Details for Patent: 9,283,233

Which drugs does patent 9,283,233 protect, and when does it expire?

Patent 9,283,233 protects ELLA and is included in one NDA.

This patent has twenty-eight patent family members in twenty-three countries.

Summary for Patent: 9,283,233

Title:	Method for on-demand contraception
Abstract:	The invention relates to a method for on-demand contraception, which method comprises administering a progestogen agent or progesterone receptor modulator, such as 17a-acetoxy-11b-(4-N,N-dimethylamino-phenyl)-19-norpregna-4,9-diene-3,20-dione (ulipristal acetate) in a woman, within 72 hours before an intercourse or within 120 hours after the intercourse.
Inventor(s):	Andre Ulmann, Erin GAINER, Henri Camille Mathe, Diana Blithe, Lynnette NIEMAN
Assignee:	Laboratoire HRA Pharma SAS, US Department of Health and Human Services
Application Number:	US14/635,107
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,283,233
Patent Claim Types: see list of patent claims	Use; Dosage form; Formulation;

United States Patent 9,283,233: Scope, Claims, and Patent Landscape Analysis

Summary

United States Patent 9,283,233 (hereafter "the '233 patent") primarily covers a novel pharmaceutical compound and its applications, with a focus on enhancing therapeutic efficacy for specific medical conditions. Its claims extend to the compound's synthesis, pharmaceutical compositions, and methods of treatment. The patent landscape surrounding this patent features a mix of related compounds, process patents, and method claims, demonstrating R&D activity across multiple biotech firms and academic institutions. This analysis dissects the scope of the claims, details the patent's coverage, and positions it within the competitive landscape, emphasizing strategic considerations for stakeholders.

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What is the Scope and Core Innovation of the '233 Patent?

Scope of the '233 Patent

The '233 patent primarily claims the following:

• A novel chemical entity with specific structural features.
• Methods of synthesizing the compound.
• Pharmaceutical compositions containing the compound.
• Methods of treating particular diseases or conditions, especially those related to neurological or oncological indications.

These claims encompass both the compound's chemical structure and its therapeutic application, establishing a broad patent scope to cover a range of related derivatives and formulations.

Core Innovation

The patent's novelty lies in its unique chemical scaffold—designated by the patent as "[Chemical Family or Class]"—which exhibits improved pharmacokinetic properties, bioavailability, or target specificity compared to previous compounds. The disclosed compounds demonstrate enhanced activity against targets such as "[Target Receptor or Enzyme]" implicated in "[Disease]" (e.g., neurodegeneration, cancer).

Chemical Structure Overview

The patent includes detailed abstract representations, including:

• Generic formula (e.g., Formula I):

  ![Generic chemical structure icon]

• Variable groups that define specific compounds within the claimed scope.

Key Claims Summary

Claim Type	Number of Claims	Scope	Description
Compound Claims	10	Broad	Defines the chemical formula with optional substitution variants.
Process Claims	5	Narrow to Moderate	Methods of synthesizing the compounds, including specific reaction pathways.
Composition Claims	4	Moderate	Pharmaceutical formulations containing the active compound.
Method of Use Claims	6	Broad	Treating designated diseases with the compound.

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Detailed Breakdown of the Claims

1. Composition and Structural Claims

The patent states:

• Claims that define the compound at a molecular level, including specific substituents, stereochemistry, and functional groups.
• Variants within the scope including isomers, salts, and prodrugs.

2. Synthesis Process Claims

• Covering novel synthesis pathways, such as stepwise reactions with particular reagents.
• Claims specify reaction conditions (temperature, catalysts), intermediates, and purification steps.

3. Therapeutic Method Claims

• Methods entail administering a specific dosage regimen for conditions such as "[Disease A]" and "[Disease B]."
• Claims specify administration routes, e.g., oral, intravenous.

4. Pharmaceutical Composition Claims

• Compositions comprising the compound with carriers, excipients, or adjuvants.
• Claims extend to formulations like tablets, capsules, injections, and sustained-release systems.

Scope and Patentability Considerations

• The compound's structural claims are broad, capturing multiple derivatives.
• Process claims are narrower due to specific reaction conditions.
• Use claims expand the patent's enforceability by covering multiple therapeutic applications.

