Details for Patent: 9,700,537

Which drugs does patent 9,700,537 protect, and when does it expire?

Patent 9,700,537 protects VASCEPA and is included in one NDA.

This patent has nine patent family members in six countries.

Summary for Patent: 9,700,537

Title:	Composition for preventing the occurrence of cardiovascular event in multiple risk patient
Abstract:	Disclosed is a composition which is useful for preventing the occurrence of a cardiovascular event, particularly a composition which is expected to show a prophylactic effect on a cardiovascular event occurring in a hypercholesterolemia patient despite providing the patient with a treatment with HMG-CoA RI or a cardiovascular event occurring in a multiple risk patient.
Inventor(s):	Mitsuhiro Yokoyama, Hideki Origasa, Masunori Matsuzaki, Yuji Matsuzawa, Yasushi Saito
Assignee:	Mochida Pharmaceutical Co Ltd
Application Number:	US15/431,958
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,700,537
Patent Claim Types: see list of patent claims	Use;

United States Patent 9,700,537: Scope, Claims, Expiration, and Icosapent Ethyl Patent Landscape

US Patent 9,700,537 protects a narrow cardiovascular-risk-reduction method using ethyl icosapentate, also known as icosapent ethyl, together with a statin. The independent claims target patients without a prior cardiovascular event who have elevated triglycerides and low HDL-C. Claim 9 adds elevated total cholesterol or LDL-C.

The patent is associated with Mochida Pharmaceutical’s icosapent ethyl technology and the Vascepa commercial product marketed by Amarin in the United States. Its projected statutory expiration is May 29, 2029, based on the earliest claimed priority date. The patent’s commercial value comes from its method-of-use coverage, but its infringement scope is constrained by multiple patient-selection, laboratory-value, treatment-history, drug-dose, and statin requirements.

What drug and therapeutic use does US Patent 9,700,537 protect?

US Patent 9,700,537 protects the use of ethyl icosapentate with a statin to reduce cardiovascular events in a selected hypercholesterolemia population.

The protected therapy requires:

• Ethyl icosapentate, or icosapent ethyl.
• Concomitant treatment with a specified HMG-CoA reductase inhibitor.
• A patient who has not previously experienced a cardiovascular event.
• Triglycerides of at least 150 mg/dL.
• HDL-C below 40 mg/dL.
• For claim 9, total cholesterol of at least 220 mg/dL or LDL-C of at least 140 mg/dL.
• A statin dose within the ranges recited in the claims.

The commercial product most closely associated with the claims is Vascepa, an oral prescription product containing icosapent ethyl. The FDA approved Vascepa in 2012 for severe hypertriglyceridemia and expanded the indication in 2019 to reduce cardiovascular risk in certain statin-treated patients with elevated triglycerides and established cardiovascular disease or diabetes plus additional risk factors. [1]

The patent claims are directed to a treatment method, not to the molecular composition of icosapent ethyl itself.

How many independent claims does US 9,700,537 have?

The patent has two materially independent method claims: claims 1 and 9.

Claim	Patient-selection requirements	Additional limitation
Claim 1	TG at least 150 mg/dL; HDL-C below 40 mg/dL; no prior cardiovascular event	Combination of ethyl icosapentate and a specified statin
Claim 9	TC at least 220 mg/dL or LDL-C at least 140 mg/dL; TG at least 150 mg/dL; HDL-C below 40 mg/dL; no prior cardiovascular event	Same combination therapy and statin-dose requirements

Claims 2 through 8 depend from claim 1. Claims 10 through 16 depend from claim 9. The second claim set is narrower because it adds a total-cholesterol or LDL-C threshold.

What are the principal claim limitations?

Patient laboratory thresholds

The core biomarker profile is:

• TG of at least 150 mg/dL.
• HDL-C below 40 mg/dL.

Claim 9 adds:

• TC of at least 220 mg/dL, or
• LDL-C of at least 140 mg/dL.

These thresholds create a defined dyslipidemic subgroup. A patient with triglycerides of 150 mg/dL but HDL-C of 40 mg/dL would not satisfy the literal HDL limitation. Likewise, a patient with low HDL-C and high triglycerides but a prior myocardial infarction would not satisfy the “has not previously had a cardiovascular event” limitation.

