Court of Justice sprints to reasoned order in Case C-422/11

A Court of Justice judge models
his new uniform ...

 The SPC Blog has received today a note from Brian Cordery (Bristows) concerning the Reasoned Order of the Court of Justice of the European Union in Case C-442/11Novartis v Actavis, this being a reference from the Patents Court, England and Wales (Floyd J), noted on this blog here. The Reasoned Order is dated 9 February but was only released to the parties' lawyers at the end of last week.

Brian observes that the operative part of the ruling [which is not yet available on Curia but you can read it in full, here] is as follows:

"Articles 4 and 5 of Regulation ... 469/2009 ...  concerning the supplementary protection certificate for medicinal products 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, a supplementary protection certificate 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."

He adds, and this blogger agrees, that most SPC devotees will not be surprised by this ruling: it appears to be the logical consequence of the recent Court of Justice rulings in Medeva and Georgetown.

One point of interest is how (relatively) speedily the Court of Justice dealt with this reference. Admittedly, it didn't require detailed knowledge of the field of technology and the reference was on an issue on which it has been focusing a good deal in recent times, but the time between the referring court's decision to refer and the Court of Justice's order was little over eight months.

Thanks, Brian, for letting us know!

Planting another seed

The SPC blog has received information that there may be yet another CJEU referral on the way....our informant reports as follows:

In the Hussar case (C-229/09) the CJEU concluded that it is possible to obtain an SPC for a plant protection product on the basis of a provisional marketing approval granted in accordance with Art. 8(1) of directive 91/414 EPC (which requires a level of testing equivalent to that necessary in order to obtain a definite marketing approval issued under the conditions laid down in Art. 4 of that directive).

Due to the considerable legal uncertainty prior to Hussar (which was further compounded by conflicting information provided by the GPTO at that time), a number of SPC applications had been filed in Germany on the basis of a so-called “emergency approval” granted in accordance with Art. 8(4), (which unlike the provisional or definite approval is issued for a limited period not exceeding 120 days).

In the case at hand (SPC filing number DE 12 2004 000 021.0) , an SPC application was filed within six months of the issue of such an emergency approval, which by this time had already expired. The provisional Art 8(1) approval issued shortly after the filing date of the SPC application, followed by the subsequent definite approval in accordance with Art. 4.

Oral proceedings were held in December before the Federal Patent Court, which is evidently now minded to refer the case to the CJEU in February 2012.

While the exact wording of the questions to be referred to CJEU is not yet available, it would appear that the central issues are as follows:

1. For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must account be taken exclusively of a Marketing Authorisation under Article 4 or 8(1) of Directive 91/414 EEC or can a certificate also be issued pursuant to a Marketing Authorisation which has been granted on the basis of Article 8(4) of Directive 91/414 EEC? 

2. For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must the authorisation to place the product on the market still be valid at the application date of the SPC?

The SPC blog will let you know if and when we hear more....

Yeda, by Order of the Court

Somehow, with all the excitement of the unified patent court and the unitary patent system for Europe buzzing round his ears, this member of The SPC Blog team quite forgot that Case C‑518/10, Yeda Research and Development Company Ltd, Aventis Holdings Inc v Comptroller General of Patents, Designs and Trade Marks, a reference for a preliminary ruling from the Court of Appeal (England and Wales), was still in the pipeline. This case has sped through the judicial corridors of Luxembourg, arriving in November 2010 and departing -- in the form of an Order -- on 25 November which was handed down this morning.

The following is written in substantial reliance on a very helpful note prepared by Hugh Goodfellow (Carpmaels & Ransford), sent to this weblog by his colleague Edward Oates.

Yeda held a basic patent for a therapeutic composition that includeda monoclonal antibody and an anti-neoplastic agent. The marketing authorisation which Yeda cited in support of its SPC application related to a medicinal product (Erbitux) which contained the antibody alone (cetuximab) but mentioned that the antibody was indicated to be used in combination with the anti-neoplastic agent (irinotecan).

In its SPC filing strategy, Yeda attempted to cover two options, by filing one SPC application that identified the product merely as "cetuximab" and another application for "cetuximab in combination with irinotecan". The UK IPO refused both SPC applications.

• The "cetuximab" SPC application was refused for failing to satisfy the requirements of Article 3(a) of the SPC Regulation because the basic patent did not protect the specified product. 
• The combination SPC application was refused under Article 3(b) of the Regulation because the referenced marketing authorisation related to the active ingredient cetuximab alone. 

Yeda appealed this decision to the High Court for England and Wales, arguing that its patent allowed it to oppose any use by a third party of the active ingredient cetuximab, including use as a single agent treatment, because such use would constitute indirect (or contributory) infringement of its patent for the purpose of Section 60(2) of the UK Patents Act 1977. Yeda therefore said that, for the purposes of the application of Article 3(a), the active ingredient at issue was protected by the patent. While this initial appeal was unsuccessful, the Court of Appeal was persuaded that the law was not clear and referred the matter to the Court of Justice for a preliminary ruling.

The Court of Justice considered that the referred question was, for all essential purposes, answered by the judgment in Medeva (C-322/10) and therefore delivered a Reasoned Order. The Court's language is closely modelled on that used Medeva and concludes that Article 3(a) precludes the grant of a SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent. The ruling of the Court is therefore as follows:

"Article 3(a) ... must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate where the active ingredient specified in the application, even though identified in the wording of the claims of the basic patent as an active ingredient forming part of a combination in conjunction with another active ingredient, is not the subject of any claim relating to that active ingredient alone".

