Federal Court Confirms Patentability of Medical Treatment
Claims and Other Aspects of Australian Patent Law
Keen followers of Australian patent law,
particularly those with an interest in medical technology, may be aware that in 1998
Australian Federal Court Judge Heerey J. in the case Bristol-Myers Squibb Company v. F H
Faulding & Co. Ltd. (1998) 41 IPR 467 held that a claim directed to a method of medical treatment was not patentable subject matter in Australia. In coming to that
conclusion, Heerey J. held himself not to be bound by the majority of the full Federal
Court judgement in Anaesthetic Supplies v. Rescare Ltd (1994) 28 IPR 383.
Heerey J.s decision on the patentability
of medical treatments has now been overturned unanimously on appeal to the full Federal
Court. The appeal decision has not yet appeared in the law reports, but is available
electronically from the Australasian Legal Information Institute website at the link: www.austlii.edu.au/au/cases/cth/federal_ct/2000/316.html.
In the appeal judgement, Black CJ and Lehane J
preferred the reasoning of the majority in Rescare, noting that it would be difficult to
draw a logical distinction between patentability of a product for treating the human body
and a method of treatment. The other judge, Finkelstein J, held that medical
treatment and surgical processes are patentable under the legislation and that, if public
policy requires a different result, it is for Parliament to amend the Patents Act to
specify this rather than for the Courts to decide issues of ethics and morality.
Other aspects of the appeal decision are also
of importance to the development of Australian patent law.
The appeal decision has corrected the
Courts previous interpretation of the contributory infringement provisions of the
Patents Act 1990, which had left the contributory infringement provisions of the Act
essentially redundant. This new interpretation provides the patentee greater
protection in situations where a supplier supplies a product with instructions to use the
product in a manner which would infringe a patent claim, although the Court in
Bristol-Myers flagged a possible ambiguity in the contributory infringement provisions in
situations where the supplier simply had reason to believe that the supplied product would
be put to an infringing use, without providing instructions.
An important aspect of the Bristol-Myers
appeal decision relates to what is commonly called the "threshold requirement of
inventiveness" for an Australian patent as held by the High Court in NV Philips
Gloeilampenfabrieken v. Mirabella International Pty Ltd (1995) 32 IPR 449.
The Bristol-Myers appeal addressed two
important issues unresolved in Philips: against what body of knowledge is the
inventiveness judged, and what level of inventiveness is required by this threshold
test? The full Federal Court in Bristol-Myers held that the relevant body of
knowledge is the common general knowledge of the skilled worker in the field of Australia,
and equated the level of inventiveness required to the statutory requirement of the
Whilst the Bristol-Myers appeal judgement is
in general a welcome clarification of the law on the threshold inventiveness requirement,
the Court expressed the view that any prior art recited in the patent specification may
ordinarily be considered to be admission of the state of common general knowledge. The
practical implication of this is reinforcement that patent specifications drafted for
filing in Australia ought often recite less prior art than the corresponding European or
U.S. patent specification, although this is still balanced with the requirement that the
specification fully describe the invention. Where it is desirable in the
specification to recite prior art which may not be common general knowledge in Australia,
consideration should be given to including in the specification a disclaimer that any
recitation of prior art in this specification is not an admission of that prior art being
common general knowledge in Australia before the priority date of the claims hereof. A similar disclaimer might also be added to any existing patents which are at risk of being held to lack of inventive step on the basis of the admitted prior art.
Further discourse on the ramifications to Australian patent practice of the Bristol-Myers appeal decision on contributory infringement and inventiveness is presently being compiled, and will be posted on this website and forwarded upon request to those interested.
As always, we remain at your disposal should you need more specific advice in relation to any of the above.
Halford & Co.
Despite overturning several issues of Heerey
J.s decision at first instance, Bristol-Myers appeal failed. Their petty
patent claims, which related to an administration regime for the anti-cancer drug Taxol,
were found invalid on the grounds of lack of novelty and for lacking fair basis on the