Litigation Details for Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2022)

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Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2022)

Docket		Date Filed	2022-11-21
Court	Court of Appeals for the Federal Circuit	Date Terminated	2024-06-25
Cause		Assigned To
Jury Demand		Referred To
Parties	JONATHAN DARROW, ESQ.
Patents	10,278,935; 10,383,840; 10,568,861; 7,022,713; 7,511,131; 8,293,727; 8,293,728; 8,298,554; 8,314,086; 8,318,715; 8,357,677; 8,367,652; 8,377,920; 8,410,086; 8,431,560; 8,440,650; 8,455,472; 8,518,929; 8,524,698; 8,546,372; 8,551,521; 8,563,608; 8,617,593; 8,617,594; 8,623,406; 8,642,077; 8,669,245; 8,680,144; 8,691,871; 8,703,185; 8,709,475; 9,603,826; 9,610,272; 9,623,001; 9,693,984; 9,693,985; 9,693,986; 9,700,537; 9,918,954
Attorneys	Sara Wexler Koblitz, -
Firms	Direct: 202-525-5717, American University, Washington College of Law
Link to Docket	External link to docket

Details for Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Fed. Cir. 2022)

Date Filed	Document No.	Description	Snippet	Link To Document
2022-11-21				External link to document
2022-11-21	15		005,852, filed on Jun. 12, 2018, now Pat. No. 10,278,935, which is a continuation of application …present filed Jun. 12, 2018 (now U.S. Pat. No. 10,278,935), which …asserted patents the ’537 and ’861 patents USPTO United States Patent and Trademark…relationship between the non-patented use and patented use is reversed: the non- patented use here (i.e., the …the broader, off-patent use induced the specific, patented use because the off-patented treatment of severe	External link to document
2022-11-21	47		listed U.S. Patent 9,700,537 (“the ’537 patent”) and U.S. Patent 10,568,861 (“the ’861 patent”) (collectively…the ’537 patent, and at least claims 1 and 2 of the ’861 patent. Claim 1 of the ’537 patent recites:…]hen the brand’s patent on the drug compound has expired and the brand holds patents on only some approved…asserted U.S. Patent 8,642,077 against Hikma, but the parties’ dispute as to that patent has been resolved…dium. ’537 patent, col. 15, l. 64–col. 16, l. 22. Claims 1 and 2 of the ’861 patent recite:	External link to document

Amarin Pharma v. Hikma Pharmaceuticals USA: Litigation Summary, Patent Analysis, and Generic Entry Risk

Last updated: October 31, 2026

The Federal Circuit’s 2024 decision in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 23-1169, revived Amarin’s induced-infringement case involving Vascepa, or icosapent ethyl. The court held that substantial evidence supported a jury finding that Hikma’s generic label, product communications, and marketing activities encouraged infringement of Amarin’s cardiovascular-risk-reduction patents. The decision did not invalidate Hikma’s FDA approval or create a product-wide injunction. It returned the case to the District of Delaware for further proceedings, including damages-related issues. (Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 104 F.4th 1370 (Fed. Cir. 2024)).

What patents protect Vascepa in the Amarin v. Hikma litigation?

The appeal principally concerned two Amarin patents covering cardiovascular-risk-reduction methods using icosapent ethyl:

Patent	Core subject matter	Litigation significance
U.S. Patent No. 9,700,537	Methods of reducing cardiovascular risk using icosapent ethyl in patients with elevated triglycerides receiving statin therapy	One of the asserted patents at trial and on appeal
U.S. Patent No. 10,568,861	Related methods for reducing cardiovascular events in patients with controlled LDL cholesterol and elevated triglycerides	Second principal patent asserted against Hikma

Amarin’s patent estate also includes patents directed to Vascepa formulations, manufacturing processes, purity, dosing, and methods for treating hypertriglyceridemia. The Federal Circuit appeal focused on method-of-use infringement rather than a challenge to the chemical composition of icosapent ethyl.

The claims at issue were associated with the REDUCE-IT cardiovascular indication. That indication generally involved administration of 4 grams per day of icosapent ethyl to statin-treated patients with elevated triglycerides and controlled low-density lipoprotein cholesterol. FDA approved the indication for reducing the risk of cardiovascular events in December 2019. (FDA, 2019).

What was the Amarin v. Hikma patent dispute about?

