Details for Patent: 10,894,028

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Which drugs does patent 10,894,028 protect, and when does it expire?

Patent 10,894,028 protects VASCEPA and is included in one NDA.

This patent has one hundred and thirteen patent family members in forty-one countries.

Summary for Patent: 10,894,028

Title:	Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Abstract:	In various embodiments, the present invention provides methods of reducing the risk of a cardiovascular event in a subject on statin therapy and, in particular, a method of reducing the risk of a cardiovascular event in a subject on statin therapy having a fasting baseline triglyceride level of about 135 mg/dL to about 500 mg/dL, and administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of eicosapentaenoic acid ethyl ester or a derivative thereof.
Inventor(s):	Paresh Soni
Assignee:	Amarin Pharmaceuticals Ireland Ltd
Application Number:	US16/775,521
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 10,894,028: Claim Scope, Orange Book Position, Litigation Risk, and Generic Entry Analysis

U.S. Patent No. 10,894,028 covers a method of reducing myocardial-infarction risk by administering approximately 4 g per day of ethyl icosapentate, also known as icosapent ethyl, to diabetic patients with at least one additional cardiovascular risk factor. The claims narrow the method to defined triglyceride and LDL-C ranges, high-purity ethyl icosapentate formulations, four-capsule dosing, long-term treatment, statin use, and specified diabetic complications or risk factors.

The patent is a use patent for Vascepa, not a composition-of-matter patent. Its commercial value depends on whether a generic manufacturer markets icosapent ethyl for the claimed cardiovascular-risk-reduction population, rather than merely for severe hypertriglyceridemia. The principal legal issue is obviousness in view of the REDUCE-IT clinical protocol, prior omega-3 studies, and earlier Vascepa method patents.

What does U.S. Patent 10,894,028 protect?

The patent protects a treatment method with five core limitations:

Claim element	Scope
Active ingredient	Ethyl icosapentate, commonly called icosapent ethyl
Daily dose	About 4 g per day
Clinical objective	Reducing risk of myocardial infarction
Patient population	A subject with diabetes and at least one additional cardiovascular-risk factor
Treatment duration	A period effective to reduce risk; dependent claim 5 specifies at least two years

Claim 1 is the independent claim. Claims 2 through 10 add patient-selection, formulation, dosing, duration, and risk-factor limitations.

The patent does not broadly cover every use of icosapent ethyl. It does not claim:

• Any dose of icosapent ethyl;
• Treatment of hypertriglyceridemia without a cardiovascular-risk-reduction objective;
• Patients without diabetes;
• Treatment with a lower daily dose;
• Generic mixtures containing EPA and DHA;
• Purely prophylactic use outside the claimed cardiovascular population;
• Every reduction in triglyceride levels; or
• Every cardiovascular outcome.

The legal scope is determined by the claim language, specification, prosecution history, and construction of terms such as “about,” “reducing risk,” “additional risk factor,” and “period effective to reduce risk.” The patent specification and prosecution history may affect whether the claims are construed as requiring a demonstrated clinical benefit, a treatment intention, or both. [1]

How do the individual claims of U.S. 10,894,028 operate?

What does claim 1 require?

Claim 1 requires all of the following:

1. A subject with diabetes.
2. At least one additional cardiovascular-disease risk factor.
3. Administration of about 4 g of ethyl icosapentate per day.
4. Administration for a period effective to reduce the risk of myocardial infarction.

The claim is a patient-selection and treatment-regimen claim. A product manufacturer could practice the claim through labeling, promotional materials, dosing instructions, or instructions directed to the claimed diabetic population.

The phrase “about 4 g” likely covers ordinary manufacturing and dosing variation around a nominal 4-g daily dose. Four 1-g capsules taken daily would be the clearest commercial embodiment.

What does claim 2 add?

Claim 2 limits the subject to:

• Fasting baseline triglycerides of about 135 to about 500 mg/dL; and
• Fasting baseline LDL-C of about 40 to about 100 mg/dL.

These ranges are important because they track the patient profile associated with the REDUCE-IT cardiovascular-outcomes program and distinguish the claimed population from patients treated solely for very high triglycerides.

A patient outside either range may fall outside claim 2 but could still fall within claim 1 or another dependent claim if the remaining limitations are satisfied.

What does claim 3 protect?

Claim 3 requires ethyl icosapentate to be present in a pharmaceutical composition in which it comprises at least approximately 96 weight percent of all omega-3 fatty acids.

This limitation excludes ordinary fish-oil formulations containing substantial quantities of DHA or other omega-3 fatty acids. It aligns the claim with highly purified icosapent ethyl products rather than mixed EPA/DHA products.

