U.S. Patent 7,592,339: Rivaroxaban Method-of-Use Claims, Scope and Patent Landscape

U.S. Patent No. 7,592,339 covers methods of inhibiting thrombus formation and preventing or treating thromboembolic disorders with rivaroxaban, including its hydrate. The claims are method-of-use claims, not claims to the active compound, a formulation, a dosage regimen, or a manufacturing process. The patent’s ordinary U.S. patent term expired in December 2023, leaving its historical claims important for prior-art and litigation analysis but providing no current U.S. blocking right absent an identified term extension.

What drug does U.S. Patent 7,592,339 protect?

The compound identified by the omitted formula is rivaroxaban, also known as BAY 59-7939. Rivaroxaban is an oral direct factor Xa inhibitor marketed by Bayer and Janssen under the brand name Xarelto.

The patent is directed to therapeutic use of rivaroxaban and its hydrate for:

Inhibiting thrombus formation;
Preventing thromboembolism;
Preventing venous thromboembolism;
Preventing pulmonary embolism;
Preventing deep-vein thrombosis;
Treating pulmonary embolism and deep-vein thrombosis;
Preventing or treating myocardial infarction;
Preventing or treating unstable angina;
Preventing or treating stroke;
Preventing or treating transient ischemic attacks; and
Preventing or treating peripheral arterial occlusive disorders.

The patent does not claim rivaroxaban as a chemical entity. Rivaroxaban’s composition-of-matter protection arose from earlier Bayer patent families, including U.S. Patent No. 7,157,456. [1]

What do the claims of U.S. 7,592,339 cover?

The independent claims fall into four functional groups.

Claim group	Claims	Covered conduct
Thrombus inhibition	1-5	Administering rivaroxaban or its hydrate to inhibit thrombus formation
Thromboembolism prevention	6-9	Administering rivaroxaban to prevent thromboembolism, VTE, PE, or DVT
Disorder prevention	10-16	Preventing specified thrombotic disorders
Disorder treatment	17-21	Treating specified thrombotic disorders

How broad is claim 1?

Claim 1 is the broadest claim. It requires:

A method for inhibiting thrombus formation;
A patient in need of that method;
Administration of an effective amount;
Rivaroxaban or its hydrate.

The claim does not specify:

Dose;
Frequency;
Route of administration;
Treatment duration;
Patient age;
Disease stage;
Concomitant therapy;
Tablet strength;
Pharmaceutical excipients; or
A particular clinical setting.

The phrase “comprising administering” is open-ended. A competing product could therefore infringe if it administers rivaroxaban in a manner that satisfies the claim, even if the treatment also includes another anticoagulant or antiplatelet agent.

The central limitations are the identity of the compound and the therapeutic purpose. The claim is not a general anticoagulant claim. A different factor Xa inhibitor, such as apixaban or edoxaban, would not satisfy the rivaroxaban compound limitation.

What do claims 2 through 5 add?

Claims 2 through 5 narrow claim 1 by specifying thromboembolism and, ultimately, venous thromboembolism, pulmonary embolism, or deep-vein thrombosis.

They do not add a specific dose or administration schedule. Their principal value is diagnostic and litigation-related: they identify particular disease categories that may be easier to prove from a prescription, medical record, product label, or treatment indication.

What do claims 6 through 9 cover?

Claims 6 through 9 address prevention rather than the general inhibition of thrombus formation. Claim 6 requires administration in an amount effective to inhibit thrombus formation and prevent thromboembolism. Claims 7 through 9 narrow the prevention claim to VTE, PE, and DVT.

These claims could historically have applied to prophylactic use after surgery, during hospitalization, or in other settings where rivaroxaban was administered to reduce the risk of venous clot formation.

What do claims 10 through 16 cover?

Claims 10 through 16 cover prevention of a closed list of disorders:

Myocardial infarction;
Unstable angina;
Stroke;
Transient ischemic attack;
Peripheral arterial occlusive disorder;
Pulmonary embolism; and
Deep venous thrombosis.

