Austrian SPC decision on an SPC application based on a variation type II of an existing MA

Bianca-Lucia Vos and Klemens Stratmann of Hoffmann-Eitle have generously provided a copy of a recent decision of the Higher Regional Court of Vienna (here) regarding an SPC application based on a variation type II of an existing marketing authorisation.  An English translation of the decision can be obtained here.  Bianca-Lucia and Klemens comment:

On January 21, 2016 the Higher Regional Court of Vienna, Austria, issued a decision (34 R 104/15) on the interpretation of Art. 3(b) of Regulation 469/2009 in the light of the Neurim judgment of the CJEU (case C-130/11). In the case underlying the appeal to the Higher Regional Court of Vienna, the Austrian Patent Office had rejected an SPC application that was based on a second medical use patent (EP 0 758 900) and a Type II variation of an existing (national) marketing authorization for Botox due to which the indication protected by the selected basic patent, i.e. treatment of chronic migraine, was added to the already approved indications of Botox. The Examiner had calculated the 6-month time limit for filing the SPC application according to Art. 7(1) of Regulation 469/2009 from the date of the very first marketing authorization for Botox in Austria. In his view, the amendment by a Type II variation of a marketing authorization does not newly trigger the 6-month time limit for applying for an SPC.

However, following the considerations of the European Court of Justice in the Neurim decision C-130/11, the Higher Regional Court of Vienna ruled that a marketing authorization as amended by a Type II variation can be considered as a valid marketing authorization in the sense of Art. 3(b) of Regulation 469/2009. The Court also emphasized that patent protection and marketing authorization must harmonize in terms of content, and that earlier authorizations do not deprive the more recent authorization of a patented use from being the “first authorization” pursuant to Art. 3(d) of Regulation 469/2009, if the earlier authorization refers to areas not protected by the basic patent.

Accordingly, the Court also held that an earlier authorization granted for a use outside the scope of protection of the patent has no negative effect in so far as it does not trigger the 6-month time limit pursuant to Art. 7(1) of Regulation 469/2009.  Therefore, the contested decision had to be reversed, and the Patent Office ordered to render a decision on the merits as to whether the application had been filed in due time.

Applying the principles set forth by the CJEU in Neurim, the Higher Regional Court Vienna hence confirmed that an SPC application may be filed on the basis of a Type II variation of an existing marketing authorization as “valid authorization to place the product on the market” according Art. 3(b) and “first authorization” in the sense of Art. 3(d) of Regulation 469/2009.

Many thanks to Bianca-Lucia and Klemens for sharing this decision!

MAs and APIs: the Austrian Supreme Court applies Forsgren ruling

Last week our friend Rainer Schultes (Geistwert) posted on his blog this note, which we are happy to reproduce below with his permission, on the Austrian Supreme Court's application of the provisions of the SPC Regulation in the light of a recent ruling of the Court of Justice of the European Union (CJEU) in response to the Austrian court's reference in the Synflorix case.  For the benefit of any first-time readers, API stands for "active pharmaceutical ingredient" and an MA is not a higher degree but a marketing authorisation:

The API of an SPC need not be mentioned in the MA

In Case C-631/13 Forsgren [noted briefly here on The SPC Blog], the CJEU already ruled: Article 3(b) of Regulation 469/2009 must be interpreted as precluding the grant of a supplementary protection certificate for an active ingredient whose effect does not fall within the therapeutic indications covered by the wording of the marketing authorisation.

Article 1(b) of Regulation 469/2009 must be interpreted as meaning that a carrier protein conjugated with a polysaccharide antigen by means of a covalent binding may be categorised as an ‘active ingredient’ within the meaning of that provision only if it is established that it produces a pharmacological, immunological or metabolic action of its own which is covered by the therapeutic indications of the marketing authorisation.

GEISTWERT has blogged already (link).

Now, the Austrian Supreme Court shed further light on the SPC Regulation when applying the CJEU's judgment (Austrian Supreme Court, 4Ob20/15t).

In the matter at stake an SPC was requested for a protein D, which is a carrier protein covalently bonded to other active ingredients. Covalent binding does not exclude an SPC.

The Supreme Court analysed the context between the order for reference, the statement of the European Commission and the CJEU’s judgment: The Supreme Patent- and Trademark Senate, which referred the question to the CJEU had individualized the protein D as a carrier for which no pharmaceutical effect was mentioned in the Marketing Authorisation (MA). With regard to that, the Commission meant that the protein’s activity had to be mentioned in the MA, otherwise the request for SPC was not justified. The CJEU did not follow that but referred to the facts, thus to the effectiveness of the protein within Synflorix.

Upon this analysis, the Supreme Court now held that an own pharmacological, immunological or metabolic action of the protein D within the indications covered by the MA has to be established but it is not necessary that the protein D is explicitly mentioned in the Marketing Authorisation.

To verify that, the matter was referred back to the first instance.

Thanks so much, Rainer, for keeping us informed!

