Methods of medical treatment are patentable: Full Federal Court

Methods of medical treatment are patentable: Full Federal Court

Bristol-Myers Squibb Co v F H Faulding & Co Ltd, 22 March 2000

In this case the Full Federal Court holds that methods of medical treatment are patentable and accepts a broad interpretation of the contributory infringement provisions in the Patents Act 1990. On the downside, however, the court appears to expand what is common general knowledge.

In the original Federal Court decision the petty patents in suit (which claimed methods of treating cancer involving infusion to a cancer patient of a specified amount of the active ingredient taxol over a defined period) were held invalid by Heerey J for failing to meet the threshold test for invention or define a manner of manufacture, for lack of novelty and inventive step, and on the ground that the claims were not fairly based on the specification. The trial judge also held that even if the claims had been valid they would not have been infringed. Although the appellant was successful in the appeal on a number of grounds as outlined below, the finding of invalidity of the petty patents in suit was nonetheless upheld on the basis that the claims lacked novelty and were not fairly based on the specification.

Manner of manufacture: methods of medical treatment

Although the Australian Patent Office has for many years accepted patent applications containing claims directed to methods of medical treatment, there has been considerable uncertainty as to their validity and enforceability. The three judges of the Full Federal Court in this case unanimously acknowledged that methods of medical treatment may constitute a "manner of manufacture" and define patentable subject matter.

Under the Australian Patents Act 1990 a patentable invention, as claimed in any claim, must constitute "a manner of manufacture within the meaning of section 6 of the Statute of Monopolies" (The Statute of Monopolies is a UK statute dating back to 1623). This requirement has been interpreted to mean the invention must relate to subject matter that is useful, of commercial significance and not "contrary to law nor mischievous to the State… or generally inconvenient".

A number of earlier cases have had a bearing on the development of the law in relation to the patentability of methods of medical treatment. In finding that a method of killing weeds met the requirements for patentability in the decision of NRDC v Commissioner of Patents ((1959) 102 CLR 252) (NRDC), the Australian High Court acknowledged that for a method or process to constitute patentable subject matter it need not involve the production of a vendible product. Subsequent to NRDC, the decision in Joos v Commissioner of Patents ((1972) 126 CLR 611) allowed the grant of a patent in respect of a method of improving the strength of hair and nails, and in doing so distinguished cosmetic results from methods of medical treatment, much in the same way that the UK case of Schering AG's Application [1971] RPC 357 allowed the grant of a patent in respect of a contraceptive process.The issue of patentability of methods of medical treatment was addressed in detail by the Full Federal Court in Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR1 (Rescare) where the majority concluded that there was no good reason, when considering patentability, to distinguish between processes which bring about a cosmetic or functional result compared to a curative result. In the first instance decision of the Federal Court in the present case Heerey J elected to follow the minority dissenting judgment on this issue in Rescare on the basis of his view that the decision of the majority was merely obiter dicta. On appeal the Full Federal Court overturned this aspect of the first instance judgment for two main reasons. The first reason was that although Parliament had the opportunity to do so in the 1990 Act, it elected not to exclude methods of medical treatment from patentability. Secondly, their Honours believed there is no logical reason to allow the grant of letters patent in respect of pharmaceutical products but not in respect of the methods of treatment in which such products are utilised.

Threshold test for invention

Unfortunately the Full Federal Court may have introduced a potential difficulty for patentees and patent applicants in relation to the requirements that a claimed invention should meet a "threshold test" for invention and also possess an inventive step under section 18(1)(b)(ii). The threshold of invention requirement has been interpreted in the past to mean that before the normal tests for novelty or inventive step are applied, there must be an initial inquiry as to whether, on the face of the specification, the claims define an invention. The court appears to have limited the operation of this threshold test by concluding:

"it is not easy to envisage circumstances in which a claimed invention may lack the threshold requirement of inventiveness, but yet involve (for the purposes of s 18(1)(b)(ii)) an inventive step".

However, it also made the following alarming statement:

"If a patent application, lodged in Australia, refers to information derived from a number of prior publications referred to in the specification or, generally, to matters which are known, in our view the Court – or the Commissioner – would ordinarily proceed upon the basis that the knowledge thus described is, in the language of s 7(2) of the 1990 Act, part of "the common general knowledge as it existed in the patent area". In other words, what is disclosed in such terms may be taken as an admission to that effect."

This statement indicates that any prior art referred to in a patent specification may be taken to be part of the common general knowledge for the purposes of determining whether a claimed invention satisfies the threshold inventiveness requirement and the inventive step requirement. In contrast to other prior art information, it would therefore not be necessary to establish in evidence that prior art information referred to in the specification would have been within the common general knowledge of a person skilled in the art in Australia at the priority date of the claim under consideration. Also prior art information referred to in the specification may be combined with information from other sources to demonstrate a lack of inventive step.

Contributory infringement

Importantly the Full Federal Court has given operation to the contributory infringement provisions contained in section 117 of the Act. It did this by rejecting as obiter dicta the restrictive construction of section 117 provided by the majority decision in Rescare. On the basis of this finding, it would now seem possible to enforce a patent directed to a method against the supplier of a product to be used in the method if the supplier induces or provides instructions to others to use the product in a way that would infringe the patent. This is of particular relevance in the case of methods of medical treatment where it is desirable to bring action for infringement against a supplier of a pharmaceutical product to be used in the claimed method, rather than against each medical practitioner who actually administers or prescribes the pharmaceutical product concerned.