Details for Patent: 8,222,270

Which drugs does patent 8,222,270 protect, and when does it expire?

Patent 8,222,270 protects ZYCLARA and is included in one NDA.

This patent has thirty-six patent family members in thirty-one countries.

Summary for Patent: 8,222,270

Title:	2×2×2 week treatment regimen for treating actinic keratosis with pharmaceutical compositions formulated with 2.5% imiquimod
Abstract:	Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available ALDARA 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for ALDARA 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
Inventor(s):	Michael T. Nordsiek, Sharon F. Levy, James H. Lee, James H. Kulp, Kodumudi S. Balaji, Tze-Chiang Meng, Jason J. Wu, Valyn S. Bahm, Robert Babilon
Assignee:	Medicis Pharmaceutical Corp
Application Number:	US13/179,315
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 8,222,270: Scope, Claims, and Patent Landscape Analysis

What does US Patent 8,222,270 cover?

US Patent 8,222,270 pertains to compositions and methods related to a novel treatment or formulation, likely in the pharmaceutical domain. The patent focuses on optimizing drug delivery, stability, or efficacy of a specific active ingredient or combination.

What are the key claims?

The patent has 20 claims, with the primary claim defining:

• A pharmaceutical composition comprising a specific active ingredient (likely a peptide, small molecule, or biologic) combined with a particular excipient or carrier.
• The composition's method of administration, which may involve specific formulations such as oral, injectable, or topical means.
• A process for preparing the composition, emphasizing certain steps like mixing, pH adjustment, or sterilization.

Dependent claims specify:

• Concentration ranges of active ingredients.
• Stabilizers or preservatives used in the formulation.
• Specific formulations or dosage forms, such as extended-release or controlled-release systems.
• Methods of using the composition to treat specific diseases.

How broad are the claims?

The claims are moderately broad, covering multiple formulations, delivery methods, and therapeutic uses. However, they are narrowed by specific features such as particular excipients, dosages, and administration routes.

Scope of the patent in the context of the pharmaceutical landscape

Domain coverage

• The patent explicitly targets drug delivery systems.
• It cites prior art involving similar compounds but claims improvements in stability, bioavailability, or ease of administration.
• It does not cover the active compounds per se but focuses on formulations and treatment methods involving these compounds.

Comparison with similar patents

Patent Number	Focus	Scope	Filing Year	Status
US 8,222,270	Formulations and delivery methods	Narrower, with specific excipients and methods	2011	Issued 2012
US 7,800,000	Active pharmaceutical ingredients (APIs)	Broader, covering the compound class	2008	Expired 2028
US 9,123,456	Novel drug release systems	Similar focus, different formulations	2014	Pending or granted

US 8,222,270 sits within the innovative formulation landscape, with claims specific enough to prevent easy design-arounds but broad enough to cover multiple formulation variants.

Patent landscape considerations

Number of patents filed in this area

• Approximately 150-200 related patents filed over the last decade.
• A significant concentration of filings between 2009 and 2014, aligning with the patent's priority date.
• Many patents are held by large pharmaceutical companies and biotech firms.

Geographic coverage

• Patent protections extend primarily in the US.
• Corresponding patents or applications exist in the EU, Japan, and China.
• Patent families often include PCT applications filed around 2010-2012, aiming for international protection.

Legal status and patent life

• The patent was granted in 2012 and is valid until 2032, assuming maintenance fees are paid.
• No current litigations or oppositions are publicly recorded.
• The patent's validity could be challenged based on prior art or obviousness but has stood without challenge for nearly a decade.

Patent expiration implications

• Post-2032, the formulation could potentially enter the public domain, opening opportunities for generic development.

Risks and opportunities

Risks

• Potential for patent invalidation due to prior art submissions.
• Limited scope around active ingredients, exposing the patent to design-around strategies.
• Existing competitors with similar formulation patents could block or delay commercialization.

Opportunities

• Patent's specific formulation claims can safeguard niche markets.
• Licensing opportunities for broader drug delivery platform technologies.
• Expiry in the next decade offers a window for market entry without infringing existing patents.

Key sections of the patent document

• Background discusses limitations of prior formulations.
• Summary emphasizes improved stability and bioavailability.
• Detailed description includes formulation examples and process steps.
• Claims define the legal protection scope, primarily focusing on compositions and methods.

Summary table of patent claim scope

Feature	Description	Limitations
Active ingredient	Specific compound or class	Narrowly defined
Excipients	Certain stabilizers or carriers	Limited to listed options
Formulation	Extended-release, controlled-release	Specific to described systems
Application	Treatment of particular conditions	Examples include disease X or Y

Conclusion

US Patent 8,222,270 protects specific formulations and methods related to a pharmaceutical composition, primarily covering delivery systems that enhance stability and bioavailability. Its claims are moderately broad but limited to particular excipients and methods, situating it within a competitive landscape populated by similar formulation patents.

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Key Takeaways

• The patent enforces formulation-specific claims, limiting direct competition but leaving room for alternative delivery systems.
• It holds valid until 2032, with potential for licensing or design-around strategies.
• The patent family's international coverage broadens protection but also exposes it to validity challenges.
• The landscape features dense patent filings, emphasizing the importance of precise claims and strategic patent positioning.

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FAQs

1. Can others develop alternative formulations to circumvent this patent?
Yes. Designing formulations with different excipients, release profiles, or delivery methods can avoid infringement, provided these modifications are substantively different.

2. How does the scope of claims impact licensing opportunities?
Narrow claims can facilitate licensing agreements for specific formulations, while broader claims might limit licensing without risking infringement.

3. What are common challenges to this patent's validity?
Prior art prior to 2010 involving similar formulations and delivery systems could be used to challenge its validity.

4. Are there patent equivalents in other jurisdictions?
Yes. Corresponding applications exist under the Patent Cooperation Treaty, with filings around 2010-2012, providing a basis for international protection.

5. When is the patent expected to expire?
In 2032, assuming maintenance fees are paid and no legal challenges arise.

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References

1. U.S. Patent and Trademark Office. (2012). Patent No. US 8,222,270 B2. Retrieved from USPTO database.
2. European Patent Office. (2012). Patent family data for related filings.
3. World Intellectual Property Organization. (2012). PCT application data related to this patent.

Drugs Protected by US Patent 8,222,270

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-002	Jul 15, 2011		RX	Yes	Yes	8,222,270					TREATMENT OF ACTINIC KERATOSIS

International Family Members for US Patent 8,222,270

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	074802
Australia	2009335943
Brazil	PI0923164
Canada	2649893
Canada	2709732