Negative term SPC duration: a business intelligence consultant's perspective

Martin Paltnoi (Principal Consultant, Martin Paltnoi Associates) has written to The SPC Blog with the following observations:

"As a business intelligence consultant covering pharmaceuticals in general and patents in particular I have been following the SPC situation since its inception in 1993. Also in my capacity as joint editor of Pharma Patent Bulletin,  reporting in that journal on SPCs on a regular basis, I have obviously noticed the existence of negative SPC duration.

This phenomenon has been incurred through the existence of the paediatric investigation plans (PIP) through the Paediatric Use Marketing Authorisation (PUMA). This has evoked raised eyebrows and objections, the latest coming from Greg Perry, the EGA's Director General,  who is quite naturally concerned about giving more exclusivity to originators and thereby holding up access to generic activity. In the EGA's press release "Better Patents Make Better Medicines..." it was stated that "zero or negative term SPCs should not be extended".

This prompted me to look a little closer into the whole matter. It must be understood that the extra exclusivity time allowed was as an incentive and/or reward to conduct more work on paediatric medicines. This reward was to be by adding extra time (six months) to the SPC, but is this the right way? We have seen that there have been those originators whose patents give more than the minimum fifteen years exclusivity and thereby do not qualify for an SPC. But should they be excluded from qualifying for the extra six months for extra paediatric work? I suggest not. The way this has been dealt with is to allow negative duration SPCs.

Should the argument against negative SPCs be successful, this could have a negative effect. If there is no reward there will be no activity, which would be contrary to the objectives of PUMA. On the other hand, should these objections be noted by the European Commission's pharmaceutical sector enquiry, one possible outcome is that the extra six months be allowed either on the SPC or patent, whichever has the later expiry. This would definitely be against the intentions of the EGA, but would be more realistic as a means of rewarding paediatric product development".

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