Observing that this Order will come as no surprise to commentators in the field following Medeva, Hugh adds that we might expect to see further Reasoned Orders, for example in the Queensland and Daiichi referrals. He continues:

"It will be interesting to see whether the Court's reasoning in this case could be avoided in future cases by using different claim language, e.g. by using method features to define the combination therapy. Would such claims still be considered to specify the active ingredient as "forming part of a combination in conjunction with another active ingredient? Another approach, which does not appear to have been pleaded in Yeda, would have been to argue that the patent is for an "application" of the active ingredient in the sense of Article 1(c) (with the "application" being a combination therapy with the other active ingredient). Unfortunately, however, the CJEU's order is couched in terms that will make it difficult to run such an argument in the future".

Düsseldorf Novartis/Actavis order now in English too

In "Düsseldorf valsartan/HTC proceedings referred for preliminary ruling" (here) The SPC Blog received an update from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf, acting for the Actavis defendanta) on the proceedings in Novartis/Actavis before the Düsseldorf District Court. The update contained the order of that court in the original German, here.

The SPC Blog has since received two English translations of the order of the Düsseldorf District Court.

The first translation to arrive came from Cordula Tellman and Frank-Erich Hufnagel (Freshfields Bruckhaus Deringer LLP), which you can read as a pdf file here. As Cordula and Fran-Erich kindly explain, the Court reconfirms the position which it expressed in its ruling in the previous preliminary injunction proceedings: that is, a protection certificate granted for a single active ingredient (e.g. valsartan) would be infringed by a medicinal product containing this single active ingredient, even if combined with another active ingredient (e.g. valsartan + hydrochlorothiazide).  The Court discusses in detail the arguments brought forward by the parties and gives extensive reasoning for its opinion that the SPC is infringed (see in particular paragraphs 17, 20, 22, 24, 28 and 30 of the order).

The second translation, which arrived in a welter of emails following the resumption of this blogger's internet connectivity, came from Thomas and Henrik. You can read it as a pdf file here.

The SPC Blog is grateful to the lawyers of both firms for their efforts to make the ruling and the reasoning of the Düsseldorf court both available and accessible to the SPC community and for their enthusiasm for the subject.

Düsseldorf valsartan/HTC proceedings referred for preliminary ruling

Düsseldorf District Court

The SPC Blog has received from Thomas Bopp and Henrik Holzapfel (Gleiss Lutz, Düsseldorf) an important update on the proceedings between Novartis on the one hand and Actavis Deutschland GmbH and Actavis Malta Ltd on the other before the Düsseldorf District Court (Thomas and Henrik are representing the two Actavis companies in the action on the merits pending before the Düsseldorf District Court).  This is what they have told us:

"The SPC Blog entries of 21 and 24 March 2011 (here and here, respectively) provided the following information:

1. On 8 March 2011, the Düsseldorf District Court held in preliminary injunction proceedings (case nos. 4b O 280/10 and 4b O 287/10) that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCT) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036). 

2. The Düsseldorf District Court ordered Novartis to file actions on the merits.

On 8 April 2011, Novartis filed such action on the merits (jointly) against Actavis Germany and Actavis Malta (case no. 4b O 66/11).

The latest news is that that on 8 November 2011 the Düsseldorf District Court decided to stay the infringement proceedings.

The question of whether the scope of protection of an SPC which has an active ingredient as its subject matter also extends to a combination of this active ingredient with a further active ingredient was regarded as decisive for the outcome of the infringement proceedings. Obviously, this question is precisely what the dispute between the parties is about. The court did not want to decide the question. It was considered necessary that the interpretation of Articles 5, 4 SPC Regulation be clarified by the Court of Justice of the European Union (CJEU). The Düsseldorf District Court referred the following question for a preliminary ruling to the CJEU:

"Must Articles 5, 4 of EC Regulation No. 469/2009 be interpreted to mean that the protection conferred by a certificate granted for a single active ingredient (in this case valsartan) extends to an embodiment that contains this single active ingredient in combination with another active ingredient (in this case valsartan + hydrochlorothiazide)?"

The Düsseldorf District Court also summarised the parties' pleadings, which differ to a certain extent from those in the parallel UK proceedings (where the High Court made a referral which is already pending before the CJEU as Case C-442/11)".

Thomas and Henrik have kindly sent us the order of the Düsseldorf District Court that the proceedings are stayed and referred to the CJEU, which readers can access here.

JIPLP note on Medeva, Georgetown Opinion available online

"Supplementary Protection Certificates for combination products" is the title of a Current Intelligence note by Tim Powell and Rebecca Lawrence (Powell Gilbert LLP) on the Advocate General's Opinion of 13 July 2011 in Joined Cases C322/10 Medeva and C422/10 Georgetown University.

The Fourth Chamber of the Court of Justice of the European Union will -- as regular readers of this weblog know -- be giving judgment on Thursday 24 November.  It may be a few weeks till the printed version of Tim and Rebecca's note is published in the Journal of Intellectual Property Law & Practice (JIPLP). Meanwhile, you can read it in full on the jiplp weblog here.

Medeva and Georgetown rulings: save the date!

