Details for Patent: 9,693,985

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Which drugs does patent 9,693,985 protect, and when does it expire?

Patent 9,693,985 protects VASCEPA and is included in one NDA.

This patent has sixty-seven patent family members in thirty-nine countries.

Summary for Patent: 9,693,985

Title:	Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
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:	US15/422,634
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,693,985
Patent Claim Types: see list of patent claims	Use; Composition;

United States Drug Patent 9,693,985: Scope, Claims, Expiration, Litigation, and Vascepa Patent Landscape

U.S. Patent No. 9,693,985 protects cardiovascular-risk-reduction methods using approximately 4 grams per day of icosapent ethyl, marketed as Vascepa, in statin-treated patients with fasting triglycerides of approximately 135 to 500 mg/dL. The patent is directed to the REDUCE-IT-type use of icosapent ethyl, not to the molecule generally or to every pharmaceutical composition containing it.

The patent’s principal commercial significance is its coverage of patients with established cardiovascular disease or elevated cardiovascular risk who receive icosapent ethyl in addition to statin therapy. The reported expiration date is August 22, 2033, subject to the patent’s recorded term adjustments and any applicable terminal-disclaimer or post-grant changes recorded by the USPTO and FDA.

What does U.S. Patent 9,693,985 protect?

U.S. Patent 9,693,985 claims methods of reducing cardiovascular events by administering about 4 grams per day of ethyl icosapentate to patients taking statins and having moderately elevated triglycerides.

The independent claims are claims 1 and 17:

Claim	Protected method	Principal limitations
1	Cardiovascular risk reduction in a subject on statin therapy	About 4 g/day, at least about 2 years, fasting triglycerides about 135-500 mg/dL
17	Cardiovascular risk reduction in a subject with established cardiovascular disease	About 4 g/day, at least about 4 months, fasting triglycerides about 135-500 mg/dL

The claimed cardiovascular outcomes are cardiovascular death, coronary revascularization and unstable angina. Dependent claims add myocardial infarction and stroke as further reduced risks.

The patent does not claim:

• Icosapent ethyl as a chemical compound in the abstract;
• Every dose of icosapent ethyl;
• Every use of icosapent ethyl for hypertriglyceridemia;
• A generic omega-3 product;
• A broad composition claim covering all ethyl esters of omega-3 fatty acids;
• A biosimilar or biologic product.

Its legal and commercial value lies in the method-of-use limitations tied to a specific patient population, dose, background statin therapy, triglyceride range and cardiovascular endpoint.

How do the claims of Patent 9,693,985 operate?

Claim 1: Statin-treated population and long treatment duration

Claim 1 requires all of the following:

1. A subject receiving statin therapy.
2. Administration of a pharmaceutical composition containing about 4 g of ethyl icosapentate per day.
3. Treatment for at least about two years.
4. A fasting baseline triglyceride level of about 135 to about 500 mg/dL.
5. Reduction in the risk of cardiovascular death, coronary revascularization and unstable angina.

The claim is cumulative. A product or treatment regimen that satisfies only the dose and triglyceride range, but not the statin-therapy requirement, would not meet claim 1 as written.

The “about” language creates an ordinary claim-construction issue. It does not necessarily make the claim unlimited, but it can permit reasonable variation around 4 grams per day and the stated laboratory ranges. The scope would depend on intrinsic evidence, prosecution history, expert testimony and the court’s construction.

Claim 17: Established cardiovascular disease and shorter duration

Claim 17 is broader in treatment duration because it requires at least about four months rather than at least about two years. It is narrower in patient population because the subject must have established cardiovascular disease.

Claim 18 identifies qualifying disease as one or more of:

• Documented coronary artery disease;
• Documented cerebrovascular disease;
• Documented carotid disease;
• Documented peripheral arterial disease; or
• A combination of those conditions.

This claim structure is commercially important. A generic label directed to cardiovascular-risk reduction in patients with documented atherosclerotic disease could create infringement exposure even if the label excludes some other patient groups.

Dosage-unit limitation

Claims 2 and 19 require administration in one to four dosage units per day. This limitation is consistent with Vascepa’s commercial dosing, generally supplied as 0.5-gram or 1-gram capsules depending on product presentation.