Because claim 10 uses “selected from the group consisting of,” the listed disorders define a closed Markush group. A disorder outside the listed group would not fall within claim 10 solely because it also involves thrombosis.

What do claims 17 through 21 cover?

Claims 17 through 21 cover treatment, rather than prevention, of the same listed disorders. Claims 18 through 21 narrow the treatment claim to pulmonary embolism, DVT, myocardial infarction, and stroke.

The distinction between “preventing” and “treating” can matter in an infringement dispute. Prophylaxis in an asymptomatic patient is more naturally analyzed under claims 6 through 16. Administration to a patient with an established thrombotic event is more naturally analyzed under claims 17 through 21.

What limitations affect infringement of U.S. 7,592,339?

A claimant would generally need to establish each required limitation, including the following.

Rivaroxaban or its hydrate must be administered

The patent does not cover use of an unrelated anticoagulant. The product administered must contain the claimed rivaroxaban compound or the claimed hydrate.

Rivaroxaban tablets are commonly supplied as immediate-release oral dosage forms. The presence of excipients, a different tablet strength, or a different package does not ordinarily avoid a compound-specific method claim if the administered product contains rivaroxaban.

The amount must be effective

“Effective amount” is a functional limitation. The administered amount must be capable of producing the claimed antithrombotic result in the relevant patient. This limitation would usually be assessed using the product label, clinical evidence, dosing instructions, pharmacology, and patient records.

The patient must be in need of the method

The claims require a patient in need of thrombus inhibition, prevention, or treatment. Routine administration to an individual without a relevant thrombotic risk or disorder would present a different claim analysis.

The claimed purpose must be met

The claims distinguish inhibition, prevention, and treatment. A label or prescription directed to DVT prophylaxis may implicate prevention claims, while treatment of an established DVT may implicate treatment claims.

When did U.S. Patent 7,592,339 expire?

The patent’s earliest priority date was December 20, 2002. Its standard 20-year term therefore ran to approximately December 20, 2023, subject to any applicable patent-term adjustment or extension recorded by the USPTO. [2]

The patent issued on September 29, 2009. Issue date did not determine its expiration date because the patent term was measured principally from the earliest effective nonprovisional filing date.

The patent is not the principal composition-of-matter patent for rivaroxaban. Its commercial role was as a later method-of-use patent covering clinical applications of the compound.

Event	Date
Earliest priority date	December 20, 2002
U.S. patent issue date	September 29, 2009
Ordinary 20-year expiration	December 20, 2023
Current blocking status	Expired under ordinary term analysis

A six-month pediatric exclusivity period, if applicable to a listed product patent, would have to be confirmed through the FDA’s Orange Book and patent-term records. It would not ordinarily be assumed for this method patent without a specific FDA or USPTO record.

What is the Orange Book status of U.S. 7,592,339?

The patent’s relevance to the Orange Book depends on whether it was listed against an approved Xarelto use and whether FDA listing records identified it as a patent claiming the drug or an approved method of using the drug.

Xarelto’s Orange Book patent estate has included several different categories:

Patent category	Typical subject matter	Commercial function
Composition patents	Rivaroxaban chemical structure	Core molecule protection
Method-of-use patents	VTE, PE, DVT, stroke or cardiovascular use	Indication protection
Regimen patents	Dose, timing, or patient population	Label-specific protection
Formulation patents	Tablet or dosage-form characteristics	Product design protection
Process patents	Synthesis or purification	Manufacturing protection

U.S. Patent 7,592,339 is principally a method-of-use patent. Its listing, if applicable to a particular approved indication, could historically have triggered a Paragraph IV certification and patent litigation by an ANDA applicant seeking approval for a corresponding method.