Primary-prevention population

The claims expressly exclude patients who have already experienced a cardiovascular event. This is a primary-prevention limitation.

That distinction matters because the FDA’s cardiovascular-risk-reduction indication for Vascepa includes patients with established cardiovascular disease as well as patients with diabetes and additional risk factors. The FDA label is therefore broader in some respects than the patent claims, while the patent claims are more specific in requiring HDL-C below 40 mg/dL and excluding prior cardiovascular events. [1]

Statin combination

The claims require simultaneous or sequential administration of ethyl icosapentate and an HMG-CoA reductase inhibitor. The statin may be administered before, during, or after ethyl icosapentate treatment.

The recited statins are:

• Pravastatin
• Lovastatin
• Simvastatin
• Fluvastatin
• Atorvastatin
• Pitavastatin
• Rosuvastatin
• Salts of those compounds

The claim text also recites a cerivastatin sodium dose range, although cerivastatin is not included in the preceding Markush list of selected statins. That internal inconsistency could create a claim-construction issue. A court could treat the omission as limiting, interpret the dosage language as an inadvertent drafting artifact, or examine the prosecution history and specification to resolve the scope.

Icosapent ethyl dose and purity

Dependent claims add several limitations:

• Claims 2 and 10: oral dose of 1.8 g/day to 2.7 g/day.
• Claims 7 and 15: oral dose of 0.3 g/day to 6 g/day.
• Claims 8 and 16: at least 96.5% ethyl icosapentate by weight among fatty acids administered simultaneously.
• Claims 4 and 12: daily administration for at least two years.
• Claims 3 and 11: male patient.
• Claims 5 and 13: fatal cardiovascular event.
• Claims 6 and 14: TG/HDL-C ratio of at least 3.75.

The 1.8 g/day to 2.7 g/day range is particularly relevant to Vascepa because the approved cardiovascular-risk-reduction dose is 4 g/day, generally administered as 2 g twice daily. [1] A marketed regimen at 4 g/day would fall within the broader 0.3 g/day to 6 g/day dependent range but would not fall within the narrower 1.8 g/day to 2.7 g/day range.

What is the patent expiration date for US 9,700,537?

The projected statutory expiration date is May 29, 2029.

Event	Date
Earliest claimed priority	May 29, 2009
U.S. patent application publication	2012
U.S. patent grant	July 25, 2017
Projected statutory expiration	May 29, 2029

The patent term is generally calculated from the earliest effective nonprovisional U.S. filing date, not from the grant date. Patent-term adjustment, terminal disclaimers, patent-term extension, or later administrative corrections can affect the final enforceable term. The patent is a method-of-use patent and does not receive the type of Hatch-Waxman patent-term extension commonly associated with a regulatory review period for the active ingredient.

Is US 9,700,537 listed in the Orange Book?

US 9,700,537 is associated with the Vascepa patent estate and has been treated as a cardiovascular-risk-reduction method patent in the U.S. regulatory and litigation context. The Orange Book listing is important because it can support a listed-drug patent notice and a Paragraph IV litigation framework for an ANDA applicant.

Orange Book method-of-use listings do not prevent all generic icosapent ethyl sales. They primarily create risk for an ANDA applicant whose labeling encourages use covered by the listed method. A generic applicant may attempt to use a section viii “skinny label” that removes the patented indication or otherwise avoids instructions that encourage the claimed use. [2]

The distinction between product and use patents is central:

Patent category	Relevance to generic entry
Drug-substance or composition patent	Can block sale of the active ingredient for all uses
Formulation patent	Can block a specific dosage form or formulation
Method-of-use patent	Can block labeled use if the generic label encourages the patented method
Manufacturing patent	Can create process or supply-chain risk but may not block every product

US 9,700,537 is principally a method-of-use patent.

What Paragraph IV challenges affect icosapent ethyl?

The principal generic challenge to Vascepa was brought by Hikma Pharmaceuticals. Hikma filed an ANDA for icosapent ethyl capsules and asserted Paragraph IV positions against patents in the Vascepa estate.

