Swiss-type claims and combination treatments

In our article here we discussed the importance of how Swiss-type claims are worded in New Zealand with particular reference to the Assistant Commissioner's decision in Taiho Pharmaceutical Co. Ltd[2020] NZIPOPAT 5 (Taiho Pharmaceutical).

This article focuses on the Assistant Commissioner's additional comments regarding how an invention which lies in a combination treatment with two or more different active ingredients should be claimed.

At paragraph [0099] of Taiho Pharmaceutical the Assistant Commissioner states:

"Accordingly a Swiss-style claim that is commensurable with the disclosed method of therapy should require the use of both of the drugs (the combination drug and the anti-body) in the manufacture of medicaments for the treatment of breast and colorectal cancer by way of co-administration at the dosages as specified in the current claims."

The Assistant Commissioner went on to state at [00108]:

"A Swiss-style claim that is directed to the use of only one of the compositions in the manufacture of the medicament for the newly discovered purpose is incommensurable with the disclosure that the method of therapy essentially involves the co-administration of two compositions, the FTD/TPI combination drug and the antibody. It is difficult to see how a Swiss-style claim that is incommensurable with the method disclosed can be supported by the matter disclosed in the complete specification."

Thus, according to the Assistant Commissioner, where the specification discloses the invention as a method of co-administration (i.e. a combination treatment), a Swiss-type claim will only be supported where both of the active ingredients are used in the manufacture of a medicament.

This approach is different to how the Swiss-type claims to combination treatments have previously been treated during examination. In the past the examinations team, under both the old Patents Act 1953 and the new Patents Act 2013, have allowed Swiss-type claims directed to the use of just one of the active ingredients, in the manufacture of a medicament, provided the purpose of the claim is clearly limited to the combination treatment of both.

We have now started to see preliminary objections being raised by examiners on the basis of the comments in Taiho Pharmaceutical, suggesting there may have been a change of practice. However, we are yet to see a clear statement as to how the Office will examine combination type Swiss-type claims in light of the decision.

Clearly such a change in practice would be of concern to Applicants. A claim limited in the suggested way could be interpreted as only being infringed in the situation where both drugs are manufactured by the same manufacturer, and potentially only if they end up in the same medicament. It is of course common for drugs to be sourced from different manufacturers and frequently the two drugs will be are administered at completely different times, or by different routes and may never in fact be in the same room together (except within the body of the patient). Thus an approach following the Assistant Commissioner's comments would result in a very narrow scope of protection.

However, with respect to the Assistant Commissioner, we consider there are very good reasons why the examination team should not follow his reasoning and require a Swiss-type claim be restricted to the use of both (or all) active ingredients in the manufacture of the medicament.

The only binding precedent regarding Swiss-type claims in New Zealand is the Court of Appeal decision in Pharmaceutical Management Agency Ltd v Commissioner of Patents [1999] NZCA 330. In his decision for the Court, Justice Gault stated at [0065]:

Once it is accepted that there can be new invention in the discovery of previously unrecognised advantageous properties in a chemical compound, the obligation to make patent protection available must apply. The provisions of the Patents Act should if possible be construed so as to give that effect. …[P]erhaps the logical approach would be to permit claims to extend to the method of treatment using the compound or composition but to require from the patentee a disclaimer of any right to sue the practitioner. That would leave vulnerable as indirect infringers those providing the product for the purpose of that treatment: Innes v Short and Beal (1898) 15 RPC 449. Essentially the same situation will be achieved by allowing claims in the Swiss form. In such a claim the integer representing the inventive subject-matter and novelty is the new use for which the medicament is made. In this particular field where that cannot be captured with a method claim, we would accept the designation of purpose as sufficient. In this way the somewhat anomalous distinction between first and second pharmaceutical uses will no longer apply and the international obligation will be satisfied. [emphasis added]

Thus Justice Gault was explicit that, as far as possible, a patentee should give a level of protection the same as would have been given to an excluded method of treatment claim.

Section 141 of the Patents Act 2013 makes it clear that a person supplying an essential element of an invention where they knew or ought reasonably have known that the element would be used for putting the invention into effect can be an infringer of the patent.

If a claim to a method of treatment using a novel drug combination were to be allowed, the supplier of one of the drugs in the combination would be an indirect infringer provided they have the requisite knowledge and an actual infringement takes place. However, the same would not apply to a Swiss-type claim which recites the use of drug A and drug B in the manufacture of medicament:- in most cases there will not have been an act of primary infringement. In order that a Swiss-type claim achieve "essentially the same situation" as envisaged in Pharmac, then it is necessary that the claim to be directed to the use of the supplied compound, in the manufacture of a medicament, for the newly discovered purpose, the new combination therapy.

This suggests the Assistant Commissioner's approach in Taiho Pharmaceutical, requiring both active ingredients to be used in the manufacture of a medicament, is at odds with the Court of Appeal in Pharmac. For this reason alone we do not consider this approach persuasive.

In addition, the comments regarding the requirement for both compounds to be used in the manufacture of a medicament were unnecessary for the Assistant Commissioner to come to his conclusion. The Assistant Commissioner had already decided that the therapeutic method was not inventive, and that the wording of the claims (as discussed our article here) did not limit the therapeutic purpose of the claim to the co-administration.

Conclusion

In light of the above, we suggest that there is ample reason to suggest that the examination team, future Assistant Commissioner's decisions and Court decisions should not follow this aspect of Taiho Pharmaceutical. A Swiss-type claim which recites just one of the compounds in the manufacture of a medicament, but where the combination therapy is a clear limitation on the purpose should be considered supported by a specification that discloses a novel and inventive method of treatment by combination therapy.

It may be some time until this matter becomes clear, but we will keep you updated. In the meantime, if you are facing a particular issue of this sort, please do not hesitate to contact us.

In the context of the present article, a 'combination treatment' includes the situation, for example, where two or more active ingredients are administered at different times.

A decision of the Assistant Commissioner is not technically binding on the examinations team except in that particular case.

David Nowak - March 2021

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