Some readers may not have seen the news, but the Curia diary shows that the Court of Justice will be giving its rulings in Case C-322/10 Medeva and C-422/10 Georgetown University and others in less than a month from now:

Thursday 24/11/2011 09:30

Judgment C-322/10

Approximation of laws Medeva Court of Justice - Fourth Chamber

Thursday 24/11/2011 09:30

Judgment C-422/10

Approximation of laws Georgetown University and Others Court of Justice - Fourth Chamber

The SPC Blog will do its best to bring speedy coverage.

Daiichi: SPC validity not an issue

The SPC Blog reported a few days ago that Case C-414/11 Daiichi Sankyo Co. Ltd, currently before the Court of Justice of the European Union, concerned among other things a supplementary protection certificate, this being the Greek SPC for levofloxacin hemihydrate, and its infringement by the Greek generics company Demo AEVE.

We have since heard from Constantinos Kilimiris (Patrinos & Kilimiris, Athens) that the litigation in question does not involve any objections to the validity of the SPC. He explains

"As the patent on which the SPC was based was granted in 1986, Demo had argued that the product claims contained in the patent cannot be enforced because of the prohibition of patenting pharmaceutical products per se, which was in force in Greece at the time of filing. 

We had argued, on behalf of Daiichi, that the provisions of Articles 27 and 70.2 of TRIPS prevail over the relevant legislation and that full protection should be available based on the product claims. 

The court found that there is a matter of interpretation of Articles 27 and 70 of TRIPS, which constitute an integral part of community law and decided to refer three questions to the Court of Justice of the European Union.

I would be happy to provide more information if anyone is interested".

Many thanks, Constantinos, for your clarification.

TRIPS case heading for the ECJ has an SPC in the underlying dispute

Readers of The SPC Blog may be aware of Case C-414/11 Daiichi Sankyo Company Limited, Sanofi-Aventis Deutschland GmbH v DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon, a reference for a preliminary ruling on certain TRIPS-related matters from the Polimeles Protodikio Athinon (Greece).

From information posted on the IPKat today it can be seen that the underlying dispute involves a patent and a supplementary protection certificate for levofloxacin hemihydrate, an active ingredient of a product sold under the trade mark TAVANIC.

That mystery reference: all is revealed

Further to our previous post on the mysterious reference to the Court of Justice in Novartis v Actavis, The SPC Blog thanks Laura Reynolds and Brian Cordery (both of Bristows) for forwarding copies of the approved judgment of Mr Justice Floyd and the order for a reference.

Plot spoiler: it's another valsartan thriller!

Synthon ruling "raises inevitable concerns"

Placed online yesterday is a Current Intelligence note, "Court of Justice rules on material scope of supplementary protection certificate regime", which will be published in a forthcoming issue of the Journal of Intellectual Property Law and Practice (JIPLP).  This note, authored by Riccardo Sciaudone (Grimaldi e Associati), discusses the ruling of the Court of Justice just five weeks ago in Case C-195/09 Synthon BV v Merz Pharma GmbH & Co. KGaA, Court of Justice of the European Union (Second Chamber), 28 July 2011 (noted here on The SPC Blog).

After reviewing the facts of the ruling and the relevant law, the author comments:

"This much-awaited decision is welcomed for the clear and, in principle, correct answer given to an important point of law. It is crystal clear, from now on, that an SPC for a medicinal product will be valid only if the first marketing authorization in the EU is in line with Europe-wide regulatory rules. 

However, on a more practical level, the ECJ's decision raises inevitable concerns on a possibly significant number of similar cases that could be soon brought before national courts in order to verify the validity of any SPC in question. Furthermore, this situation could also affect additional research and investment for medicinal products that will soon be under scrutiny in respect of their SPC".

Medeva and the interpretation of EU law: literal or teleological?

Earlier this week The SPC Blog posted "The holiday is over: a close reading of the Opinion in Medeva", in which Paul Inman expressed some bewilderment as to what precisely the Advocate General was advising the Court of Justice. It seems that Paul is not alone, since the blog has now received a further admission from a reader that this Opinion has caused confusion, this coming from International Patent Consultant Herwig von Morze. Writes Herwig:

"I share Paul Inman's confusion regarding paras 67-69 of the Advocate General's Opinion in Medeva, in particular since Art.1(c) uses the word "protects". May I add a confusion of my own? I am confused by the fact that the AG uses a literal interpretation for the purpose of rejecting the infringement test as the basis for the assessment of Art. 3(a). However, thereafter in the paras starting with 75, she rejects the literal interpretation essentially of the same articles as in conflict with the aims of the regulation. 

I haven't read any ECJ decision or AG Opinion which vacillates between literal interpretation for arriving at one conclusion and teleological interpretation to support the aims of a regulation. Such a selective approach seems arbitrary to me. Perhaps somebody with more ECJ experience can help and set me straight?"

