Germany - District Court lifts several ex-parte preliminary injunctions granted for Merck Sharpe & Dohme Corp.

Recently, the District Court in Düsseldorf lifted several ex-parte preliminary injunctions granted for Merck Sharpe & Dohme Corp. (MSD) against various generic companies. The District Court’s decision in German language can be found (HERE) as well as the English translation thereof (HERE). Phillip Rektorschek (Taylor Wessing) and Derk Vos (Maiwald), who acted i.a. for Hexal AG and 1A Pharma, have provided the following summary on the case: 

"Earlier this year MSD, based on SPC DE 12 2004 000 026.1, applied for preliminary injunctions against eight generic companies in order to prevent market entry of generic versions of MSD’s cholersterol-lowering combination product Inegy®. Inegy® is a fixed dose combination of the actives ingredients ezetimibe and simvastatin. While, the present SPC in question, DE 12 2004 000 026.1 is directed to a product covering ezetimibe or pharmaceutically acceptable salts thereof in combination with simvastatin, MSD had also held an earlier SPC in Germany on the very same basic patent EP 1 720 599 B1, which covered the mono-product of ezetimibe (tradename EZETROL®), which expired in April 2018. 

In May 2018 the District Court in Düsseldorf granted MSD ex-parte preliminary injunctions against the generic companies.  

Seven of these generic companies appealed against the preliminary injunction granted by the District Court. It was argued that the SPC-in-suit is invalid and was granted contrary to the requirements of Art. 3 a), 3 c) and 3 d) SPC-Regulation. 

With the decision of 1 October, 2018, these seven injunctions have now been lifted. According to the District Court’s assessment, the validity of SPC DE 12 2004 000 026.1 is not sufficiently secured and the SPC is expected to be invalidated. 

In the District Court’s opinion, the requirements of Art. 3 a) SPC-Regulation were fulfilled for the combination product in question, since the combination of ezetimibe and simvastatin was mentioned in the claims as well as in the specification of the basic patent. Further, the skilled person would have known from the prior art that simvastatin would also be a suitable drug for reduction of cholesterol. Based on the fact that ezetimibe and simvastatin would act via a different mechanisms of action, the skilled person would expect achieving an additive effect with the administration of the two active ingredients. 

However, the District Court concluded that the requirements of Art. 3 c) SPC-Regulations were not fulfilled for the product-in-suit. 

Contrary to MSD’s submission, ezetimibe would be the sole subject matter of the invention protected in the basic patent in an SPC specific meaning. The combination of ezetimibe and simvastatin would not be the core of the technical teaching of the basic patent and should therefore not be awarded a separate SPC. 

The Court made clear that according to their interpretation of the CJEU’s case law, an SPC should be granted for compensating for the duration of the authorization procedure but not for the effort/cost associated with the authorization procedure. Moreover, the extension of protection should only be granted once for a product which may be understood as an active ingredient or combination of active ingredients in the narrower meaning. This approach may lead to situations wherein a combination of active ingredients is in fact considered to be protected in the meaning of Art. 3 a) SPC-Regulaiton, but in view of Art. 3 c) SPC-Regulation there should only be awarded an SPC if a product represents the core inventive advance of the basic patent at its priority date. 

This requirement was considered not to be fulfilled in the present case since the combination of ezetimibe and simvastatin is not the core inventive advance of the basic patent, but only ezetimibe. According to the District Court, the technical contribution for which the SPC should be rewarded must represent the actual technical teaching of the basic patent. In particular for combination preparations, the combination must address a specific problem in the treatment, prevention or diagnosis of a disease, for which the technical solution must be different from the solution provided by the mono product.In the District Court’s opinion not only a synergism of the two actives would qualify for such a different effect but also a reduction of side effects or the like, under the condition that this effect is different from the one observed for the mono-product. However, for the difference relied upon, there must be disclosure in the basic patent at the priority date. Referring to the recent decision C-121/17 – Teva, the District Court stated that it is not sufficient that such differences or effects were only revealed during the authorization procedure. In such a case the aim of the Regulation, namely to compensate for the duration of the authorization procedure would not be fulfilled. 

