Litigation Details for Amarin Pharma Inc. v. West-Ward Pharmaceuticals Corp (D. Nev. 2016)

Amarin Pharma Inc. v. West-Ward Pharmaceuticals Corp (D. Nev. 2016)

Docket		Date Filed	2016-10-31
Court	District Court, D. Nevada	Date Terminated
Cause	35:271 Patent Infringement	Assigned To	Miranda Mai Du
Jury Demand	None	Referred To	Nancy J. Koppe
Patents	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; 8,518,929; 8,524,698; 8,546,372; 8,617,594
Link to Docket	External link to docket

Details for Amarin Pharma Inc. v. West-Ward Pharmaceuticals Corp (D. Nev. 2016)

Date Filed	Document No.	Description	Snippet	Link To Document
2016-10-31	135		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. West-Ward Pharmaceuticals Corp. Litigation Summary and Patent Analysis

Last updated: August 11, 2026

Amarin Pharma Inc. v. West-Ward Pharmaceuticals Corp., No. 2:16-cv-02525-MMD-NJK, was a Hatch-Waxman patent case concerning generic icosapent ethyl, marketed by Amarin as Vascepa. West-Ward, later operating as Hikma Pharmaceuticals USA Inc., filed an abbreviated new drug application for a generic version of Vascepa. The litigation ended with a defense judgment that eliminated Amarin’s asserted patent barriers to generic entry. Hikma launched its generic product in 2020 after FDA approval.

The case materially weakened Amarin’s U.S. patent position for Vascepa’s cardiovascular-risk-reduction indication. The principal issues were obviousness, infringement based on a proposed “skinny” label, and whether Amarin’s patents validly covered the clinical use of icosapent ethyl in patients with elevated triglycerides and cardiovascular risk.

What drug and generic product were involved in the Amarin v. West-Ward case?

The case involved Vascepa, whose active ingredient is icosapent ethyl, a highly purified ethyl ester of eicosapentaenoic acid, or EPA.

Item	Details
Brand	Vascepa
Active ingredient	Icosapent ethyl
Brand company	Amarin Pharma Inc.
Generic applicant	West-Ward Pharmaceuticals Corp., later Hikma Pharmaceuticals USA Inc.
Regulatory pathway	ANDA
District court	U.S. District Court for the District of Nevada
Case number	2:16-cv-02525-MMD-NJK
Primary judge	Miranda M. Du
Therapeutic areas	Severe hypertriglyceridemia and cardiovascular-risk reduction

The FDA initially approved Vascepa in 2012 as an adjunct to diet for adults with triglyceride levels of at least 500 mg/dL. FDA later approved the product for reducing the risk of cardiovascular events in statin-treated adults with elevated triglycerides and established cardiovascular disease or diabetes plus additional risk factors. That later indication generated the most commercially significant patent dispute.[1]

What patents did Amarin assert against West-Ward?

Amarin’s litigation position centered on patents covering methods of using icosapent ethyl to treat patients with elevated triglycerides and cardiovascular risk. The asserted patents were method-of-use patents rather than composition-of-matter patents directed broadly to EPA itself.

The principal patents at issue in the dispositive proceedings included:

Patent	General subject matter	Litigation relevance
U.S. Patent No. 9,566,122	Methods of treating hypertriglyceridemia with icosapent ethyl	Asserted method-of-use patent
U.S. Patent No. 9,700,067	Methods of reducing cardiovascular risk using icosapent ethyl	Central cardiovascular-risk patent
U.S. Patent No. 8,110,578	Earlier Vascepa-related patent protection	Part of the broader Orange Book estate
U.S. Patent No. 8,815,949	Additional Vascepa-related protection	Part of the broader patent portfolio

The case did not involve a conventional patent covering the basic chemical identity of icosapent ethyl. That distinction mattered. Once the method claims were held invalid or otherwise unable to block the proposed generic labeling, Amarin had limited remaining leverage against an ANDA applicant.

What did the '122 and '067 patents claim?

The '122 patent generally addressed treatment of patients with elevated triglycerides using icosapent ethyl. The '067 patent focused on reducing cardiovascular risk in patients receiving the drug, including patients with elevated triglyceride levels.

