Enlarged Board of Appeal Sounds Death Knell for Swiss Type Claims

In a recent decision of the Enlarged Board of Appeal of the European Patent Office, a surprising step was taken by the enlarged board to effectively abolish Swiss type medical use claims in Europe.

Under the European patent convention medical methods are excluded from protection. New drugs could be protected as products but problems arose if the drug was already known and therefore not novel but a new treatment had been found for the known drug.  A new method of use was excluded from protection.  A solution was found in G5/83 to close the loophole.  Since the decision in G5/83 it has been possible to protect a new and inventive second medical use of a known pharmaceutical by means of a special type of claim known as a Swiss claim having the format:-

Use of X in the manufacture of a medicament for the treatment of disease Y (Swiss Type Claim).

Under EPC 2000, Art. 54(5) it is also possible to use the simplified wording of:-

X for use in the treatment of Y (Art. 54(5))

Essentially, the novelty of such claims arises from the purpose of the claimed drug i.e. the therapeutic use whether it is a new illness or one or more new steps in a therapeutic method which would otherwise be excluded under Art 53(c) EPC.

In G02/08, the enlarged board was asked if claims of the above type could be used to protect a new and inventive treatment if X was already known for the same illness.

The enlarged board have confirmed that it is possible to patent X for use in the treatment of Y again if the treatment claimed is novel and inventive.  They also confirmed that the treatment could be a new and inventive dosage regime.  However, the board went on to decide that the above Swiss type claims were now no longer applicable and gave a 3 month deadline for applicants to end the practice of filing Swiss type claims in accordance with G05/83.  The board reasoned that such claims were inappropriate because they had been allowed to close a loophole in the old law which was now closed by Art 54(5) instead.  Furthermore, the board pointed out that such claims have not been considered ideal because of the difficulties associated with the absence of a functional relationship between the new and inventive therapeutic use and the manufacturing process.  The abolition of the old type Swiss claims will not be retroactive however and the new law will come into force 3 months after publication of this decision in the EPO Journal.

Despite the implications of this development in European Patent Office practice, Dr David Walsh, a chemical and pharmaceutical specialist at Appleyard Lees advises "In practice, it would be advisable to still draft Swiss type claims as a precaution in PCT and priority applications to support the Art 54(5) claims, should the latter be found unacceptable in other foreign jurisdictions."

The full text of G02/08 is available here: http://documents.epo.org/projects/babylon/eponet.nsf/0/1c9976e4866080a2c12576cf00417e3e/$FILE/G2_08_en.pdf