A regimen of four 1-gram capsules per day would fall within the ordinary commercial implementation of the claim. The number of units is separate from the total daily dose. A formulation containing 4 grams in one dosage unit could satisfy the dose limitation but might not satisfy a dependent claim limited to one to four units unless the dosage-unit definition is met.

Purity limitation

Claims 3 and 20 require ethyl icosapentate to comprise at least about 96 weight percent of all omega-3 fatty acids in the composition.

This limitation distinguishes a substantially purified icosapent ethyl product from mixed omega-3 preparations containing meaningful quantities of docosahexaenoic acid, other fatty acids or broader fish-oil mixtures. A competing product may avoid these dependent claims if its omega-3 profile does not meet the specified purity threshold, although it could still implicate the independent claims if all independent-claim elements are satisfied.

Baseline lipid-profile limitations

Claims 5, 6, 22 and 23 add ranges for baseline lipid measures, including:

Biomarker	Claimed range
Non-HDL-C	About 200-300 mg/dL
Total cholesterol	About 250-300 mg/dL
VLDL-C	About 140-200 mg/dL
HDL-C	About 10-30 mg/dL
LDL-C	About 40-100 mg/dL

Claims 5 and 22 use “one or more of,” while claims 6 and 23 use substantially the same collection of ranges. These claims are narrower than claims 1 and 17 and would generally require proof that the patient’s baseline laboratory results fell within the recited parameters.

Prior-treatment exclusions

Claim 8 excludes patients who received specified therapies shortly before initiation, including:

• At least 200 mg per day of niacin and/or fibrates during the preceding 28 days;
• Prescription omega-3 fatty acids during the preceding 28 days; or
• Dietary omega-3 supplements during the preceding 28 days.

Claims 9 and 10 extend the relevant period through at least six months and identify longer periods of six months, one year, two years, three years, four years, five years or more than five years.

These limitations are relevant to clinical-trial replication and induced-infringement analysis. A label that instructs physicians to exclude recent omega-3 supplementation may track the claimed protocol rather than avoid it.

What is the FDA and Orange Book status of Patent 9,693,985?

Vascepa is approved under FDA NDA 202057. The initial approval covered severe hypertriglyceridemia. FDA later approved the cardiovascular-risk-reduction indication for statin-treated adults with elevated triglycerides and established cardiovascular disease or diabetes plus additional risk factors.

The FDA-approved cardiovascular indication is closely aligned with the subject matter of Patent 9,693,985.

FDA milestone	Date
Initial Vascepa approval for severe hypertriglyceridemia	July 26, 2012
Cardiovascular-risk-reduction supplemental approval	December 13, 2019
RLD	Vascepa, icosapent ethyl
FDA pathway	NDA, followed by supplemental NDA
Orange Book relevance	Method-of-use patent listing associated with the approved product and indication

The Orange Book lists patents and regulatory exclusivity information submitted by the NDA holder. Listing status can change through patent delisting, expiration, litigation outcomes and FDA administrative updates. Patent listing does not establish validity or infringement. It gives an ANDA applicant a framework for Paragraph IV certification and creates potential statutory litigation consequences under the Hatch-Waxman Act. [1]

When does Patent 9,693,985 expire?

The reported expiration date for U.S. Patent 9,693,985 is August 22, 2033.

Patent	Issue date	Reported expiration	Patent type
U.S. 9,693,985	June 27, 2017	August 22, 2033	Cardiovascular-risk-reduction method-of-use patent

The effective exclusivity date can differ from the nominal expiration date because of:

• Patent-term adjustment;
• Patent-term extension;
• Terminal disclaimers;
• PTA calculations across related applications;
• Post-grant proceedings;
• Orange Book listing decisions;
• Litigation settlements or launch licenses.

For generic planning, the practical question is not only whether the patent remains unexpired. It is whether an ANDA applicant can obtain approval for a non-infringing label, prevail in Paragraph IV litigation, obtain a license, or launch after a settlement date.

What other patents protect Vascepa and icosapent ethyl?

Patent 9,693,985 is part of a broader Vascepa estate. The estate has included composition, purity, formulation, manufacturing and method-of-use patents.