After expiration, the patent no longer provides a current basis to block an ANDA or commercial generic launch. Other unexpired Xarelto patents, regulatory exclusivities, labeling restrictions, or settlement terms could still affect launch timing. The FDA Orange Book remains the controlling source for current listed patents and exclusivity codes. [3]

Did U.S. 7,592,339 support Paragraph IV litigation?

A Paragraph IV certification could have been directed to this patent if:

An ANDA applicant sought approval for rivaroxaban;
The patent was listed for a relevant approved method of use;
The applicant certified that the patent was invalid, unenforceable, or would not be infringed; and
The patent remained listed and enforceable when the certification was submitted.

The principal legal issues would have included:

Whether the ANDA product label induced infringement of the claimed method;
Whether the proposed label carved out patented indications;
Whether the claimed method was anticipated or obvious;
Whether the patent adequately described and enabled the claimed therapeutic uses;
Whether the “effective amount” and “patient in need” limitations were satisfied; and
Whether the patent had expired before commercial launch.

Because the patent’s ordinary term ended in 2023, a current Paragraph IV challenge to this patent alone would have limited commercial value. The commercial dispute would instead focus on later-expiring patents in the Xarelto estate.

What formulation patents protect Xarelto?

U.S. Patent 7,592,339 does not claim a tablet formulation, particle size, dissolution profile, excipient combination, or manufacturing process. A generic manufacturer could therefore avoid this patent, while still needing to assess other patents covering:

Rivaroxaban solid forms;
Immediate-release tablets;
Specific dosage strengths;
Pharmaceutical compositions;
Manufacturing or purification processes;
Pediatric formulations; and
Dose-specific or indication-specific regimens.

The patent’s hydrate language is a compound-form limitation. It does not convert the claims into formulation claims. A formulation containing the claimed hydrate could fall within the method claims if administered for a claimed purpose, but the formulation itself is not claimed.

How does this patent compare with the main competing anticoagulants?

Drug	Active ingredient	Drug class	Relationship to U.S. 7,592,339
Xarelto	Rivaroxaban	Direct factor Xa inhibitor	Directly covered by the claimed compound
Eliquis	Apixaban	Direct factor Xa inhibitor	Outside the compound limitation
Savaysa	Edoxaban	Direct factor Xa inhibitor	Outside the compound limitation
Pradaxa	Dabigatran etexilate	Direct thrombin inhibitor	Outside the compound limitation
Warfarin	Warfarin	Vitamin K antagonist	Outside the compound limitation

The patent does not create a class-wide monopoly over factor Xa inhibition. Its scope is compound-specific and depends on administration of rivaroxaban or the claimed hydrate.

How strong was the patent estate for rivaroxaban?

U.S. Patent 7,592,339 had meaningful historical breadth because it covered several major thromboembolic indications without specifying dose or route. Its weaknesses were structural:

It was a method patent rather than a composition patent;
Infringement could depend on the product label and physician conduct;
“Effective amount” and “patient in need” are fact-sensitive limitations;
Several listed indications were broader than the principal approved Xarelto indications at particular times; and
The patent had a finite term ending before several later Xarelto patents.

The strongest historical protection for rivaroxaban came from the combined estate: composition-of-matter protection, method claims, dosing claims, formulation claims, and regulatory exclusivity. U.S. 7,592,339 alone did not prevent development of alternative anticoagulants or non-rivaroxaban products.

What generic entry risks remain after expiration?

Expiration of U.S. 7,592,339 removed one method-of-use barrier. Remaining generic-entry risks could include:

Unexpired Xarelto composition, formulation, or regimen patents;
Patent litigation concerning later-listed patents;
Label carve-out limitations;
FDA requirements for bioequivalence and product quality;
REMS, safety, or labeling obligations;
Commercial settlement agreements between patent holders and ANDA applicants; and
Manufacturing risks involving non-infringing synthesis and purification.

The compound-specific method claims in U.S. 7,592,339 do not create a biosimilar issue. Rivaroxaban is a chemically synthesized small molecule, not a biologic. The relevant FDA pathway is the ANDA pathway for generics, not the abbreviated biosimilar pathway under the Public Health Service Act. [4]

What is the geographic coverage of U.S. 7,592,339?

