The Full Court decision on sufficiency in Tramanco v BPW Transpec (reported here) has now been applied to claims for methods of medical treatment in Apotex Pty Ltd v Warner-Lambert Company LLC (No 2)  FCA 1238.
The claims were directed to a method for treating pain comprising administering a therapeutically effective amount of a defined compound to a mammal in need of said treatment. The Patent described tests performed on rats to demonstrate the comparative efficacy of various compounds in treating pain.
On the question of sufficiency, the patentee argued that the test to be applied was as set out in Kimberly-Clark v Arico namely whether there is disclosure enabling the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study. It was said that this test would be satisfied if the patent contained sufficient information to enable the skilled addressee to perform the invention in relation to rats, being mammals and therefore within the scope of the claims.
The Court rejected that argument stating “although the claims refer to mammals rather than humans, and the various test results reported in the Patent all relate to experiments on rats, it is clear that the Patent is primarily directed to the treatment of pain in humans… Not for a moment would the skilled addressee understand this Patent as directed to the medical treatment of rats experiencing pain”.
Referring to the decision in Tramanco, the Court held that “the test of insufficiency propounded by the High Court in Kimberly-Clark based upon a test originally formulated outside the context of methods of treatment claims cannot be sensibly applied to a case such as this. In my respectful opinion, it would be a nonsense to say that the invention was sufficiently described if it enabled the skilled addressee to perform the method of the invention on rats (or other mammals) but did not enable it to be performed on humans”.
Ultimately, the claims were found to be sufficiently enabled because on the evidence the specification provided enough information for a skilled addressee to perform the claimed invention in relation to humans without new inventions or additions or prolonged study.
This decision appears to continue the recent approach of the Court to look to the “substance” of an invention which may not be entirely coincident with the invention as claimed.