As per patent office journal dated 08/10/2021, patent number 378301 has been granted to MERZ PHARMA GMBH & CO. KGAA that is titled PROCESS FOR PREPARING A HIGHLY PURE NEUROTOXIC COMPONENT OF A BOTULINUM TOXIN AND USES THEREOF.
The primary independent claim of this patent states a process for preparing a highly pure neurotoxic component of a botulinum toxin. The method includes cultivation of Clostridium Botulinum under conditions that allow production of a botulinum toxin. Further, the neurotoxic component from the botulinum toxin is isolated. These cultivating and isolating steps of the method are conducted in a pressure gradient device. The device includes a first isolator unit containing a fermenter for cultivating Clostridium botulinum and a safety work bench, the first isolator unit being located in a production room that is connected to the environment via an air lock, wherein the pressure in the first isolator unit is lower than that in the production room, the pressure in the production room is lower than ambient pressure, and the pressure in the air lock is higher than ambient pressure. The safety work bench is located in the production room and is a Class II BSC (Biological Safety Cabinet) provided with a transfer system that allows for the aseptic transfer of material into and out of the BSC, and wherein the cultivating temperature is maintained at a temperature of 33.5 °C ± 1.0 °C.
During the patent prosecution, the patent examiner objected to this patent under section 3(d) of the Indian Patents Act. The patent applicant responded to this objection by stating that the claimed process does not pertain to mere forms/derivatives of known compounds. The applicant further submits that the examples provided in the filed specification show the enhanced efficacy of the claimed highly pure neurotoxic component. The applicant further submits that the claimed invention is not only about “purity” in the usual sense of the word but also includes the aspect of biochemical purity in terms of the single-chain content. It is a key feature of the present invention that the claimed neurotoxic component of botulinum toxin has a low single-chain content. Therefore, the present invention does not fall under section 3(d) of the Patents Act.
This patent falls under the category of Chemical. Overall, this patent covers a process for preparing a highly pure neurotoxic component of a botulinum toxin by cultivating Clostridium botulinum under conditions that allow production of a botulinum toxin, and isolating the neurotoxic component from the botulinum toxin. In addition, the present invention relates to a highly pure neurotoxic component of a botulinum toxin obtainable by the process of the present invention.
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