The claim does not necessarily require the entire capsule to contain at least 96% ethyl icosapentate. The relevant comparison is the amount of ethyl icosapentate against all omega-3 fatty acids in the composition.

What does claim 4 protect?

Claim 4 requires approximately 1 g of the pharmaceutical composition in each of four capsules. It therefore describes the commercial four-capsule, 4-g-per-day regimen associated with Vascepa.

This limitation may be avoided by a product using a materially different capsule strength or dosage form. A manufacturer cannot assume that changing capsule count alone avoids infringement, however. The analysis would depend on whether the accused regimen still satisfies the broader “about 4 g per day” language in claim 1.

What does claim 5 require?

Claim 5 requires treatment to continue for at least two years after initial administration.

This is a significant limitation for enforcement. A short-duration prescription may not satisfy claim 5, although it could still implicate claim 1 or another dependent claim. The two-year limitation also creates proof issues because infringement may depend on the actual treatment period rather than the initial prescription.

What do claims 6 through 10 add?

Claim	Added limitation
6	The patient is on statin therapy
7	Triglycerides are at least 135 mg/dL
8	Triglycerides are at least 135 mg/dL and the patient is on statin therapy
9	The additional risk factor is hypertension, smoking, retinopathy, or albuminuria
10	The patient has at least two additional cardiovascular-risk factors

Claims 6 and 8 are commercially important because the cardiovascular-outcomes population generally involved statin-treated patients. Claims 9 and 10 further narrow the population through risk-factor requirements.

What clinical population does Patent 10,894,028 target?

The claim set targets a diabetic, statin-treated or otherwise high-risk population with moderately elevated triglycerides and controlled LDL-C. The closest commercial and clinical reference point is the REDUCE-IT population.

The FDA-approved Vascepa label identifies cardiovascular-risk-reduction use in adults with established cardiovascular disease or diabetes and at least two additional risk factors, in combination with maximally tolerated statin therapy. The label also includes a separate indication for severe hypertriglyceridemia. [2]

Patent claim 1 is broader than the FDA cardiovascular indication in one respect because it requires diabetes plus at least one additional risk factor, while the approved diabetes population generally requires at least two additional risk factors. Claim 10 tracks the narrower two-risk-factor population.

This difference creates a regulatory and patent-enforcement issue. A generic product may receive a carved-out label for non-cardiovascular uses while still being exposed to induced-infringement arguments if the product is promoted or routinely prescribed for the patented cardiovascular indication.

What is the Orange Book status of U.S. 10,894,028?

U.S. Patent 10,894,028 should be assessed through the current FDA Orange Book patent listing for the relevant icosapent ethyl product and application. The Orange Book controls whether the patent generates a statutory listed-patent certification obligation for an abbreviated new drug application.

For a listed method-of-use patent, a generic applicant may:

• File a Paragraph III certification and wait for patent expiry;
• File a Paragraph IV certification alleging that the patent is invalid, unenforceable, or not infringed; or
• Use a section viii statement to carve out the patented method, if the FDA-approved labeling permits a lawful noninfringing indication.

The Orange Book listing does not establish validity. It establishes the patent’s role in the ANDA approval process. A listed use patent can be challenged in district court after a Paragraph IV notice, while FDA approval timing depends on the applicable statutory stay and exclusivity rules. [3]

When does U.S. 10,894,028 lose exclusivity?

The claims supplied do not identify the patent’s earliest effective nonprovisional filing date, patent-term-adjustment amount, or any patent-term extension. Those facts determine the legally operative expiration date.

The patent’s expiration cannot be calculated reliably from the issue date alone. Patent term is generally measured from the earliest effective U.S. nonprovisional filing date, subject to:

• Patent-term adjustment;
• Terminal disclaimers;
• Patent-term extension;
• Disclaimer or correction records; and
• Any post-grant legal event affecting enforceability.

The relevant commercial date is therefore the expiration date shown in the current USPTO record and, if listed, the FDA Orange Book. The two-year limitation in claim 5 does not extend patent term. Nor does the length of the REDUCE-IT treatment period create regulatory exclusivity.

FDA approval exclusivity and patent exclusivity are separate. The cardiovascular indication may be protected by patents even after any statutory new-chemical-entity or other FDA exclusivity period has ended.

What generic entry risks exist for icosapent ethyl?