Amarin alleged that Hikma induced infringement by encouraging physicians and patients to use generic icosapent ethyl for the patented cardiovascular indication, even though Hikma’s FDA label carved out that indication.

Hikma’s generic product was approved with a label directed to treatment of severe hypertriglyceridemia. The label did not expressly include Vascepa’s cardiovascular-risk-reduction indication. Hikma argued that the carved-out label prevented infringement because the approved labeling did not instruct use within the scope of the asserted method claims.

Amarin relied on the totality of Hikma’s conduct, including:

• The generic product’s dosing instructions.
• Label language applicable to patients with elevated triglycerides.
• Hikma’s product website.
• Press releases and other public statements.
• The practical overlap between the severe-hypertriglyceridemia population and patients receiving cardiovascular-risk-reduction therapy.
• Evidence that physicians could prescribe the generic product for the carved-out cardiovascular indication.

The legal issue was whether Hikma’s conduct constituted active encouragement of direct infringement under 35 U.S.C. § 271(b), despite the label’s formal omission of the patented indication.

What did the Federal Circuit decide in No. 23-1169?

The Federal Circuit vacated the district court’s judgment as a matter of law in Hikma’s favor and reinstated the jury-supported inducement theory.

The court held that a reasonable jury could find that Hikma’s communications and labeling encouraged physicians to use the generic product in a manner covered by Amarin’s patent claims. The court rejected the proposition that a carved-out label automatically defeats inducement where other evidence supports an inference of encouragement.

The decision turned on the evidence as a whole. The Federal Circuit emphasized that inducement can be established through a combination of:

1. The content of the product label.
2. The relationship between the labeled and patented uses.
3. Marketing materials.
4. Public statements.
5. The foreseeability and likelihood of infringing use.
6. Evidence showing that physicians would understand the product information as encouraging the patented use.

The court did not hold that every skinny label creates inducement liability. It held that the jury had a legally sufficient evidentiary basis to find inducement in this case.

What were the key litigation dates?

Date	Event
July 26, 2012	FDA approved Vascepa for severe hypertriglyceridemia
December 2019	FDA approved Vascepa’s cardiovascular-risk-reduction indication based on REDUCE-IT
2020	Hikma received FDA approval for generic icosapent ethyl with a carved-out cardiovascular indication
2020	Amarin brought Hatch-Waxman litigation against Hikma in the District of Delaware
2022	A jury found in Amarin’s favor on induced infringement issues involving the asserted method patents
2023	The District of Delaware entered judgment for Hikma as a matter of law on the inducement issue
February 2023	Amarin filed Federal Circuit appeal No. 23-1169
May 2024	Federal Circuit issued its decision reversing the judgment of non-infringement and remanding the case
After remand	The case remained subject to further district-court proceedings, including damages and other unresolved issues

The Federal Circuit’s decision was not a final commercial resolution of all monetary or injunctive consequences. It restored Amarin’s ability to pursue the induced-infringement verdict.

How did the skinny-label issue affect the case?

The case is significant for the limits of skinny-label strategies under the Hatch-Waxman framework.

A generic applicant can generally omit a patented indication from its labeling under the section viii procedure. That omission can reduce direct label-based infringement risk. It does not necessarily eliminate inducement risk when the generic manufacturer separately communicates information that encourages use for the patented indication.

The decision distinguishes between:

• A label that merely describes a noninfringing use; and
• A label or marketing program that, viewed in context, encourages the patented use.

Hikma’s position was that its label was limited to severe hypertriglyceridemia and that physicians could independently choose to prescribe the drug for cardiovascular-risk reduction. Amarin argued that the label and external communications made the patented use an expected and commercially foreseeable use.

The Federal Circuit accepted the second theory as sufficient to support the jury verdict. The ruling increases the importance of post-approval communications, websites, sales materials, press releases, and prescribing information in generic patent litigation.

What was the FDA and Orange Book status of Vascepa?

Vascepa is an FDA-approved prescription product containing icosapent ethyl, an ethyl ester of eicosapentaenoic acid. Amarin’s product was approved under NDA No. 202057.

The principal FDA milestones were:

FDA milestone	Date
Initial approval for severe hypertriglyceridemia	July 26, 2012
Approval of cardiovascular-risk-reduction indication	December 13, 2019
Generic icosapent ethyl approvals	Beginning in 2020

Amarin listed method-of-use patents in the Orange Book in connection with the cardiovascular-risk-reduction indication. Orange Book listing does not establish validity or infringement. It triggers the Hatch-Waxman certification and litigation framework.