Patent family or patent	General subject matter	Commercial relevance
U.S. 8,293,728	Icosapent ethyl composition and related product protection	Early product protection
U.S. 8,598,227	Purified ethyl icosapentaenoate compositions and use	Product and purity barriers
U.S. 9,693,985	Cardiovascular-risk-reduction treatment method	REDUCE-IT-type indication
U.S. 9,700,501	Icosapent ethyl formulation or use-related protection	Product and commercial formulation coverage
U.S. 10,098,833	Cardiovascular-use or related therapeutic claims	Follow-on method-of-use coverage
U.S. 10,251,865	Icosapent ethyl therapeutic use	Follow-on cardiovascular protection
U.S. 10,610,575	Related therapeutic or formulation claims	Later-expiring estate component

The relevant scope differs by patent. Some earlier patents addressed the product or purified composition. Later patents concentrated on clinical use, cardiovascular outcomes and patient selection. Patent 9,693,985 is therefore more valuable against a generic that seeks to reproduce the approved cardiovascular indication than against a manufacturer selling a product only for severe hypertriglyceridemia.

Exact expiration dates must be evaluated patent by patent. A generic manufacturer can face a staggered estate in which some claims expire earlier while later method-of-use or formulation patents remain listed.

What formulation patents protect icosapent ethyl?

Patent 9,693,985 is not principally a formulation patent. Its composition language appears as a limitation within a treatment method. The formulation must contain approximately 4 grams per day of ethyl icosapentate, and dependent claims may require at least approximately 96 weight percent of omega-3 fatty acids to be ethyl icosapentate.

Separate Vascepa patents have addressed:

• High-purity icosapent ethyl;
• Low-level contaminants and related fatty acid components;
• Capsule formulations;
• Dosing regimens;
• Pharmaceutical compositions containing substantially purified EPA ethyl ester;
• Use of the formulation in cardiovascular-risk reduction.

The formulation and purity estate can create manufacturing barriers even when a generic applicant removes the cardiovascular indication from its label. A generic must still produce a product that meets the approved quality specifications and must avoid any unexpired product or formulation claims.

How strong is the patent estate for Vascepa?

The estate is strongest against an ANDA applicant that seeks approval for the full cardiovascular-risk-reduction indication at 4 grams per day.

Strongest infringement scenario

Risk is highest when the generic label instructs use in:

• Statin-treated patients;
• Patients with triglycerides of at least 135 mg/dL;
• Patients with established cardiovascular disease or diabetes plus risk factors;
• A 4-gram daily dose;
• Long-term cardiovascular-event reduction.

That label would reproduce the core clinical-use architecture of claims 1 and 17.

Lower-risk scenario

Risk is lower when the generic label is limited to severe hypertriglyceridemia, particularly where it omits:

• Cardiovascular-risk reduction;
• Statin co-therapy;
• Established cardiovascular disease;
• The 135-500 mg/dL triglyceride range;
• REDUCE-IT-type outcome language.

A lower-risk label does not eliminate risk. Physicians may prescribe the product off-label, and a brand company may argue that promotional activity, product materials or distribution practices induce infringement.

Which companies have challenged the Vascepa patents?

The main Hatch-Waxman challengers have included Hikma Pharmaceuticals and Dr. Reddy’s Laboratories, along with other generic manufacturers that filed ANDAs or participated in related patent disputes.

Company	Role in competitive landscape	Main issue
Hikma Pharmaceuticals	Early generic challenger and commercial entrant	ANDA approval, skinny-label and induced-infringement dispute
Dr. Reddy’s Laboratories	ANDA challenger	Patent validity, infringement and launch timing
Teva Pharmaceuticals	Generic competitor	Potential product and indication competition
Apotex	Generic applicant or market participant in related proceedings	ANDA and patent-estate exposure
Amarin Pharma	Vascepa sponsor and patent holder	Enforcement and settlement strategy

The central legal question in the Hikma dispute was whether a generic company could avoid infringement through a label that carved out the patented cardiovascular indication while the product remained capable of off-label use. The dispute illustrates the importance of label language, marketing conduct and the distinction between direct infringement by a physician or patient and induced infringement by the generic manufacturer.

What Paragraph IV challenges affect Patent 9,693,985?

An ANDA applicant may file a Paragraph IV certification asserting that an Orange Book-listed patent is invalid, unenforceable or not infringed. The NDA holder can sue within the statutory period, potentially triggering a 30-month stay of FDA approval under the Hatch-Waxman framework, subject to statutory exceptions and litigation developments. [2]

For Patent 9,693,985, likely Paragraph IV theories include:

• Lack of written description for the cardiovascular-outcome method;
• Lack of enablement for long-term event reduction;
• Obviousness based on prior omega-3 and statin studies;
• Failure to prove the claimed clinical effect across the full scope;
• Non-infringement based on a carved-out label;
• Failure to satisfy the “established cardiovascular disease” limitation;
• Failure to satisfy the triglyceride or statin-therapy limitations.