The District Court further stated that also the other effects relied upon by the Claimant were not disclosed in the basic patent and have been classified as “surprising” by the Claimant itself. It is therefore apparent, that the effect relied upon by the Claimant are based on additional insight gained only during the authorization procedure, but are not disclosed in the basic patent. 

Moreover, in the Court’s view the fact that the majority of the relevant clinical studies for the marketing authorization of the combination product were already conducted for the authorization of the mono-product aggrevates the situation. Only marginal additional data on the effectiveness were provided with the marketing authorization for the combination product, which, however, did not provide any additional gain in knowledge in view of the data contained in the earlier authorization of the mono-product Ezetrol®.
According to the District Court, the mere fact that the combination is provided as a “fixed dose” cannot chance the situation, since it was known to the skilled person at the priority date that patient compliance is improved by fixed dose preparations. In addition, there is no indication that the provision of the fixed dose preparation was associated with any difficulties for the skilled person. 

Summarizing, the District Court found that the SPC was granted contravening the requirements of Art. 3 c) SPC-Regulation and thus the validity of the SPC is not secured and therefore the preliminary injunctions had to be revoked."

MSD has filed an appeal against the first instance decision.

Many thanks to Derk Vos and Philip Rektorschek!

Germany - Gilead's SPC for Truvada nullified by the Federal Patent Court

Last week, the German Federal Patent Court nullified Gilead's German SPC for the combination of tenofovir disoproxil and emtricitabine.  Eva Geschke (Wildanger) and Derk Vos (Maiwald), who acted for Generics UK, have provided the following summary on the case:

"On May 15 the 4th Nullity Senate of the German Federal Patent Court (FPC) nullified Gilead’s German SPC DE 2005 000 0041.8, which had been granted for tenofovir disoproxil in combination with emtricitabine. 

This combination of active ingredient is present in various anti-HIV drugs marketed by Gilead and other companies such as TRUVADA® and ATRIPLA®. Four claimants (Teva GmbH, Hexal AG, Generics [U.K.] Ltd., and Hormosan Pharma GmbH) had challenged the validity of the SPC arguing that the product in question was not protected by claim 27 of the basic patent.  While tenofovir disoproxil was specified in the claim, the parties were in dispute on the issue whether the active ingredient emticitabine was specified in the wording of claim 27 of the basic patent by the term “other therapeutic ingredients” for the purpose of Art. 3 (a) SPC-Regulation according to the criteria set by the CJEU in Eli Lilly (C-493/12). 

The FPC in its preliminary opinion had outlined its interpretation on the criteria set by the Eli Lilly decision (C-493/12) in that a functional definition – as a broad generic term, under which various actives may fall – only relates implicitly, but necessarily and specifically, to the active in question as defined in the SPC, i.e. emtricitabine in the present case – if said active forms an active ingredient which is comprised by said generic term. The FPC demands at the same time that it is excluded that other active ingredients are representatives of said generic term, which, however, do not share the specific medicinal characteristics of the active ingredient in question. 

In defending their SPC, Gilead took the position that the CJEU’s case law, and in particular the Eli Lilly decision, does not require any further criteria than the assessment of Art. 69 EPC and the protocol of its interpretation for the determination whether a product is protected by the basic patent or not. 

It appears that the FPC did not follow the interpretation advanced by Gilead on the Eli Lilly decision but considered that further criteria are to be met in addition to the coverage of the product by Art. 69 EPC for an active ingredient to be implicitly, but necessarily and specifically referred to in a claim of the basic patent. 

The Claimants argued that the generic term “other therapeutic ingredients” was completely unspecific and covered various compound classes with different medicinal characteristics and thus the wording used in claim 27 was not suitable to specifically identify the active ingredient emtricitabine of the product in question. 

The FPC decided that the wording “other therapeutic ingredients” was insufficient to specify the active ingredient emtricitabine according to the criteria set by the Eli Lilly decision. Consequently, the requirements of Art. 3 (a) SPC-Regulation were not fulfilled for the product in dispute.

The decision taken by the FPC is in line with the decision taken by the Munich District Court in the preliminary injunction proceedings initiated by Gilead in August 2017, where the District Court rejected Gilead’s request on the grounds that Art. 3 (a) of the SPC-Regulation is not met. 

