Isoxadifen: here's the original reference

Following our earlier post this morning, it is with great thanks to Justizhauptsekretärin Elke Höchner of the German Bundespatentgericht that The SPC Blog is delighted to be able to offer readers the full text of the decision -- in German -- in which the status of safeners was referred to the Court of Justice of the European Union for a preliminary ruling in Case C-11/13 Bayer CropScience. You can read it here.

Isoxadifen reference: can you help?

One of our readers has written in to ask:

"Would it be possible to ask the SPC community for a copy of the decision of the German Federal Patent Court (BPatG; file number: 15 W (pat) 14/07 with regard to the corn safener Isoxadifen from Bayer) with regard to the recent referral to the Court of Justice of the European Union in Case C-11/13 Bayer CropScience? The referred question seems to ask whether a "safener" can be a product and an active ingredient according to Article 3(1) and Article 1 No. 8 and No. 3 of Regulation 1610/96. Unfortunately (although the court decided the referral as long ago as July 2012) the decision has not yet been published".

While this weblog is inevitably much more focused on pharma products than on the agrochemical sector, we do have some readers on that side too. Can they, or indeed anyone, help?

Denmark's new post-Medeva guidelines on "specified"

From our friend Sidsel Hauge (Partner and European Patent Attorney, Awapatent A/S, Copenhagen) comes news of the Danish Patent Office's new guidelines on the interpretation of "identified/specified" after Medeva.  The following is Sidsel's unofficial translation:

Protection by a basic patent, particularly for combination products (Last update: 17‐12‐2012)

___________________________________________________ 

Before a product which consists of a composition of two or more active ingredients, known as a combination product, can be considered to be protected by a basic patent according to the Regulation, the combination of the active ingredients must be specified by the wording of the claims of the basic patent in accordance with the judgment of 24 November 2011 in Case C‐322/10 (Medeva) of Court of Justice of the European Union. 

For example, a combination product consisting of the two active ingredients A and B is considered to be protected by a basic patent, if the combination A and B appear in the wording of the claims. 

The product is considered to be specified in the wording of the claims when the product is described by a chemical name or a structural formula, i.e. specifically mentioned or being comprised by a Markush formula. 

A product may in some cases be considered to be specified in the wording of the claims of the basic patent, if the product is specified by functional terms. The actual protection will always be decided from case to case on a case by case basis. 

If the basic patent in an administrative re‐examination could be limited so that the combination of the active ingredients remains in wording of the claims of the basic patent, we also consider the combination product to be protected by the basic patent and thus Article 3, point a, to be fulfilled. 

You can read more about the effects of the foregoing for applications for a certificate for combination products under Combination products.

Valsartan: France back in line with the rest of Europe

From our good friend Laëtitia Bénard (Partner, Allen & Overy LLP, Paris) comes some more fascinating and instructive material for our readers. Laëtitia (whose firm acted as counsel to Novartis in the Valsartan case, and to MSD and Du Pont in the Losartan case) writes:

Novartis v Actavis on the Valsartan SPC: the French Supreme Court has quashed the decision of the Paris Court of Appeals and has put France back in line with the CJEU and national courts in Europe by ruling that an SPC covering Valsartan confers the same rights as the basic patent and is infringed by a medicinal product comprising Valsartan in combination with another active ingredient

Further to a preliminary injunction rendered against Actavis on 28 January 2011, which ruled that Actavis' generic medicines containing a combination of Valsartan and HCTZ infringed the SPC of Novartis for Valsartan, the Paris Court of Appeals rendered a decision on 16 September 2011 inconsistent with the almost unanimous interpretation of the SPC Regulation across Europe on the subject matter and effects of an SPC, including France, reversing the preliminary injunction measures ordered in first instance.

On 15 January 2013, ruling on Novartis' appeal, the French Supreme Court quashed the decision of the Paris Court of Appeals, aligning at the highest level the French case law with the interpretation of the SPC Regulation by the CJEU in its Reasoned Orders of 9 February 2012 (C-442/11 and C-574/11), as previously did the Paris First Instance Court ruling on the merits on 8 June 2012 in the Losartan case (decision now final -- you can read the French decision of 8 June 2012 here and the English translation here).

The French Supreme Court ruled that an SPC covering Valsartan confers the same rights as the basic patent and is infringed by a medicinal product comprising Valsartan in combination with another active ingredient.