The resulting litigation focused heavily on whether the proposed generic label induced infringement of cardiovascular-risk-reduction patents. In Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., the District of Delaware found that Hikma’s proposed label did not support induced infringement of the asserted patents because the label did not sufficiently encourage the patented cardiovascular-risk-reduction use. [3]

The litigation had several commercial consequences:

1. The generic product could enter for the non-infringing hypertriglyceridemia indication.
2. The branded company faced difficulty using method-of-use patents to block a label that omitted the protected cardiovascular indication.
3. Physicians could prescribe generic icosapent ethyl off-label, creating practical erosion risk even where the generic label did not expressly carry the patented indication.
4. Patent enforcement depended on label language and actual prescribing behavior, not merely on the chemical identity of the generic product.

The public litigation record involving Hikma principally centered on earlier Vascepa patents, including patents directed to the composition and cardiovascular-risk-reduction use. US 9,700,537 remains relevant as part of the broader estate, but its enforceability cannot be assessed solely by the outcome of litigation involving a different patent or a different claim set.

How strong is the patent estate for Vascepa and icosapent ethyl?

The patent estate is layered but uneven.

Composition and purity patents

Composition patents generally provide stronger exclusionary leverage than method patents because they can cover the active product regardless of the indication. Vascepa’s estate includes patents directed to highly purified ethyl icosapentate and related composition characteristics.

The purity limitation in claims 8 and 16 of US 9,700,537 is narrower than the primary method claims. It could be relevant where a competing product contains other fatty acids or uses a less-purified omega-3 composition. It does not automatically cover every icosapent ethyl product because infringement would depend on the product’s fatty-acid composition and the manner of simultaneous administration.

Formulation patents

Formulation protection may cover:

• Soft-gel capsules.
• Capsule fill composition.
• Dissolution or stability characteristics.
• High-purity icosapent ethyl formulations.
• Packaging or manufacturing controls.

A generic manufacturer can reduce formulation risk by using a non-infringing formulation, but it must still satisfy FDA bioequivalence and quality requirements.

Method-of-use patents

US 9,700,537 is strongest when the accused product label or prescribing evidence identifies the specific primary-prevention population. Its claim limitations also create multiple factual questions:

• Were the patient’s TG and HDL-C values documented?
• Did the patient have a prior cardiovascular event?
• Was the patient receiving one of the listed statins?
• Was the statin dose within the claimed range?
• Was ethyl icosapentate administered at a claimed dose?
• Was the treatment period at least two years?
• Was the use intended to reduce cardiovascular events?

These requirements make direct infringement fact-intensive. They also make induced-infringement claims dependent on the content of the generic label and promotional conduct.

Obviousness exposure

The patent’s central technical concept combines:

• Known cardiovascular use of EPA.
• Statin background therapy.
• Elevated triglycerides.
• A low-HDL subgroup.
• Long-term cardiovascular-event reduction.

Prior clinical evidence, including the Japan EPA Lipid Intervention Study, established cardiovascular-outcome research involving purified EPA and statin-treated patients before the patent’s priority date. [4] That prior art creates an obviousness risk, particularly for broad claim 1. The strongest patentability argument lies in the claimed subgroup definition and the asserted clinical benefit in patients without a prior cardiovascular event.

Claim 9 has additional TC or LDL-C thresholds and is narrower. Narrower claims may be harder to read on ordinary prescribing but can sometimes present a stronger validity position if the added patient-selection criteria were not suggested in the prior art.

What generic launch scenarios exist for icosapent ethyl?

Scenario 1: Full cardiovascular label after patent challenge

A generic applicant could seek approval with the cardiovascular-risk-reduction indication and challenge the relevant Orange Book patents under Paragraph IV. This creates a conventional patent litigation risk and potentially a 30-month stay under Hatch-Waxman procedures. [2]

Scenario 2: Skinny label

The applicant could omit the patented cardiovascular-risk-reduction indication and retain only an unprotected or differently protected hypertriglyceridemia indication. This is the most important pathway for method-of-use patent circumvention.

