South Australian medical firm Fusetec 3D filed the Federal Court lawsuit on Wednesday alleging a patent owned by California healthcare company Dignity Health was invalid and should be revoked.
The patent describes an invention for creating artificial anatomical models, in particular of human spines, which can be used while training surgeons, testing new surgical devices, and trying out new procedures.
While cadavers are typically used for these purposes, they come with a variety of drawbacks, the patent claims.
"Disadvantages of cadaveric spine models include their expense, difficulty in acquisition (via donors at the time of death), human tissue handling restraints and institutional requirements for cadaveric testing (and) risk to laboratory personnel when handling human tissue," the patent says.
Cadavers also vary in their quality and properties, leading to inconsistent test results, Dignity Health writes.
The patent describes a method of configuring a computer and 3D printer to create customised synthetic cadavers which overcome the limits and difficulties of working with real human bodies.
In its lawsuit, which also targets Arizona-based surgical training device firm SpineSTUD, Fusetec claims the patent should be revoked because it does not describe a patentable invention.
Fusetec alleges the patent does not contain a manner of manufacture. In other words, it does not contain components which function together to produce something new.
"The alleged invention insofar as claimed in any claim is directed to known 3D printing steps of anatomical components, using technology that is known and, further or alternatively, generic," the firm wrote.
The entire patent was not novel, as it could have been created using information already publicly available, and lacked what is called an "inventive step," Fusetec said.
"The alleged invention as claimed in each of the claims would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed before the earliest asserted priority date."
As well as the revocation of the patent, Fusetec is also seeking its legal costs.
The Adelaide-based firm creates artificial body parts which feel like tissue and bone but act as a clean and consistent alternative to dead flesh.
The parts can be used to prep surgeons for complex operations or train fledgling doctors for advanced surgery.
The realistic and anatomically accurate bone, skin and muscle structures are designed to be safer and easier to obtain - and dispose of - than actual human cadavers.
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