The most important generic-entry scenarios are these:

Generic strategy	Patent risk
Launch only for severe hypertriglyceridemia	Lower method-of-use risk if labeling and promotion avoid cardiovascular-risk reduction
Launch with a skinny label excluding cardiovascular use	Risk depends on label language, marketing, prescribing behavior, and evidence of inducement
Launch for cardiovascular-risk reduction	Direct exposure to claims 1, 6, 8, 9, and 10
Use a non-four-capsule regimen	May avoid claim 4 but not necessarily claim 1
Use a lower-purity omega-3 formulation	May avoid claim 3, but product may not be therapeutically or regulatorily equivalent
Use a different patient population	May avoid narrowed claims but not claims covering broader diabetic populations
Challenge validity under Paragraph IV	Requires litigation over anticipation, obviousness, enablement, written description, and claim construction

The FDA label is central. A generic sponsor cannot rely solely on removing the words “reduce risk of myocardial infarction” if the remaining labeling directs use in a population that necessarily practices the patent. Courts evaluate the totality of the labeling and conduct.

Which companies have challenged the Vascepa patent estate?

Amarin’s broader Vascepa patent estate has faced major ANDA litigation involving generic manufacturers including Hikma Pharmaceuticals, Dr. Reddy’s Laboratories, and Teva Pharmaceuticals. In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., the Federal Circuit affirmed the invalidity of asserted Vascepa patents on obviousness grounds. The decision materially weakened Amarin’s earlier cardiovascular-use patent position. [4]

That decision does not automatically invalidate U.S. 10,894,028. Patent claims must be evaluated separately, although prior-art findings and factual conclusions may affect later litigation involving related continuation patents.

The key distinction is between:

• Earlier patents asserted against generic entry;
• Continuation patents directed to narrower patient subgroups or regimens; and
• Patents listed after earlier litigation or issued from related applications.

A continuation patent can contain narrower claims that survive an earlier invalidity ruling. It can also remain vulnerable if it repeats the same inventive concept and relies on the same clinical evidence.

How strong is the patent estate for icosapent ethyl?

The estate has commercial strength but material litigation risk.

Strengths

• The claims are tied to a specific cardiovascular-outcomes use.
• The 4-g daily dose corresponds to the marketed regimen.
• The high-purity limitation distinguishes icosapent ethyl from mixed fish-oil products.
• The diabetes, statin, triglyceride, LDL-C, and risk-factor limitations identify a commercially meaningful population.
• A labeled cardiovascular indication can create inducement risk even where direct patient administration is the relevant infringement act.

Weaknesses

• The 4-g dose and patient population were publicly associated with the REDUCE-IT program.
• The clinical regimen may be viewed as an obvious application of a known drug to a studied high-risk population.
• The claims are method claims, not composition claims.
• Narrow dependent claims may be difficult to enforce against prescriptions that do not document every patient characteristic.
• A skinny-label generic may reduce direct labeling exposure.
• Earlier Federal Circuit decisions have already created adverse precedent for parts of the Vascepa cardiovascular patent estate.

The patent is stronger as a regulatory and settlement asset than as an unqualified barrier to all icosapent ethyl competition. Its value increases if the generic label includes cardiovascular-risk reduction and decreases if the generic launches only for severe hypertriglyceridemia with effective labeling carve-outs.

What manufacturing and formulation barriers remain?

Claim 3 creates a formulation-based distinction, but it is not a broad manufacturing monopoly. A competitor can potentially develop:

• A different capsule strength;
• A different capsule count;
• A formulation with a different omega-3 purity profile;
• A different excipient system; or
• A product directed to a noninfringing indication.

The commercial difficulty is that an alternative formulation must also satisfy FDA requirements for pharmaceutical equivalence, bioequivalence, stability, quality, and labeling. A formulation design-around that avoids claim 3 may not be therapeutically or regulatorily interchangeable with Vascepa.

The manufacturing process itself is not the principal protection in the supplied claims. The claims focus on the administered product, dose, patient population, and clinical objective.

How does Patent 10,894,028 compare with composition and formulation patents?

Protection type	Typical subject matter	Relevance to icosapent ethyl
Composition-of-matter patent	Chemical molecule or defined composition	Broadest protection, but generally unavailable for an older known omega-3 ester
Purity patent	High-purity EPA or reduced DHA content	Can limit alternative omega-3 formulations
Formulation patent	Capsule, excipient, stability, or dosage form	Can restrict product design and manufacturing
Method-of-use patent	Treatment of a disease or reduction of an event	U.S. 10,894,028 falls primarily in this category
Method-of-manufacture patent	Purification, esterification, or processing	Can create supply-chain barriers
Regulatory exclusivity	FDA statutory exclusivity	Separate from patent rights

U.S. 10,894,028 is most relevant to the cardiovascular-use label. It does not replace broader formulation or manufacturing patents, and it does not provide composition-of-matter exclusivity over ethyl icosapentate.