Amarin argued that the clinical evidence supporting the cardiovascular indication, including the ANCHOR and REDUCE-IT programs, established patentable therapeutic results. West-Ward challenged the patents based on prior-art disclosures involving EPA, triglyceride reduction, cardiovascular risk, and related clinical studies.

The litigation therefore turned on whether the claimed patient population, dosage regimen, and therapeutic outcomes represented an inventive advance over the prior art.

When did West-Ward file its ANDA and when was the lawsuit filed?

West-Ward filed an ANDA seeking approval to market generic icosapent ethyl capsules. Amarin filed the patent lawsuit in 2016 under the Hatch-Waxman Act.

The filing of the ANDA created a statutory act of infringement under 35 U.S.C. § 271(e)(2), allowing Amarin to sue before commercial launch. The litigation was initially designed to obtain a judgment before FDA approval or commercial marketing.

The case was filed as Amarin Pharma Inc. v. West-Ward Pharmaceuticals Corp. under docket No. 2:16-cv-02525. West-Ward later became associated with Hikma’s U.S. generic business, and subsequent case materials commonly refer to Hikma rather than West-Ward.

What was the main legal issue in the case?

The central legal issue was whether West-Ward’s ANDA and proposed labeling infringed valid Amarin method-of-use claims.

Amarin pursued two related theories:

1. The generic product and proposed instructions would directly infringe method claims when used by patients.
2. West-Ward would induce infringement by marketing the generic product with labeling that encouraged the claimed uses.

West-Ward argued that its proposed labeling carved out the patented cardiovascular-risk-reduction indication. Under the Hatch-Waxman “skinny-label” framework, an ANDA applicant may omit a patented indication from its labeling if the remaining instructions do not encourage infringement.

The court also considered validity. West-Ward contended that Amarin’s claims were obvious in light of prior-art EPA studies and the state of knowledge regarding triglyceride reduction and cardiovascular disease.

How did the court decide the patent validity issues?

The district court ruled against Amarin on the asserted patent claims. The court concluded that the relevant claims were invalid for obviousness, eliminating the need for those claims to block the generic product.

The obviousness analysis addressed whether a skilled person would have been motivated to use icosapent ethyl in the claimed patient population, with a reasonable expectation of achieving the claimed therapeutic effects. The court considered prior-art information involving:

• EPA and omega-3 fatty acids;
• triglyceride reduction;
• cardiovascular risk;
• statin-treated patients;
• the ANCHOR study and related clinical data; and
• dosage and patient-selection considerations.

Amarin argued that the REDUCE-IT results showed an unexpected cardiovascular benefit that was not predicted by the prior art. The court did not accept that evidence as sufficient to preserve the asserted claims against the obviousness challenge.

The outcome was commercially significant because the invalidity ruling removed the principal patent-based basis for preventing generic entry before the key Vascepa indication reached broad market adoption.

Did the court find that West-Ward infringed the Vascepa patents?

The dispositive result favored West-Ward. Amarin did not obtain an enforceable injunction preventing generic entry based on the asserted claims.

The case involved a technical dispute over induced infringement and the scope of the generic label. A generic applicant may face infringement exposure even when it omits a patented indication if its label, promotional materials, dosage instructions, or other conduct still encourages the patented use. Here, however, Amarin’s infringement theory could not overcome the invalidity ruling and the limits of the proposed generic labeling.

The decision reduced the practical importance of the label dispute. An invalid patent cannot support an injunction, damages award, or launch restriction regardless of whether the generic label would otherwise create infringement risk.

What was the litigation timeline?

Date	Event
2012	FDA approved Vascepa for severe hypertriglyceridemia
2016	Amarin filed the Hatch-Waxman action against West-Ward
2017	FDA approved the expanded cardiovascular-risk-reduction indication for Vascepa
2018-2019	Parties litigated claim construction, validity, infringement, and the scope of the proposed generic label
2020	District court proceedings resulted in a defense judgment resolving the asserted patent claims against Amarin
May 2020	Hikma received FDA approval and launched generic icosapent ethyl
2020 onward	Generic competition affected Vascepa pricing, prescriptions, and Amarin revenue

The exact commercial timing reflected the interaction between the court’s patent ruling, FDA approval, and Hikma’s decision to launch. The ANDA litigation prevented Amarin from using the asserted patents to delay market entry after FDA approval.

What was the Orange Book status of Vascepa?

