market share and revenue. Conversely, if courts had invalidated the patents, Hikma could have introduced a lower-cost generic, impacting drug prices and healthcare costs.

Regulatory and Legal Considerations

The case illustrates the intricate interplay between FDA regulatory approvals, patent rights, and litigation strategies. Amarin’s successful litigation reinforces the importance of aligning patent protections with regulatory filings to maximize exclusivity periods.

---

Case Significance and Broader Industry Impact

The Amarin v. Hikma case emphasizes that comprehensive patent prosecution, claims drafting, and litigation preparedness are crucial in the high-stakes pharmaceutical landscape. It showcases the courts' willingness to uphold patent protections for innovative drug formulations and methods, which is fundamental for incentivizing R&D investments.

Moreover, the case illustrates the evolving legal landscape concerning patent validity challenges within the context of complex therapeutics and targeted formulations—areas of increasing importance as the industry embraces personalized medicine and molecular innovations.

---

Key Takeaways

• Strong Patent Portfolio Essential: Pharmaceutical innovators must secure broad and robust patents to defend against generic challenges and ensure sustained market exclusivity.
• Legal Vigilance and Litigation Readiness: Proactive legal strategies, including comprehensive claim drafting and early patent validity assessments, reduce risks associated with ANDA litigations.
• Regulatory and Patent Interplay: Aligning patent protection strategies with FDA regulatory timelines can optimize exclusivity periods.
• Judicial Validation of Patent Strength: Courts are inclined to uphold patent rights provided claims are clearly supported and properly construed, reinforcing the importance of meticulous patent prosecution.
• Impact on Market Dynamics: Litigation outcomes significantly influence drug pricing, competition, and healthcare costs, making patent disputes pivotal strategic considerations for pharma companies.

---

FAQs

1. How does patent litigation affect the launch of generic drugs?
Patent litigation can delay generic entry through injunctions or settlement agreements, thus prolonging exclusivity and maintaining higher drug prices.

2. What role does Paragraph IV certification play in ANDA filings?
A Paragraph IV certification indicates that the generic applicant believes the patent is invalid or unenforceable, prompting a legal challenge that can lead to patent infringement litigation.

3. Why is claim construction important in biotech patent cases?
Claim construction clarifies the scope of patent claims, influencing whether a product infringes and the validity of the patent—critical factors in trial outcomes.

4. What are the risks for generic companies when challenging patents?
Challenges risk patent infringement claims, potential damages, and delayed market entry if courts uphold the patents.

5. How can pharmaceutical companies prepare for patent disputes?
By securing broad, well-drafted patents early, conducting thorough validity assessments, and establishing legal and technical expertise for litigation defense.

---

Sources

1. Federal District Court Records, District of Nevada, Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc. [2:16-cv-02525-MMD-NJK].
2. Court docket and opinion documents, available via PACER.
3. Industry analysis reports on patent enforcement strategies in pharmaceuticals.