Detailed Analysis of the Scope and Claims of United States Patent 10,028,963
Introduction
United States Patent 10,028,963, titled "Methods for treating intrapulmonary infections," is a significant patent in the field of pharmaceuticals, particularly for the treatment of bacterial infections within the lungs. This patent, assigned to Merck Sharp & Dohme Corp., provides insights into the use of ceftolozane, a cephalosporin antibiotic, in combination with tazobactam, for treating various intrapulmonary infections.
Inventors and Assignees
The patent was invented by Gurudatt A. Chandorkar, Jennifer A. Huntington, Tara Parsons, and Obiamiwe C. Umeh, and is assigned to Merck Sharp & Dohme Corp.[2].
Publication and Expiration Dates
The patent was issued on July 24, 2018, and is set to expire on September 7, 2032[2][4].
Scope of the Patent
Treatment of Intrapulmonary Infections
The patent primarily focuses on methods for treating intrapulmonary bacterial infections, including nosocomial pneumonia, ventilator-acquired pneumonia, and hospital-acquired pneumonia. It outlines the use of ceftolozane, either alone or in combination with tazobactam, for these treatments[1][2].
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include ceftolozane, with or without tazobactam. These compositions are administered intravenously, typically every 8 hours, to achieve therapeutic levels of the antibiotics in the epithelial lining fluid (ELF) of the lungs. The specified dosage often involves 3.0 g of ceftolozane, and in combination therapies, 1.5 g of ceftolozane and tazobactam are administered together[1].
Claims of the Patent
Administration Methods
The patent claims include methods for intravenously administering ceftolozane, either alone or in combination with tazobactam, to treat intrapulmonary infections. The administration is typically every 8 hours to maintain effective concentrations of the antibiotics in the ELF[1].
Therapeutic Concentrations
The claims specify that the concentration of ceftolozane in the ELF should be at least about 8 μg/ml to be effective in treating intrapulmonary infections[1].
Patient Population
The patent targets patients who have or are at risk of having nosocomial pneumonia, ventilator-acquired pneumonia, or hospital-acquired pneumonia. These patients are typically humans in a clinical setting[1].
Patent Landscape
Related Patents
Several related patents complement this invention, including patents for solid forms of ceftolozane, tazobactam arginine compositions, and other ceftolozane-tazobactam pharmaceutical compositions. These patents, also held by Merck Sharp & Dohme Corp. and Calixa Therapeutics, Inc., cover various aspects of the drug's formulation, synthesis, and use[2][4].
Patent Expiration Dates
The patent landscape indicates that multiple patents related to ceftolozane and tazobactam are active, with expiration dates ranging from 2028 to 2035. This extended patent protection period ensures that the proprietary rights over these pharmaceutical compositions remain with the patent holders until the respective expiration dates[2][4].
Exclusivities
In addition to patent protection, the FDA has granted exclusivities to Zerbaxa (the brand name for the ceftolozane-tazobactam combination), which further delay the potential launch of generic or bioequivalent versions of the drug. These exclusivities play a crucial role in maintaining market exclusivity beyond the patent expiration dates[4].
Impact on Treatment
The methods and compositions described in this patent have significant implications for the treatment of intrapulmonary bacterial infections. By ensuring therapeutic levels of ceftolozane and tazobactam in the lungs, these treatments can effectively combat Gram-negative bacteria, which are often resistant to other antibiotics.
"Ceftolozane, in combination with tazobactam, has been shown to be effective against a broad spectrum of Gram-negative bacteria, including those that produce extended-spectrum beta-lactamases (ESBLs) and carbapenemases"[1].
Industry and Clinical Significance
This patent is crucial for the pharmaceutical industry as it provides a robust method for treating severe bacterial infections in the lungs. Clinically, it offers healthcare providers a reliable treatment option for patients with nosocomial pneumonia and other intrapulmonary infections, which are often life-threatening.
Key Takeaways
- The patent describes methods for treating intrapulmonary bacterial infections using ceftolozane with or without tazobactam.
- The treatment involves intravenous administration every 8 hours to achieve therapeutic concentrations in the ELF.
- The patent targets patients with nosocomial pneumonia, ventilator-acquired pneumonia, and hospital-acquired pneumonia.
- Related patents cover various aspects of the drug's formulation and use.
- Exclusivities granted by the FDA extend market protection beyond patent expiration dates.
FAQs
What is the primary focus of United States Patent 10,028,963?
The primary focus is on methods for treating intrapulmonary bacterial infections using ceftolozane, with or without tazobactam.
Who are the inventors and assignees of this patent?
The inventors are Gurudatt A. Chandorkar, Jennifer A. Huntington, Tara Parsons, and Obiamiwe C. Umeh, and it is assigned to Merck Sharp & Dohme Corp.
What is the typical dosage and administration schedule for ceftolozane and tazobactam?
The typical dosage involves administering 3.0 g of ceftolozane, or 1.5 g of ceftolozane and tazobactam, intravenously every 8 hours.
What is the therapeutic concentration of ceftolozane required in the ELF?
The concentration of ceftolozane in the ELF should be at least about 8 μg/ml to be effective.
What are the implications of FDA exclusivities on generic versions of Zerbaxa?
FDA exclusivities delay the launch of generic or bioequivalent versions of Zerbaxa, ensuring market exclusivity beyond the patent expiration dates.
Cited Sources:
- US10028963B2 - Methods for treating intrapulmonary infections - Google Patents
- Generic Zerbaxa Availability - Drugs.com
- Patent Claims and Patent Scope - SSRN
- Zerbaxa patent expiration - Pharsight
- Treating Bacterial Infections of the Lung - Patent US-2016296552 - PubChem
