A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Monday, 29 November 2010

SPCs and the "Salt" Problem No.2

Issue 4 of 2010 of Sweet & Maxwell's Intellectual Property Quarterly (IPQ) carries an interesting and highly relevant article by Dr Herwig von MorzĂ© -- who is well known to readers of this weblog (click here).  The article, "SPCs and the "Salt" Problem No.2", has an abstract that reads as follows:
"Several provisions of the medicinal product SPC Regulation 1768/92 (codified as Regulation 469/2009) have been subject to interpretation and clarification by the ECJ. Because the initial administrative interpretation of a provision is undertaken by 27 national patent offices, it is not surprising that different national outcomes will result. Different outcomes may be confirmed at a national judicial level, unless a national court refers the issue to the ECJ.

Recital 14 of the plant protection product SPC Regulation 1610/96 has been subject to diverse national interpretation. This Recital also applies mutatis mutandis to the interpretation of several provisions of Regulation 469/2009. It concerns the issue of an SPC for a derivative of an active substance based on a second marketing authorisation issued for the derivative if an earlier authorisation exists for the active substance.

The article proposes the application of an existing regulatory approach to prevent disharmony within the EU. Notwithstanding the differences between EU and US law, recent US case law appears to support the appropriateness of the regulatory approach proposed in this article".


Anonymous said...

Can you post a copy of the article please?

Anonymous said...

Yes please!