My personal recollection is that the ECJ seems to favour starting from the teleological approach in intellectual property references even when its application contradicts the clear and unambiguous literal meaning of plainly expressed words (see eg Case C-292/00 Davidoff v Gofkid).  However, as a common lawyer I have no problem with inconsistency between the two approaches since I was brought up to believe that they were complementary rather than in conflict: one started with the literal interpretation and applied it -- unless (i) there was an ambiguity as to how it should be applied or (ii) its application produced a result that was clearly nonsensical, in which case one moved straight away to a teleological approach. The ECJ's approach is fortified by the availability of considerable material that is prepared for the purpose of aiding interpretation of Directives and Regulations, particularly in the form of the recitals in the preamble, whereas domestic statutory interpretation in the United Kingdom does not have such useful guidance, especially in the case of older statutes. However, the Court of Appeal for England and Wales in Neurim must have been wearing teleological spectacles when it viewed the law on SPCs and questuined whether it was "fit for purpose"

Readers' thoughts on Herwig's and Paul's comments are very welcome.

"Déjà vu at the ECJ?": a note on Neurim

"Déjà vu at the ECJ?" is a Current Intelligence note by patent attorneys Mike Snodin and John Miles (Potter Clarkson LLP, United Kingdom) on Neurim Pharmaceuticals (1991) Ltd v The Comptroller-General of Patents [2011] EWCA Civ 228, 3 February 2011 (on which see The SPC Blog here and here).  This note is published in the Journal of Intellectual Property Law & Practice (2011) 6 (8): 513-515.  Its salient points are reproduced here:

"The Court of Appeal for England and Wales (CA) has referred questions to the Court of Justice of the European Union (ECJ) on whether a supplementary protection certificate (SPC) can be obtained for active ingredients which have previously been authorized for a different use. Although the ECJ may well feel that it has considered this issue previously, the case again highlights weaknesses of the legislation governing SPCs, and has even prompted the CA to question whether it is fit for purpose.
...

The precise questions referred by the CA have not previously been considered by the ECJ. However, similar factual situations have been the background to earlier references to the ECJ in respect of Pharmacia Italia, MIT and Yissum cases (cases C-31/03, C-431/04 and C-202/05, respectively).

In particular, the Pharmacia Italia case led to the ECJ deciding that an earlier veterinary MA for a formulation containing cabergoline was prejudicial to the grant of a SPC based upon the first MA for a human use of cabergoline. Although the decision in Pharmacia Italia related specifically to the transitional provisions of the legislation (Article 19(1) of Regulation 1768/92), another ECJ decision (case C-127/00, Hässle) has made it clear that the words “first marketing authorisation” must take the same interpretation for all provisions of the SPC legislation.
...

Underlying referral of questions in Neurim appears to be the CA’s perception that there is an injustice in not awarding an SPC to the holder of a patent for a new (and non-obvious) use of a previously authorized substance which is the subject of a new MA. In this respect, it will be interesting to see how the ECJ answers the questions referred. To date, the ECJ has interpreted Article 3(d) in a manner that takes no account of the perceived injustices outlined by the CA. Instead, it has simply adopted a ‘one bite of the cherry’ approach, in which the availability and term of all SPC protection for an active agent is based upon the first MA issued for that active agent (for any human or veterinary use).
....

If Neurim succeeds in persuading the ECJ that Article 4 should be taken into account when interpreting the term ‘first marketing authorization’ in Article 3(d) of Regulation 469/2009, this would significantly increase the number of patents to (approved) second medical uses that might qualify for SPC protection.

Success for Neurim based only on its potentially most persuasive arguments (relating to the regulatory burden faced by those seeking the first ever authorization for a human use of an active agent) would have a more limited impact: the relevance of the decision might be restricted to only those factual situations where the existence of one or more earlier MAs for certain uses does not in any way reduce the regulatory burden for the sponsor of (pre-)clinical trials for a different, separately patented use.

However, it is far from certain that Neurim will succeed in relation to any of its arguments. Success depends upon persuading the ECJ to depart completely from the logic applied in previous ECJ decisions relating to Article 3(d).

In any event, the case will be watched closely by SPC aficionados, as a decision completely adverse to Neurim could lead to questioning whether the legislation is fit for purpose, or even to calls for its complete overhaul".

The holiday is over: a close reading of the Opinion in Medeva

Will our correspondent be applying
for a Supplementary Holiday
Certificate ...?

Paul Inman (Partner, Wragge & Co LLP) has been taking a close look at the recently-delivered Opinion of the Advocate General in Joined Cases C‑322/10 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks and C‑422/10 Georgetown University, University of Rochester and Loyola University of Chicago v Comptroller-General of Patents, Designs and Trade Marks (noted here by The SPC Blog, with further comments here). He writes (and the comments in square brackets are his asides, not our additions):

"Dear SPC Blog

Sorry for harking back to the Medeva AG opinion (but its holiday season and some of us have been away!)

As regards the first question in this reference - what is meant by "the product is protected by a basic patent in force", it seems to me (unless I have missed something) that the AG has -- in rather an off-hand manner -- answered this in passing somewhere around the late 60s (paras).

• In para 67 she makes reference to the "subject matter" of a patent when she states that the subject matter of each of the three categories of patent referred to in Art 1(c) (i.e. product, process and use) is always the "active" [not sure if this is correct -- but anyway]. 

• In para 68, she then appears simply to proclaim that "the subject matter" of a patent equates to the "extent of protection" of that patent. [So there we have her answer: "protected by a basic patent" = "the subject matter of a basic patent"]. Somewhat bizarrely, she then differentiates this concept of "extent of protection" from "the protective effect" of the basic patent (despite the obvious link in the word "protect" in both phrases). Whilst there may indeed be a distinction between these two concepts, there appears to me to be no reasoning behind her proclamation that "extent of protection" equates to "the subject matter". [and anyway -- what does that mean?] 

