In countries such as the US and Australia methods of medical treatment are patentable subject matter. However, in many countries including New Zealand, methods of medical treatment of humans do not constitute patentable subject matter. Enter the Swiss-type claim.
In this situation Swiss-type claims can be used not only to protect the manufacture of a known medicament for a novel pharmaceutical use; but also as substitute claims in place of claims for methods of human medical treatment.
A Swiss-type claim is generally worded as follows:
On 19 February 2010 the European Patent Office's (EPO's) Board of Appeal ruled that Swiss-type claims will no longer be considered patentable subject matter, and a new claim type will take its place. The EPO's newly proposed claim structure, which we have coined a Euro-type claim, will read:
"A [known substance or composition] for use in [new therapeutic use]."
Thus, an exemplary fictional claim could be:
"A salicylic acid composition for use in the treatment of foot ache."
This change at the EPO is likely to occur in the next 6-12 months.
As changes at the EPO are often followed by the New Zealand Patent Office, it would be no surprise if New Zealand follows the EPO's lead at some point in the near future.
So if you are considering patent protection in Europe, what are the implications for patent protection in this jurisdiction?
On the one hand, it appears that the Euro-type claim is geared at the manufacture and sale of the composition for the intended new use - so, this is similar to a Swiss style claim. However, upon closer inspection the wording of the Euro-type claim also suggests that the scope may offer broader protection. This is because the words "for use in the treatment of" may be interpreted to mean the actual use of the composition, not just manufacture/sale of the composition for a particular use.
Any difference in claim interpretation will likely be left to the Courts to clarify. It is interesting to note, however, that the EPO does not intend the new claims to alter the scope of the protection.
Numerous other questions remain to be answered.
For instance, if the scope of protection extends to the actual use, will this constitute protection for methods of medical treatment? In both Europe and New Zealand, methods of medical treatment are strictly not patentable subject matter as they are considered contrary to public good. This could result is greater confusion surrounding what is patentable in certain jurisdictions.
Furthermore, will the new claim structure, if introduced into New Zealand, support novel dosage regimes, as previously provided by Swiss-type claims? The EPO has just recently signalled that dosage regimes will remain patentable subject matter, despite Swiss-type claims being banned. In Europe, this is excellent news for pharmaceutical companies looking for additional patent protection to replace their initial patent upon its expiry.
In the event a practice note issues from the New Zealand Patent Office, we will report again. We will outline the Patent Office's views on this matter and how this may affect protection of 2nd use pharmaceutical claims in New Zealand.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
James and Wells is the 2009 New Zealand Law Awards winner of the Intellectual Property Law Award for excellence in client service.