Hikma’s ANDA certification and associated litigation allowed the generic product to obtain FDA approval while Amarin’s patent claims remained contested. The litigation therefore concerned patent enforceability and induced infringement after regulatory approval, not whether FDA had authorized the generic product for the patented cardiovascular indication.

When do the Amarin Vascepa patents lose exclusivity?

The Federal Circuit opinion did not resolve the ultimate expiration of every patent in Amarin’s broader Vascepa estate. Patent expiration must be evaluated on a patent-by-patent basis using the patent term, terminal disclaimers, patent-term adjustment, patent-term extension, and Orange Book data.

For the two patents central to the appeal, the practical exclusivity analysis is:

Patent	Exclusivity issue
U.S. Patent No. 9,700,537	Method-of-use protection for cardiovascular-risk-reduction treatment; expiration depends on the applicable 20-year term and any patent-term adjustment
U.S. Patent No. 10,568,861	Later-issued method patent with a separate term analysis; its remaining value depends on claim scope and enforceability after the Hikma ruling

The relevant commercial point is that FDA approval of a generic product does not necessarily mean unrestricted use for every approved product indication. A generic may enter with a carved-out label while still facing later inducement liability based on conduct outside the label.

What generic entry risks exist after the Federal Circuit ruling?

The decision creates several risks for generic manufacturers using section viii labeling:

Label-content risk

A label can create inducement exposure when its dosage, patient-selection, and treatment instructions materially overlap with a patented use. The analysis is not limited to whether the patented indication appears as a heading in the label.

Promotional-communication risk

Websites, press releases, investor communications, sales materials, and medical-information responses can be used to prove intent and encouragement. Statements that connect the generic product to clinical outcomes studied under the patented indication can increase risk.

Physician-prescribing risk

Evidence that physicians commonly use the generic product for the patented indication can support the inference that the manufacturer’s conduct encouraged infringement. The manufacturer does not need to instruct every physician directly if its communications predictably influence the relevant prescribing behavior.

Post-approval liability

FDA approval does not immunize a generic company from patent liability. Regulatory approval and patent infringement are separate legal questions.

Damages exposure

A finding of inducement can support damages based on lost profits, a reasonable royalty, or another legally available measure. The economic analysis may focus on prescriptions for the patented indication rather than all prescriptions for the generic product.

How strong is Amarin’s patent estate after the decision?

The Federal Circuit ruling strengthens Amarin’s enforcement position for method-of-use claims, but it does not establish that every Vascepa patent is valid, infringed, or enforceable.

Strengths

Amarin’s strongest points include:

• A clinically specific cardiovascular-risk-reduction indication.
• A large overlap between the commercial patient population and the asserted method claims.
• FDA approval supported by REDUCE-IT clinical data.
• Evidence beyond the generic label.
• A Federal Circuit ruling recognizing that inducement may arise from the totality of a generic manufacturer’s conduct.

Limitations

The estate also has structural limitations:

• The asserted claims are method claims rather than composition claims covering icosapent ethyl itself.
• Section viii carve-outs remain available to generic applicants.
• Infringement depends heavily on facts concerning communications and prescribing behavior.
• Patent expiration and terminal-disclaimer issues limit long-term exclusivity.
• A finding of inducement for one generic manufacturer does not automatically establish infringement by other manufacturers.

The estate is stronger against active promotion of the patented use than against a generic manufacturer that maintains a narrow label and avoids communications linking its product to cardiovascular-risk reduction.

Which companies challenge or compete with Amarin’s Vascepa franchise?

The principal competitive risks include:

Company or product category	Competitive position
Hikma Pharmaceuticals	Generic icosapent ethyl defendant in the Federal Circuit litigation
Other ANDA applicants	Potential generic competition through narrow or full labels
Teva Pharmaceuticals	Previously involved in separate Vascepa patent litigation and settlement activity
Generic manufacturers generally	Price competition in the severe-hypertriglyceridemia market and potential off-label cardiovascular use
Omega-3 products	Compete for physician and payer attention but are not necessarily substitutable for prescription icosapent ethyl

Vascepa also competes indirectly with fibrates, prescription omega-3 products, statins, and other cardiovascular-risk-reduction therapies. The REDUCE-IT indication is differentiated by its use as adjunctive therapy in statin-treated patients with persistent triglyceride elevation.

