Novelty is one of the basic criteria of patentability, inventiveness and industrial applicability being the other two. If the use of a substance or a composition for a specified medical purpose is new, a claim in a patent application directed at this use will be considered as novel even if the same substance had previously been used in medicine for a different purpose. Satisfying the patentability criteria, a further or second medical use of a substance or composition can be protected by a claim to the use of the substance for the manufacture of a medicament for a specified medical use. Such claims are called ‘Swiss-type’ or ‘Swiss-style’ claims, as it was a decision of the Swiss Federal Intellectual Property Office in 1984 that first allowed patents with this type of claims.
The following illustration is aimed at further explaining the ‘Swiss-type’ claims. A claim for a second medical use can be as follows:
- ‘The use of (substance X) in the manufacture of a medicament for the therapeutic and/or prophylactic treatment of (medical condition Y).’ This is the usual form of a Swiss-type claim.
- ‘The use of (substance X) in the preparation of (an anti-Y agent) in ready-to-use drug form for treating or preventing (medical condition Y).’ The expression "in ready-to-use drug form" was intended to mean "as presented for sale", i.e. packaged. ‘The use of (substance X) in the manufacture of (an anti-Y agent) in a package together with instructions for its use in the treatment of (medical condition Y).’
However, a method of treatment claim can be disguised in the form of Swiss-type claims, for e.g.:
- ‘The use of substance X in the treatment of disease Y.’
Swiss-type claims are, therefore, permissible only if the national patents law permits the patentability of new use for a known substance. Some of the major Patent Offices now allow such claims. In the US, claims addressed at methods of treatment are accepted. Since Swiss-type claims are drafted in a manner that is designed to avoid the prescription against the patentability of method of treatment claims, grant of such claims is not a requirement in the US. However USPTO accepts Swiss-type claims.
The European Patent Office (EPO) considers methods of treatment as not being capable of industrial application and consequently not patentable. However, subsequent to the allowance of the ‘Swiss-type’ claims by the Swiss Patent Office, the Enlarged Board of Appeal of the European Patent Office (EPO) started accepting such claims. In John Wyeth and Brothers Ltd's Application and Schering AG's Application (1985), the Enlarged Board of Appeal of the EPO held that, whilst a claim to the method of use could not be permitted, a claim for the use of a product for the manufacture of a medicament for a specified new and inventive medical use (the Swiss-type claim) could be permitted on the basis that the novelty of the claim resided in the new therapeutic use and not the method of manufacture.
The Australian Patent Office started accepting the Swiss-type claims only in 1998, after a decision in Bristol-Myers Squibb v Faulding. This case involved two patents having claims directed to methods of administering a known anti-cancer drug (Taxol) at a particular dosage for a length of time that was demonstrated to be effective. It was held that the patents were invalid as they were directed to the treatment of a life threatening disease and allowing such patents would be ‘generally inconvenient’ and hence unpatentable under Australian practice. This decision, however, lead to the change of practice of the Patent Office, allowing Swiss-type claims.
The Indian Patents Act, 1970 (the Act) does not allow claims directed to a new use for a known substance. Section 3(d) of the Act states that the mere discovery of any new property or new use for a known substance is not an invention and hence not patentable. The Act also does not allow claims directed at process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or animals.
However, the currently pending Patents (Amendment) Bill, 2003 proposes to amend sub-section (d) of Section 3 of the Act to substitute the words ‘new use’ with ‘mere new use’. This would imply that only a mere use of a known substance would not be patentable. Corollary, a new use of a known substance, to produce a useful and non-obvious end result, would be patentable. Hence, a new use of a known substance (a drug) in a known or a new way to produce a non-obvious and useful result would be patentable. Therefore, it can be construed that the proposed amendment in the Patents (Amendment) Bill 2003 opens a way for the allowability of Swiss-type claims.
Considering the current status of the R&D in India the protection of new uses may be advantageous for India. The trend of acceptance of Swiss-type claims has started in the other Developing countries. Malaysia has incorporated in its patent law a provision for accepting claims drafted as uses of compounds to treat medical problems. Hopefully, an Examination Guideline by the Controller of Patents, India may clarify the Indian position in the near future. In the alternative, the Intellectual Property Appellate Board is the appropriate forum to determine the intent behind substituting the words ‘new use’ with ‘mere new use’ in Sub-clause (d) of Section 3 of the Act.
© Lex Orbis 2004
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