United States Patent 7,569,612: Fenofibric Acid Immediate-Release 105 mg Patent Scope and Landscape

US Patent 7,569,612 covers a specific treatment method using an immediate-release 105 mg fenofibric acid dosage form for primary hypercholesterolemia or mixed hyperlipidemia. The claim is narrower than a general fenofibric acid composition patent because infringement requires proof of the disease indication, dose, release profile, and administration without regard to meals.

The claim is commercially relevant to products corresponding to the 105 mg fenofibric acid tablet strength, including Fibricor-type products. It does not, on its face, cover all fenofibric acid products, delayed-release capsules, other strengths, or every use of fenofibric acid in lipid disorders.

What does US Patent 7,569,612 claim?

Claim 1 requires all of the following:

Claim limitation	Scope
Patient treatment	A method claim requiring administration to a patient
Disease	Primary hypercholesterolemia or mixed hyperlipidemia
Active ingredient	Fenofibric acid
Dose	105 mg
Dosage form	Immediate-release dosage form
Release test	At least 90% of fenofibric acid released at two hours
Test condition	Measured in a single pH buffer
Administration condition	Administered without regard to meals

The claim is a cumulative limitation claim. Failure to satisfy any one limitation should avoid literal infringement of claim 1.

What is the protected drug product?

The protected product is an immediate-release dosage form containing 105 mg of fenofibric acid. The claim is directed to fenofibric acid itself rather than fenofibrate, although fenofibric acid is the active pharmacological moiety generated from fenofibrate products.

The 105 mg strength is important. A 35 mg product, 45 mg product, 67 mg product, 135 mg product, or another dosage strength would not literally satisfy the stated dose limitation unless the product is administered in a manner that produces the claimed 105 mg dose.

The claim also requires a dosage form. It therefore does not directly cover administration of unformulated fenofibric acid or a different dosage form that does not meet the claimed immediate-release test.

How should “immediate-release” be construed?

Claim 1 defines immediate release functionally. The dosage form must release 90% or more of its fenofibric acid within two hours, measured in a single pH buffer.

This limitation has four components:

At least 90% release.
The measurement point is two hours.
The test uses a single pH buffer.
The release profile must qualify as immediate release under that test.

The claim does not state in the supplied language which pH buffer, buffer volume, agitation speed, apparatus, temperature, sampling intervals, or assay method must be used. Those parameters may be supplied by the patent specification or interpreted through the prosecution history. They are material because a product may pass or fail depending on the test protocol.

Why the single-pH-buffer limitation matters

The single-buffer requirement distinguishes the claim from release testing across multiple sequential gastrointestinal pH conditions. A product that releases 90% or more at two hours in the claimed single-buffer test may fall within the claim even if its in vivo absorption profile is more complex.

Conversely, a manufacturer may dispute infringement if:

the patent requires a particular buffer not used for the accused product;
the product releases less than 90% at two hours;
the test is conducted using a different pH or apparatus;
the product is delayed release or enteric coated;
the fenofibric acid assay does not measure the relevant active ingredient accurately.

The specification and prosecution history are central to construction of this limitation. The phrase “in a single pH buffer” may limit the claim to a defined analytical method rather than merely describing a general release characteristic.

Does the claim cover administration with or without food?

Yes. The phrase “without regard to meals” requires that the claimed treatment be suitable for administration without a meal restriction. The claim is therefore aimed at a dosage form that can be administered in the fed or fasted state.

A product label directing patients to take the 105 mg dosage form with or without food would be strong evidence supporting this limitation. A product that must be taken with food, or whose labeling requires a meal for adequate absorption, would present a stronger noninfringement position.

The claim does not necessarily require that every patient take the product in both fed and fasted conditions. The ordinary meaning of “without regard to meals” is that meal timing is not a required condition of administration. The specification and prosecution history could narrow or expand that interpretation.

What disease indications are covered?

