“New Use Claims” – New Indian patent law heralds fundamental changes

The recently promulgated Indian Patent Ordinance indirectly recognizes ‘new uses’ as patentable in India. Thus far, new use of a known substance was unpatentable. Section 3 of the Indian Patents Act 1970 excluded ‘new use’ from the scope of patentable inventions. The recent amendment enables pharmaceutical companies to protect new use of patented drug molecules, which is a move welcomed by the global pharmaceutical companies.

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.

The following illustration further explains ‘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).’

The Patents Ordinance amended Section 3 (b) of the 1970 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. Hence, a new use of a known substance in a known or a new way to produce a non-obvious and useful result would be patentable. Therefore, it can be construed that this amendment opens up a new avenue for preserving claim coverage, albeit indirectly, of important drug molecules.