Vascepa’s Orange Book listings included patents directed to the product and its approved methods of use. The most important commercial protection came from method-of-use patents associated with the cardiovascular-risk-reduction indication.

Orange Book listing does not establish patent validity. It gives a brand company a mechanism to trigger a statutory stay when an ANDA applicant files a Paragraph IV certification, but the listed patent remains subject to invalidity and noninfringement challenges.

For Vascepa, the practical value of the Orange Book estate declined after the district court rejected the asserted patent barriers. The existence of other listed patents did not automatically prevent launch if those patents were expired, not asserted, carved out of the generic label, or unable to withstand validity challenges.[2]

Was this a Paragraph IV challenge?

Yes. The case arose from West-Ward’s ANDA patent certifications and Amarin’s resulting Hatch-Waxman lawsuit. A Paragraph IV certification alleges that a listed patent is invalid, unenforceable, or not infringed. The certification allows the generic applicant to challenge the patent before approval rather than waiting for expiration.

The litigation illustrates the commercial importance of a Paragraph IV case:

• The brand company can sue before generic launch.
• FDA approval may be delayed during the statutory stay.
• The generic applicant can obtain an early judgment on patent validity.
• A successful invalidity judgment can clear multiple indications if the claims are central to the product’s commercial use.

What was the effect of the case on Vascepa exclusivity?

The case did not change the statutory expiration dates of Amarin’s patents. It changed whether those patents could be enforced against the generic applicant.

Vascepa’s exclusivity profile consisted of several layers:

Exclusivity type	Effect
FDA regulatory exclusivity	Protected approved indications for defined periods
Orange Book patents	Created potential launch barriers through Hatch-Waxman litigation
Method-of-use patents	Targeted specific populations and treatment outcomes
Formulation or product patents	Could protect dosage form or manufacturing attributes
Market exclusivity	Depended on the enforceability and scope of the patent estate

The court’s ruling weakened patent exclusivity before the latest listed patent expiration dates. This distinction is important for valuation: a patent may have years remaining on its term but little effective exclusivity if a court finds the claims invalid or a generic can enter with a noninfringing label.

Were formulation patents or manufacturing patents decisive?

No. The case was principally a method-of-use dispute. Amarin’s strongest commercial claims concerned the clinical use of icosapent ethyl, not a difficult-to-replicate formulation or manufacturing process.

A formulation patent can create a stronger barrier when the generic must use the claimed formulation to meet FDA requirements. Manufacturing patents can also create risk if the generic relies on the patented process. Those protections were not the principal basis for blocking Hikma’s generic Vascepa product.

The absence of a durable composition or formulation barrier increased the importance of the method claims. Once those claims failed, generic entry became commercially feasible.

How strong was Amarin’s Vascepa patent estate after the judgment?

The estate was commercially weakened but not necessarily extinguished in every jurisdiction or against every product configuration. The specific asserted claims in this action could not be used to block Hikma’s launch.

Strengths

• FDA-approved cardiovascular indication supported a large commercial market.
• Amarin had multiple Orange Book-listed patents.
• The REDUCE-IT clinical results created a potentially valuable differentiation argument.
• The method claims targeted a clinically defined population and treatment regimen.

Weaknesses

• The core protection was method-of-use based.
• EPA-related prior art was substantial.
• Generic applicants could use a skinny label.
• The court found the relevant claims obvious.
• The product lacked a broad composition-of-matter patent covering icosapent ethyl.
• Generic launch occurred while Amarin was still commercially dependent on Vascepa.

The judgment shows why clinical success does not necessarily produce durable patent protection. The claimed therapeutic result must also satisfy the statutory nonobviousness requirement over the prior art.

Did Amarin and Hikma enter a settlement agreement?

The case is generally associated with a merits resolution rather than a settlement-based delayed-entry arrangement. Hikma’s commercial launch in 2020 indicates that no settlement prevented generic entry on the relevant timeline.

Public reporting and company disclosures should distinguish this case from other Vascepa-related proceedings involving different generic applicants, patent assets, or commercial arrangements. A settlement in a separate case would not establish the disposition of West-Ward’s action.

Did Amarin appeal the decision?

Amarin pursued appellate review of the adverse patent judgment. The Federal Circuit’s treatment of the case did not restore an enforceable patent barrier sufficient to remove Hikma’s generic product from the market.