Claim 1 covers treatment of:

primary hypercholesterolemia; and
mixed hyperlipidemia.

It does not expressly cover every dyslipidemia indication. Potentially distinct conditions include isolated hypertriglyceridemia, severe hypertriglyceridemia, dysbetalipoproteinemia, or other lipid disorders unless they fall within the claimed disease terms or are covered by separate claims.

A product label that includes primary hypercholesterolemia or mixed hyperlipidemia creates a direct relevance to the claim. A label limited to another indication may reduce direct induced-infringement exposure, although actual prescribing and promotional conduct could still be relevant.

How strong is the patent scope?

Strengths

The claim has several commercially specific limitations:

the 105 mg strength;
an immediate-release formulation;
a quantitative release threshold;
administration without regard to meals; and
two defined lipid disorders.

These limitations can make design-around practical. A competing manufacturer may avoid the claim by using a different strength, a delayed-release formulation, a meal-dependent product, or a release profile below the claimed threshold.

The claim also protects a treatment method rather than merely a formulation. A manufacturer may therefore face induced-infringement exposure if it markets a product with instructions that encourage the claimed use.

Weaknesses

The claim is vulnerable to challenges based on written description, enablement, anticipation, obviousness, indefiniteness, and infringement proof.

The most sensitive issues are likely to be:

whether the prior art disclosed a 105 mg immediate-release fenofibric acid dosage form;
whether administration without regard to meals was known or predictable;
whether the release test is sufficiently definite;
whether the specification supports the entire range of formulations meeting the 90% threshold;
whether the claimed clinical use was obvious in view of earlier fenofibric acid and fenofibrate products.

A prior-art reference need not disclose every commercial brand name. A reference combining the same active ingredient, strength, release characteristics, indication, and meal-independent administration could be relevant to validity.

How does the patent compare with delayed-release fenofibric acid patents?

Fenofibric acid products have been developed in both immediate-release and delayed-release forms. The principal distinction is the release mechanism and corresponding product labeling.

Attribute	US 7,569,612 claim 1	Delayed-release fenofibric acid product
Strength	105 mg	Commonly 45 mg or 135 mg
Release profile	At least 90% at two hours in a single pH buffer	Delayed or modified release
Meal instruction	Without regard to meals	Product-specific
Claim type	Treatment method	Often formulation, composition, or method claims
Likely product association	Fibricor-type tablet	Trilipix-type delayed-release capsule
Design-around route	Change strength or release profile	Use immediate release or another formulation platform

A delayed-release 135 mg capsule would not literally satisfy the supplied claim merely because it contains fenofibric acid. It would need to meet the 105 mg and immediate-release limitations, among others.

What is the FDA regulatory status of the relevant products?

The relevant regulatory distinction is between fenofibric acid products approved as tablets and those approved as delayed-release capsules.

Fibricor was approved as a fenofibric acid tablet product in 35 mg and 105 mg strengths. Trilipix was approved as a delayed-release fenofibric acid capsule in 45 mg and 135 mg strengths. FDA labeling for these products identifies the therapeutic uses and meal-administration instructions that are relevant to method-of-use analysis.[1][2]

The FDA-approved label is important evidence for three reasons:

It identifies the marketed strength.
It states the approved indications.
It supplies the prescribing instructions that may encourage or avoid the claimed method.

FDA approval does not itself establish patent infringement. Patent liability depends on the claim language, product characteristics, labeling, and conduct.

What is the Orange Book status?

The Orange Book is relevant only if the patent is listed against an approved drug application and remains listed for the relevant product. Patent listing is product-specific and does not establish that every claim of the patent covers every approved strength or dosage form.

For fenofibric acid products, the relevant analysis should separate:

patents listed for immediate-release tablets;
patents listed for delayed-release capsules;
formulation patents;
method-of-use patents;
patents with pediatric extensions;
patents that have expired or been delisted; and
patents that remain relevant only through litigation or contractual restrictions.