In addition, the position from the FPC is also in agreement with the opinion of the AG Wathelet, issued on April 25, 2018 in the CJEU referral C-121/17, which referral originates from the parallel invalidation proceedings in the UK. 

The reasons for the decision will be issued by the FPC in due time. "

Many thanks to Eva and Derk!

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.

Memantine: the Bundesgerichtshof speaks

From Cordula Tellmann (Freshfields Bruckhaus Deringer LLP, Düsseldorf) comes some helpful information concerning a judgment by the Bundesgerichtshof -- the German Federal Supreme Court -- regarding the supplementary protection certificate for memantine. The judgment was delivered in proceedings between Merz, as the owner of the SPC, against an entire bevy of companies which maintained that the SPC was invalid because the underlying patent was itself invalid: Neuraxpharm, Teva, Synthon, Pliva and Chemo Ibérica.

The Bundesgerichtshof held that the SPC was invalid, since the underlying basic patent was invalid for lack of novelty.

Cordula has kindly provided this weblog with a copy of the German original of the judgment. While the decision was issued following an oral hearing on 9 June 2011, it is only now that the written decision has been published only now.

According to Cordula, the Court held that the discovery that a certain active ingredient (here memantine) is effective against a pathological situation in a specific illness (in this case Alzheimer's disease) does not lead to a novel teaching if it was known in the state of the art that patients with this illness were treated with this active ingredient to alleviate such symptoms and if the patent does not teach a new way of dosage or a new group of patients which previously did not receive such treatment.

The decision must be read in the context of the decision of the Court of Justice of the European Union in Case C-195/09 Synthon on 28 July 2011 (noted by The SPC Blog here) regarding the validity of SPCs where there has been a pre-65/65 authorizations. In the German case, the Bundesgerichtshof did not have to address this question as the SPC was already invalid due to the invalidity of the basic patent.

German Escitalopram ruling in English: now we know why there's no ECJ reference

The deckchair is empty:
we're all at work!

Last Wednesday The SPC Blog posted here a note on the recent Escitalopram SPC decision from Germany. The text of this decision was kindly supplied by Chris Hayes (Lundbeck), who offered us sight of an English translation once it became available. This afternoon, some ten minutes ago in fact, this member of the blogging team found the English translation sitting in his in-box. He has lost no time in uploading it here for the benefit of anyone who finds the original German text too difficult. As mentioned in last week's post, the German Patent Court declined to make a further reference to the Court of Justice for a preliminary ruling. Said the Court:

"The present legal dispute does not raise any questions not yet clarified as to the interpretation of Regulation (EC) 469/2009, and this is why the Board has not followed the suggestion of Plaintiff to stay the proceedings in accordance with Art. 267 Treaty on the Functioning of the European Union (TFEU) and to refer the questions Plaintiff has formulated to the European Court of Justice as part of proceedings for a request for preliminary ruling. Such a referral is only possible if questions need to be decided regarding Community law, which cannot be answered either on the basis of legal sources nor have been sufficiently clarified in the case law of the European Court of Justice. Plaintiff was not able to formulate such a question of the law nor is such a question otherwise apparent. In the present nullity proceedings, the question is, on the contrary, decisively the subsumtion of the specific facts under the legal rules pertinent in this regard. The question that is of major significance in this case is whether escitalopram has its own medicinal effect and thus must be considered to be a different active ingredient than is citalopram. However, the Board cannot present the European Court of Justice with this factual question. The viewpoint in connection with this of whether the authorization for a medicinal product that contains as active ingredient a chemical compound as racemate that bars the grant of an SPC for a medicinal product that contains as active ingredient an enantiomer of the racemic compound and is the subject matter of a later marketing authorization as well as its own substance patent, also does not raise any legal questions requiring clarification. The purpose of Art. 3 (d) Regulation (EC) 469/2009 as a regulation lies in the objective to not prolong the overall term of protection granted by an SPC for a product in that several subsequent certificates can be granted for one and the same product (cf. German Federal Court of Justice decision “Escitalopram” in GRUR 1010, at 123, no. 76). Since, however, it must be assumed – as presented – for lack of any convincing, contradictory reference points that escitalopram is, within the terms of Art. 1(b) Regulation (EC) 469/2009, a different product than is citalopram, this viewpoint does not bar the grant of the SPC. That no other conclusion could be derived from the decision of the German Federal Court of Justice of 14 October 2008 (“Doxorubici-Sulfat”, X ZB 4/08, in GRUR 2009, at 41) was already specifically clarified by the Federal Court of Justice in its “Escitalopram” decision (see Federal Court of Justice “Escitalopram” decision in GRUR 2010, at 123, no. 77).

