Taihoa! Care needed when 'formulating' Swiss-type claims

Taihoa, often miswritten as tai ho, is a Te Reo Māori word which has come to be used in New Zealand slang to mean hold on or wait a second. A recent decision of the New Zealand Assistant Commissioner of Patents has highlighted the importance of taking the time to carefully consider the wording of Swiss-type claims in New Zealand.

Methods of medical treatment are excluded from patentability by virtue of section 16(2) of the Patents Act 2013. However, Swiss-type claims are available for the protection of second medical uses, including where the invention lies in the new dosage regime1, mode of administration2 or patient group3. The decision of the Assistant Commissioner of Patents in Taiho Pharmaceutical Co. Ltd [2020] NZIPOPAT 5 (Taiho Pharmaceuticals) has highlighted the importance of how Swiss-type claims are worded, especially in those cases where the inventive step lies in the new dosage, mode of administration or patient group.

In that case the invention related to the treatment of cancer using a combination drug A comprising trifluridine and tipracil hydrochloride, and an antibody B selected from bevacizumab, cetuximab and panitumumab. Claim 1 of the application in question recited a number of features. But for the purposes of the present discussion it can be abridged to read:

1. Use of [a combination drug A] for the manufacture of a medicament for the prevention or treatment of cancer in a subject, wherein the medicament comprises:

- the [combination drug A] which is formulated for co-administration [at a defined dose] with [antibody B at a defined dose]; and

wherein the cancer is colorectal cancer or breast cancer. [emphasis added]

The Assistant Commissioner considered that the "medicament" being "formulated for" co-administration was not a limitation on the claimed therapeutic purpose of treating colorectal or breast cancer. Rather the Assistant Commissioner found that the wording formulated for co-administration merely required that the medicament be suitable for co-administration at the particular dose. As a result, the Assistant Commissioner considered that the claim both lacked support and lacked an inventive step.

At paragraphs 100-101 the Assistant Commissioner stated (with references to the claim above added in square brackets):

100. Claim 1 includes the statement that the FTD/TPI combination drug [combination drug A] is formulated for co-administration with an anti-body [antibody B] of specified types and specified dosages. The applicant appears to consider that this is a statement of a new therapeutic purpose for the FTD/TPI combination drug [combination drug A] by means of which, according to Gault J. in Pharmac, the novelty and inventiveness of the Swiss-type claim is intended to be established.

101. In my view the statement does not define a new therapeutic purpose for the FTD/TPI combination drug [combination drug A]. The preposition "for" in this statement simply specifies that the medicament is "suitable for" co-administration with an anti-body [antibody B] of the specified types and dosages. As the applicant clearly discloses, the "suitability" comprises nothing other than the usual recommended oral dosage form of the FTD/TPI combination drug [combination drug A] administered alone and, according to the preference expressed in the complete specification at page 12, at the same dosage as the known preferred dosage when the combination drug is used alone. The applicant has not disclosed a "newly discovered purpose" for the combination drug. Within the claim the purpose for which the combination drug is to be used is for the treatment of breast cancer and colorectal cancer, but that purpose was known before the priority date of the claim. The claim is drafted in the form of a Swiss style claim but the features that are recited as part of the 'newly discovered purpose" do not relate to a newly discovered purpose at all. The claim is not in a form that has been allowed by the Commissioner or Court.

The interpretation taken by the Assistant Commissioner is arguably consistent with the preeminent (and only!) New Zealand Court decision on Swiss-type claims: the New Zealand Court of Appeal in Pharmaceutical Management Agency Ltd v Commissioner of Patents [1999] NZCA 330 (Pharmac)4. At paragraph at paragraph [0059] Justice Gault for the Court stated:

"As already mentioned, the Swiss type claim is a use claim not a product claim. It is directed to use in manufacture for a purpose e.g. use of a known pharmaceutically active chemical compound plus a suitable carrier in the manufacture of a new cancer treatment medicine. [emphasis added]

Thus, at least in the New Zealand context, it is the purpose of the manufacture which is relevant for a Swiss-type claim. Features preceded by wording such as "formulated for" or "adapted for" will usually be features of the medicament itself, rather than limitations on the purpose of the manufacture. As such they are open to be interpreted as mere statements of the suitability for use of the medicament5 (as in this case) or as implying some physical change to the medicament to make it able to be used in that manner.

Unfortunately, in some cases New Zealand examiners may not have appreciated this distinction6, leading to applicants receiving routine objections to wording such as "are administered" or "is administered" even when they are clearly limitations on the therapeutic purpose of the claim. Indeed it appears as though this may have occurred in this case, possibly resulting in the insertion of the "formulated for administration" language. Of even more concern is the occasional suggestion from examiners that such an issue can be addressed by amending to wording such as "adapted for administration…" or "formulated for administration…".

Conclusion

There is no substitute for careful consideration of the wording of a Swiss-type claim. Routine or formulaic approaches, especially those based on the law of other jurisdictions can result in a reduced scope of protection, or worse, as in this case, a claim which is held invalid.

In Taiho Pharmaceuticals the Assistant Commissioner found that the method of treatment itself was obvious, so rewording the claims was likely to have been irrelevant to the outcome, but the applicant could have saved themselves one line of reasoning if they had phrased the claim so that the co-administration and dosage regimes were clearly limitations on the purpose of the manufacture, for example "wherein the prevention or treatment of cancer comprises co-administration of combination drug A with an antibody B".

Further comment

Amongst other issues, the Assistant Commissioner in Taiho Pharmaceuticals seems to suggest that for a co-administration type claim, both compounds need to be used in the manufacture of a medicament,, e.g. "The use of combination drug A and antibody B in the manufacture of a medicament…". We do not consider this suggestion to be in line with the decision in Pharmac and would be concerned if it were to be adopted. For a more detailed discussion see our follow-up article.

1Merck & co. Inc. v Arrow Pharmaceuticals (NZ) Limited [2006] NZIPOPAT 3 (31 January 2006), Genetech Inc and Washington University [2007] NZIPOPAT 1 (23 January 2007).

2Epicept Corporation [2007] NZIPOPAT 29 (1 October 2007)

3Astrazeneca AB [2007] NZIPOPAT 23 (3 September 2007)

4Although perhaps not consistent with the approach taken previously by the Assistant Commissioners in Merck & co. Inc. v Arrow Pharmaceuticals (NZ) Limited (Ibid), Genetech Inc and Washington University (Ibid), Epicept Corporation (Ibid) and Astrazeneca AB (Ibid)

5Under New Zealand law a "Compound for use" is interpreted is limited to a compound suitable for that use. It is not possible to claim a purpose limited compound as for example under the EPC2000.

6Indeed, the author was an examiner in a former life and did not at that time appreciate the distinction!

MoST Content Management V3.0.7525