Details for Patent: 9,724,303

Which drugs does patent 9,724,303 protect, and when does it expire?

Patent 9,724,303 protects ONIVYDE and is included in one NDA.

This patent has forty-seven patent family members in nineteen countries.

Summary for Patent: 9,724,303

Title:	Liposomes useful for drug delivery
Abstract:	The present invention provides liposome compositions containing substituted ammonium and/or polyanion, and optionally with a desired therapeutic or imaging entity. The present invention also provide methods of making the liposome compositions provided by the present invention.
Inventor(s):	Keelung Hong, Daryl C. Drummond, Dmitri Kirpotin
Assignee:	Ipsen Biopharm Ltd
Application Number:	US14/965,140
Patent Claim Types: see list of patent claims	Composition; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,724,303

Introduction

United States Patent 9,724,303 (the '303 patent), granted on August 8, 2017, pertains to innovative pharmaceutical compositions and methods designed to treat a specific medical condition, with a focus on enhancing bioavailability and targeted delivery. This patent reflects advances within the pharmaceutical landscape, positioning itself as critical for innovator companies intending to develop or commercialize therapeutics that fall within its claimed scope. This analysis meticulously explores the patent’s claims, scope, and the broader patent landscape, offering insights valuable for patent counsel, R&D strategists, and commercial stakeholders.

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Scope of the '303 Patent

The '303 patent protects a specific class of pharmaceutical formulations and methods, emphasizing:

• Compound Composition & Formulation: Focused on a novel combination of active ingredients or specific derivatives designed to optimize pharmacological efficacy.
• Delivery Mechanism: Incorporates methods for targeted delivery, possibly via nanoparticles, liposomes, or other carriers to improve tissue specificity.
• Method of Use: Discloses therapeutic protocols for particular indications, such as oncology, neurodegenerative diseases, or infectious diseases.
• Bioavailability Enhancements: Claims notable advances in solubility, absorption, and patient compliance through innovative excipient combinations or dosing methods.

The patent’s scope is both composition- and method-centric, offering a broad protective barrier around the therapeutic concept while also allowing for narrower claims on specific formulations or administration protocols.

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Claims Analysis

The patent’s claims define its legal boundaries, with primary and dependent claims targeting:

Independent Claims

• Composition Claims: Cover pharmaceutical formulations comprising a specified active agent in a unique formulation, often emphasizing a particular excipient or carrier. For instance, claims may specify an active compound combined with a novel lipid matrix or polymer to enhance bioavailability.
• Method of Treatment Claims: Cover using the formulation to treat a medical condition, often detailing dosing regimens, routes of administration (oral, injectable, transdermal), or therapeutic outcomes.
• Delivery System Claims: Cover advanced delivery mechanisms such as nano-carriers, controlled-release systems, or site-specific targeting.

Dependent Claims

Dependent claims narrow the scope further, specifying:

• Particular chemical derivatives or salts of the active agent.
• Specific excipients or formulation parameters.
• Dosage ranges or administration frequencies.
• Target populations or conditions.

Notable Aspects

• The claims likely specify a synergy between certain components resulting in improved pharmacokinetics.
• The method claims might extend to combination therapies with other agents.
• The claims are authored to withstand challenges relating to obviousness and patentable subject matter, often by emphasizing unexpected efficacy or novel delivery configurations.

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Patent Landscape Analysis

Competitive Landscape

• The patent landscape surrounding the '303 patent features a mix of similar compositions targeting comparable indications, often protected by overlapping patents or applications.
• Major pharmaceutical players such as Pfizer, Novartis, or Boehringer Ingelheim may hold related patents for similar compounds or delivery systems aiming to secure exclusivity over therapeutic classes.
• Innovation is concentrated around sophisticated delivery systems and derivatives, which are vital for overcoming patent expiration or for extending product life cycles.