The commercial risk remains substantial because physicians may prescribe the product outside the approved label. A skinny label does not eliminate all potential inducement theories, but it reduces the branded company’s ability to rely on the generic label itself as evidence of encouragement.

Scenario 3: Delayed launch after settlement

A settlement could establish a licensed entry date before patent expiration, subject to regulatory approval and other conditions. The economic value of such a settlement would depend on:

• The number of asserted patents.
• The agreed entry date.
• Authorized-generic provisions.
• Royalty or supply terms.
• Whether the settlement permits the cardiovascular indication.

No settlement should be assumed from the existence of a Paragraph IV notice alone.

Scenario 4: At-risk launch

A generic company could launch before final resolution if it accepts potential damages and injunction exposure. This is less attractive where composition or formulation patents remain in force, but method-only exposure can alter the risk calculation.

When does Vascepa lose exclusivity?

Vascepa does not have one single exclusivity date because regulatory exclusivity, composition patents, formulation patents, and method-of-use patents expire at different times.

Protection	Approximate end point	Commercial effect
New chemical entity exclusivity	Expired	No longer blocks ANDA filing
Core icosapent ethyl patents	Generally around 2030, depending on patent	May affect product-level entry
US 9,700,537 method patent	May 29, 2029	Covers specified primary-prevention use
Later formulation or method patents	Some extend into the early 2030s	May affect specific products or indications
Generic entry	Potentially before all patent expirations through skinny-label strategies	Depends on patent scope and litigation outcome

FDA approval of a generic product does not establish that the generic may market every indication covered by the branded label. The ANDA applicant’s labeling strategy is therefore a central part of the exclusivity analysis.

What geographic coverage does the patent provide?

US 9,700,537 provides U.S. patent rights only. It does not directly control sales in Japan, Europe, Canada, or other territories.

Mochida developed the icosapent ethyl technology and licensed commercial rights in North America to Amarin. Amarin’s U.S. commercialization rights do not expand the territorial scope of the patent. Foreign counterparts must be analyzed separately for:

• Filing and priority dates.
• National-phase prosecution.
• Granted claims.
• Patent-term adjustments.
• Supplementary protection certificates.
• Local validity decisions.
• Local regulatory exclusivity.

A U.S. Paragraph IV decision has no automatic legal effect outside the United States.

Are biosimilars a risk to Vascepa?

No. Biosimilar risk is not applicable because icosapent ethyl is a chemically synthesized small molecule, not a biologic.

The relevant competitive pathway is an abbreviated new drug application under section 505(j) of the Federal Food, Drug, and Cosmetic Act. Generic applicants must address pharmaceutical equivalence, bioequivalence, labeling, and listed patents. [2]

The main barriers are:

• Patent litigation.
• Formulation and purity differences.
• FDA requirements for capsule performance and bioequivalence.
• The ability to commercialize a non-infringing label.
• Physician substitution and payer coverage.

What licensing arrangements affect the patent landscape?

Mochida Pharmaceutical is the originating technology holder for icosapent ethyl. Amarin obtained commercial rights for major Western markets and developed Vascepa in the United States. The companies’ agreements govern commercialization, development, royalties, supply, and enforcement responsibilities, while the patent remains legally enforceable according to its recorded ownership and licensing arrangements.

Licensing is commercially important because a generic challenge may affect both:

• The U.S. product revenue stream.
• Royalty and supply economics between the originator and licensee.

The patent assignment and recorded license history should be distinguished from the underlying claim scope. A license changes who may enforce or commercialize; it does not broaden the claims.

What is the revenue exposure from US 9,700,537?

Vascepa generated hundreds of millions of dollars in U.S. revenue before generic competition intensified. Amarin reported approximately $614 million in net product revenue in 2020, following the 2019 cardiovascular-risk-reduction approval. [5]

US 9,700,537 alone does not protect all Vascepa revenue. Its economic exposure is limited to the portion of prescriptions directed to the claimed primary-prevention population. The broader revenue risk is determined by the combined estate:

1. Product and composition patents.
2. Formulation patents.
3. Cardiovascular-risk-reduction method patents.
4. The availability of a skinny-label generic.
5. Off-label prescribing.
6. Payer substitution policies.

