Dr Jim Onishi and Dr Paul Warden-Hutton
In recent years, the Australian Courts have provided guidance on the kinds of Patent Claims that can form the basis of an Extension of Term Request under section 70(2)(b) of the Patents Act 1990. An extension of the term of pharmaceutical patents can be of significant value to patent owners in providing up to an additional five years of patent monopoly in Australia.
Only Product Claims can form the basis of Extension of Term Requests. The full Federal Court has held that Method or Process Claims do not satisfy the requirements of Section 70(2)(b) because they are not directed to a “pharmaceutical substance per se”. For a more detailed discussion on the requirements for an Extension of Term Request, please refer to our article, “Swiss-Type Claims Cannot be Basis for a Patent Term Extension in Australia”.
Claims to a method of treatment are patentable in Australia. Method of Treatment Claims specify a step (or a set of steps) directed to either therapy or surgery. Such Claims are directed to the cure, alleviation, the removal or the lessening of the symptoms of, or to the prevention or reduction of the possibility of contracting any disorder, or to the malfunction of the human or animal body. An example of a Method of Treatment Claim is as follows:
Swiss-Style Claims are not directed to a “pharmaceutical substance per se”
In Commissioner of Patents v AbbVie Biotechnology Ltd  FCAFC 129, the Full Federal Court considered whether Swiss-style Claims could form the basis of Extension of Term Requests for three patents claiming products produced using recombinant DNA technology.
Use of a compound of formula Y for the manufacture of a medicament for treating disease X.
The matter concerned the therapeutic agent adalimumab, sold under the Humira® Trade Mark. The relevant patent Claims were directed to a known antibody used in the manufacture of medicaments for treating ulcerative colitis, Crohn’s disease and rheumatoid spondylitis, respectively.
The matter was referred to the Full Federal Court on appeal, to consider the question of whether an Extension of Term Request is applicable to Swiss-style Claims.
It was held that that Swiss-style Claims were not directed to one or more pharmaceutical substances per se, as required by Section 70(2)(a) of the Patents Act 1990. Rather, Swiss-style Claims are directed to uses for making a medicament for a specific therapeutic purpose. Thus, the Full Federal Court confirmed the position in Australia that Method or Process Claims cannot form the basis of an Extension of Term Request.
Could Product-by-Process Claims be a Useful Alternative?
Australian Courts have not yet had an opportunity of considering whether Product-by-process Claims could be used to extend the term of a patent.
Product-by-process Claims typically recite the process for fabricating a product and are usually in the form of “product A produced by process B” or “product A obtained by process B”. The patentability of such Claims can be limited in certain jurisdictions. For instance, the European Patent Office (EPO) has indicated that a product of a process Claim is admissible only if the product is otherwise patentable and it cannot be defined satisfactorily by reference to its composition, structure or some other testable parameter (Case Law No: T 0956/04, decision date: 17 January 2008. The Boards of Appeal of European Patent Office. 2008).
Patent owners do not usually regard Product-by-process Claims as being of primary importance. Such Claims can be difficult to enforce against infringers who produce products by different processes. Furthermore, Product-by-process Claims can be difficult to prosecute, because the novel features usually reside in the process and not in the product. In Australia, unlike some other jurisdictions, the process steps are considered limiting. In fact, the Australian Patent Manual of Practice & Procedure presents a dichotomy, in that while the National section refers to such Claims as being directed to the product only when obtained or produced by the process (Section 18.104.22.168.11 of the Australian Patent Manual of Practice & Procedure), in contrast, the International section refers to such Claims as being directed to the product per se and “is not rendered novel merely by the fact that it is produced by means of a new process” (Section 22.214.171.124 of the Australian Patent Manual of Practice & Procedure).
Product-by-process Claims are considered by many to cause difficulties in their prosecution and enforcement. However, such Claims may still be useful to support an Extension of Term Request of a pharmaceutical Patent in Australia. A Product-by-process Claim may be considered to meet the Section 70(2)(a) requirement for an Extension of Term Request. In other words, a Product-by-process Claim may be interpreted as being “directed to one or more pharmaceutical substances per se, or one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology”.
The above may apply in circumstances where the relevant product is a new and inventive pharmaceutical substance that can only be defined by reference to the process by which it was made (e.g. compound X obtainable by process Y), because the chemical structure or composition is undetermined. Such circumstances may arise in respect of higher technological inventions, produced using recombinant methods. The increasing complexity of biological components and the recombinant methods used to generate them could mean that the resultant products cannot be fully defined by reference to their one-dimensional nucleic acid or amino acid sequence. Furthermore, the three-dimensional structure of such products may remain undetermined. In such cases, a Claim defining the substance by reference to such method steps would be considered to be a Claim to the substance per se (Zentaris AG  APO 41; Pharmacia Italia SpA v Mayne Pharma Pty Ltd  FCA 305).
Owners of pharmaceutical patents who are considering extending their patent monopoly in Australia could possibly look to utilise Product-by-process Claims as a basis for an Extension of Term Request. While such Claims are considered difficult to prosecute and/or enforce, their value could instead lie in potentially forming the basis of an Extension of the Term of a Patent in Australia.
Australian Courts have not yet had opportunity to specifically consider Product-by-process Claims that are drafted in the form of “product A produced by process B” or “product A obtained by process B”. Until then, Patent Applicants for pharmaceutical inventions may wish to consider including Product-by-process Claims during prosecution, even if such Claims are of limited scope. This may be particularly advantageous in circumstances where such Claims define the product by reference to the process by which it is made, because the chemical structure or composition may still be undetermined.
We recommend the inclusion of Product-by-process Claims during prosecution of your Australian Patent Application. If you require assistance in drafting such Claims, or if you wish to file a Request an Extension of Term of an Australian Patent, please do not hesitate to contact us.