On 28 April 2011, the Japanese Supreme Court ruled that a term extension can be allowed for a patent covering a subsequent therapeutic product based on the same active ingredient as a product having an earlier regulatory approval date. This decision further confirms that the approach taken in Australia is at odds with many of the nation’s major trading partners.
We have written previously about pharmaceutical extensions of term (see Pharmaceutical Extensions and International Inequities). The basic principle is simple enough – where a patentee experiences delays in its ability to exploit a patent due to the requirements of obtaining regulatory approval (e.g. permission to market a drug for treatment of humans), it may apply for an extension to the normal 20-year patent term as whole or partial compensation for such delays.
To prevent the patentee from unfairly extending its monopoly, there are restrictions on the grant of an extension of term. In particular, it is generally the case that an extension is only available on the basis of the first inclusion of a therapeutic product on the relevant register. Thus a subsequent patent, directed perhaps to some variation, improvement, or new delivery method, might not be eligible for extension if the active ingredient had previously been registered in its own right.
The recent Japanese decision appears to adopt a more lenient approach to such restrictions than is currently the case in Australia, and seems more in line with the US approach.