A patent listed for a 105 mg tablet does not automatically block approval of a 135 mg delayed-release capsule. The dosage form, strength, and approved use must correspond to the listed patent claims.

When does US Patent 7,569,612 lose exclusivity?

The effective patent expiration date must be determined from the patent’s term calculation, including:

the earliest effective nonprovisional filing date;
any patent term adjustment;
any patent term extension;
terminal disclaimers;
any pediatric exclusivity; and
the status of related continuation or divisional applications.

The nominal expiration date printed in patent databases may not equal the enforceable market-exclusivity date. A definitive generic-entry analysis should use the USPTO Patent Center record, the patent’s front-page term information, the FDA Orange Book listing, and any applicable regulatory exclusivity.

Because claim 1 is a US method claim, expiration ends the enforceability of the claim in the United States. It does not remove separate claims in related patents or foreign counterparts.

Are Paragraph IV challenges likely for this patent?

A generic applicant seeking approval for a 105 mg immediate-release fenofibric acid product would need to address the patent if it is listed for the relevant reference product. The applicant could submit a Paragraph IV certification asserting that the patent is invalid, unenforceable, or not infringed.

The principal Paragraph IV theories would likely include:

Noninfringement

A generic applicant could argue that its product:

does not release at least 90% within two hours;
uses a different test condition;
is not immediate release under the claim;
is not labeled for primary hypercholesterolemia or mixed hyperlipidemia;
requires administration with food; or
does not contain 105 mg of fenofibric acid.

Invalidity

Potential invalidity arguments could focus on:

prior fenofibrate or fenofibric acid dosage forms;
known 105 mg strengths;
meal-independent administration;
release testing disclosed in earlier references;
obvious optimization of dose and release characteristics;
lack of written description for the claimed formulation class; and
indefiniteness caused by the single-buffer test language.

Litigation timing

A Paragraph IV notice can trigger Hatch-Waxman litigation and, if timely filed by the patent owner, a statutory stay of FDA approval for up to 30 months, subject to statutory exceptions and court orders.[3] The stay affects approval timing, not necessarily the earliest possible commercial launch if the patent is successfully challenged or settled.

What generic launch scenarios exist?

Scenario	Commercial consequence
Product avoids all claim limitations	Approval and launch may proceed without waiting for claim expiration, subject to other patents
Product meets the claim but applicant wins Paragraph IV litigation	Launch may proceed after judgment or settlement terms permit
Product meets the claim and patent survives	Launch is delayed until expiration or authorized entry
Product uses a different strength	The specific claim may not block launch, but other patents may apply
Product uses delayed release	Claim 1 may not read on the product, but delayed-release patents may create separate barriers
Product label omits the claimed indications	Risk may decline, but actual promotion and prescribing remain relevant
Product is launched “at risk”	The applicant may face damages, injunction exposure, and market disruption if the patent is upheld

The most credible design-around is a formulation that fails the immediate-release limitation or uses a different dosage strength. That strategy does not eliminate risk from other formulation, composition, manufacturing, or method-of-use patents.

What manufacturing and formulation barriers remain?

A competitor must reproduce more than the 105 mg active-ingredient amount. It must develop a tablet with acceptable:

content uniformity;
dissolution performance;
stability;
manufacturability;
impurity profile;
bioavailability; and
regulatory comparability.

The release limitation may be relatively easy to design around if the product uses a different excipient system or a modified-release technology. The commercial difficulty is proving that the alternative remains bioequivalent and satisfies FDA requirements while avoiding listed patents.

Manufacturing process patents may create separate barriers even where the final dosage form does not infringe claim 1. Such patents can cover particle size, salt or crystal form, granulation, compression, coating, dissolution control, or synthetic intermediates.

How does the patent landscape affect licensing and competitive strategy?

The patent is most valuable against a competitor developing the same 105 mg immediate-release product for the same lipid indications. Its value is lower against:

delayed-release fenofibric acid products;
non-105 mg strengths;
fenofibrate products;
combination products with different labeling;
products with meal-dependent administration; and
products that do not promote the claimed indications.

