IPO consults on extending 'Appointed Person' facility to SPC appeals

The United Kingdom Intellectual Property Office (IPO) has published a consultation paper on whether to extend the use of Appointed Persons from trade mark law to to patents. At present, trade mark appeals from the decisions of IPO hearing officers may be made to the High Court (of which the Patents Court forms part) or to a specially designated Appointed Person. In the former case, further appeals may be made to the Court of Appeal and Supreme Court, while in the latter case -- as a means of preventing the costs of an appeal from spiralling upwards -- the decision of the Appointed Person is final and no appeal may be made on substantive legal grounds. According to the IPO:

"This discussion document takes a look at the issues surrounding introducing an Appointed Person appeal route for patents matters (and, by extension, matters relating to supplementary protection certificates)".

It is difficult to imagine why proprietary pharma companies and their generic counterparts would wish to opt for an appeal against which there is no appeal in an area of law which is so complex and uncertain -- but we won't know for a while what the outcome of this consultation will be, since the closing date for the submission of responses is 21 May 2013.

Click here for a little more background
Click here for the consultation paper

"Dysfunctional" SPC system needs revision, says judge

Glaxosmithkline Biologicals SA v Comptroller-General of Patents, Designs and Trade Marks [2013] EWHC 619 (Pat), a Patents Court for England and Wales ruling of Mr Justice Arnold, has become the latest SPC case to be the subject of a reference to the Court of Justice of the European Union for a preliminary ruling. 

In short, GSK applied for a supplementary protection certificate for "an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", an adjuvant known as AS03 protected by European Patent (UK) No 0 868 918. Later, GSK applied for a supplementary protection certificate for "an adjuvanted influenza vaccine comprising an influenza virus component which is an influenza virus antigen from an influenza virus strain that is associated with a pandemic outbreak or has the potential to be associated with a pandemic outbreak, wherein the adjuvant is an oil in water emulsion comprising squalene, DL-α-tocopherol and polysorbate 80", a vaccine comprising an antigen and AS03 protected by European Patent (UK) No 1 618 889.  In both cases GSK relied upon marketing authorisation EU/1/08/453/001 for a pre-pandemic influenza vaccine against the H5N1 subtype of influenza A virus marketed by GSK under the trade mark Prepandrix. In decision BL O/506/12 the UK IPO decided that neither application was allowable: AS03 was not an "active ingredient" of Prepandrix. GSK appealed to the Patents Court and Arnold J decided to refer the following questions to the Court of Justice:

"1. Is an adjuvant which has no therapeutic effect on its own, but which enhances the therapeutic effect of an antigen when combined with that antigen in a vaccine, an 'active ingredient' within the meaning of Article 1(b) of Regulation 469/2009?

2. If the answer to question 1 is no, can the combination of such an adjuvant with an antigen nevertheless be regarded as a 'combination of active ingredients' within the meaning of Article 1(b) of Regulation 469/2009?"

Andrew Waugh QC (3 New Square) and Emma Fulton (Hogan Lovells International LLP) both emailed to draw the attention of this blogger to the text which we have reproduced in bold type.

84. In case it assists, I shall state my own view on these questions. While I acknowledge the force of counsel for GSK's argument that the primary purpose of the SPC Regulation is to reward innovative research of the kind that led to the development of AS03 and Prepandrix, I find the arguments presented by counsel for the Comptroller more convincing. In particular, I consider that the SPC Regulation was intended to provide a simple and predictable system that could be operated by the competent authorities of the Member States, and in particular the national patent offices, in a uniform manner. To achieve those objectives, it is necessary to have bright-line rules. Article 1(b) is such a rule. In my view the Court of Justice was correct to hold in Pharmacia, MIT and Yissum that it should be strictly interpreted. The result of a strict interpretation is to deny extended protection for what may well be meritorious inventions, but the price of not adopting a strict interpretation is a level of uncertainty and inconsistency which in my opinion is unacceptable. Accordingly, I would answer both questions no.

85. It is worth adding that, as counsel for the Comptroller pointed out, GSK may be able to obtain an SPC for the antigen contained in Prepandrix based on the 889 patent and the marketing authorisation for Prepandrix. Thus refusal of the appeal would not necessarily leave GSK bereft of protection.

86. Finally, I would observe that this is the third time in six months that I have had to refer questions of interpretation of the SPC Regulation to the CJEU. I do so with considerable regret. That this should be necessary demonstrates the dysfunctional state of the SPC system at present. This is primarily due to the poor drafting of the SPC Regulation and to the failure of the European Commission, Council and Parliament to revise it to address the problems which have emerged. Matters have not been assisted, however, by the fact that the Court of Justice's recent case law interpreting the SPC Regulation has not provided the level of clarity and consistency that is required.

This blogger is fully in agreement with the judge's comments.

Switzerland, Liechtenstein and the AstraZeneca reference: your chance to comment

Readers of The SPC Blog will be familiar with the UK litigation between AstraZeneca AB and the Comptroller of Patents, Designs and Trade Marks since this blog posted a note on it back in October of last year.  This case has now resurfaced as a reference to the Court of Justice of the European Union with the new designation of Case C-617/12  AstraZeneca.

The UK's Intellectual Property Office reminds us that the referring court has asked the following questions:

"1. Is a Swiss marketing authorisation not granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, but automatically recognised by Liechtenstein, capable of constituting the 'first authorisation to place the product on the market' for the purposes of Article 13(1) of Regulation 469/2009/EC?

2. Does it make a difference to the answer to the first question if:

(a) the set of clinical data upon which the Swiss authority granted the marketing authorisation was considered by the European Medicines Agency as not satisfying the conditions for the grant of a marketing authorisation pursuant to Regulation 726/2004/EC; and/or

(b) the Swiss marketing authorisation was suspended after grant and was only reinstated following the submission of additional data?

3. If Article 13(1) of Regulation 469/2009 refers solely to marketing authorisations granted pursuant to the administrative authorisation procedure laid down in Directive 2001/83/EC, does the fact that a medicinal product was first placed on the market within the EEA pursuant to a Swiss marketing authorisation automatically recognised in Liechtenstein which was not granted pursuant to Directive 2001/83/EC render that product ineligible for the grant of a supplementary protection certificate pursuant to Article 2 of Regulation 469/2009?".

If you would like to comment on this case and, by doing so, encourage the UK government to take a position on whether to make observations to the CJEU, please email policy@ipo.gsi.gov.uk by 28 February 2013.  We know there's not much time, but ...

Isoxadifen and SPCs for safeners: UK invites comments

Following on from The SPC Blog's earlier posts here and here, the UK Intellectual Property Office has now issued a circular inviting interested parties to comment on the Court of Justice of the European Union reference in Case C-11/13 Bayer CropScience so that the UK government can decide what, if any, position it wishes to take with regard to the question referred. To jog readers' memories, the IPO explains:

The appellant is seeking a supplementary protection certificate for ‘Isoxadifen and the salts and esters thereof’. Isoxadifen is a ‘safener’, that is, a substance added to a product to prevent the harmful action of an herbicide in plants.

The referring Court asks whether such a safener falls within the meaning of the terms ‘product’ in Article 3(1) and Article 1(8), and ‘active substance’ in Article 1(3) of the Regulation.

While the precise official English version of the reference from the German Bundespatentgericht does not appear to be available, the gist of the question is clear.

If you would like to comment on this case please email policy@ipo.gsi.gov.uk by 25 February 2013.

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.