A narrow method patent can have high settlement value if the branded indication drives substantial prescriptions, but its standalone blocking power is weaker than that of a composition patent.

Key Takeaways

• US 9,700,537 is a method-of-use patent for ethyl icosapentate combined with a statin.
• Independent claim 1 requires TG of at least 150 mg/dL, HDL-C below 40 mg/dL, no prior cardiovascular event, and treatment with a listed statin.
• Independent claim 9 adds TC of at least 220 mg/dL or LDL-C of at least 140 mg/dL.
• The projected statutory expiration date is May 29, 2029.
• The patent is narrower than the FDA’s overall Vascepa cardiovascular-risk-reduction indication in several respects.
• The patent does not create biosimilar risk; icosapent ethyl is a small molecule subject to ANDA competition.
• Generic risk is concentrated in Paragraph IV litigation, skinny-label approval, and off-label prescribing.
• The patent’s commercial strength is moderate: the clinical-use concept is valuable, but infringement requires proof of multiple patient and treatment conditions.
• Composition, purity, and formulation patents may provide stronger product-level protection than this method patent.
• Prior EPA/statin cardiovascular-outcome evidence creates an obviousness vulnerability, particularly for the broadest claims.

Frequently Asked Questions

Can a generic sell icosapent ethyl before May 29, 2029?

Yes, potentially. A generic could pursue a Paragraph IV challenge, use a section viii skinny label, or launch after resolving relevant patents. May 29, 2029 is the projected expiration of US 9,700,537, not necessarily the earliest date for every generic product or indication.

Does a patient need to be male to infringe the patent?

No. Male status is required only by dependent claims 3 and 11. Claims 1 and 9 do not require the patient to be male.

Does the patent cover 4 g/day Vascepa treatment?

The broad claims do not specify an icosapent ethyl dose. The 4 g/day regimen may fall within dependent claims 7 and 15, which cover 0.3 g/day to 6 g/day, but not within claims 2 and 10, which are limited to 1.8 g/day to 2.7 g/day.

Does the patent cover patients who previously had a heart attack?

No, not literally. Both independent claims require that the patient has not previously had a cardiovascular event.

Can a non-statin lipid-lowering drug satisfy the combination requirement?

No. The claims require one of the listed HMG-CoA reductase inhibitors, or an applicable salt. Ezetimibe, fibrates, PCSK9 inhibitors, and other non-statin therapies do not satisfy that limitation by themselves.

Does US 9,700,537 protect the icosapent ethyl molecule itself?

No. It protects a treatment method. Patents directed to the active ingredient, purity, formulation, or manufacturing process must be analyzed separately.

References

1. U.S. Food and Drug Administration. (2024). Vascepa (icosapent ethyl) prescribing information. FDA.

2. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations, 43rd ed. FDA.

3. Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 20-1630, 2020 WL 3420761 (D. Del. June 22, 2020).

4. Yokoyama, M., Origasa, H., Matsuzaki, M., Matsuzawa, Y., Saito, Y., Ishikawa, Y., Oikawa, S., Sasaki, J., Hishida, H., Itakura, H., Kita, T., Kitabatake, A., Nakaya, N., Sakata, Y., Shimada, K., Shirato, K., & JELIS Investigators. (2007). Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients: The Japan EPA Lipid Intervention Study. The Lancet, 369(9567), 1090-1098.

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

6. U.S. Patent No. 9,700,537. (2017). Methods of reducing occurrence of cardiovascular events in a hypercholesterolemia patient. U.S. Patent and Trademark Office.

Drugs Protected by US Patent 9,700,537

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	9,700,537					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE OCCURRENCE OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH HYPERCHOLESTEROLEMIA
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	9,700,537					USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE OCCURRENCE OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH HYPERCHOLESTEROLEMIA

Foreign Priority and PCT Information for Patent: 9,700,537

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2006-152740	May 31, 2006

International Family Members for US Patent 9,700,537

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2022495		122021000058	Germany
European Patent Office	2022495		132021000000154	Italy
European Patent Office	2022495		C202130051	Spain
European Patent Office	2022495		21C1045	France
Canada	2653787
European Patent Office	2777701