None of the other disputed questions decisive for the present nullity proceedings reveals an abstract, not-clarified legal question which would require an interpretation by the European Court of Justice. For these reasons, the Board did not order a stay of the proceedings pursuant to Art. 267 TFEU nor did it refer the case, in accordance with the suggestion made by Plaintiff as an auxiliary motion, to the European Court of Justice. The Board believes that its opinion is confirmed by the evaluation voiced by the Federal Court of Justice in its “Escitalopram” decision which insofar was also based on an “acte claire” (see Federal Court of Justice “Escitalopram” decision in GRUR 2010, at 123, no. 78)".

Escitalopram decision from Germany -- but no ECJ reference this time

From Chris Hayes (Lundbeck) comes news of another Escitalopram SPC decision, this time from the German Patent Court (you can download it here). An English translation has been promised in due course. Chris explains:

"The case was heard earlier this year, but we have only just received the full reasons for judgment. This was an attack on the SPC only, and the Patent Court's decision is in alignment with the earlier decision of the German Supreme Court on the validity of the basic patent and the SPC.

A reference to the ECJ was refused, as the Court decided that this was a purely factual dispute. The Court decided that foreign regulatory proceedings had no bearing on the validity of the SPC;, nor did decisions of the German pricing authorities".

Thanks so much, Chris, for this judgment.

Novartis v Actavis and Valsartan in Düsseldorf: an update

On Monday 21 March, The SPC Blog posted this item on two decisions of the Düsseldorf District Court, issued on 8 March 2011, in preliminary proceedings which had been initiated by Novartis AG against Actavis Deutschland GmbH and Actavis Ltd, Malta. Our information was kindly supplied by Frank-Erich Hufnagel and Cordula Tellmann (Freshfields, Bruckhaus Deringer LLP, Düsseldorf) who acted for Novartis.

We have now heard from Henrik Holzapfel and Thomas Bopp(Gleiss Lutz), who acted for the two Actavis defendants. They comment as follows:

"We fully agree with Frank-Erich's and Cordula's report on the proceedings, but we thought it would be worth mentioning two additional matters which may or may not be interesting for your readers.

1. In the joint oral hearing for both proceedings, the court acknowledged that difficult questions of interpretation of the SPC Regulation were at stake. The issue was to be finally decided by the ECJ. In this context, it is particularly noteworthy that the court has made any enforcement of the preliminary injunctions dependent on Novartis providing securities (of EUR 12 million against Actavis Germany and EUR 3.6 million against Actavis Malta).

2. The court has ordered Novartis to file actions on the merits against Actavis Germany and Actavis Malta by 8 April 2011. In actions on the merits, a referral to the ECJ will be possible, other than in preliminary injunction proceedings".

Henrik and Thomas have also sent the blog this order of 17 March 2011, in which the Düsseldorf District Court ordered Novartis to file an action on the merits against Actavis Germany. In the parallel preliminary injunction proceedings against Actavis Malta there is an equivalent decision.

Coincidentally, The SPC Blog received -- in the same batch of emails and just a few seconds after that of Henrik and Thomas -- another email from Cordula accompanied by this English language translation of the decision of 8 March which was the subject of the earlier post.

The SPC Blog thanks all the attorneys involved for their willingness to share this information with our readers. For those of us with little experience of the manner in which litigation is conducted in Germany, it has been very helpful and instructive.

