Belgian Office for Intellectual Property issues practice note on the calculation of the duration of SPCs

The Belgian Office for Intellectual Property recently issued a circular letter (here in Dutch and here in French) providing details on the calculation of the duration of SPCs in view of the CJEU Seattle Genetics (C-471/14) and Incyte (C-492/16) decisions.  Stijn Lagaert of Gevers provides below an overview of the practice at the Belgian office.

Background
In 2015, the Court of Justice of the European Union (CJEU) issued a decision in C-471/14 (Seattle Genetics). As discussed in more detail here, it ruled that the date for calculating the SPC duration is the date of notification of the decision granting Marketing Authorization (MA), rather than the decision date itself. While Belgium previously already calculated the duration based on the notification date of EU marketing authorizations, it issued a 2016 circular letter to detail its practice. More recently, the CJEU provided more details about the correction of SPC durations that were granted based on the decision date (C-492/16 – Incyte). 

Circular letter of March 2018
The Belgian Office for Intellectual Property has recently issued a circular letter providing further details about the practice in Belgium in relation to the date of the MA. While the practice remains the same for an MA granted by the European Commission (i.e. the notification date published in the Official Journal), the circular letter is perhaps more interesting in relation to the notification date of a national MA. The Belgian Office states that it will consider the date of the decision to be the date of the MA if there is no official publication of the notification date. The applicant has the option to provide proof that it was only notified at a later date in order to use that notification date as the date of the MA. 

Fellow practitioners will appreciate that the circular letter links its practice for the ‘date of the MA’ to both Art. 7 and Art. 13 of the SPC Regulations. Thus, the Belgian Office will use the notification date both for the calculation of the SPC duration and for calculating the deadline for filing the SPC application.  

After Seattle Genetics, some SPC specialists cautioned that the CJEU decision only ruled in relation to the date used for determining the duration of the SPC (Art. 13), but did not necessarily read on the grant date of the MA for the calculation of the deadline for filing the SPC application (Art. 7). In addition, it did not provide guidelines for determining the notification date of national MAs, beyond referring to national law. These issues were e.g. raised by Mike Snodin and Michael Pears. The circular letter provides some welcome clarifications about both aspects, at least under Belgian practice. 

Advice
As the notification date of a national MA will likely be a few days after its decision date, we suggest saving and filing proof of the date of notification in these instances to enjoy the longer SPC duration in Belgium. The proof can be an official publication of the notification date or any other proof. This is of course only relevant in those cases were the national MA is the first to place the product on the European market.

Res judicata, invalidity and prima facie validity: a curious Belgian concoction

"Invalidated SPC retains prima facie validity in preliminary injunction proceedings" is the grand title of a note by Kathleen Mercelis and Philippe de Jong (Altius) which was recently published on International Law Office.  The note deals with a Belgian Supreme Court ruling on the end-game in a battle between generics manufacturer Eurogenerics and Lundbeck, whose SPC for escitalopram had been invalidated.  The facts are a little unusual, as appears from the text:

Background 

Pharmaceutical company Lundbeck held a European patent for escitalopram, the active substance of an antidepressant commercialised in Belgium under the trademark SIPRALEXA. The patent expired in 2009, but Lundbeck obtained a supplementary protection certificate (SPC) extending protection for escitalopram until June 1 2014. However, the SPC was invalidated by the Brussels Commercial Court following a nullity suit brought by several generic manufacturers. Lundbeck appealed that decision. 

Pending the outcome of the appeal, another generic company, Eurogenerics, brought its generic version of escitalopram to market. Lundbeck started preliminary injunction proceedings against Eurogenerics based on the invalidated SPC. At first instance, Lundbeck's claim was rejected, but its appeal was successful and the Brussels Court of Appeal issued an injunction against Eurogenerics. According to this court, the Supreme Court decision of January 5 2012(1) – which held that the revocation of a patent by the European Patent Office's opposition division, against which an appeal had been lodged pursuant to Article 106(1) of the European Patent Convention, did not affect the prima facie validity of the Belgian counterpart of the revoked patent – was equally applicable to the present circumstances. The court held that the appeal of a nullity decision of a Belgian court has suspensive effect as well. Lundbeck's SPC was therefore found to retain its prima facie validity pending the outcome of the appeal against the first instance invalidation decision (in which the SPC was eventually upheld).(2) 

Supreme Court decision 

Eurogenerics appealed to the Supreme Court, claiming that the annulment of the SPC by the first instance court had the authority of res judicata (ie, the fact that a case has already been decided) and should therefore have been respected by the court that issued the preliminary injunction. 

The Supreme Court rejected Eurogenerics's reasoning and upheld the decision of the Brussels Court of Appeal on the following grounds: 

• There is a difference between the authority of res judicata, which is attributed to every final court decision that has not been overruled, and the force of res judicata (ie, an unappealable decision). As long as the decision has no force of res judicata, the authority of res judicata is only conditional.

• According to the Belgian Patent Act, a decision by which a patent is invalidated normally has the authority of res judicata. However, such decisions are not recorded in the patent register before obtaining the force of res judicata.

• The Patent Act also states that an appeal to the Supreme Court has suspensive effect with respect to an invalidated patent.

