Back in September I asked readers of The SPC Blog if they could recommend any good reading on the commercial and economic aspects of supplementary protection certificates. There hasn't been much of a response as yet, though I've been sent copies of two short articles by Mike Snodin and John Miles of (formerly Eric) Potter Clarkson. Both pieces are published in RAJ Pharma and they share the same title: "Making the Most of Paediatric SPC Extensions".* The July 2007 article (RAJ Pharma, 18(7), 459-463, (2007)) discusses three possible models for calculating the term of "extended" SPCs. Two of the three models involve the new concept of applying for SPCs that, without the six-month extension, would have no term (or even a negative term). The authors add:
"The conclusions that we reach could have a significant impact upon strategies for product lifecycle management. ... [I]f paediatric trials are to be conducted on a product, then it may always be worth applying for an SPC, even if fewer than five years have elapsed between patent filing and the grant of the marketing authorisation".* The June 2008 article (RAJ Pharma, 19(6), 387-388, (2008)) is a two-page note on a UK IPO decision on whether it is possible to obtain a zero or negative-term SPC in order to base a paediatric extension on it (see the earlier SPC Blog post here). The authors conclude:
"It remains to be seen whether it will be possible to persuade a patent office (or a national court or the European Court of Justice) to accept a calculation of extended SPC term".The first article can be accessed here; the second article can be accessed here. Many thanks, Mike and John, for letting us know about these.
