Details for Patent: 7,541,347

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Which drugs does patent 7,541,347 protect, and when does it expire?

Patent 7,541,347 protects XIMINO and SOLODYN and is included in two NDAs.

This patent has twelve patent family members in nine countries.

Summary for Patent: 7,541,347

Title:	Minocycline oral dosage forms for the treatment of acne
Abstract:	Minocycline oral dosage forms containing a controlled release carrier are useful for the treatment of acne.
Inventor(s):	Mitchell Wortzman, R. Todd Plott, Kuljit Bhatia, Bhiku Patel
Assignee:	Medicis Pharmaceutical Corp
Application Number:	US11/695,528
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,541,347
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

U.S. Patent 7,541,347: Claim Scope, Solodyn Patent Landscape, Exclusivity and Generic Entry Risk

U.S. Patent No. 7,541,347 protects a method of treating acne with a once-daily, extended-release minocycline hydrochloride dosage form. The independent claim is unusually narrow because it combines an exact 400 mg formulation, a defined 90 mg minocycline hydrochloride dose, specific intragranular and extragranular excipients, pharmacokinetic performance, weight-based dosing, treatment outcomes, and patient-facing clinical-trial information.

The patent is directed to a formulation and dosing method associated with extended-release minocycline products such as Solodyn. It is not a broad composition patent covering all minocycline extended-release products. A competing product would need to satisfy every limitation of claim 1 for literal infringement. The patent’s principal commercial value lies in its use against a 90 mg once-daily acne product with comparable release characteristics and labeling.

What does U.S. Patent 7,541,347 protect?

The patent protects a method that requires both administration of a defined oral dosage form and provision of specified safety information to the patient.

Core claim limitations

Claim element	Requirement
Active ingredient	90 mg minocycline hydrochloride
Dosage-form weight	400 mg total
Intragranular matrix	108 mg hydroxypropyl methylcellulose and 152 mg intragranular lactose
Extragranular carrier	41 mg lactose monohydrate
Release architecture	Extragranular lactose partially or completely encapsulates or coats the intragranular blend
Other excipients	3.0 mg silicon oxide and 6.0 mg magnesium stearate
Dosing frequency	Once daily
Dose exposure	0.75 to 1.5 mg/kg minocycline hydrochloride
Loading regimen	No initial loading dose
Release profile	Slow, continuous release
Pharmacokinetics	Cmax approximately 3.2 to 4.5 hours after administration
Indication	Acne and specified related conditions
Information requirement	Patient receives clinical-trial results comparing the dosage form with placebo for at least one adverse effect

The claim is a combination claim. It does not claim each excipient independently, and it does not claim minocycline treatment generally. Infringement requires the accused method to practice the full combination or an equivalent combination under applicable claim-construction principles.

How narrow is claim 1 of U.S. Patent 7,541,347?

Claim 1 is narrow in formulation terms and narrow in method-of-use terms.

The exact quantities create a substantial literal-infringement barrier. A product containing 90 mg of minocycline but a different quantity of hydroxypropyl methylcellulose, lactose, silicon oxide, or magnesium stearate may fall outside the literal scope. The claim also requires a total dosage-form weight of 400 mg.

The release architecture creates a second limitation. The claim requires an intragranular blend and an extragranular lactose monohydrate component that partially or completely encapsulates or coats the intragranular material. A formulation using a conventional hydrophilic matrix, film coating, multiparticulate pellet, osmotic system, or different granulation structure may not satisfy this limitation.

The method also requires a specific clinical-use pattern:

1. Once-daily administration.
2. No initial loading dose.
3. A weight-based exposure of 0.75 to 1.5 mg/kg.
4. Slow, continuous delivery.
5. Acne treatment.
6. Provision of clinical-trial safety information to the patient.

A manufacturer that sells the dosage form but does not induce the claimed administration method may have a stronger noninfringement position. The patient-information limitation is particularly important because it may limit direct method infringement to circumstances in which the required information is actually provided.

What do claims 2 through 6 add?

The dependent claims narrow the scope further.

Claim 2: adverse-effect information

Claim 2 limits the information to clinical-trial results concerning one or more listed effects, including headache, fatigue, dizziness, pruritus, malaise, mood alteration, somnolence, urticaria, tinnitus, vertigo, dry mouth, and myalgia.

A label or patient information document that discusses adverse events generally may not meet claim 2 unless it provides the required comparison of the dosage form with placebo for a listed adverse effect.