Licensing negotiations should separate rights to the composition, dosage form, manufacturing process, method of treatment, and regulatory dossier. A license limited to US Patent 7,569,612 would not necessarily provide freedom to operate for all fenofibric acid products.

Geographic coverage and foreign patent risk

US Patent 7,569,612 provides rights only in the United States. Foreign counterparts must be analyzed independently by jurisdiction. Differences may include:

claim scope;
patent-term dates;
prosecution amendments;
supplementary protection certificates;
regulatory-data exclusivity;
patent-listing systems;
claim construction;
litigation outcomes; and
compulsory-license rules.

A US noninfringement position does not establish freedom to operate in Europe, Canada, Japan, China, or other markets.

Key Takeaways

Claim 1 is a narrow method claim covering treatment with a 105 mg immediate-release fenofibric acid dosage form.
The required release profile is at least 90% release at two hours in a single pH buffer.
The claimed treatment must address primary hypercholesterolemia or mixed hyperlipidemia.
Administration must occur without regard to meals.
A delayed-release 45 mg or 135 mg product does not literally satisfy the supplied claim.
The strongest design-arounds are a different strength, a delayed-release profile, or labeling that does not encourage the claimed indication.
Paragraph IV risk depends on the patent’s Orange Book listing, related patents, the generic label, and the product’s dissolution data.
Patent-term analysis must account for patent term adjustment, pediatric exclusivity, terminal disclaimers, and related patent rights.
Formulation and manufacturing patents may create separate barriers after claim 1 is avoided.
US rights do not determine foreign freedom to operate.

FAQs

Does US Patent 7,569,612 cover Fibricor 105 mg?

The supplied claim is directed to the same general product profile as a 105 mg immediate-release fenofibric acid tablet used for the claimed lipid disorders. Whether a specific Fibricor product is covered requires comparison of its approved label, formulation, dissolution data, and the complete patent claim set.

Does the claim cover fenofibrate?

Not on its face. The claim recites fenofibric acid and a 105 mg fenofibric acid dosage form. A fenofibrate product would require a separate infringement analysis.

Can a generic avoid the patent by using 100 mg or 110 mg?

A product outside the 105 mg limitation may avoid literal infringement of claim 1. Other claims, related patents, equivalence theories, and regulatory requirements could still affect launch risk.

Does FDA approval prove patent infringement?

No. FDA approval establishes regulatory authorization. Infringement requires that the product, labeling, and relevant conduct satisfy every limitation of an enforceable patent claim.

Can a delayed-release fenofibric acid capsule infringe claim 1?

A delayed-release capsule would generally have a strong noninfringement position against the supplied claim because claim 1 requires an immediate-release dosage form releasing at least 90% within two hours. Other claims or related patents could still apply.

References

U.S. Food and Drug Administration. (n.d.). Fibricor (fenofibric acid) tablets: Prescribing information.
U.S. Food and Drug Administration. (n.d.). Trilipix (fenofibric acid) delayed-release capsules: Prescribing information.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
United States Patent and Trademark Office. (n.d.). U.S. Patent No. 7,569,612: Patent Center records and patent term information.
U.S. Patent No. 7,569,612. (2009). Fenofibric acid immediate-release dosage forms and methods of treatment. United States Patent and Trademark Office.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rosemount	FIBRICOR	fenofibric acid	TABLET;ORAL	022418-001	Aug 14, 2009		DISCN	Yes	No	7,569,612	⤷ Start Trial				ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS	⤷ Start Trial
Rosemount	FIBRICOR	fenofibric acid	TABLET;ORAL	022418-002	Aug 14, 2009		DISCN	Yes	No	7,569,612	⤷ Start Trial				ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Details for Patent: 7,569,612

Which drugs does patent 7,569,612 protect, and when does it expire?

Summary for Patent: 7,569,612