Death of the Swiss?
14/06/2011

Death of the Swiss?
Section 25(11) of the South African Patents Act 57 of 1978 prohibits the patenting of any invention for “a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body”.

However, in terms of section 25(9) of the Act, “an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body” shall be patentable even if the substance or composition per se is known, provided that the use in the method of treatment is "new" and “non-obvious” as defined in the Act.

These provisions of the Act have received the attention of a South African Court, for the first and only time, in the case of Elan Transdermal Ltd. vs Ciba Geigy. In his judgment, MacArthur J. adopted the British Patent Court's approach in John Wyeth & Brothers Ltd's application, Schering AG's application 1985 RPC 545 at 557-558, i.e. that a known substance or composition can only be claimed for use in a method of medical treatment the first time that it is disclosed as being useful in medical treatment.

A claim directed to such a first medical use of a known substance or composition is referred to as a so-called “first medical use”, or, “compound for use” type claim, and has the general style

“Substance A for use in treating disease B”.

The Elan Transdermal case also dealt with and addressed the validity of claims in the so-called “Swiss form”, such as

"The use of substance A in the manufacture of a medicament to treat disease B".

It was held that a Swiss form claim is really a claim to the method of manufacturing a medicament using substance A, and that a second or subsequent medical use of substance A is patentable only by way of a Swiss form claim, if the statutory requirements of novelty are met. In the John Wyeth case it was held that with a Swiss form claim the requisite novelty might be found in the new second (or subsequent) medical use.
European Patent Convention (EPC)
The situation in Europe is different to South Africa, and has moved with the times. The provisions of EPC 1973 relating to medical use claims, were similar to the corresponding provisions of the South African, and the European, Patents Acts’. Changes to the EPC 1973 provisions were introduced by the EPC 2000 revision, which came into force on 13 December 2007. Prior to EPC 2000 the EPC allowed claims directed to a substance or composition for use in a first medical use only. Inventions relating to a second or subsequent medical use of a known substance or composition could only be protected if the claims were drafted in the Swiss form.

However, after EPC 2000 came into force, the EPC allowed claims directed to a substance or composition for use in a first, second or subsequent medical use, and no longer required inventions directed to a second or subsequent medical use to only be drafted in the Swiss form.

On 13 December 2007, the European Patents Act 2004 implemented the revised provisions of EPC 2000 relating to medical use claims, and introduced new Section 4A(4) to the Patents Act of 1977, which allowed claims directed to a substance or composition for use in a second or subsequent medical use to be drafted either in “first medical use” style or in the Swiss form.

Subsequent to the EPC 2000 revision, case law has developed in Europe regarding in what circumstances Swiss form claims may still be used.
Decision G 02/08 ABBOTT RESPIRATORY/Dosage regime - 19 February 2010
Abbott Respiratory LLC filed a European patent application, which was refused on the grounds of lack of novelty, and because it did not meet the requirements of EPC 1973, i.e. the application contained claims directed to a second or subsequent medical use of a known compound which were not drafted in the Swiss form. The applicant went on Appeal after the EPC 2000 revision came into force, and the European Board of Appeal (EBoA) decided that the application was to be decided under the revised EPC 2000 provisions.

Under EPC 2000, new Article 54(5) expressly acknowledges the patentability of any substance or composition for any specific use in a medical method provided that such use is not comprised in the state of the art.

Insofar as the use of Swiss form claims is concerned, the EBoA expressly stated that “When the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so-called Swiss-type claim”.

However, it left open the question as to whether or not a medicament already known for use in the treatment of a particular illness, could be patented for use in a different, new and inventive treatment for therapy, albeit of the same illness.

In considering the potential breadth of second medical use claims, the EBoA referred to the fact that Article 54(5) EPC 2000 stipulates that any specific use not comprised in the state of the art may be eligible for patent protection. As such, it would not be appropriate for the EBoA to impose a distinction whereby the specific use must necessarily relate to treatment of a different disease. Thus, the EBoA concluded that the new use within the meaning of Article 54(5) EPC 2000 need not be the treatment of another disease.

A second and more specific question the EBoA had to consider was: If the answer to the previous question is yes, is such patenting also possible where the only novel feature of the treatment is a new and inventive dosage regime? The EBoA held that this question should be answered in the affirmative provided that there was a new technical effect.

Article 54(5) refers to “any specific use”, and this “specific use” may refer to a dosage regime on the basis that there is no reason to give a feature consisting of a new dosage regime of a known medicament a different treatment to other novel features.

The EBoA confirmed that these new provisions shall have no retroactive effect i.e. it would appear that Swiss form claims do not have to be removed from pending applications in Europe. However, there was to be a three-month time limit after publication of the decision for future applications to comply with this new decision. As such, new applications filed in Europe after 29 April 2011, may no longer claim second or subsequent medical uses of known compounds in the Swiss form. Claims directed to a new dosage regime, however, may still be drafted in the Swiss form.
Actavis UK Ltd. v. Merck & Co. Inc., [2008] EWCA Civ 444 (Court of Appeal 2008)
Actavis sued to revoke Merck's patent which contained a second medical use claim (in Swiss form) directed to the use of finasteride in the preparation for a drug to treat androgenic alopecia with a lower dosage than disclosed in the prior art.

The Court of Appeal reaffirmed that Swiss form claims directed to second or subsequent medical uses of known compounds will no longer be allowed, but that claims directed to a new dosage regime, may still be drafted in the Swiss form thus filling the lacuna left by Decision G 02/08.
Conclusion
Although “first medical use” claims are now acceptable in Europe in terms of EPC 2000, and the changes to the European Patents Act, for a second or subsequent medical use of a known substance or composition, the corresponding changes have not been made to South African law. Therefore, claims directed to a second or subsequent medical use of a known substance or composition would still need to be drafted in the Swiss form when filing a patent application in South Africa, until a similar amendment is made to the South African Patents Act. The aforementioned case law also provides important clarification that dosage regimes may be protected, in Europe at least, provided they meet the requirements for patentability and are drafted in the Swiss form.
Wilhelm Prozesky
Associate
wilhelm-p@adamsadams.co.za
Alison Baker
Baker has since left the firm