Valsartan: now it's the turn of Düsseldorf

The SPC Blog thanks Frank-Erich Hufnagel and Cordula Tellmann (Freshfields, Bruckhaus Deringer LLP, Düsseldorf) for drawing our attention to two decisions by the Düsseldorf District Court.  Both were issued on 8 March 2011 in preliminary proceedings which had been initiated by Novartis AG against Actavis Deutschland GmbH and Actavis Ltd, Malta. Frank-Erich and Cordula (who acted for Novartis in these proceedings) explain as follows:

"On 8 March 2011, in preliminary proceedings initiated by Novartis AG against Actavis Deutschland GmbH and Actavis Ltd, Malta, the Düsseldorf District Court held that Actavis' products containing the active ingredients valsartan and hydrochlorothiazide (HCTZ) would infringe Novartis' German SPC relating to valsartan (DE 196 75 036).  However, in view of the pre-trial correspondence between the parties, there was no imminent threat as to an infringement of the underlying basic patent EP 0 443 983 B1. These decisions may be appealed.

The key legal question before the court was whether a combination product containing two active ingredients (in this case valsartan and HCTZ) would fall under the scope of a SPC for just one of those active ingredients, valsartan. The Court explained: 

"In view of the not very precisely phrased and thus not easy to understand wording of article 4 of the SPC Regulation, the legislative purpose of the limitation of the protection only to "the product covered by the marketing authorisation" is of key importance for the interpretation of this article."  

The Court then refers to Recitals 3, 6 and 7, 8 and 9 of the SPC Regulation and summarized them thus:

"The cited Recitals show that the Regulation aims at a de facto extension of the patent protection in order to achieve a compensation of the loss of effective patent protection ...

In view of this ratio of the SPC Regulation, the content of Articles 4 and 5 SPC Regulation and its relationship between each other must be understood as follows: Article 5 SPC Regulation concerns -- as is confirmed by its official title -- the effects of a certificate and stipulates that they are identical to the effects of the underlying basic patent. On the other hand the purpose of Article 4 SPC Regulation is to determine the object of these effects - i.e. the subject-matter. In this context, Article 4 uses three criteria: 

- First - and actually merely declaratory - it is clarified that the absolute limit is set by the scope of protection of the basic patent. 

- Then the product is identified in order to delimit it from other compounds which potentially are also encompassed by the basic patent. Here, Article 4 SPC Regulation does not - contrary to the view of the Defendant - aim for a limitation to the specific authorised medicinal product, as results from various passages of the SPC-Regulation which speak about the product identified by the marketing authorisation: Articles 8(1)(b) and (c), 9(3)(d), Article 11(1)(d), SPC Regulation. 

- Finally, Article 4 SPC Regulation stipulates a purpose-bound compound protection by limiting the subject-matter to the authorised uses (see Kraßer, § 26 A II, p. 586). This third criterion confirms that with regards to the understanding presented here Article 4 SPC Regulation is not redundant and cannot simply be replaced by a mere term extension for the basic patent. 

The limitation of the subject-matter of a certificate in Article 4 SPC Regulation as a whole has to be understood in a sense that it has the sole purpose to exclude an "over-extensive" protection: In case the basic patent protects further products or active ingredients which are not subject-matter of the certificate, it stipulates an exception from the principle of Article 5 SPC Regulation that the protection of basic patent and certificate are identical. When determining the subject-matter of the certificate the patent claims which possibly also protect further compounds fictitiously have to be regarded as if they only contained the active ingredient indicated in the certificate; Article 4 SPC Regulation thus leads to a hypothetical patent claim which is product and purpose related (see Benkard/Grabinski, PatG, 10th edition, § 16a, note 38). The compensation is not limited to an authorisation procedure for a specific medicinal product, but for the term since the filing of the basic patent during which a product according to the invention cannot be marketed (considering also a maximum term of 5 years since the certificate entered into effect, Article 13 SPC Regulation)." 

The Court also rejected Actavis' position that the purpose of an SPC was a reward for obtaining a marketing authorisation, pointing out that this approach would mean that "the compensation for loss of effective patent protection could be circumvented all too easily which would contradict the purpose of the SPC Regulation (see ECJ, GRUR Int. 2000, 69, 70 et seq. - Farmitalia)".

A copy of the German original of the decision against Actavis Deutschland GmbH can be accessed here. Frank-Erich and Cordula inform the blog that, possibly early this week, they might be able to provide us with a full English translation of the judgment.

Full translation of German Sitagliptin Referral Available

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

Escilatopram - English translation of German decision available

Yesterday, we posted a piece on the German Federal Supreme Court decision on Escilatopram.