• In para 69 she fortifies her position by stating "The decisive consideration in that context is the fact that the definition of the basic patent in Art 1(c) of [the Regulation] takes as its basis the subject matter of the patent, and not its protective effect." (emphasis in original). Again, there seems to be no basis for this statement, despite the fact that Art. 1(c) uses the word "protects" and not "subject matter". Nevertheless, the entire remainder of the Opinion is built on this "rock" of principle - that "protects" in Article 1(c) actually means "is the subject matter of", and "protected by" in Art. 3(a) actually means "the subject matter of".

Looking at this from a wider perspective of the legislation - what does Art. 4 now mean?

• That article is entitled "Subject matter of protection". Should this be construed (in the context of this Regulation) as "Subject matter of subject matter"? 

• The substance of Art. 4 states: "Within the limits of protection conferred by the basic patent …". Does this therefore mean "Within the subject matter of the basic patent"? 

• Art. 4 goes on: "the protection conferred by a certificate shall extend only to the product …". Does this mean "the subject matter of the certificate shall extend only to the product …"? If that is the case, how does her inference that SPCs for active(s) forming only part of multi-active medicinal products will protect those multi-active medicinal products stack up?

Finally, does this mean we now have to refer to this Regulation as the 'Supplementary Subject Matter Certificate Regulation'?

Back from Holiday and Confused".

As ever, readers' thoughts and comments are invited.

For the sake of completeness, here's the Generics ruling

Also before the Court of Justice of the European Union today was Case C‑427/09, Generics (UK) Ltd v Synaptech Inc., a reference for a preliminary ruling from the Court of Appeal (England and Wales).  This time the contested substance was not memantine but galantamine -- which had been on sale as a medicinal product in various European countries for more than 40 years. In central Europe, it was used to treat neuromuscular conditions. In 1963 a marketing authorisation was issued in Austria, under that countty's 1947 medicines regulations, to use galantamine in the treatment of poliomyelitis under the trade mark Nivalin. In Germany, galantamine was already on the market in the 1960s under the same trade mark and, under the German Law of 1976, galantamine could remain on the German market as a product deemed to be authorised as a medicinal product under a ‘fictitious’ authorisation.

In January 1987 Synaptech filed an application for a basic galantamine patent in the European Patent Office, claiming the use of galantamine for the treatment of Alzheimer’s Disease. In 1997 Janssen-Cilag took over distribution of Nivalin in Austria and, in 1999, filed an application in Sweden for a marketing authorisation for the use of galantamine in a medicinal product to treat Alzheimer’s Disease under the brand name Reminyl. After an assessment carried out in accordance with Directive 65/65, Reminyl was authorised in March 2000. Six months later, the United Kingdom also issued a market authorisation for Reminyl.

All good fictions come to an end, and the fictitious authorisation of Nivalin was no exception: the German and Austrian authorisation were withdrawn in the second half of 2000 and in 2001 respectively.

In December 2000 Synaptech applied for a UK SPC for galantamine, listing the Swedish marketing authorisation as the first authorisation to place the product on the market as a medicinal product in the Community. Based on that marketing authorisation, Synaptech's application was granted with a maximum term of five years, expiring in January 2012, with the basic galantamine patent expiring on 16 January 2007.

Generics was not happy about this, taking the view that the SPC’s date of expiry had not been calculated correctly by the UK Patent Office when it chose to rely on the Swedish marketing authorisation. Generics therefore sought rectification under section 34 of the Patents Act 1977. That claim was rejected, so Generics appealed to the Court of Appeal. The company accepted that the German and Austrian marketing authorisations had never complied with the requirements of Directive 65/65 and that the first authorisation that did comply with it was the Swedish authorisation.  The Court of Appeal (England and Wales) (Civil Division) had doubts as to the interpretation which should be given to the concept of ‘first authorisation to place the product on the market in the Community’ in Article 13(1) of Regulation 1768/92, so it decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) For the purposes of Article 13(1) of [Regulation No 1768/92], is the “first authorisation to place the product on the market in the Community” the first authorisation to place the product on the market in the Community which was issued in accordance with [Directive 65/65] (now replaced with Directive 2001/83/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67)]) or will any authorisation that enables the product to be placed on the market in the Community or [European Economic Area] suffice? 

(2) If, for the purposes of Article 13(1) of [Regulation No 1768/92], an “authorisation to place the product on the market in the Community” must have been issued in accordance with [Directive 65/65] (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of [Directive 65/65]) and that was never amended to comply with [that directive] and was ultimately withdrawn in 2001, to be treated as an authorisation granted in accordance with [that directive] for that purpose?’

The Court today, in a very short ruling indeed, observed that the answer to these questions is relevant only if galantamine is within the scope of that regulation and can thus be the subject of an SPC. Citing this morning's other SPC in Case C‑195/09 Synthon [2011] (noted here), the Court said Article 2 of Regulation 1768/92 means that a product like galantamine, placed on the market in the Community as a medicinal product for human use before receiving a Directive 65/65 marketing authorisation and without undergoing safety and efficacy testing, was not within the scope of Regulation 1768/92 and could not therefore be the subject of an SPC. Since galantamine couldn't be the subject of an SPC, Articles 13 and 19 of Regulation 1768/92 don't apply. If they don't apply, the Court doesn't need to interpret them.

