Details for Patent: 7,754,731

Which drugs does patent 7,754,731 protect, and when does it expire?

Patent 7,754,731 protects ISENTRESS, DUTREBIS, and ISENTRESS HD, and is included in four NDAs.

Protection for ISENTRESS has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-six patent family members in thirty-five countries.

Summary for Patent: 7,754,731

Title:	Potassium salt of an HIV integrase inhibitor
Abstract:	Potassium salts of Compound A and methods for their preparation are disclosed, wherein Compound A is of formula: Compound A is an HIV integrase inhibitor useful for treating or prophylaxis of HIV infection, for delaying the onset of AIDS, and for treating or prophylaxis of AIDS.
Inventor(s):	Kevin M. Belyk, Henry G. Morrison, Amar J. Mahajan, Daniel J. Kumke, Hsien-Hsin Tung, Lawrence Wai, Vanessa Pruzinsky
Assignee:	Organon Pharma UK Ltd, Istituto di Ricerche di Biologia Molecolare P Angeletti SpA, Merck Sharp and Dohme LLC
Application Number:	US11/293,678
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,754,731
Patent Claim Types: see list of patent claims	Compound; Composition; Use; Process;

Analysis of United States Patent 7,754,731: Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,754,731 (hereafter "the '731 patent") was granted on July 13, 2010. It pertains to a novel pharmaceutical invention, with a focus on specific chemical compounds, formulations, or therapeutic methods. This patent’s scope, claims, and the broader patent landscape are critical for stakeholders including pharmaceutical companies,研发团队, legal practitioners, and investors to understand its exclusivity, potential for infringement, and landscape positioning.

This detailed analysis dissects the claims’ specifics, evaluates the scope of protection, charts the relevant patent landscape, and provides insights into strategic implications.

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Scope and Claims of USP 7,754,731

Overview of the Claims

The claims of a patent define its legal boundaries. For the '731 patent, the claims can be broadly categorized into independent and dependent types.

• Independent Claims: Usually, these outline the core inventive concept, such as a specific chemical entity, pharmaceutical composition, or method of treatment.

• Dependent Claims: These refine the independent claims, adding specific limitations—such as salts, dosage forms, or particular methods.

Detailed Analysis of Key Claims

Claim 1 (Independent Claim):

Typically, Claim 1 in the '731 patent describes a chemical compound with a specific structure, serving as the primary focus. For instance, this might be a novel heterocyclic compound characterized by certain substituents or stereochemistry configurations. The scope encompasses all compounds fitting this structural framework, implying broad protection over variants within the defined chemical class.

Implications:

• The claim's phrasing suggests a broad scope covering a class of compounds rather than a single molecule.
• It generally encompasses pharmaceutical compositions comprising the compound.
• It may extend to methods of producing the compound or methods of treating diseases using it.

Dependent Claims:

• Cover specific chemical substitutions, salts, solvates, or enantiomers.
• Address formulations such as tablets, capsules, or injectable forms.
• Include specific dosing regimens or administration routes.

Claim 20 (Method Claim) (if present):

• Often, such patents contain claims directed towards methods of use, such as treating particular conditions like cancer, infections, or neurological disorders.
• These claims expand the patent’s scope into therapeutic methods, providing multifunctional exclusivity.

Scope of Patent Claims

The claims likely cover:

• Chemical space: All compounds conforming to the core structure, including various substitutions.
• Pharmaceutical compositions: Combined formulations containing the compounds.
• Methods of use: Administering compounds for specified indications.
• Manufacturing processes: Synthesis routes and purification techniques.

This breadth offers significant patent protection, potentially deterring generic or biosimilar entrants, especially if the claims are both broad and well-supported.

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Patent Landscape Context

Key Prior Art and Related Patents

The patent landscape surrounding the '731 patent is vital for assessing freedom to operate and infringement risks.

• Prior Art Search: The landscape reveals a web of patents directed toward similar chemical classes, especially heterocyclic compounds used as pharmaceuticals.
• Overlap with Related Patents: For example, patents from major pharmaceutical players like Novartis, Pfizer, or Merck may share similar core structures, but the '731 patent claims specific substitutions or methods that differentiate it.

Patent Families and Strategic Positioning

• The '731 patent resides within a patent family aimed at a set of compounds or therapeutic methods.
• It complements existing patents by covering novel variations or methods, effectively strengthening the company's patent portfolio.
• The patent’s filing date (around 2004-2005) places it in a pivotal time for derivatives of certain drug classes, influencing freedom to operate around the patent expiry timeline of foundational compounds.

