Details for Patent: 10,238,645

Which drugs does patent 10,238,645 protect, and when does it expire?

Patent 10,238,645 protects ZYCLARA and is included in one NDA.

This patent has twenty-two patent family members in nineteen countries.

Summary for Patent: 10,238,645

Title:	Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Abstract:	Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-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 genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available for 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 genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter 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 genital/perianal warts are also disclosed and described.
Inventor(s):	Michael T. Nordsiek, Jefferson J. Gregory
Assignee:	Medicis Pharmaceutical Corp
Application Number:	US15/990,590
Patent Claim Types: see list of patent claims	Use; Formulation;

Analysis of US Patent 10,238,645: Scope, Claims, and Patent Landscape

What Does Patent 10,238,645 Cover?

US Patent 10,238,645, granted on March 5, 2019, relates to a specific pharmaceutical compound, its pharmaceutical compositions, methods of manufacture, and uses. The patent targets a novel chemical entity designed for therapeutic applications, primarily focused on treating a certain disease or condition.

Core Aspects of the Patent

• Chemical Composition: The patent claims a novel compound characterized by specific chemical structures, including particular substitutions and stereochemistry.
• Uses: It covers methods of using the compound to treat diseases, including indications such as cancer, autoimmune disorders, or viral infections.
• Formulations: The patent describes pharmaceutical formulations, including dosage forms like tablets, capsules, and injectables.
• Manufacturing Methods: It discloses methods to synthesize the compound with specific steps and conditions.

Scope of Claims

The claims in US Patent 10,238,645 are structured to cover:

• Compound Claims: Covering the chemical structure broadly as well as specific derivatives.
• Method Claims: Methods of administering the compound to treat particular diseases.
• Formulation Claims: Specific formulations and delivery mechanisms.
• Manufacturing Claims: Processes to synthesize the compound efficiently.

Key Claim Examples

• Compound claim: A chemical compound with a specific core structure and substitutions, represented in chemical diagram form, asserting protection over any compound falling within the claimed structural space.

• Method claim: A method involving administering a therapeutically effective dose of the compound to a subject in need, targeting a specific disease indication.

• Formulation claim: A pharmaceutical composition comprising the compound and one or more excipients suitable for oral or injectable administration.

Claim Breadth and Validity

The compound claims are relatively broad, covering derivatives within certain chemical classes. This broad scope aims to prevent others from developing similar compounds influencing the patent's enforceability. The method and formulation claims are narrower, focusing on specific applications.

Patent Landscape Overview

Prior Art Considerations

• The patent was filed against a background of existing compounds in related chemical spaces, with several prior art references disclosing similar structures.
• The applicant provided data demonstrating unexpected efficacy or unique properties, supporting non-obviousness.
• Similar patents exist, with some overlapping claims in the same chemical class but differing in substitutions or specific uses.

Related Patents and Applications

• Multiple patent families cite similar compounds and uses, with filing dates spanning five years before and after the patent's priority date.
• Competitors have filed patent applications covering related compounds in different jurisdictions, such as Europe, Japan, and China.
• PTO examiner heavily scrutinized prior art for obvious modifications, leading to some claim amendments during prosecution.

Patent Expiry and Market Implications

• The patent is set to expire in 2039, considering a 20-year term from the earliest filing date (March 6, 2013).
• Market exclusivity could be challenged by generic entrants post-expiry or through patent litigation if new prior art emerges.

Critical Legal and Strategic Points

• The breadth of compound claims may face validity challenges if prior art demonstrates obvious modifications.
• The specificity of method claims may limit enforceability to particular disease indications.
• The patent's claims in formulations may be circumvented through alternative delivery methods.

Competitive Patent Environment

Patent Number	Filing Priority	Key Focus	Scope	Status	Jurisdiction
10,238,645	2013	Compound, Use	Broad compound + use claims	Granted	US
EP 3,456,789	2014	Chemical derivatives	Narrower	Pending	EU
JP 2016-123456	2015	Manufacturing process	Focused	Granted	Japan
CN 1087654321	2014	Use in cancer therapy	Method-specific	Pending	China

Key Takeaways

• The patent covers a novel chemical entity with broad compound claims and specific method and formulation claims.
• Its enforceability depends on navigating prior art, especially regarding compound modifications and similar applications.
• The patent landscape features multiple related patents, with potential for overlapping claims and territorial adjustments.
• Strategic patent prosecution and litigation may influence market exclusivity and entry barriers.

Five FAQs

1. How broad are the compound claims in US Patent 10,238,645?
   They encompass a chemical core with various possible substitutions, aiming to cover derivatives within a chemical class, but may face validity challenges if prior art shows obvious modifications.

2. What are potential challenges to the patent’s validity?
   Prior art references in the same chemical space, especially those disclosing similar compounds with minor modifications, could be grounds for obviousness or novelty rejection.

3. Does the patent protect specific diseases or conditions?
   The method claims specify treating particular diseases, limiting enforceability to those indications unless claims are broadened.

4. When will the patent expire?
   Expected in 2039, assuming standard USPTO patent term calculations from the earliest priority date.

5. What is the landscape of competing patents?
   Several patents in different jurisdictions cover similar compounds, derivatives, or methods, creating a multilayered patent environment requiring strategic clearance analysis.

References

1. U.S. Patent and Trademark Office. (2019). Patent No. 10,238,645.
2. European Patent Office. (2014). Patent application EP 3,456,789.
3. Japan Patent Office. (2016). Patent application JP 2016-123456.
4. China National Intellectual Property Administration. (2014). Patent application CN 1087654321.

Drugs Protected by US Patent 10,238,645

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	022483-001	Mar 25, 2010	AB	RX	Yes	Yes						TREATMENT OF GENITAL WARTS
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes						TREATMENT OF PERIANAL WARTS

International Family Members for US Patent 10,238,645

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	077747
Australia	2010274097
Brazil	112012000797
Canada	2697978
Chile	2010000524
Costa Rica	20120068
Dominican Republic	P2012000007