Claim 3: approximately 1.0 mg/kg/day

Claim 3 narrows the dose to approximately 1.0 mg/kg/day. This limitation is commercially relevant because a once-daily 90 mg product administered to a patient weighing approximately 90 kg produces that exposure.

The term “about” introduces claim-construction and scientific-equivalence questions. The claim does not necessarily require mathematical identity with 1.0 mg/kg/day, but the permissible range would depend on the intrinsic evidence, prosecution history, and expert testimony.

Claim 4: delayed Cmax

Claim 4 requires minocycline to reach maximum blood concentration approximately 3.2 to 4.5 hours after administration.

This limitation is more difficult to evaluate from product labels alone. Bioequivalence studies, pharmacokinetic reports, regulatory submissions, and product testing may be required. A product with a materially earlier or later Cmax could avoid this dependent claim while still presenting risk under claim 1 if the broader “slow, continuous” limitation is met.

Claim 5: specified acne-related conditions

Claim 5 covers acne vulgaris, acne rosacea, acne conglobata, acne fulminans, gram-negative folliculitis, and pyoderma faciale.

The commercial significance is limited because FDA-approved minocycline products are generally labeled for acne vulgaris. The additional conditions may have greater relevance to off-label use, medical-information activities, or induced-infringement theories.

Claim 6: additional safety disclosures

Claim 6 requires information concerning gastrointestinal disorders, blurred vision, autoimmune syndromes, or adverse renal reactions.

This claim creates a potentially significant design-around path. A label that omits these categories, or provides safety information without a placebo comparison, may not satisfy the claim.

What patent expiration date applies to U.S. Patent 7,541,347?

The ordinary 20-year patent-term calculation is based on the relevant nonprovisional filing date, not the patent’s issue date. Public patent records identify the relevant application history as dating to December 23, 2005, with an earlier priority claim in the family. On that basis, the ordinary term endpoint is approximately December 23, 2025, subject to any patent-term adjustment or extension reflected in the official USPTO record.[1]

The patent issued on June 2, 2009. Issuance does not establish the expiration date.

Event	Date
Earliest cited family priority	December 2003 or December 2004, depending on the family record used
Relevant nonprovisional filing	December 23, 2005
Patent issued	June 2, 2009
Ordinary 20-year term endpoint	December 23, 2025
Pediatric extension	No pediatric extension is established by the claim information provided
Patent type	Small-molecule pharmaceutical patent

A definitive freedom-to-operate opinion should use the USPTO patent-term-adjustment record and the FDA Orange Book entry in effect for the relevant product and date. The ordinary term calculation does not by itself establish the effective commercial exclusivity date.

What is the Orange Book status of U.S. Patent 7,541,347?

U.S. Patent 7,541,347 has been associated with the Solodyn extended-release minocycline product and its regulatory patent disputes. The relevant Orange Book question is not only whether the patent appears in the database, but also:

• which NDA lists the patent;
• which strengths are covered;
• whether the listing is for drug substance, formulation, or method of use;
• the expiration date reported by FDA;
• whether a use code limits the listed indication;
• whether the patent remains active for the product at issue.

An Orange Book listing can support a Paragraph IV certification and trigger the Hatch-Waxman 30-month stay. It does not itself determine infringement or validity. The listing also does not mean that every generic version infringes every claim.

Which patents form the broader Solodyn patent estate?

The Solodyn estate included formulation and method patents beyond U.S. Patent 7,541,347. Public litigation involving Medicis and generic applicants identified foundational Solodyn patents, including U.S. Patent Nos. 7,211,267 and 7,232,572.[2]

Patent	General subject matter	Commercial role
U.S. 7,211,267	Extended-release or controlled-release minocycline technology	Foundational formulation protection
U.S. 7,232,572	Minocycline dosage-form and release technology	Formulation and product protection
U.S. 7,541,347	Acne treatment method using a defined 90 mg extended-release dosage form	Dosing, formulation, PK, and information method
Later continuation or related patents	Method, formulation, or regulatory-use claims	Potential secondary barriers, depending on listing and status

The first two patents were central to litigation over generic Solodyn products. Their terms were separate from the term of the ’347 patent and required individual analysis. A generic applicant could prevail against one patent while remaining blocked by another listed patent or settlement restriction.

How did Paragraph IV challenges affect Solodyn?

