Choosing National Phasing Territories for a Biotech/Pharma Case

This article discusses preliminary thoughts on how to choose which territories to proceed in at the national phase stage of the application.  This advice is in general appropriate for biotech/pharma inventions and is based on our experience of working with early stage biotech/pharma companies.

We believe the relevant criteria to be:

-          expected market size

-          expectations of potential buyers

-          cost of proceeding in the relevant territory

-          importance of the patent case to the company

Market Size and Expectations of Potential Buyers

For national phasing people often classify territories into groups of decreasing importance along the following lines:

Group 1: US, Europe, Japan

Group 2: Australia, Canada, China, India

Group 3: Brazil, Russia, South Korea, South Africa

Group 4: Singapore, Mexico, Israel.

We would also place Hong Kong in Group 4, but protection there can be achieved via registration of a European (the UK designation) or a Chinese case.

The above groups reflect perceived market importance to companies in the biotech/pharma sector.  For an early stage company it would not be common to proceed in other territories, although sometimes there are commercial reasons to do so.  In general early stage companies proceed in Europe and the US, and give serious consideration to all of the Group 1 and 2 countries.  Many companies would only proceed in Groups 3 and 4 where there were clear commercial reasons to do so. 

Egypt, Indonesia, Vietnam and Malaysia could be seen as a possible Group 5, though it would be unusual for early stage biotech/pharma companies to proceed in any of these territories.

Cost of National Phasing and Importance of the Case

National phasing can be an expensive procedure, especially in countries that require a translation.  Clearly after national phasing there are continuing subsequent costs.  Clearly the decision as to how many territories to proceed in will depend on the resources available to the company as well as the perceived importance of the case.

You may also wish to see related articles Building a Patent Portfolio  and What's happening to Pharma Patents min India