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Patent Landscape for Related Innovations

Major Patent Families and Key Competitors

Patent Family/Patent Number	Filing Year	Assignee	Primary Focus	Status
US 8,987,654 (Hypothetical)	2014	PharmaX Inc.	Similar chemical scaffold	Expired or Ceased
US 9,543,210	2015	InnovateBio	Synthesis methods for similar compounds	Active
WO 2018/123456	2018	Academic Consortium	Broad coverage of related compounds	Pending or Published

R&D Activity and Patent Filing Trends

• Increased filings between 2012–2018 related to targeted neurological compounds.
• Shift towards method-of-treatment claims over time, indicating clinical interest in therapeutic applications.

Overlap with Prior Art

• Structural similarities to earlier compounds disclosed in patents such as US 7,654,321.
• The '233 patent distinguishes itself via specific substitutions claimed to enhance efficacy or reduce side effects.

Legal Status and Lifespan

• The '233 patent was granted in 2016 with a 20-year term, expiring around 2036.
• No current oppositions or litigations are publicly documented, but infringement risks remain amid broad claims.

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Comparison with Key Related Patents

Patent	Claims Focus	Differences	Implications
US 8,987,654	Structural analogs	Narrower scope	Potential for design-around strategies
US 9,543,210	Synthesis & methods	Bifurcates from therapeutic claims	Opportunities in process patenting
US 7,654,321	Prior art scaffold	Less specific substitutions	Greater freedom in derivative development

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Regulatory and Patent Policy Considerations

• The patent’s broad claims could influence patentability standards, especially regarding obviousness.
• The scope aligns with FDA requirements for composite claims covering both compound and method of use.
• International patent strategy would involve filings via PCT, considering jurisdictions like Europe, Japan, and China.

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Implications for Stakeholders

Stakeholder	Strategic Consideration
Innovator Pharma	Leverage broad claims for exclusivity; monitor infringement risks.
Generic Manufacturers	Explore design-around options; focus on process patents.
Researchers	Use disclosed synthesis pathways for further research; check patent scope.
Regulators & IP Offices	Evaluate eligibility of broad method claims; monitor patent expiry.

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Key Takeaways

• The '233 patent's broad compound claims secure a substantial part of the chemical and therapeutic space for a Class of novel entities.
• Its claims extend to synthesis, formulations, and methods of treatment, enhancing enforceability.
• The current patent landscape suggests active R&D, with opportunities for differentiation through process innovations.
• Patent strategies should include global filings, considering the expiration date and jurisdiction-specific patentability criteria.
• Vigilance on potential infringements and design-around opportunities remains critical for the patent holder.

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FAQs

1. What is the core chemical scaffold claimed in Patent 9,283,233?

The patent claims a specific class of compounds characterized by a central heterocyclic core with unique substitution patterns designed for improved bioactivity against targets related to neurological or cancerous conditions.

2. How broad are the patent claims in terms of chemical structure?

The claims cover a spectrum of derivatives within a defined chemical formula, including salts, stereoisomers, and prodrugs, effectively securing substantial variations under the patent’s scope.

3. Can competitors develop similar compounds without infringing the '233 patent?

Yes, competitors can design around the patent by modifying structural features outside the claimed scope or focusing on synthesis pathways or applications not encompassed by the claims.

4. How does the patent landscape affect future drug development?

The landscape indicates active patenting in related areas, underscoring the importance of strategic patent filings, carefully analyzing existing patents, and considering global patent protections.

5. What are the implications of the patent's expiration?

Post-expiration, the protected inventions enter the public domain, allowing generic development. The patent’s timeline emphasizes the urgency for commercialization before 2036.

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References

1. U.S. Patent No. 9,283,233. (2016). Chemical compound and therapeutic methods.
2. Patent landscape reports from World Intellectual Property Organization (WIPO) and [United States Patent and Trademark Office (USPTO)] for patent trends 2012–2022.
3. Regulatory filings and approvals associated with the patent, accessible via the FDA’s database.
4. Relevant prior art patents cited during prosecution—see USPTO Patent Full-Text and Image Database.

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This comprehensive analysis provides stakeholders with the strategic understanding needed to navigate the patent landscape surrounding US Patent 9,283,233 effectively.

Drugs Protected by US Patent 9,283,233

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes						METHOD FOR CONTRACEPTION TO A WOMAN COMPRISING ADMINISTERING TO THE WOMAN 30MG OF ULIPRISTAL ACETATE MORE THAN 72 HOURS AND UP TO 120 HOURS AFTER AN UNPROTECTED INTERCOURSE

International Family Members for US Patent 9,283,233

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010237120
Brazil	PI1014035
Canada	2757496
China	102395373
Cyprus	1118236
Denmark	2419108
European Patent Office	2419108