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On 18 August 2017, the Australian Full Federal Court has overturned a prior decision made by the Administrative Appeals Tribunal in 5 September 2016 over Re AbbvVie Biotechnology Ltd  APO 45, with regard to several applications for an extension of term for Australian patents 2012261708, 2013203420 and 2013257402. Patent extensions of five years are permissible in Australia for pharmaceutical products. These patents contain claims of a type called “Swiss type claims”. As the Full Court noted, “Speaking broadly, such claims are, in form, directed to the use of a substance in the manufacture of a medicament to be administered for a specified therapeutic purpose. An invention in this form is appropriately characterised as a “method or process”, not as a “product”.”
Swiss type claims are drafted by patent attorneys in order to endeavour to accrue patent protection in certain jurisdictions for the discovery of new medical uses for known compounds. In around 80 jurisdictions, patenting methods of medical treatment is prohibited (although not so in Australia as a consequence of the 2013 High Court decision inApotex Pty Ltd v Sanofi-Aventis Australia ). Swiss style claims are intended to catch any method of making a drug of any kind where that drug includes a known compound as an active constituent. Swiss type claims hinge upon the artificial premise that the prerequisites of novelty and inventiveness follow the discovery of the compound’s activity, but in relation to the new condition. This is even though there may be nothing new in manufacturing drugs consisting of the known compound. The concept relies upon the public policy position of rewarding with a patent monopoly the outcomes of successful and helpful medical research.
Each of the original patent term extension application made by AbbVie concerns a pharmaceutical substance called “adalimumab”. This is used in the manufacture of a medicament for the treatment of ulcerative colitis, Crohn’s disease, and rheumatoid spondylitis. Adalimumab is already marketed under the name “Humira.”
The Deputy Commissioner of Patents had originally rejected the request to extend the patents. In his decision, the Deputy Commissioner said,
“…while notionally directed to a method or process of manufacturing a medicament, the claims are characterised by a therapeutic use. Consequently, on the basis of my reasons in ThromboGenics I do not find that a pharmaceutical substance, when produced by a process that involves the use of recombinant DNA technology, in substance falls within the scope of the claims. I must therefore refuse the application for an extension of term.”
The Administrative Appeals Tribunal said that AbbVie’s patents were capable of extension because they satisfied s 70(2)(b) of the Australian Patents Act 1990. This was on the basis that adalimumab is “produced by a process that involves the use of recombinant DNA technology” which meant that AbbVie was trying to patent the process and not the product.
The Full Federal Court disagreed and looked to the term “pharmaceutical substance” and how it relates only to products, not processes. The Full Court said,
“58.The first and critical matter to note about Swiss type claims is that they are not claims to pharmaceutical substances at all. They are method or process claims which, in this connection, exhibit a dual character. First, they are directed to a method or process in which a substance is used to produce a medicament. Secondly, they have an additional method or process element constituted by a specific purpose to which the medication is to be used. Thus, the scope of Swiss type claims is fundamentally different to the scope of the claims addressed by s 70(2) of the Patents Act.
59.With specific reference to the present case, adalimumab is a pharmaceutical substance produced by a process that involves recombinant DNA technology. However, the claims in suit are not directed to adalimumab produced by recombinant DNA technology. They are directed to different subject matter. First, they are directed to a method or process in which adalimumab is used to produce a medicament. Secondly, they are directed to a medicament containing adalimumab that is to be used for specific therapeutic purposes, being those identified at  above. These claims do not meet the requirements of s 70(2)(b). In our respectful view, the Tribunal erred in concluding otherwise.”
(There was also discussion in the decision about the inclusion of the words “per se”, an important drafting issue we do not discuss in this summary, and there are also obvious consequences for drugs produced using rDNA technology.)
What does this decision mean for Swiss type claims in Australia? It poses a dilemma of indeterminate proportions by the patent owner at the time of drafting the patent. As stated above, Swiss type claims are not necessary in Australia, but provide benefits in foreign jurisdictions. This is of assistance when extending the patent by way of the Patent Cooperation Treaty into foreign markets. But within Australia, this decision quashes the potential to extend the life of a patent incorporating Swiss type claims. We note that Swiss type claims are invalid in Europe. But, practically speaking, given the relatively small size of the Australian pharmaceutical market compared to the global market where Swiss type claims are applicable, and the relatively small financial benefit arising from an additional five years of protection in this jurisdiction, there is probably no additional incentive to avoid using Swiss type claims arising from this decision.
This article is general information only, at the date it is posted. It is not, and should not be relied upon as, legal advice. This article might not be updated over time and therefore may not reflect changes to the law. Please feel free to contact us for legal advice that is specific to your situation.