Non-German speakers will be delighted to know that the English translation of the decision can be obtained here. It was kindly provided to the Blog by Klemens Stratmann (Hoffmann-Eitle, Munich)

Escilatopram in Germany - the BGH decides

The German Federal Supreme Court (FSC) recently reversed the German Patent and Trademark Court decision on the validity of Escilatopram patent EP 0347 066 and its related SPC (SPC No. 103 99 030 to Escitalopram and non-toxic acid addition salts thereof) - Read the decision in original - here (unfortunately, no English language version available). The IPKat (Thanks!) provides a short summary of the facts of the case here.

On SPCs, the FSC held that a marketing authorisation for a racemic product does not prevent the grant of a supplementary protection certificate to an enantiomer form of the product based on a later marketing authorisation to the enantiomer of the product and a patent on that enantiomer.

You might recall that this case has also been heard and decided in the Netherlands (here in Dutch, and here for an English translation) and the UK (here).

SPC practice in Germany - changes due to the PatModG

Klemens Stratmann (Hoffman-Eitle, Munich) has kindly informed us of some recent developments on SPCs practice in Germany due to the Patentrechtsmodernisierungsgesetz (shortened - PatModG; English translation - The Act to simplify and modernise the Patent Act), which entered into force on 1 October 2009:

"One change concerns requests for the correction of the duration of granted SPCs. Prior to 1 October 2009, the terms of granted SPCs could only be corrected by lodging a request for partial nullification at the Federal Patent Court. The SPC proprietor was barred from filing such request. Although there is no explicit legal basis for requests of this type to be found in Regulation 1768/92, that this can be allowed may be derived from Art. 17(2) and Recital 17 of Regulation 1610/96 (Federal Patent Court decision "Finasterid", 15 March 2007, 3 Ni 2/06).

New Sec. 49a (4) of the German Patent Act allows for the first time the filing of requests for the correction of an SPC at the German Patent and Trademark Office. Further, such requests can be filed by the owner of the SPC, for instance if he was in error regarding the first authorization to place the product on the market in the Community when filing the SPC request.

New Sec. 49a(3) of the German Patent Act implements the provisions of Regulation 1901/2006 on medicinal products for paediatric use.

The German legislators also took the opportunity with this change to introduce fees for extensions of paediatric SPCs. Should an SPC application already be pending, the request to extend the SPC costs 100 € as of October 1, 2009. If the request for SPC extension is lodged after the SPC application, the fee is 200 €."

The SPC Blog would be interested in knowing how corrections are handled in other European countries. Please post your comments below.

More on Menantine - from the Netherlands and Germany

On 26 March 2009, the Netherlands Patent Office handed down its decision on Memantine. Here's a short English summary of the case:

Synthon requested that the Octrooicentrum revoke the certificate or revise the date of the certificate based on the earlier marketing authorisations that were not granted in accordance with directive 65/65. The Netherlands Patent Office denied this request. In their view it follows mainly from the recitals in the preamble that the relevant first marketing authorisation is an authorisation in accordance with directive 65/65, i.e. for a medicinal product which has been tested thoroughly for quality, safety and efficacy.

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

Just in case you missed out on the German Patent Court decision on Memantine of 11 December 2007, you can get it here.

Tour of Patent Offices - Germany

For the first posting in 2009, the SPC blog decided it was time to check out the scene in Germany.

Information about patent applications, patents, including status can be obtained from the register website of the German Patent Office (here, https://dpinfo.dpma.de/). Although there is an English language search mask, the results are posted in German. You can however click to a table containing a translation of the terms listed in the search results. The site may be rather slow during peak usage times and refuse to run your search.

The site does provide information on whether an SPC application was filed, but unfortunately, no information on the status of the SPCs can be obtained.

For those interested in reading up on German SPC case law, the website of the German Patent and Trade Mark Court is your place to look (that is, if you want it for free). You can search cases from 2003 onwards by date, case number and term. But a word of warning, you'll have to brush up your German because there isn't an English language site. If the case has gone up to the Federal Supreme Court, you can check out the pages of the Bundesgerichtshof for cases back to 2000. Here again, the site's in German.

Hopefully, short summaries of future cases will be published here in English, for those that don't have a grasp of the lovely language of Goethe.