The patent holder’s strongest response is that the claimed regimen reflects the specific REDUCE-IT population, dose and clinical result rather than a routine substitution of one omega-3 product for another. The generic’s strongest response is that the claimed treatment was obvious from prior EPA studies, lipid-management guidelines and known cardiovascular-risk therapies.

What patent litigation affects Vascepa?

The most commercially significant litigation involved Amarin’s efforts to enforce its Vascepa patents against generic ANDA applicants. Courts examined whether a generic’s label and conduct encouraged use for the patented cardiovascular indication.

The litigation record has several commercial implications:

1. A skinny label can reduce, but not necessarily eliminate, induced-infringement exposure.
2. The approved indication matters because it determines how closely the generic label tracks the patent claims.
3. FDA approval for a triglyceride indication can enable early generic competition even while cardiovascular-use patents remain in force.
4. Patent validity and infringement are separate questions.
5. Settlements can establish launch dates that precede patent expiration.

Reported proceedings involving Amarin, Hikma and other generic applicants produced a more complex result than a simple all-or-nothing product monopoly. Generic icosapent ethyl became commercially available for non-cardiovascular indications while the branded company continued to assert method-of-use protection for cardiovascular-risk reduction.

Are biosimilars relevant to Patent 9,693,985?

No. Biosimilar law does not apply to icosapent ethyl because Vascepa is a small-molecule drug, not a biologic.

The relevant competitive pathway is the abbreviated new drug application, or ANDA, under section 505(j) of the Federal Food, Drug, and Cosmetic Act. Generic applicants rely on pharmaceutical equivalence and bioequivalence rather than biosimilarity. [3]

The relevant IP barriers are therefore:

• Orange Book-listed patents;
• Paragraph IV certifications;
• Formulation and composition patents;
• Method-of-use patents;
• Manufacturing patents;
• Hatch-Waxman litigation;
• Settlement and license terms.

What generic launch scenarios exist for Vascepa?

Scenario 1: Non-cardiovascular label launch

A generic launches for severe hypertriglyceridemia while omitting the cardiovascular-risk-reduction indication. This is the lowest-friction route and has already shaped the Vascepa market.

Scenario 2: Cardiovascular label after patent expiry

A generic waits until the relevant listed method-of-use patents expire or becomes licensed to launch with the full cardiovascular indication.

Scenario 3: Pre-expiration launch under settlement

The generic receives a contractually permitted launch date before the nominal expiration of all listed patents. The commercial date depends on settlement terms, supply arrangements and regulatory approval.

Scenario 4: Full Paragraph IV litigation

The generic challenges validity or infringement and launches if it prevails, if the court denies injunctive relief, or if the brand company does not obtain effective relief.

Scenario 5: Authorized generic or license arrangement

The brand or an affiliated company supplies the product, licenses the intellectual property, or otherwise permits earlier market access. This can reduce litigation exposure but increase price erosion.

What is the commercial exposure from generic competition?

Vascepa’s commercial exposure is concentrated in the cardiovascular-risk-reduction market, where the branded product commands substantially greater value than its earlier severe-hypertriglyceridemia indication.

Amarin reported approximately $614 million in Vascepa net product revenue for 2020, reflecting substantial demand following the 2019 cardiovascular indication expansion. [4] Generic entry into the non-cardiovascular indication creates immediate price and volume pressure. Full-label cardiovascular generic entry would create materially greater erosion because it would directly compete for the REDUCE-IT population.

The key variables are:

• Whether the generic label includes the cardiovascular indication;
• The number of approved generic suppliers;
• Settlement launch dates;
• Generic reimbursement and substitution;
• Continued validity of formulation and method-of-use patents;
• Physician prescribing after label carve-outs;
• Payer treatment of generic icosapent ethyl;
• The strength of Amarin’s enforcement position.

How does Patent 9,693,985 compare with competing omega-3 products?