The ECJ therefore ruled as follows:

"A product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65 ... as amended ... may not be the subject of a supplementary protection certificate.".

Synthon ruling rejects pre-65/65 authorisations

This morning the Court of Justice of the European Union handed down its ruling in Case C‑195/09 Synthon BV v Merz Pharma GmbH & Co. KGaA, this being a reference for a preliminary ruling from the Patents Court, England and Wales.

To summarise, even before 1 September 1976 Merz was offering memantine for sale in Germany as a medicinal product for human use under the brand name Akatinol. That product, used in the treatment of Parkinson’s Disease and for other indications, was covered by an authorisation issued in accordance with German legislation from 1961 which did not requiere medicinal products to be tested for safety or efficacy. Under the German Law of 1976 memantine was granted a marketing authorisation in Germany without going through the procedures required under Directive 65/65, the first-ever European pharma Directive.

In June 1983 Merz applied to the competent Luxembourg authorities for a marketing authorisation for that medicinal product.  This was was issued in September 1983 under a Luxembourg Law of 1983. However, the Luxembourg authorities relied on the German marketing authorisation issued previously and did not test the safety and efficacy of memantine. In April 1989 Merz applied for a European patent for memantine hydrochloride which was granted even though memantine was already available commercially, on the ground that the patent was for a second medical use of memantine: for the preparation of a medicinal product to treat Alzheimer’s Disease. This patent expired on 13 April 2009.

Both the German and Luxembourg marketing authorisations were withdrawn when, in May 2002, a series of marketing authorisations valid within the European Community (‘the 2002 marketing authorisations’) were issued to Lundbeck as a licensee of Merz under Council Regulation 2309/93. This authorisation of 2002 was for the medicinal product Ebixa, the brand name adopted in order to market memantine's second medical use. Before this authorisation was issued, the safety and efficacy of Ebixa had been tested by the European Agency for the Evaluation of Medicinal Products, in accordance with Directive 65/65.

In November 2002 Merz applied to the United Kingdom Patent Office for an SPC for memantine. In its application, Merz referred to the basic patent valid in the UK and also to the 2002 marketing authorisation, but not to the prehistoric German or Luxembourg marketing authorisations. The SPC was granted in August 2003 for a term of five years.

Generics manufacturer Synthon then challenged the validity of Merz's SPC and maintained that, if valid, its term of protection should be fixed at zero. The Patents Court had some doubt both as to the scope of the SPC regulation, Regulation 1768/92, and the definition of ‘first authorisation to place … on the market in the Community’, within the meaning of Articles 13 and 19 of that regulation, it decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], is an authorisation a “first authorisation to place … on the market in the Community” if it is granted in pursuance of a national law which is compliant with [Directive 65/65], or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that directive? 

(2) For the purposes of Articles 13 and 19 of [Regulation No 1768/92], does the expression “first authorisation to place … on the market in the Community” include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with [Directive 65/65]? 

(3) Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in [Directive 65/65] within the scope of [Regulation No 1768/92] as defined by Article 2? 

(4) If not, is an SPC granted in respect of such a product invalid?’

Today's ruling runs as follows:

"1. Article 2 of Council Regulation ...1768/92 ... must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65 ... and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation ...1768/92, as amended, and may not, therefore, be the subject of a supplementary protection certificate.

2. A supplementary protection certificate granted for a product outside the scope of Regulation No 1768/92, as amended, as that scope is defined in Article 2 of that regulation, is invalid".

The Court's ruling is, by ECJ standards, unusually short and to-the-point for an intellectual property ruling.  The SPC Blog's post on the Advocate General's Opinion, on which the Court's ruling was based, can be read here.

Some comments on the Medeva, Georgetown Opinion

The Advocate General delivered his Opinion last week in the Medeva and Georgetown references for a preliminary ruling to the Court of Justice of the European Union (see earlier SPC Blog post here, which has attracted a record-breaking number of comments).

Since then we have received this link to a comment by Niklas Mattsson (Partner, Awapatent AB, Sweden). He succinctly observes:

"The opinion contains a very detailed analysis of the EU law on the subject, and is interesting reading. To summarize the AG’s position in relation to the ultimate question, however, does not take more than a few words: the AG is of the opinion that the infringement test is definitely not the correct test, but that national law still has to be applied in order to determine whether a combination product forms the subject-matter of the basic patent".

We have also received a briefing from Tim Powell and Rebecca Lawrence (Powell Gilbert LLP, London) who comment as follows:

"The references concerned SPC applications for vaccines. For public health reasons, it is desirable to have vaccines against multiple diseases combined in a single shot. However, this poses an issue for a patentee that has a patent against a component or sub-set of components of a multi-disease vaccine. If the "product" that is authorised in Europe is the multi-disease vaccine containing components A+B+C+D can an SPC be granted for a patent that only claims components A+B? The approach of the UKIPO and the UK courts has been to deny SPC protection in such cases, on the basis that there is a mis-match between the totality of the active ingredients of the authorised combination product and the subject matter of the patent. 