Generic applicants challenged Solodyn patents through abbreviated new drug applications and Paragraph IV certifications. Medicis brought patent litigation against generic applicants, including Actavis, in federal court. The Federal Circuit addressed validity and infringement issues involving the Solodyn patent estate in Medicis Pharmaceutical Corp. v. Actavis Mid-Atlantic LLC.[2]

The principal legal issues in this litigation included:

• obviousness of extended-release minocycline formulations;
• construction of formulation and release limitations;
• the relationship between pharmacokinetic properties and structural formulation limitations;
• whether generic products practiced claimed release characteristics;
• the effect of ANDA filings under the Hatch-Waxman framework.

A Paragraph IV certification is an allegation that an Orange Book-listed patent is invalid, unenforceable, or not infringed. It is not an adjudication. The generic applicant must establish its position through litigation, settlement, or an alternative regulatory outcome.

What generic entry risks exist for a product covered by the ’347 patent?

The main generic-entry scenarios are as follows.

Scenario 1: Literal noninfringement

A generic applicant may use a different matrix polymer, different excipient quantities, a different granulation process, or a different release profile. This is the cleanest design-around path because claim 1 contains multiple structural limitations.

Scenario 2: Label-based noninfringement

A generic label may omit the patented adverse-effect comparisons or use narrower patient information. The generic company may argue that the approved labeling does not instruct physicians or patients to perform the claimed method.

This strategy is constrained by FDA labeling requirements. A generic generally must match the reference product’s labeling, subject to permitted differences. That regulatory requirement can make method-of-use claims more difficult to avoid than purely optional promotional statements.

Scenario 3: Validity challenge

The accused company may challenge the claims under sections 102, 103, 112, or 116 of the Patent Act. Likely validity themes include:

• anticipation based on earlier controlled-release minocycline formulations;
• obviousness based on combining known hydrophilic matrix systems with lactose carriers;
• lack of written description for the exact excipient architecture;
• enablement challenges to the full claimed clinical and pharmacokinetic scope;
• indefiniteness involving “slow,” “continuous,” “about,” or the encapsulation/coating limitation.

The exact quantities and clinical-information limitation may support validity arguments if the prior art did not disclose the same combination. They may also narrow the claim enough to reduce practical infringement coverage.

Scenario 4: Settlement or licensed entry

A settlement can permit a generic launch before the patent’s ordinary expiration date. The entry date, supply restrictions, authorized-generic rights, and licensing terms depend on the agreement. Hatch-Waxman settlements may receive Federal Trade Commission review under applicable reporting requirements.[3]

How strong is the patent estate for generic minocycline?

The estate is stronger against a close copy of the reference product than against a substantially redesigned extended-release minocycline product.

Strength factors

• Exact composition and dosage-form limitations can map directly to regulatory product data.
• The claim combines formulation, dose, PK, treatment, and labeling elements.
• Once-daily acne treatment is commercially aligned with the reference product.
• FDA regulatory materials may provide evidence concerning formulation and intended use.
• Related Solodyn patents created cumulative litigation risk.

Weakness factors

• Claim 1 is highly crowded with limitations.
• The clinical-trial information requirement may complicate proof of method infringement.
• Functional terms such as “slow, continuous fashion” may require expert evidence.
• A generic can potentially alter excipient quantities or release architecture.
• A product can challenge the claims even if it remains bioequivalent to the reference product.
• The claims do not cover all minocycline products, all acne treatments, or all extended-release dosage forms.

Overall, the ’347 patent is best characterized as a targeted product-and-use patent rather than a broad platform patent.

Are biosimilar risks relevant to minocycline?

No. Minocycline hydrochloride is a chemically synthesized small-molecule active ingredient. Follow-on products are regulated as generics under the ANDA pathway, not as biosimilars under section 351(k) of the Public Health Service Act.

The relevant competitive threats are:

• ANDA applicants;
• authorized generics;
• alternative extended-release minocycline products;
• immediate-release minocycline products;
• branded acne therapies with different mechanisms;
• topical retinoids, benzoyl peroxide, clindamycin combinations, and isotretinoin.

How does the ’347 patent compare with formulation patents?

A formulation patent usually creates more predictable product-level infringement questions than a method claim requiring patient information.

Issue	’347 patent	Typical formulation patent
Primary subject	Method of treatment	Composition or dosage form
Exact excipients	Yes	Often yes
Patient conduct required	Yes	Usually no
Labeling evidence	Highly relevant	Relevant but less central
PK limitation	Included in dependent claim	May be structural or functional
Design-around potential	Moderate to high	Depends on claim breadth
ANDA litigation risk	Product plus labeling	Primarily product composition

The ’347 patent’s strongest enforcement position is against a generic whose formulation matches the specified matrix system and whose labeling or patient information reproduces the relevant clinical safety comparisons.

What manufacturing and geographic barriers apply?

