Smith & Nephew Pty Ltd v Wake Forest University Health Sciences [2009] FCAFC 142 (9 October 2009)
This case resulted from an expedited application for leave to appeal and appeal. The lower court had issued an injunction against the applicant, Smith and Nephew.
The question to be determined was whether or not the applicant had sufficiently demonstrated in the lower court that claim 49 of the patent was invalid. That would raise a defence to infringement. Then there would not be a serious question to be tried and the injunction would be an error.
The patent was for an apparatus that applies negative pressure to a wound. Claim 49 is worth setting out:
"An apparatus for applying negative pressure to a wound beneath a fluid-impermeable seal comprising:
a screen means for positioning beneath said seal for preventing overgrowth of tissue in the wound, said screen means being sufficiently porous to allow gases to reach the wound and sufficiently rigid to prevent wound overgrowth, said screen means comprising an open cell polymer foam section configured to overlie the wound such that said negative pressure is maintained within said foam and applied to the wound;
a flexible tube having an inlet and inserted into said open cell polymer foam section and an outlet end for extending from beneath said seal and for supplying said negative pressure; and
wherein said apparatus is in an aseptic package."
A mere collocation of parts, each performing its own separate function, is not patentable. That is, it does not define subject matter that is inherently patentable. However, a number of elements that interact with each other to produce a new result or product is patentable.
The parties accepted that the integers of claim 49, except the aseptic package, interact with each other to produce a new product or result. But the respondents argued that the package limited the claim without affecting the invention defined by the other integers. In short, they held that the package was a feature of the apparatus in a kit form.
However, the court said that the construction advanced by the respondents included the package as an essential integer. So the respondents were to be confined to that construction for the purposes of testing whether or not claim 49 defined patentable subject matter.
The question to be asked was how, if at all, does the aseptic package interact with the other integers to produce the result of negative would pressure.
Claim 49 was specifically drawn to include the aseptic package. In the lower court the respondents asserted that the package was an essential integer. Thus the package should not be treated as a mere optional addition within the claim or as a limitation on the scope of the claimed combination. All the integers of claim 49 were to be considered in determining whether claim 49 is a "mere collocation".
According to their honours, once the aseptic package was said by the respondents to be an essential integer and part of the invention claimed, it must interact purposefully and functionally with the other integers to produce the negative wound pressure. It did not, so claim 49 was found to be invalid. The injunction was therefore found to be an error.