The Advocate General recognised that applying a literal interpretation of the SPC Regulation would lead to a conclusion that such SPC's should be refused. However, she was concerned that taking such a literal approach would not be in accordance with the aims of the Regulation as it would lead to the denial of SPC protection for extremely valuable combination products. In some therapeutic areas manufacturers find themselves obliged to include multiple components for legal or practical reasons. The Advocate General therefore adopted a "teleological" interpretation of the Regulation, concluding that it was possible to select a sub-set of components of a multi-component medicinal product as forming the subject matter of the certificate. A certificate could issue on this sub-set and would extend to all medicinal products containing that sub-set of active ingredients authorised before the certificate expires. However the abuse of "evergreening" (which had been of concern to the UK courts) would be avoided because a patentee could not apply for further SPC's of longer duration under the same patent even if later product approvals issue to the sub-set which is the subject of the SPC in combination with different active ingredients. 

On balance, this Opinion seems favourable to the research based pharmaceutical industry in that the Regulation has been interpreted to avoid an unduly harsh refusal of SPC protection".

Marjan Noor and Andrew Hutchinson (Simmons & Simmons LLP, London) comment thus:

"The AG notes the risk that a manufacturer could seek to obtain successive SPCs on the same patent based on differing combinations containing the same patented active (or combination of active), for example a first covering the patented active ingredient and a second SPC covering the patented active in combination with another active. To avoid 'such an undermining of the system', the AG states that the manufacturer must designate the patented active or patented combination of actives as its product and then only one SPC can be granted with respect to that product, consistent with Article 3(c) which requires that the product must not already be the subject of an SPC. 

The knock on effect is also seen in Articles 4 and 5 which concern the scope of an SPC. Articles 4 and 5 were also not the subject of the referral but the AG states that the SPC for a single active or combination of actives gives protection against unauthorised production and distribution of all subsequent medicinal products that contain that active or combination of actives. This issue has been the subject of pan-European litigation relating to Losartan, which have resulted in inconsistent decisions from the French and Belgian courts.

The Opinion creates confusion with respect to whether or not the number of SPCs linked to the basic patent is restricted to one. This would be a departure from current practice where there are examples of more than one SPC per patent. In the context of combinations, if a patent 'protects' both active A and combination A+B, currently the patentee can obtain SPCs on A and A+B on the basis that each would be interpreted as a different 'product'. However, the Opinion (at para 103) suggests that a patentee would need to pick either A or A+B, even if they are both protected by the basic patent. In light of the preceding paragraphs of the Opinion, it may be the case that the AG is considering the situation of combinations consisting of the patented product alongside other non-patented actives. In other words where a patent covers A+B and the patentee has an authorisation for A+B+C and one for A+B+D, an SPC would not be available for both as they would be with respect to the same product (ie A+B) - again consistent with Article 3(c). The AG may also have made these comments under an assumption that a patent does not cover A and A+B.

Though clearly influenced by the importance of vaccines in the medical field which appears to have led the AG to adopt her teleological approach, the AG states that there is no special case for multi-disease vaccines under Article 3.

If the ECJ follows the AG Opinion, SPCs on combination products will no longer need to mirror the exact combination the subject of the marketing authorisation. Instead a patentee would match its SPC product to the product the subject of its patent. A knock on effect is that the scope of the SPC would then be more commensurate with the scope of the patent, ie the SPC could be enforced against any unauthorised use of a product containing the product the subject of the SPC rather than be limited to the product the subject of the SPC. 

Interesting follow-on issues include:
1. How will the subject matter test be applied in practice? The Daiichi case referral may provide useful guidance in the absence of any harmonised European legal test for determining the subject matter of a patent.

2. Despite the AG's opinion in the context of combinations and the commentary on one SPC per patent, (a) where a basic patent protects A and A+B, would obtaining an SPC on A prevent a subsequent SPC on A+B on the same patent and (b) where a basic patent protects A and separately B (eg as part of a markusch formula - no combination intended), can the patentee have an SPC on each of A and B based on the same patent? 

3. Whether a combination product A+B the subject of its own separate patent is entitled to an SPC where the same patentee has already obtained an SPC on A based on an earlier patent and which would have been enforceable against A+B, given the AG's comments on Article 4?
As is customary with SPC law, no doubt many further questions will arise".

Medeva and Georgetown: AG's Opinion published today

The Curia website has just posted a 124-paragraph Advocate General's Opinion in Joined Cases C‑322/10 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks and C‑422/10 Georgetown University, University of Rochester and Loyola University of Chicago v Comptroller-General of Patents, Designs and Trade Marks, both of which are references from England and Wales. You can read the Opinion in full here.

The SPC Blog plans to post some comments on the Opinion. In the meantime, the Advocate General recommends the Court of Justice to rule as follows:

"A – Questions 1 to 5 of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10)

(1) The condition for the classification of an active ingredient or combination of active ingredients of a medicinal product as a product within the meaning of Article 3(a) of Regulation ... 469/2009 ...  concerning the supplementary protection certificate for medicinal products is that that active ingredient or combination of active ingredients forms the subject‑matter of a basic patent within the meaning of Article 1(c) of that regulation. Whether an active ingredient or combination of active ingredients of a medicinal product forms the subject‑matter of a basic patent within the meaning of Article 1(c) and whether that active ingredient or combination of active ingredients is protected by a basic patent in force in accordance with the requirement of Article 3(a) are determined, in principle, according to the rules governing the basic patent. However, the definition of the basic patent laid down in Article 1(c) of the regulation precludes use of the protective effect of the basic patent from being invoked as a criterion for the purpose of answering the question whether an active ingredient or combination of active ingredients of a medicinal product forms the subject‑matter of a basic patent.