The U.S. patent has territorial effect. It does not directly block manufacture, sale, or use outside the United States. International exposure depends on corresponding national patents and the status of each foreign family member.

Manufacturing records can be important because the claim distinguishes intragranular and extragranular components. Batch records, granulation instructions, excipient addition points, dissolution data, and bioequivalence reports may reveal whether an accused product practices the claimed architecture.

A manufacturer can reduce risk by using:

• a different matrix-forming polymer;
• a different carrier system;
• a different granulation sequence;
• a coating that does not encapsulate the intragranular blend;
• different excipient quantities;
• a release profile outside the claimed PK range;
• labeling that does not provide the claimed placebo-comparison information.

These changes must remain compatible with FDA requirements, bioequivalence standards, stability, dissolution, manufacturability, and product performance.

What is the commercial significance of the patent?

The patent’s commercial exposure is tied to the extended-release minocycline acne market and the reference product’s 90 mg strength. Revenue risk is greatest where a generic can reproduce the reference product’s dose, release profile, and labeling with minimal development changes.

The patent does not independently protect all Solodyn revenue. Commercial protection depended on the combined status of:

• the ’347 patent;
• related formulation patents;
• Orange Book listings;
• regulatory exclusivity;
• litigation outcomes;
• settlement terms;
• generic launch timing;
• authorized-generic strategy;
• physician and payer substitution behavior.

FDA approval of an ANDA does not automatically establish a right to launch. Patent certifications, court orders, settlements, and expiration dates determine the practical launch position.[4]

Key Takeaways

• U.S. Patent 7,541,347 claims a highly specific method using a 400 mg, 90 mg minocycline hydrochloride extended-release dosage form.
• The claim requires exact excipient amounts, intragranular and extragranular architecture, once-daily dosing, no loading dose, a defined weight-based dose, acne treatment, and patient safety information.
• Claims 2 through 6 narrow the scope through adverse-effect categories, 1.0 mg/kg/day dosing, delayed Cmax, specified acne conditions, and additional safety disclosures.
• The ordinary term calculation points to December 23, 2025, subject to official patent-term adjustment or extension records.
• The patent is stronger against a close Solodyn copy than against a redesigned extended-release minocycline product.
• Generic competition is governed by ANDA and Paragraph IV procedures, not biosimilar regulation.
• The broader Solodyn estate included earlier formulation patents, including U.S. Patent Nos. 7,211,267 and 7,232,572.
• The patient-information limitation creates both enforcement value and noninfringement opportunities.
• Orange Book listing, use codes, related patents, litigation outcomes, and settlement terms must be assessed together.

FAQs About U.S. Patent 7,541,347

Does U.S. Patent 7,541,347 cover all 90 mg minocycline products?

No. It covers a method using a specific 400 mg dosage form with defined excipient quantities, release architecture, dosing conditions, and patient information.

Can a generic avoid the ’347 patent by changing the hydroxypropyl methylcellulose amount?

Potentially. A different amount may avoid literal infringement, but the effect depends on claim construction, equivalents, prosecution history, and whether other related patents cover the redesigned formulation.

Is the Cmax limitation in claim 4 required for infringement of claim 1?

No. Claim 4 is dependent on claim 1. Claim 1 does not expressly require the 3.2-to-4.5-hour Cmax range, although it requires slow, continuous release.

Does a generic need to reproduce the reference product’s patient leaflet?

Not necessarily. The infringement analysis depends on the actual labeling, information materials, instructions, and method induced by the generic product.

Is U.S. Patent 7,541,347 a composition patent?

No. It is a method claim directed to administering a defined oral dosage form and providing specified clinical-trial safety information. The formulation limitations are embedded in the method claim.

References

1. United States Patent and Trademark Office. (2009). U.S. Patent No. 7,541,347, methods of treating acne.
2. Medicis Pharmaceutical Corp. v. Actavis Mid-Atlantic LLC, 694 F.3d 1150 (Fed. Cir. 2012).
3. Federal Trade Commission. (2023). Agreements filed with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.

Drugs Protected by US Patent 7,541,347

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-001	Jul 11, 2012		DISCN	No	No	7,541,347					TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-003	Jul 11, 2012		DISCN	No	No	7,541,347					TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Journey	XIMINO	minocycline hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	201922-005	Jul 11, 2012		DISCN	No	No	7,541,347					TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006		DISCN	Yes	No	7,541,347					TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS

International Family Members for US Patent 7,541,347

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2006262428
Canada	2613273
China	101208097
European Patent Office	1898925