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.
3 comments:
These are very interesting and thought provoking articles. However, I disagree with the authors regarding Model C.
During the passage of this Regulation through the EU legislative process, the Pharma industry lobbied hard for the 6m extension to be applied to either a patent or an SPC. However, its application to a patent was expressly rejected. For this reason, Model C has to be incorrect because it achieves (via the back door) a result which was clearly rejected by the legislator.
I would agree with Model A though. It can hardly have been the legislators intent to create an incentive to Pharma companies to delay obtaining a marketing authorisation (even if only for a few months) in order to avoid the "perverse result" of Model B. If I recall correctly, the Recitals of the Regulation clearly state that it was not intended to cause delay in getting products approved and into the patients who need them.
Below 5 years from patent filing, Model C involves the extension of a zero-term SPC and not extension of a patent. The two extensions are not the same, as a zero-term SPC can only be granted if the eligibility criteria (e.g. Article 3 of Regulation 1768/92) are met.
Extension of a zero-term SPC has not been rejected by the regulators, and hence appears worthwhile pursuing... at least until the ECJ has reached a decision on the matter.
Although Model C extends an SPC and not a patent, the net result is the same as if extension of patents had been allowed. But this possibility was rejected.
I hope someone does litigate the matter up to the ECJ and I hope that they succeed. However, my opinion is that they would fail.
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