The decision of Ryan J in Wake Forest University Health Sciences v Smith & Nephew granting an interlocutory injunction to restrain infringement has been overturned on appeal in Smith & Nephew Pty Ltd v Wake Forest University Health Sciences [2009] FCAFC 142.
The main issue on appeal was whether the alleged infringer had sufficiently demonstrated that the only claim in issue, claim 49, was invalid, thereby preventing there being a serious question to be tried. Claim 49 was directed to:
An apparatus for applying negative pressure to a wound beneath a fluid-impermeable seal comprising:
a) [features of the apparatus]; and
b) wherein said apparatus is in an aseptic package.
Having reviewed the reasoning at first instance, the Court found that “the primary judge failed to consider, as a separate matter from novelty, the issue of whether claim 49 comprised a ‘mere collocation of separate parts’ and was therefore invalid” and that “a mere collocation of parts, each performing its own separate function, is not patentable”. Accordingly, although not stated explicitly anywhere in the decision, the ground of invalidity under consideration appears to be whether the invention as claimed was a manner of manufacture, rather than any issue of novelty. Indeed the Court noted that “it was accepted by all parties that the integers of claim 49, other than the aseptic package, interact with each other to produce a new product and result”.
Assessing whether the packing did so interact, the Court stated:
how, if at all, does the aseptic package interact with the other integers to produce the result of negative wound pressure. It is the mere bag in which the device that ‘does the work’ is stored before use. It is discarded before any negative would pressure is applied. No doubt it is beneficial to have sterile packaging for a therapeutic device, however, the aseptic bag itself does nothing to cause, limit or affect the functional result of negative wound pressure as desired.
While the patentee referred to earlier decisions supporting the proposition that the presence of the additional integer of the aseptic packaging did not affect the validity of the claim, the Court distinguished those cases on the somewhat confusing basis that “those authorities are relevant to an additional integer that limits the scope of the claim, not an integer said to limit the invention”.
The Court concluded that the claim was invalid because:
While the integers that form the actual apparatus might be said to be a new combination, when placed with the essential feature of the aseptic package being part of the invention claimed they form a mere collocation of the apparatus on the one hand and the aseptic package on the other.
While this somewhat confusing decision may be limited to a very specific factual scenario, it illustrates how crucial claim drafting can be. The fact that the claim was directed to an apparatus for a specific purpose rather than just the apparatus itself seems to have played a significant role in the finding of invalidity.