Last month Pall filed a patent infringement action against BioQuate in the US District Court for the Eastern District of Pennsylvania, seeking damages and an injunction precluding the Florida-based company from selling its BioQuate Disposable Aseptic Connector.
According to Pall, this infringes intellectual property covering its own Kleenpack Aseptic Connector, which it claims has revolutionised the aseptic connection process by reducing connection times from 15 minutes down to a matter of seconds.
After " careful review " of Pall's action, BioQuate is asserting not only that the Disposable Aseptic Connector does not infringe on the referenced Pall patent, but that the Pall patent is " invalid for a variety of reasons ".
It therefore intends to defend its position vigorously and is confident of prevailing in court, the company said.
BioQuate would not comment on why it believes the patent for the Kleenpack Aseptic Connector is invalid or on any further details of the case.
As yet, no date has been set for a hearing.
The privately-held company would not be drawn either on the sales value of the Disposable Aseptic Connector or how essential it is to BioQuate's operations.
The device is characterized as a genderless (i.e., no male or female connectors) connection system based on ISO standards, and as the " next evolutionary step " in single-use connectors providing aseptic/sterile links between tubing and large bore for high fluid throughput.
The connectors are available in various hose barb sizes from ¼ inch up to ¾ inch, as well as in a DAC/sanitary coupling combination, so that the system " can function as the supply line, the distribution (bag) line and the sample bag line without connection difficulties ", BioQuate notes.
Among the product's claimed benefits are quick, easy and secure single-use connections, rapid set-up and clean-up, increased flexibility and simple validation.
The moulded body of the Disposable Aseptic Connector is made of a USP Class VI grade of polycarbonate, while USP Class VI silicone rubber is used for the gasket that creates a tight fluid seal.
Pall's Kleenpack connector is used for the dry connection of two pre-sterilised fluid pathways, with applications in the transfer of inocula to reactors, sampling during fermentation and handling of bulk materials in a non-sterile environment, among other functions.