United States Patent 7,115,564: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,115,564, titled "Dalbavancin compositions for treatment of bacterial infections," is a significant patent in the field of pharmaceuticals, particularly in the treatment of bacterial infections. This patent, assigned to Vicuron Pharmaceuticals Inc. (now part of Pfizer), covers crucial aspects of dalbavancin, a semi-synthetic glycopeptide antibiotic.
Background
Dalbavancin, also known as BI 397 or VER001, is designed to treat bacterial infections, including those caused by antibiotic-resistant strains such as MRSA (Methicillin-resistant Staphylococcus aureus)[3][4].
Scope of the Patent
Compositions and Methods
The patent describes compositions and methods for the treatment of bacterial infections using dalbavancin. It includes formulations that are stable and effective for administering the antibiotic, either as a single dose or in a dosing regimen that can be as infrequent as once every 5-7 days[3][5].
Pharmaceutical Window
The patent emphasizes the importance of the "pharmaceutical window," which refers to the toxicity profile of the antibiotic. It must be sufficiently acceptable to allow a large single dose without causing severe adverse reactions[3].
Serum Half-Life
The serum half-life of dalbavancin is a critical factor, as it dictates both the longevity of the drug in the body and the time it takes for the serum level to reach a minimum trough level that remains bactericidally effective[3].
Claims
The patent includes several key claims:
Composition Claims
- The patent claims compositions of dalbavancin that are stable and suitable for administration in various forms, such as solutions or lyophilized powders[3][5].
Method Claims
- It claims methods of administering dalbavancin for the treatment of bacterial infections, including specific dosing regimens and administration routes[3][5].
Therapeutic Claims
- The patent claims therapeutic effectiveness against antibiotic-resistant bacterial strains, particularly MRSA, with a dosing interval of once every 5-7 days or longer[3].
Patent Landscape
Related Patents
The patent is part of a larger family of patents related to dalbavancin. Other relevant patents include US 8,143,212 B2, US 7,119,061 B2, and US 7,115,564 B2, which cover various aspects of dalbavancin compositions and methods of administration[1][4][5].
Expiration and Status
As of the current date, several patents related to dalbavancin have expired. Specifically, US 7,115,564 B2, US 7,119,061 B2, and US 7,115,564 B2 have all expired as of November 2023. However, one active patent, US 6,900,175 B2, remains in effect until May 2028[4].
Generic Competition
The expiration of these patents opens the door for generic competition. However, the generic launch date for dalbavancin (marketed as Dalvance by Abbvie Inc.) is estimated to be May 23, 2028, due to remaining exclusivities granted by the FDA[4].
Impact on Pharmaceutical Industry
Innovation and Competition
The patent landscape around dalbavancin reflects the balance between innovation and competition in the pharmaceutical industry. The expiration of patents allows for generic competition, which can reduce drug costs and increase accessibility, while the remaining exclusivities protect the original developer's investment in research and development[2][4].
Regulatory Considerations
The FDA's granting of exclusivities plays a crucial role in delaying the generic launch of drugs like Dalvance. These exclusivities ensure that the original developer has a period of market exclusivity, even after the patent has expired[4].
Conclusion
United States Patent 7,115,564 is a pivotal patent in the treatment of bacterial infections, particularly those caused by antibiotic-resistant strains. The patent's scope and claims highlight the innovative formulations and methods of administration of dalbavancin. As the patent landscape evolves with expirations and remaining exclusivities, it sets the stage for future generic competition and continued innovation in the pharmaceutical industry.
Key Takeaways
- Dalbavancin Compositions: The patent covers stable and effective compositions of dalbavancin for treating bacterial infections.
- Dosing Regimens: It includes methods for administering dalbavancin with dosing intervals as infrequent as once every 5-7 days.
- Patent Expiration: Several related patents have expired, with one active patent remaining until May 2028.
- Generic Competition: The generic launch date for Dalvance is estimated to be May 23, 2028, due to FDA-granted exclusivities.
- Impact on Industry: The patent landscape balances innovation and competition, influencing drug accessibility and costs.
FAQs
What is the primary focus of United States Patent 7,115,564?
The primary focus is on compositions and methods for the treatment of bacterial infections using dalbavancin.
What is the significance of the "pharmaceutical window" in this patent?
The "pharmaceutical window" refers to the toxicity profile of the antibiotic, ensuring it is safe for administration in large single doses without severe adverse reactions.
How often can dalbavancin be administered according to this patent?
Dalbavancin can be administered in a dosing regimen as infrequent as once every 5-7 days.
Which company currently owns the rights to Dalvance?
Dalvance is owned by Abbvie Inc.
When is the estimated generic launch date for Dalvance?
The estimated generic launch date for Dalvance is May 23, 2028, due to remaining FDA-granted exclusivities.
Cited Sources
- United States Patent and Trademark Office, "US8143212B2 - Dalbavancin compositions for treatment of bacterial infections," March 27, 2012.
- Seyfarth Shaw LLP, "The BioLoquitur Bulletin: Drugs Available in 2018 For Generic Competition," 2018.
- Google Patents, "US7115564B2 - Stable pharmaceutical compositions of dalbavancin and methods of administration," 2006.
- Pharsight - GreyB, "Dalvance patent expiration," 2023.
- Justia Patents, "US8143212 - Dalbavancin compositions for treatment of bacterial infections," March 27, 2012.
