Method and Swiss-type Claims in Australia – A Patent Protection Strategy for Pharmaceutical Companies

Dr Jim Y Onishi

Novel compounds and any relevant medical uses of those compounds are protectable in Australia in the form of Compound Claims and Method of Treatment Claims, respectively. Subsequently identified new medical uses of a known compound may only be protectable in the form of second medical Use Claims, which are also known as “Swiss-type” Claims.

This article proposes a strategy, which is as yet untested, for pharmaceutical companies to include both Method of Treatment Claims and Use Claims in Australia, to achieve maximum patent protection.

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:

A method of treating [disease X], the method comprising the step of administering to a patient a medicament comprising a compound of formula Y or a pharmaceutically acceptable salt thereof.

Method of Treatment Claims would be infringed by medical practitioners exercising their professional skills to treat their patients, which is the primary reason for many jurisdictions banning such claims. Pharmaceutical companies who supply the medicament to medical practitioners would also infringe such Claims through contributory infringement.

Swiss-type “Use” Claims are also patentable in Australia. Swiss-type Claims are directed to the use of a compound for preparing a medicament for treating certain diseases. An example of a Swiss-type Claim is as follows:

Use of a compound of formula Y for the manufacture of a medicament for treating disease X.

Swiss-type Claims are typically used to protect second or subsequent medical uses and are infringed by a third party, which manufactures a medicament containing the compound for use in the claimed medical indications. There is no restriction requiring that Swiss-type Claims be limited to second or subsequent medical uses of a compound and such Claims can be used even when the first medical use of the compound is not previously known.

Recently, Swiss-type Claims have been accepted in Australia as purpose-limited process claims, rather than product claims, in light of confirmation by the Full Federal Court of Australia in the Judgment in The Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129.

Why was this Judgement important for Australian Pharmaceutical Patents?

Definition of “exploit
For a granted patent claim to be infringed in Australia, exploitation must have occurred.

The definition of “exploit” under the Patents Act 1990 is:

(a) where the invention is a product—make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or

(b) where the invention is a method or process—use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use.

In the previous Judgment of Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559, the expression “from such use” at the end of paragraph (b) was construed to mean “the use, anywhere, of the method or process” (emphasis added). This construction was not challenged in the Appeal in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, and later confirmed in a separate Judgement in Warner-Lambert Company LLC v Apotex Pty Limited (No. 2) [2018] FCAFC 26. Therefore, a claimed method performed outside of Australia was found to fall within the definition of “exploit”. This means that in Australia, Method and Use Claims are further reaching than Product Claims. Product Claims are “exploited” when the claimed invention occurs in Australia. In contrast, Method and Use Claims are “exploited” when the claimed invention occurs in any country in light of the definition of paragraph (b).

Infringement of Swiss-type Claims
As a result of the interpretation of “exploit” under the Patents Act 1990, Swiss-type Use Claims would be infringed by the importation of, or an offer to import, a medicament manufactured overseas for use in the claimed medical indications. However, in the recent Judgment of Mylan Health Pty Ltd v Sun Pharma ANZ Pty Ltd [2019] FCA 28, it was determined that Swiss-type Claims can only be infringed if there was an intention for the medicament to be used for the claimed medical indications. In that case, Mylan was unable to demonstrate intention by Sun Pharma despite showing evidence of bioequivalence, as well as the similarities in the product information (PI) document (the generic product was silent on the claimed medical indications). The Court in that Judgment ruled that the Swiss-type Claims were not infringed. Mylan, however, successfully demonstrated that a significant portion of the generic products would be used by medical practitioners in a manner that would infringe its Method of Treatment Claims, and accordingly, was able to rely on the contributory infringement provisions of the Patents Act 1990.

Modified Swiss-type Claims
In our opinion, the question of “intent” in relation to first medical uses could be circumvented by drafting a modified Swiss-type Claim specifying a “mode of action”, rather than specifying any diseases to be treated. For example, if the claimed compounds have been identified as inhibitors or activators of a certain enzyme, then the modified Swiss-type Claim could refer to use as a medicament for treating conditions associated with abnormal activity levels of that enzyme. Generics wishing to introduce their pharmaceutical products could provide a PI document listing all known relevant therapeutic indications, which indications would inherently occur by the claimed “mode of action”

Pharmaceutical Patenting Strategy
It would be our recommendation for Patents in the pharmaceutical fields to preferably contain both Method of Treatment Claims and “Swiss-type” Use Claims. In situations where novel pharmaceutical compounds are identified, we suggest that a modified form of Swiss-type Claim for the first medical use specifying a “mode of action” be incorporated.

Patentees should be adequately protected from any infringing activities by third parties in Australia, as well as such activities being conducted outside of Australia, by incorporating these Claim categories into Australian Pharmaceutical Patents.

If you have any questions concerning your Pharmaceutical Patents, please do not hesitate to contact Houlihan².