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

Friday 3 June 2011

Merck ECJ reference: Opinion due this Thursday

Here's a quick reminder: this coming Thursday will see the publication of the Opinion of the Advocate General in Case C-125/10 Merck & Co Inc v Deutsches Patent- und Markenamt, a reference for a preliminary ruling from the Bundespatentgericht (Germany) lodged back in March 2010.

The question referred to the Court of Justice of the European Union is this:
"Can a supplementary protection certificate for medicinal products be granted if the period of time between the filing of the application for the basic patent and the date of first authorisation for marketing in the Community is shorter than five years?"
This weblog looks forward to bringing you news of the Opinion, together with comment if appropriate.

The SPC Blog is conducting a poll, which closes at 9:30am on Thursday. You will find this located at the top of the side bar on the right of the blog's front page. Is the answer "yes" -- or is it "no"? This is your big chance to vote!


Anonymous said...

An SPC in this case can be possible. But it comes as a negative SPC term, this is benefit if applicant further apply for PED, SPC Term exten under PED exclusivity.

Anonymous said...

Come on SPC Bloggers, Kats, and whatever. This has to be a NO.

This is just some desperate wheeze by big pharma squeeze some extra months out of their blockbuster franchises. If the ECJ let's this through, imagine the chaos that will result...

Say ECJ determines that the patentee is entitled to a negative term SPC. We all know that this is so that patentee has a basis for applying for the paediatric extenion in due course (as the earlier post indicates). So patentee then gets his paediatric extension ready to file before SPC expiry. Let's assume that it's a deficient aplpication. (Imagine, say, the patentee did not harmonize his SmPC across the EU, or has not got the product authorised in every member state of the EU). Or, imagine, say, that the patentee fails to submit his application by the deadline.

So the paediatric extension application is rejected or not made at all.

What then? Reduce the patent life by the appropriate "negative term"? Seems fair to me. Result - chaos and uncertainty for 3rd parties, ultimately to the detriment of consumers.

Note to big pharma - be careful what you wish for.

Bart Jansen said...

The regular SPC was intended as a compensation for the delay in time-to-market medicines due to required tests.
The Regulation Regulation 1901/20062 for paedriatic extension intends giving companies an incentive to perform additional tests (I will not go into Big Pharma conspiracy theories here).

Not having a delay to market appears to lead to a straightforward conclusion that the applicant is not entitled to SPC extension according to its original intended use.

However, as having an SPC is a prerequisite for paedriatic extension, this would put the applicant at a disadvantage and takes away the incentive that the Regulation intends to give.

Why take away the incentive for doing the paedriatic tests for applicants who worked hard (or were lucky enough) to obtain a fast market admission?

In conclusion, I believe a zero term SPC should be possible. It would be desirable to avoid the artificial zero or negative term SPCs at all by uncoupling the normal SPC and paedriatic extension, making them separate options for extending the patent term.