Valsartan: now it's Austria's turn

From Dr Ernst Tremmel (Partner, Wiltschek Rechtsanwälte, Vienna) comes new that, in the recent past, an Austrian first instance court has delivered its judgment in the main proceedings, holding that a Valsartan/HCTZ product infringes the mono SPC for Valsartan. He tells us that, though the judgment is not yet final, he thought it might be of interest both for us at The SPC Blog and for our readers, so he has kindly furnished us with (i) a short English-language summary of the decision and (ii) the anonymised German-language version of the judgment. It is is hope that, within the next few days, he will be able to send us also an unofficial English translation.

Thanks, so much Ernst, both for this information and for your offer to deal with any questions arising out of these attachments.

Escitalopram in Austria -- Supreme Court ruling now in English too

The recent posts concerning the recent Austrian Supreme Court’s ruling concerning an SPC for Escitalopram (17 Ob 5/11a) continue to generate interest. Following Rainer Schultes's kind provision of the original German-language text of the Austrian Supreme Court's decision (here), The SPC Blog has now received via Chris Hayes (Lundbeck) an English translation of that decision (here).  Many thanks!

SPCs and Escitalopram in Austria: a correction

From our friend Rainer Schultes (ENWC Rechtsanwälte, Vienna) comes some helpfully corrective information regarding the SPC Blog's earlier post on June 28. This post referred to an item published by International Law Office (ILO) about the recent Austrian Supreme Court’s ruling on an SPC for Escitalopram (17 Ob 5/11a). Rainer explains that the facts were incorrectly represented:

"The law suit did not arise between the holder of an earlier SPC and the holder of a later SPC (and not between licensor and licensee) but between the holder of both, the earlier SPC for the racemate Citalopram and the later SPC for Escitalopram on the one side and a generic Escitalopram on the other side.

With reference to ECJ Case C-431/04 – MIT the Supreme Court confirmed that substances which do not have an effect of their own on the organism, cannot be considered “active ingredients” in the sense of EC Regulation 469/2009.

The decision was rendered in summary proceedings. On a prima facie basis, the defendant could not demonstrate that the R-enantiomer contained in the racemate Citalopram did not have an effect of its own on the human. Thus it remains to be verified in the main action whether the R-enantiomer has a clinical effect or not".

Rainer (who meanwhile points out that the illustration on the 28 June post was the Austrian Constitutional Court, not the Supreme Court -- this being an error induced by a Google Image search) has also kindly supplied this weblog with the anonymised full text of the decision in German. Rainer, thanks so much!

SPC is presumed valid in proceedings for injunctive relief, says top Austrian court

This weblog does not often receive news from Austria, but International Law Office has recently posted a note on a ruling of the Austrian Supreme Court on 16 February (17 Ob 5/11a). The ruling arose from an unusual set of facts in which the holder of an SPC challenged the grant of a later SPC which, it alleged, was based on the same active ingredient as its own earlier SPC.  In patent infringement proceedings the holder of the later SPC had secured interim injunctive relief against the holder of the earlier one but, once the patent on which the later SPC was based had expired, the holder of the earlier one sought a discharge of that injunction on the basis that, on the expiry of the admittedly valid patent, the injunction was now based only on the SPC which should not have been granted.

The Supreme Court considered that, for the purposes of interim relief -- where the degree of investigation open to the court is limited -- granted rights such as SPCs must be presumed to be valid unless there was sufficient evidence to the contrary. Interim injunctions are governed by the Austrian Enforcement Act (not the Patent Act) and, while this law provide for the possibility of a stay of enforcement if sufficient monetary security is offered, this option is not available in patent and SPC litigation since the consequences of continuation of an infringement cannot be foreseen with sufficient certainty.

Source: "Court clarifies legal aspects of supplementary protection certificates", by Ferdinand Graf and Tanja Melber, Graf & Pitkowitz Rechtsanwälte GmbH, Austria, International Law Office, 27 June 2011

SPCSs in Austria

The webpage of the Austrian Patent Office that is dedicated to Supplementary Protection Certificates is certainly an informative one -- though it strikes a somewhat gloomy note. After briefly explaining what the SPC is, it adds:

"This opportunity for extending the life-span of patents for approved pharmaceuticals in the form of a supplementary Protection Certificate was created when Austria joined the European Union in order to make the costly and protracted development of pharmaceuticals and pesticides more financially bearable".

The reader might be forgiven for assuming from the words "more financially bearable" that the SPC was more of a loss-limitation exercise than a means of making profit that a patent-originating pharmaceutical business might factor into its business plans.

The webpage then gives a list of legal provisions, with links: two EU Regulations -- Regulation (EWG) No. 1768/92 (for pharmaceuticals) and Regulation (EWG) No. 1610/96 (for pesticides), followed by Austria's Supplementary Protection Certificates Act (SchZG 1996) and Patentamtsgebührengesetz (effective as of 1 July 2005). Neither of the EU Regulation links work. If they had done, they would have disappointed the English reader, since they would have led to the German texts of the Regulations, not the English ones.

The website also provides links to the SPC application form and guidance as to how to complete it, together with details of application and renewal fees. Visitors to the site are also advised that a Protection Certificate Register is kept by the Austrian Patent Office in which the most important data on Protection Certificates is provided. This Protection Certificate Register may be viewed by anyone. It is also possible to obtain a certified excerpt from the Register. Notes regarding Supplementary Protection Certificates are also published in the Austrian Patent Gazette.