What is the biosimilar risk for icosapent ethyl?

There is no biosimilar pathway for icosapent ethyl because it is a chemically synthesized small-molecule drug. Competitive products would proceed through the ANDA pathway as generics, subject to pharmaceutical-equivalence and bioequivalence requirements.

The relevant competitive threats are:

• Authorized generic entry;
• ANDA products with a Paragraph IV challenge;
• Section viii products with carved-out labeling; and
• Non-equivalent omega-3 products competing for prescriptions or payer coverage.

What litigation and settlement outcomes are most likely?

A generic applicant seeking cardiovascular labeling would face three principal paths:

1. Paragraph IV litigation followed by a judgment on validity or infringement.
2. A settlement permitting launch on a negotiated date.
3. A skinny-label launch limited to severe hypertriglyceridemia.

A settlement could include:

• An agreed launch date;
• Restrictions on cardiovascular promotion;
• No-admission provisions;
• A covenant not to sue for particular products or uses;
• Patent-listing treatment; or
• Allocation of litigation risk between related continuation patents.

A prior adverse decision against related Vascepa patents increases settlement pressure on the innovator. A later-issued continuation with narrower claims may still support a separate action, but the patentee would need to prove that the new claims add legally meaningful limitations.

Key Takeaways

• U.S. Patent 10,894,028 is a cardiovascular method-of-use patent for approximately 4 g per day of ethyl icosapentate.
• The central population is diabetic patients with additional cardiovascular risk factors.
• Dependent claims target triglycerides of at least 135 mg/dL, LDL-C of about 40 to 100 mg/dL, statin therapy, high-purity omega-3 composition, four 1-g capsules, and treatment of at least two years.
• The patent does not broadly cover all icosapent ethyl products or all hypertriglyceridemia uses.
• Generic risk is highest when the product carries cardiovascular-risk-reduction labeling or is promoted for that use.
• A section viii carve-out may reduce risk but does not eliminate inducement exposure.
• The patent is separate from earlier Vascepa patents invalidated in litigation and must be analyzed independently.
• The exact expiration date must be taken from the controlling USPTO and Orange Book records, including any patent-term adjustment or terminal disclaimer.
• There is no biosimilar pathway. The competitive threat is ANDA-based generic entry.

Frequently Asked Questions

Does U.S. Patent 10,894,028 cover Vascepa for triglyceride lowering?

Not by itself. The supplied claims focus on reducing myocardial-infarction risk in a defined diabetic, cardiovascular-risk population. A separate indication for severe hypertriglyceridemia may fall outside these claims if it does not satisfy the cardiovascular-risk-reduction limitations.

Can a generic avoid this patent by selling two 2-g capsules instead of four 1-g capsules?

It may avoid dependent claim 4, but not necessarily claim 1. Claim 1 covers approximately 4 g per day without requiring four specific capsules.

Does a patient need to have diabetes to infringe claim 1?

Yes. Diabetes is an express limitation of claim 1. A patient without diabetes cannot satisfy claim 1, although another patent in the Vascepa estate could cover a different population.

Does the patent require the patient to have a prior myocardial infarction?

No. The claims require a method intended to reduce myocardial-infarction risk. They do not expressly require a prior myocardial infarction. Other cardiovascular-risk characteristics are specified in the dependent claims and related FDA labeling.

Can a generic sell icosapent ethyl without infringing the patent?

Potentially. A generic may reduce risk through a carved-out label, a noninfringing indication, a different patient population, or a successful invalidity or noninfringement challenge. The outcome depends on the final label, conduct, product formulation, patient population, and litigation record.

References

1. United States Patent and Trademark Office. (2021). U.S. Patent No. 10,894,028, methods of reducing risk of myocardial infarction.
2. U.S. Food and Drug Administration. (2023). Vascepa (icosapent ethyl) prescribing information.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. United States Court of Appeals for the Federal Circuit. (2020). Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 927 F.3d 1275.

Drugs Protected by US Patent 10,894,028

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes						USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF MYOCARDIAL INFARCTION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND ESTABLISHED CV DISEASE OR DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No						USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF MYOCARDIAL INFARCTION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND ESTABLISHED CV DISEASE OR DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE

International Family Members for US Patent 10,894,028

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013282394
Australia	2018204499
Australia	2020294210
Brazil	112014032905
Canada	2877514
Canada	3067008
Canada	3067012