The main findings of the French Supreme Court are as follows:

"Whereas by order of 9 February 2012 (C-442/11), the Court of Justice of the European Union ruled and held to be law that Articles 4 and 5 of Regulation No. 469/2009 must be interpreted as meaning that, where a product consisting of an active ingredient was protected by a basic patent and the holder of that patent was able to rely on the protection conferred by that patent for that product in order to oppose the marketing of a medicinal product containing that active ingredient in combination with one or more other active ingredients, an SPC granted for that product enables its holder, after the basic patent has expired, to oppose the marketing by a third party of a medicinal product containing that product for a use of the product, as a medicinal product, which was authorised before that certificate expired;  

Whereas the decision considers, in order to dismiss Novartis' claims, that the litigious generic medicinal product, comprising Valsartan associated with HCTZ, does not constitute the same product as Valsartan, solely covered by SPC No. 97C0050, and consequently that it does not appear likely that any marketing of a medicinal product containing Valsartan as an active ingredient constitutes an infringement and violates the rights owned by Novartis over this active ingredient; 

Whereas, by deciding so, without considering whether the rights owned by Novartis on patent No. EP 0 443 983 would have allowed them to oppose the use of Valsartan, as a medicinal product, in the litigious generic medicinal products associating it with HCTZ, and whether, consequently, these generic products would infringe SPC No. 97C0050, covering, as the basic patent, Valsartan, and conferring to Novartis the same rights as the patent, the Court of Appeals rendered a decision without legal basis;".

This decision of the French Supreme Court is final.

You can read the French decision of the French Supreme Court here and the English translation here. 

Paris in the springtime

It's third time around for FORUM's English SPC advanced course, 'Supplementary Protection Certificates', featuring our good friend Dr Christopher Brückner.

Christopher, regular readers may recall, is the author of this SPC commentary (which participants will receive on top of course documentation). This year's event will take place on 14 and 15 March 2012 in Paris. More information is available here.

SPC Blog readers are entitled to benefit from a 10% discount for this event (€ 1,160 instead of € 1,290).

VALSARTAN HCT France: Court of Appeals reverses trial court decision granting Novartis ex parte injunction

The SPC Blog would like to thank Floriane Codevelle and Arnaud Casalonga (Casalonga Avocats, Paris) for sharing the following information, which is of particularly interesting with regard to the availability of interim injunctive relief in France:

Alleging infringement of the European patent and the SPC by the product Valsartan hydrochlorothiazide, Zentivalab 80 mg/12.5 mg, 160 mg/12.5 mg and 160 mg/25 mg, the NOVARTIS companies submitted an application for ex parte interim measures against the companies SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS before the President of the Regional Court of Paris which, by order of 27 October 2011, granted the request.

SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS summoned NOVARTIS for rescission of the order and alternatively for the provision of a guarantee.

By order of 31 October 2011, the judge in chambers maintained the order on application in all of its provisions -- with the exception of those relating to the obligation to communicate information intended to determine the origin and the distribution networks of the pharmaceutical compositions reproducing the claims of the patent EP0443983 and of the SPC No. 97C0050.

SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS made appeal of this decision and asked the Court of Appeal, inter alia, to state that the conditions of Article L 615-3 of the Intellectual Property Code, authorizing under specific conditions ex partes interim measures, were not met.

In its decision issued on December 11, 2012, the Court annulled the order issued on October 31, 2011 and in a new ruling rescinds the order on application of 27 October 2011.

After finding that:

-          the documents at the Court’s disposal, which would be those submitted as proof of the infringement to the applications judge in support of the injunction request, did not sufficiently prove the imminent marketing of the products in question; 

-          interim measures could have been ordered through inter parte proceedings, since there are urgent short-notice summary proceedings which make it possible to observe the requirements of inter partes proceedings within a shortened period;

-          the “irremediable prejudice” invoked by NOVARTIS was not sufficient to grant ex parte interim measures, in addition to not being irremediable;

 The Court stated that

“ … the grounds invoked in support of the application for authorization of non‑compliance with the principle of inter partes proceedings are insufficient; whereas they could not allow recourse to ex partes proceedings, since inter partes proceedings were essential, the interests at stake being significant and the injunction measures sought themselves having serious consequences for the opposing parties. … it follows that as the grounds presented for justifying the departure from the principle of inter partes proceedings are unreasonable, the referred order which had to examine the ground set out for justifying the departure from this principle could only rescind the application and whereas it must therefore be annulled on this basis”.

The full text of the French decisions can be accessed in the original French (here) and in English translation (here).

Thanks so much, Floriane and Arnaud: we are most grateful to you.