The patent is enforceable only under U.S. law and covers conduct within the United States or conduct with a sufficient statutory connection to the United States. It does not directly protect rivaroxaban use in Europe, Japan, Canada, or other jurisdictions.

Foreign counterparts may have had different:

Claims;
Priority dates;
Patent-term calculations;
Opposition histories;
Supplementary protection certificates;
Litigation outcomes; and
Expiration dates.

A global freedom-to-operate review therefore cannot rely on the U.S. patent alone.

Key Takeaways

U.S. Patent 7,592,339 covers therapeutic administration of rivaroxaban or its hydrate.
Claims 1-5 cover thrombus inhibition and specified thromboembolic conditions.
Claims 6-16 cover prevention of thromboembolism and listed thrombotic disorders.
Claims 17-21 cover treatment of the listed disorders.
The claims do not cover rivaroxaban as a chemical compound, a formulation, a dose, or a manufacturing process.
The patent’s ordinary U.S. term expired around December 20, 2023.
The patent is no longer a standalone U.S. barrier to generic rivaroxaban entry.
Current commercial risk depends on other Xarelto patents, FDA listings, regulatory exclusivity, litigation, and any settlements.
The patent does not affect apixaban, edoxaban, dabigatran, warfarin, or other non-rivaroxaban anticoagulants.
Because rivaroxaban is a small molecule, generic entry proceeds through the ANDA pathway rather than the biosimilar pathway.

FAQs

Does U.S. 7,592,339 cover all uses of rivaroxaban?

No. It covers specified antithrombotic, thromboembolic, cardiovascular, cerebrovascular, pulmonary, and venous indications. It does not claim every conceivable use of rivaroxaban.

Can a generic manufacturer avoid the patent by changing the tablet strength?

Changing tablet strength alone would not necessarily avoid the claims. The patent does not require a particular strength. A generic would need to assess the compound, indication, administration, and effective-amount limitations.

Does the patent cover rivaroxaban tablets containing excipients?

The patent does not claim the tablet composition. A tablet containing rivaroxaban could be relevant to the method claims if administered for a claimed therapeutic purpose, but the excipient combination itself is outside the patent’s claim scope.

Is U.S. 7,592,339 relevant to rivaroxaban manufacturing?

Not directly. The claims do not recite a synthesis, purification, solid-form production, or manufacturing step. Manufacturing freedom to operate must be assessed against separate process and composition patents.

Can a biosimilar applicant challenge U.S. 7,592,339?

No biosimilar pathway applies to rivaroxaban because it is a synthetic small molecule. A generic applicant would use an ANDA and could address listed patents through Paragraph I, II, III, or IV certifications as applicable.

References

U.S. Patent No. 7,157,456. (2007). Oxazolidinones and their use as medicaments. United States Patent and Trademark Office.
U.S. Patent No. 7,592,339. (2009). Use of a factor Xa inhibitor for the treatment and prevention of thromboembolic disorders. United States Patent and Trademark Office.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.
U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application (ANDA) process. FDA.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1261606	⤷ Start Trial	91497	Luxembourg	⤷ Start Trial
European Patent Office	1261606	⤷ Start Trial	PA2008018	Lithuania	⤷ Start Trial
European Patent Office	1261606	⤷ Start Trial	CA 2008 00050	Denmark	⤷ Start Trial
European Patent Office	1261606	⤷ Start Trial	300370	Netherlands	⤷ Start Trial
European Patent Office	1261606	⤷ Start Trial	PA2008018,C1261606	Lithuania	⤷ Start Trial
European Patent Office	1261606	⤷ Start Trial	08C0051	France	⤷ Start Trial
European Patent Office	1261606	⤷ Start Trial	SPC/GB09/008	United Kingdom	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,592,339

Summary for Patent: 7,592,339