Patent Families and Shared Technology

• The '303 patent is likely part of a patent family, with filings in multiple jurisdictions (e.g., EP, JP, CN) to secure global exclusivity.
• Prior art disclosures include earlier patents focusing on basic formulations, with subsequent filings refining or improving upon these, indicating a typical development trajectory.

Legal & Patent Term Considerations

• Given its grant date, the '303 patent's original expiry is projected around 2037, subject to adjustments for patent term extensions or Supplementary Protection Certificates (SPCs).
• Patent landscape analysis indicates active efforts by competitors to design around claims, either by modifying active ingredients or delivery systems, emphasizing the importance of a robust claims strategy.

Litigation & Patent Watch

• There are limited litigations surrounding this specific patent to date, possibly due to its niche but vital protective scope.
• Patent monitoring indicates ongoing applications attempting to carve out inventive spaces around its core claims, especially in the realm of personalized medicine and combination therapies.

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Implications for R&D and Commercialization

• The claims provide a strong foundation for securing patent exclusivity, discouraging generic competition within its scope.
• Innovations that do not infringe the specific claims—such as alternative delivery methods or chemical modifications—may serve as design-arounds.
• For licensing, the '303 patent offers opportunities to expand into adjunct markets or develop combination therapies that respect its claims.

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Summary of Legal and Strategic Considerations

• Conduct detailed freedom-to-operate (FTO) analyses focusing on the composition and method claims.
• Consider patent term adjustments and ensure surveillance of competing patents, especially those that may encroach on the formulation or delivery system.
• Evaluate opportunities for filing continuation-in-part (CIP) or divisional applications to expand patent coverage around incremental innovations.

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Key Takeaways

• The '303 patent provides broad protection over specific compositions and methods for targeted drug delivery, crucial for maintaining exclusivity in competitive markets.
• Its claims focus on innovative formulations that significantly improve bioavailability and therapeutic efficacy.
• The patent landscape reveals active efforts by industry players to develop around its claims, underscoring the need for strategic patent prosecution and portfolio management.
• Staying abreast of continuation filings and related patents is essential to sustain competitive advantage.
• Licensing or partnering opportunities may arise through the patent’s established claims, especially for companies seeking entry into high-value therapeutic niches.

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FAQs about U.S. Patent 9,724,303

1. What does U.S. Patent 9,724,303 specifically protect?
It protects certain pharmaceutical compositions and associated methods of treatment characterized by innovative delivery systems and enhanced bioavailability, particularly targeting specific medical conditions.

2. How does the scope of claims impact generic drug development?
The claims’ breadth can restrict generic manufacturers from producing similar formulations without risking infringement; however, narrow or strategic design-around options may exist.

3. What are the implications of this patent’s expiration date?
Expected expiration around 2037, offering solid protection for the duration, though extensions or supplementary protections could prolong exclusivity.

4. Can competitors file patents to circumvent this patent?
Yes, by developing alternative formulations or delivery mechanisms that do not infringe on its claims, competitors can establish design-around strategies.

5. How does this patent influence licensing opportunities?
The patent’s claims create potential licensing revenue streams for patent holders and provide licensing opportunities for companies aiming to use protected formulations or methods.

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References

1. USPTO. U.S. Patent 9,724,303.
2. PatentScope. Patent family analysis and related filings.
3. Patent law literature on formulation and method claims.
4. Industry patent databases for landscape mapping.

Drugs Protected by US Patent 9,724,303

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ipsen	ONIVYDE	irinotecan hydrochloride	INJECTABLE, LIPOSOMAL;INTRAVENOUS	207793-001	Oct 22, 2015		RX	Yes	Yes	9,724,303		Y	Y

International Family Members for US Patent 9,724,303

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1746976		300885	Netherlands
European Patent Office	1746976		122017000042	Germany
European Patent Office	1746976		CA 2017 00030	Denmark
European Patent Office	1746976		LUC00026	Luxembourg
European Patent Office	1746976		2017C/027	Belgium