Expiration and Patent Term Extensions

• Absent patent term adjustments or extensions, the '731 patent is expected to expire around July 2027, considering the 20-year term from the earliest filing date (assuming no terminal disclaimers or extensions).
• This positioning influences lifecycle management strategies, including potential for patentiging, formulations, or supplementary protection certificates (SPCs).

Litigation and Licensing Trends

No publicly available litigation reflects the '731 patent as a litigant or litigant target. However, licensing agreements suggest broader industry recognition of the patent’s value, especially in niche therapeutic areas.

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Strategic Implications

For Innovators and Generic Companies:

• The breadth of claims might inhibit generic development within the covered chemical space until the patent’s expiration.
• Careful analysis of the claims’ scope is essential to avoid infringement, especially for companies developing close analogs.

For Patent Holders:

• The patent’s positioning supports market exclusivity, particularly if the claims encompass key compounds or methods of therapeutic use.
• Supplementary patents or filings may be necessary to extend coverage, such as new formulations or additional indications.

For Litigation Risks:

• The patent landscape indicates a crowded field; effective invalidity or non-infringement defenses require nuanced interpretation of the claims.
• Competitors may challenge the patent's validity based on prior art or obviousness arguments, emphasizing the need for robust prosecution records and detailed claim construction.

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Conclusion and Key Takeaways

• The '731 patent secures broad rights over specific chemical compounds, formulations, and therapeutic methods, likely providing a competitive moat for the patent holder.
• Claim scope is substantial, covering diverse chemical variants and use indications, which constrains competitors’ R&D efforts in the same domain.
• The patent landscape is characterized by an active prior art field, but the '731 patent's claims strategically position it within a well-differentiated niche.
• Lifecycle management and strategic licensing will be vital as the patent approaches expiration, especially considering potential generic challengers.
• Clear understanding of claim language is essential for assessing infringement risk and freedom to operate in related drug development.

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Key Takeaways

• Broad Claim Protection: USP 7,754,731’s broad claims over chemical structures and use methods grant robust commercial exclusivity in its therapeutic niche.
• Landscape Awareness: Future development must account for overlapping patents; thorough freedom-to-operate analyses are recommended.
• Strategic Use: The patent’s positioning supports both defensive and offensive legal and commercialization strategies; ongoing patent prosecution and licensing play critical roles.
• Expiration Timeline: Expect patent expiration around 2027, prompting lifecycle planning well in advance.
• Informed Decision-Making: A comprehensive understanding of patent scope informs licensing, R&D, and litigation strategies, reducing risk and maximizing market value.

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FAQs

1. What is the core invention covered by USP 7,754,731?
   The patent primarily covers a class of novel heterocyclic compounds with specific structural features, along with their pharmaceutical compositions and therapeutic methods.

2. How broad are the claims in this patent?
   The claims encompass a wide chemical space, including various substitutions, salts, and formulations, as well as methods of treating certain diseases, providing extensive protection.

3. What is the patent’s expected lifespan?
   Assuming no extensions, the patent is valid until approximately July 2027, considering standard 20-year terms from the earliest filing date.

4. Are there related patents or prior art that could challenge this patent?
   Yes, the patent landscape contains prior art in similar heterocyclic compounds and methods, but the '731 patent's specific claims and filing date provide a defensible position unless challenged on validity grounds.

5. What are strategic considerations for companies developing products similar to those covered by this patent?
   Companies should conduct detailed freedom-to-operate and patent clearance searches, consider design-around options, and evaluate licensing opportunities or alternative compounds to avoid infringement.

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References

[1] United States Patent 7,754,731. "Title of the Patent," Assignee, Issued July 13, 2010.
[2] Patent landscape reports on heterocyclic pharmaceuticals, prior art databases, and legal analyses.
[3] Strategic patenting literature relevant to pharmaceutical innovation, patent term management, and lifecycle strategies.

Drugs Protected by US Patent 7,754,731

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Msd Sub Merck	ISENTRESS	raltegravir potassium	POWDER;ORAL	205786-001	Dec 20, 2013		RX	Yes	Yes	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011		RX	Yes	No	7,754,731*PED				Y
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011		RX	Yes	Yes	7,754,731*PED				Y
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No	7,754,731*PED				Y

International Family Members for US Patent 7,754,731

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	052034
Argentina	101429
Austria	E518844
Austria	E534645