What manufacturing and intellectual-property barriers protect icosapent ethyl?

The principal barriers are no longer limited to manufacturing chemistry. Icosapent ethyl is a defined pharmaceutical ingredient, and generic manufacturers can obtain approval by demonstrating pharmaceutical equivalence and bioequivalence under the ANDA pathway.

Remaining barriers include:

• Method-of-use patents.
• Formulation and dosage patents.
• Manufacturing-process patents.
• Purity and oxidation-control requirements.
• Supply-chain qualification for pharmaceutical-grade omega-3 material.
• Regulatory compliance for capsule composition, stability, and impurities.

Manufacturing patents are commercially relevant only if they cover a process that a generic manufacturer must use or if the patented process is difficult to design around. Method-of-use claims were the central barrier in the Hikma appeal.

What settlement agreements affect Vascepa generic entry?

Amarin has entered into patent settlements and licensing arrangements with certain generic manufacturers in the broader Vascepa litigation landscape. Settlement terms may provide an agreed entry date, license rights, or other restrictions. Confidentiality and case-specific terms make it unsafe to treat one settlement as controlling for all generic companies.

The Hikma appeal is important because it proceeded through a merits determination rather than ending solely in a negotiated entry agreement. The Federal Circuit decision therefore provides precedent on induced infringement and skinny-label conduct that may affect future negotiations with other ANDA applicants.

What is the commercial impact of the litigation?

The financial exposure depends on the share of Hikma’s prescriptions attributable to the patented cardiovascular indication and the damages period. A generic product may compete broadly in the severe-hypertriglyceridemia market while still generating damages for prescriptions linked to the patented use.

For Amarin, the commercial value of the litigation depends on:

• The number of generic competitors.
• The timing of unrestricted generic entry.
• The enforceability period remaining for the asserted patents.
• The proportion of Vascepa revenue tied to cardiovascular-risk reduction.
• Payer substitution and generic price erosion.
• The availability of licenses or settlements.

The ruling improved Amarin’s litigation leverage but did not restore product-wide exclusivity. Generic availability and FDA approval remained commercial realities.

Key Takeaways

• The Federal Circuit reversed the District of Delaware’s judgment for Hikma in No. 23-1169.
• The court held that a jury could find induced infringement despite Hikma’s carved-out label.
• The decision rests on the combined effect of labeling, marketing, public statements, and foreseeable physician use.
• The ruling does not make Hikma’s FDA approval invalid or impose automatic product-wide exclusion.
• Amarin’s method-of-use patents remain the principal litigation tools for protecting Vascepa’s cardiovascular indication.
• Skinny-label strategies reduce but do not eliminate inducement risk.
• Generic manufacturers face increased exposure from promotional and post-approval communications.
• Damages and other consequences remained subject to remand proceedings.

FAQs About Amarin Pharma v. Hikma Pharmaceuticals

Did the Federal Circuit order Hikma to stop selling generic icosapent ethyl?

No. The decision reversed the judgment as a matter of law and remanded the case. It did not automatically impose a product-wide injunction.

Does a skinny label always avoid patent infringement?

No. A skinny label can avoid direct instructions for an omitted indication, but inducement may still be found based on the label and other manufacturer communications.

What drug was at issue in the litigation?

The litigation concerned generic icosapent ethyl, the active ingredient in Amarin’s Vascepa product.

Were Amarin’s patents composition patents covering all icosapent ethyl?

No. The principal patents in the appeal were method-of-use patents directed to cardiovascular-risk reduction in defined patient populations.

Can other generic manufacturers rely on Hikma’s FDA approval?

FDA approval is not a defense to patent infringement. Other generic manufacturers must assess their own labels, communications, ANDA certifications, and litigation exposure.

References

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 104 F.4th 1370 (Fed. Cir. 2024).

Food and Drug Administration. (2012). Vascepa (icosapent ethyl) approval letter and prescribing information. U.S. Department of Health and Human Services.

Food and Drug Administration. (2019). FDA approves use of drug to reduce risk of cardiovascular events in adults with elevated triglyceride levels. U.S. Department of Health and Human Services.

U.S. Patent No. 9,700,537. (2017). Methods of reducing cardiovascular risk in a subject. United States Patent and Trademark Office.

U.S. Patent No. 10,568,861. (2020). Methods of reducing cardiovascular risk in a subject. United States Patent and Trademark Office.

U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.