Product	Active ingredient	Cardiovascular-outcome method coverage	Principal distinction
Vascepa	Icosapent ethyl	Patent 9,693,985 and related estate	Purified EPA ethyl ester, REDUCE-IT indication
Lovaza	Omega-3-acid ethyl esters	Different product and patent history	Mixed EPA/DHA product, triglyceride indication
Epanova	Omega-3 carboxylic acids	Separate development and patent estate	Different chemical form and formulation
OTC fish oil	Mixed omega-3 ingredients	Generally outside the patented product profile	Variable EPA/DHA content and no equivalent FDA indication

Patent 9,693,985 is not a generic “fish oil” patent. Its claim limitations are directed to a purified EPA ethyl ester regimen in a defined clinical setting.

What geographic coverage does Patent 9,693,985 provide?

The patent provides rights only in the United States. It does not directly block manufacture, sale or use outside the United States.

International protection depends on related applications and national-phase patents. Amarin and related entities pursued patent protection in multiple jurisdictions, but claim scope, expiration, prosecution history and litigation outcomes vary by country.

For global launch planning, a company must separately analyze:

• European Patent Office and national validations;
• Canada;
• Japan;
• Australia;
• China;
• Brazil;
• Other countries where icosapent ethyl is sold or manufactured.

A U.S. patent can still affect international supply if a product is manufactured abroad and imported into the United States. U.S. importation and induced-use theories may apply even when production occurs outside the country.

Key Takeaways

• U.S. Patent 9,693,985 is a method-of-use patent for cardiovascular-risk reduction with about 4 grams per day of icosapent ethyl.
• Claim 1 targets statin-treated patients with fasting triglycerides of about 135-500 mg/dL and at least two years of treatment.
• Claim 17 targets patients with established cardiovascular disease and requires at least about four months of treatment.
• The patent does not broadly claim all icosapent ethyl products or all omega-3 products.
• Purity, dosage-unit, baseline lipid and prior-treatment limitations appear primarily in dependent claims.
• The reported patent expiration date is August 22, 2033.
• Vascepa’s patent estate includes separate composition, formulation, manufacturing and method-of-use patents.
• Generic competition is possible through a triglyceride-only label, but full cardiovascular-label entry presents greater infringement exposure.
• The relevant regulatory pathway is ANDA approval, not biosimilar approval.
• Paragraph IV litigation, skinny-label interpretation and settlement launch dates remain central to generic-entry analysis.

FAQs About U.S. Patent 9,693,985

Does Patent 9,693,985 cover generic icosapent ethyl for triglycerides above 500 mg/dL?

Generally, no. The independent claims specify a fasting baseline triglyceride range of about 135 to about 500 mg/dL. A product approved only for severe hypertriglyceridemia above that range may avoid the core method claims, subject to other Vascepa patents and induced-use facts.

Can a generic sell icosapent ethyl before August 2033?

Yes, potentially. A generic may launch for a non-patented indication, prevail in Paragraph IV litigation, obtain a license, launch under a settlement, or rely on an approved label that omits the patented cardiovascular use.

Is the 96% EPA limitation present in every claim?

No. The 96 weight-percent limitation appears in dependent claims 3 and 20. It is not an express limitation of independent claims 1 and 17.

Does a patient need to have established cardiovascular disease for claim 1?

No. Claim 1 requires statin therapy but does not expressly require established cardiovascular disease. Claim 17 includes that additional limitation.

Does Patent 9,693,985 cover stroke prevention as an independent claim?

No. Stroke appears in dependent claims 16 and 26 as a further reduced risk. The independent claims focus on cardiovascular death, coronary revascularization and unstable angina.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book. FDA.

2. U.S. Food and Drug Administration. (2017). Abbreviated new drug application regulations and Paragraph IV certifications. FDA.

3. U.S. Food and Drug Administration. (2024). Generic drug facts and abbreviated new drug applications. FDA.

4. Amarin Corporation plc. (2021). Annual report on Form 10-K for the fiscal year ended December 31, 2020. U.S. Securities and Exchange Commission.

5. U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,693,985: Methods of reducing cardiovascular risk using icosapent ethyl. USPTO.

6. U.S. Food and Drug Administration. (2019). Vascepa prescribing information. FDA.

Drugs Protected by US Patent 9,693,985

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	9,693,985					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION, AND UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	9,693,985					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION, AND UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)

International Family Members for US Patent 9,693,985

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