AG Opinion for C-125/10 - English translation available!

Earlier this month, The SPC Blog posted a short note on the AG's opinion for case C-125/10 (Merck & Co Inc v Deutsches Patent- und Markenamt). No official English translation is available yet on the Curia website. However, Monica Heinemann (Abitz & Partner, Munich) has kindly provided a translation, which you can access here. Thanks Monica!

Opinion of the AG for C-125/10 is out!

The opinion is out and is available here (but not in English yet). In short, the AG is in favour of granting a 'negative' SPC even if the period between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the community is less than five years.

Many thanks to Monika Heinemann (Abitz & Partner) and Andreas von Falck and Miriam Gundt (Hogan Lovells LLP) for passing this on.

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!

C-125/10 - Merck & Co Inc v Deutsche Patent- und Markenamt

We have known for a while that the German Federal Patent Court (GFPC) was going to refer a question to the Court of Justice in the Sitagliptin case (15 W (pat) 36/08, see our postings here). The referral now has a number: C-125/10.

Just to remind you what it is all about, here is the question the GFPC asks:

"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 the first authorisation for marketing in the Community is shorter than five years?"

Full translation of German Sitagliptin Referral Available

The SPC Blog kindly thanks Monica Heinemann (Abitz & Partner) and Miriam Gundt (Lovells)for providing a full translation of the German Federal Patent Court's Sitaglipin referral decision (see here for previous post on this matter).

Partial Translation of German Sitagliptin Referral

Thanks to Klemens Stratmann (Hoffmann Eitle) for kindly providing a partial translation (here) of the recent German referral on Sitagliptin to the Court of Justice.

CJ Referral on Negative Term SPCs

The German Federal Patent Court has decided to refer a question for preliminary ruling on negative term SPCs to the Court of Justice of the European Union in the Sitagliptin case (Case 15 W (pat) 36/08):

"Can an SPC be granted for a medicament if the period between the filing of the application for the basic patent and the time point of first authorization for marketing in the Community is shorter than five years?"

A copy of the decision can be downloaded here (for the moment, in German only).

Thanks to Klemens Stratmann (Hoffmann Eitle, Munich) for providing a translation of the question.

Zero Term SPCs: the Dutch decision

The score is now 3:3 for the grant of an SPC for sitagliptin, now that the Netherlands Patent Office (NPO) has decided to grant a zero-term SPC.

For those of you who don't quite master Ruud van Nistelrooy's native language, here is a summary of the key points the NPO argued:

• First, the grounds for refusal included in the SPC regulation appear to be limited.
  
• Secondly from the proposal of the Paediatric Regulation it is clear that the term extension was meant not only as a reward for carrying out mandatory paediatric studies for new marketing authorizations but also as an incentive for companies with existing marketing authorizations to perform such studies. It is repeatedly stated in the proposal that companies will want to develop new formulations, dosage forms and indications for their existing products in order to access the six-month SPC extension (see the references in our decision). Not granting a zero-term SPC would mean that in this case no such incentive exists. That does not seem in line with the purpose of the Paediatric Regulation which is to increase our knowledge on the safety and efficacy of medicines in the paediatric population. Furthermore applicants could also be tempted to delay granting of the marketing authorization in order to qualify for an SPC with a positive duration. Delayed entry of pharmaceuticals onto the market (and available to patients) is obviously not desirable and this is also explicitly stated in the preamble of the Paediatric Regulation (4th recital).

Thanks to Martijn de Lange from the Netherlands Patent Office for informing us on this decision.