Second medical use claims: time to drop the Swiss?
14 January 2015
In T1570/09, the Board of Appeal of the European Patent Office (EPO) had to decide on a claim set that included both a Swiss-type claim and a purpose-limited product claim under Article 54(5) EPC 2000.
The two second medical use claims were formulated as follows (emphasis added).
1. Use of at least one member selected from the group consisting of alpha-ketoglutaric acid and pharmaceutically acceptable salts thereof, for the manufacture of a pharmaceutical preparationor a food or feed supplement for increasing plasma levels of high density lipoprotein (HDL) in vertebrates, such as birds and mammals, including man.
4. A compound selected from the group consisting of alpha-ketoglutaric acid and pharmaceutically acceptable salts thereof, for use in increasing plasma levels of high density lipoprotein (HDL) in vertebrates, such as birds and mammals, including man.
Swiss-type claims, as per claim 1 above, had been permitted following the EPO Enlarged Board of Appeal decision in G 5/83 to fill a loophole in the old law (European Patent Convention (EPC) 1973) which would have otherwise precluded claims for second therapeutic indications of known medicaments on the grounds of lack of novelty. Following the introduction of EPC 2000, claims in the format of claim 4, i.e. a purpose-limited product claim, are allowable.
The appellant argued that the scope of protection conferred to the patentee with respect to claims 1 and 4 could vary depending on the differing interpretations of the national courts.
However, the Board felt that this was not a valid reason for allowing Swiss-type claims where there was no longer any legal reason for permitting them.
In particular, the Board stated:
“In the present case the appellant has been able to formulate under Article 54(5) EPC 2000 an allowable purpose-limited product claim (claim 4 of the main request) which seeks protection for the same medical indication of the same substance as in the Swiss-type claim 1, and the notional novelty of claim 1 is not derived from the “medicament” itself. Therefore, there is no longer an objective reason for justifying the simultaneous presence of both claims in the set of claims to be proposed for grant.”
Accordingly, it was held that, where a set of patent claims included a purpose-limited claim for a second therapeutic use of a known product, permissible under the European Patent Convention (EPC) 2000, the applicant could not also have a Swiss-type claim for the same product and use.
In practice it seems wise to prioritise purpose-limited claims. Swiss-type claims could also be included in a “belt and braces” approach, as the case law might develop to reveal some use for them, but until then, assuming T1570/09 is followed, they will need to be deleted before grant.
Life Sciences & Chemistry
If you require further information on anything covered in this briefing, please contact Kirsty Simpson (firstname.lastname@example.org; +44 207 940 3600) or your usual contact at the firm.
This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP, January 2015