(2) In the context of the assessment of a supplementary protection certificate application relating to a medicinal product with multiple active ingredients or to a multi‑disease vaccine, there are no further or different criteria for determining whether a product within the meaning of Article 3(a) of Regulation No 469/2009 exists and whether that product is protected by a basic patent in force.

(3) The questions whether a multi‑disease vaccine can be classified as a product within the meaning of Article 3(a) of Regulation No 469/2009 and whether that product is protected by a basic patent in force where only one of its active ingredients or each of its active ingredients against one of the diseases is protected by a basic patent in force must, in principle, be answered according to the rules governing the basic patent. However, the protective effect of the basic patent must not be used as a criterion for the purpose of answering the question whether a product within the meaning of Article 3(a) of the regulation exists.

B – Sixth question of the Court of Appeal (England and Wales) (Civil Division) (Case C-322/10) and sole question of the High Court of Justice of England and Wales Chancery Division (Patents Court) (Case C-422/10)

(4) A valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b) of Regulation No 469/2009 exists for a single active ingredient or combination of active ingredients where that active ingredient or combination of active ingredients is contained together with one or more other active ingredients in a medicinal product which was the subject of a valid marketing authorisation granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC".

Medeva, Georgetown University hearings

If you're in Luxembourg this coming Thursday, 12 May, and have nothing better to do, why not pop into the Court of Justice of the European Union and check out the hearing in Joined Cases C-322/10 and C-422/10 Medeva and Georgetown University and Others.

Just to remind you, these are references for a preliminary ruling from the Court of Appeal (England and Wales) on the interpretation of Articles 3(a) and (b) of Regulation 469/2009 regarding the meaning of ‘product protected by a basic patent in force’ and whether there exist further or different criteria in respect of a medicinal product comprising more than one active ingredient or for a multi-disease vaccine.

AG advises recognition of ancient authorisations

Galantamine -- it has been
around a long time

The second of today's two Advocate General's Opinions on SPC references, also authored by AG Mengozzi, arises from Case C‑427/09 Generics (UK) Ltd v Synaptech Inc, another British reference but this time from the Court of Appeal for England and Wales. 

In short, Galantamine received marketing authorisation in Austria in 1963 as a treatment for polio, under the trade mark ‘Nivalin’. This authorisation, granted under the Austrian 1947 medicines regulations then in force, was withdrawn in 2001. In the 1960s, Nivalin was also marketed in Germany under the legislation then in force. After the Law restructuring the legislation on medicinal products --the AMG 1976 -- came into force, Nivalin remained on the market in Germany under its provisions, but that authorisation was withdrawn between July 2000 and January 2001. In 1987 Synaptech applied for a galantamine patent at the European Patent Office, claiming the use of galantamine for the treatment of Alzheimer’s disease. The patent expired on 16 January 2007 (‘the basic patent’). In 1999 Janssen-Cilag appliedfor a marketing authorisation in Sweden for galantamine as a treatment for Alzheimer’s disease under the brand name Reminyl. This authorisation was granted on 1 March 2000. A marketing authorisation for Reminyl was granted in the UK in September 2000 based on the earlier Swedish authorisation.

In December 2000 Synaptech applied to the UK IPO for an SPC for the basic patent, listing the Swedish marketing authorisation as the first marketing authorisation for galantamine in the Community. The SPC for galantamine was granted with a term of five years, expiring on 15 January 2012. Taking the view that the SPC’s date of expiry had not been calculated correctly under Regulation 1768/92, Generics brought an action for rectification of the register of patents, which was dismissed. Following Generics' appeal, the Court of Appeal referred two questions to the ECJ:

"(1) For the purposes of Article 13(1) ..., is the “first authorisation to place the product on the market in the Community” the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65 ... (now replaced with Directive 2001/83...) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

(2) If, for the purposes of Article 13(1) ... an “authorisation to place the product on the market in the Community” must have been issued in accordance with Directive 65/65 ... (now replaced with Directive 2001/83 ...), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65...) and that was never amended to comply with [it] and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65 ... for that purpose?".

AG Mengozzi has advised as follows:

"(1) A marketing authorisation for a medicinal product granted by the competent authorities of a Member State pursuant to the transitional arrangements introduced by Article 24 of Council Directive 65/65 ... in conjunction with Article 39 of Council Directive 75/319 ... as amended by Article 37 of that directive – on the basis of a marketing authorisation granted prior to the transposition of Directive 65/65 into the legal order of that Member State, may constitute the first marketing authorisation for the purposes of Article 13 of Council Regulation ... 1768/92 ....

For the purposes of the application of Article 13 ..., an authorisation granted for use of a product, as a medicinal product, other than that or those protected by the patent which is the basic patent within the meaning of Article 1(c) of the regulation, may also constitute the first authorisation to place the product on the market in the Community.

(2) A marketing authorisation for a medicinal product granted by the competent Austrian authorities in accordance with the national legislation, and maintained in force following the accession of Austria to the European Economic Area, initially, and to the Community, subsequently, must be treated as an authorisation granted in accordance with Directive 65/65 for the purposes of applying Article 13 ...".

As with today's earlier post, this is for informational purposes only. Further comment will follow.