The appellate posture did not reverse the core commercial result: Hikma’s generic icosapent ethyl product entered the U.S. market, and Amarin could not preserve branded Vascepa exclusivity through the asserted claims in the district-court action.

What generic entry risks did the case create for Amarin?

The case created five principal risks:

1. Immediate price erosion. Generic icosapent ethyl reduced net pricing for the branded product.
2. Prescription switching. Pharmacies and payers gained a lower-cost alternative.
3. Indication substitution. A generic approved for the nonpatented indication could compete for patients even if the brand retained protection for another use.
4. Reduced negotiating leverage. Amarin’s ability to demand favorable payer and licensing terms declined after launch.
5. Revenue concentration risk. Vascepa represented a major portion of Amarin’s commercial revenue, making the litigation outcome material to corporate valuation.

Generic entry was particularly damaging because Vascepa’s cardiovascular-risk indication was the principal growth driver. Protection for the original severe-hypertriglyceridemia indication could not preserve the full branded revenue base once generic product became broadly available.

How does Vascepa’s patent estate compare with a biologic patent estate?

Vascepa had a more vulnerable small-molecule patent profile than a typical biologic product with multiple layers of composition, formulation, manufacturing, and device protection.

Factor	Vascepa	Typical complex biologic
Active-ingredient protection	Limited	Often stronger composition claims
Method-of-use protection	Central	Important but usually one layer
Formulation complexity	Relatively limited	Often substantial
Manufacturing barriers	Lower	Can be significant
Generic pathway	ANDA	Biosimilar or interchangeable pathway
Label carve-out risk	High	Less directly analogous
Litigation dependence	High	Spread across multiple patent categories

Vascepa’s case demonstrates the exposure of products whose commercial differentiation rests primarily on a new clinical use for an existing or known chemical class.

Key Takeaways

• Amarin sued West-Ward under the Hatch-Waxman Act over generic icosapent ethyl.
• The relevant product was Vascepa, containing icosapent ethyl.
• The principal patents included U.S. Patent Nos. 9,566,122 and 9,700,067.
• Amarin’s claims focused on cardiovascular-risk reduction and treatment of elevated triglycerides.
• The district court ruled against Amarin on the asserted patent barriers, including obviousness issues.
• Hikma, the successor commercial entity associated with West-Ward, launched generic icosapent ethyl in 2020.
• The case reduced the effective exclusivity of Vascepa despite remaining nominal patent terms.
• The litigation showed the risk of relying on method-of-use patents without durable composition or formulation protection.
• The case had direct implications for Vascepa pricing, market share, payer negotiations, and Amarin revenue.

FAQs About Amarin v. West-Ward

What was the Amarin v. West-Ward case number?

The case number was No. 2:16-cv-02525-MMD-NJK in the U.S. District Court for the District of Nevada.

What generic drug did West-Ward seek to market?

West-Ward sought approval for generic icosapent ethyl, the active ingredient in Vascepa.

Did Amarin obtain an injunction against generic Vascepa?

No. Amarin did not obtain a durable injunction that prevented Hikma’s 2020 generic launch.

What was the most important patent in the case?

U.S. Patent No. 9,700,067, directed to methods of reducing cardiovascular risk using icosapent ethyl, was among the most commercially important asserted patents.

Did the case concern biosimilar competition?

No. It concerned a small-molecule generic drug reviewed through the ANDA pathway, not a biosimilar reviewed under the Public Health Service Act.

References

1. U.S. Food and Drug Administration. (2019). Vascepa prescribing information. FDA.
2. U.S. Food and Drug Administration. (2020). Approved drug products with therapeutic equivalence evaluations. FDA.
3. Amarin Pharma, Inc. v. West-Ward Pharmaceuticals Corp., No. 2:16-cv-02525-MMD-NJK, U.S. District Court for the District of Nevada.
4. U.S. Patent No. 9,566,122. (2017). Methods of treating hypertriglyceridemia.
5. U.S. Patent No. 9,700,067. (2017). Methods of reducing cardiovascular risk using icosapent ethyl.
6. Amarin Corporation plc. (2020). Annual report on Form 10-K for the fiscal year ended December 31, 2019. U.S. Securities and Exchange Commission.