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Australian Full Federal Court Confirms Patentability of Medical Treatment Claims

Australian Full 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 Court’s 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 inventive step.

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.

May 2000

Footnote:    

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 specification.

Patent and Trade Mark Attorneys - Intellectual Property Specialists
 Halfords IP, Level 7, 1 Market Street, Sydney, NSW, 2000, AUSTRALIA T: +61 2 9264 8388 | F: +61 2 9264 1810