• Finally, the Belgian Judicial Code states that an appeal normally suspends the enforceability of a decision. 

The Supreme Court consequently held that a patent that was invalidated by a first instance decision can still be the basis for a subsequent preliminary injunction action. 

Comment 

In its January 5 2012 decision the Supreme Court held that the fact that a patent was revoked by the opposition division of the European Patent Office did not affect the prima facie validity of the revoked patent, as long as no final decision has been taken in the opposition proceedings, because according to Article 106(1) of the European Patent Office, an appeal against decisions of the opposition division has suspensive effect. 

In the present case, the Supreme Court took this reasoning one step further and found that the prima facie validity of a patent (or SPC) is also not affected by an invalidity decision of a national court, notwithstanding the fact that this decision has the authority of res judicata. Consequently, a patent holder requesting a preliminary injunction against an alleged infringer can rely on the prima facie validity of its patent or SPC until the decision by which the patent was invalidated has obtained the force of res judicata – that is, once an appeal to the Supreme Court has been rejected or the limitation period for bringing the appeal has expired.

Endnotes

(1) For further details please see "Prima facie validity of granted European patents in summary proceedings".

(2) Brussels Court of Appeal, September 17 2012, IRDI 2013, p 40.

Lundbeck's Belgian appeal success over escitalopram: now in English

From Annette Hirschfeld (Hoyng Monegier, Amsterdam) comes news of a case that has attracted considerable interest and attention in the world of SPCs, Lundbeck v Tiefenbacher, Ratiopharm, Teva and Eurogenerics (escitalopram).  In this Belgian litigation, the Brussels Court of Appeal reversed the decision of the Brussels Commercial Court (noted by Steven Cattoor for the EPLAW Patent Blog here) to revoke Lundbeck’s Belgian escitalopram SPC and confirmed the validity of both the SPC and its underlying basic patent: it found that both the patent's product claims and the process claim were novel and non-obvious, and that the SPC fulfilled the requirements of Articles 3(c) and 3(d) of the  SPC Regulation. Declaring that any generic product containing escitalopram as active ingredient would infringe, the Court of Appeal granted injunctive relief.

Of particular note in the Court of Appeal's judgment, which makes substantial reference to European Patent Law (EPO)  case law and Guidelines, are the following:

• As to the novelty of the product claims, in the light of the EPO decisions in T297/87 (Hoechst) and T1048/92 (Pfizer), the generic manufacturers had failed to show that the prior art (including the earlier patent on the racemate) unambiguously disclosed the specific configuration of the claimed S-enantiomer in the form of a technical teaching. Since no document cited would let the skilled person obtain the enantiomers of citalopram in an individualised form, the product claims on the S-enantiomer (i.e. the product escitalopram) were novel.

• As for inventive step, after restating the general principles of the EPO's problem-solution approach, the Court referred, inter alia, to the teaching in  T595/90 (Kawasaki Steel) that an otherwise obvious entity may become non-obvious (and thus claimable as such) if there is no known way in the art to make this entity and the patent is the first to achieve this in an inventive manner. The Court then examined whether the process set out in the patent was indeed the first and an inventive method to prepare escitalopram.

The full text of the judgment, all 128 pages of it, has now been rendered into English and can be read here.

This blogpost is based on a note by Steven Cattoor that was first posted on the EPLAW Patent Blog here.

Escitalopram again, this time in Belgium

Escitalopram is in the news again. The Belgian District Court has very recently given judgment in Ratiopharm, Tiefenbacher v Lundbeck, an action which is of great interest in Benelux circles on account of the parallel proceedings in which a decision is currently keenly awaited.

On 3 October the Belgian District Court invalidated the contested SPC, since the marketing authorization for escitalopram referred to in Lundbeck’s SPC application was not the first marketing authorization for the product under Article 3(d) of the SPC Regulation. According to the court, the SPC should have designated the marketing authorization for citalopram, not the marketing authorization for escitalopram. The court additionally found that a previous SPC had been granted for the same product (Article 3(c) of the same Regulation).

The District Court took the view, with reference to the Court of Justice ruling in Case C-431/04 MIT, that in the racemic mixture citalopram, only the S-enantiomer (es-citalopram) had "a therapeutic effect of its own". Accordingly the active substance (or "product") in citalopram and es-citalopram is the same, namely: es-citalopram. The court refers, inter alia, to the decision of the CBG (the Dutch MEB), which had decided that there were no cliniacally relevant differences between citalopram and es-citalopram and that es-citalopram was to be considered a line extension of citalopram. The court also explicitly deviated from the earlier decision of the German Federal Supreme Court (which had held the SPC valid) because, in its view, the German decision was not in line with the SPC case law of the Court of Justice -- in particular, its understanding of the word “product”.

An English translation of the Belgian District Court has been kindly provided by an anonymous benefactor. you can read it here.

Antwerp court stops infringement of valsartan/HCTZ SPC based on patent claiming valsartan alone

From Philippe de Jong (Altius, Brussels) comes details of a fascinating recent decision from the Antwerp Court of Appeal in a case concerning SPCs for combination products. The case is Novartis v Teva, case 2010/RK/456, decided on 9 February 2011. Explains Philippe:

"The Antwerp Court of Appeal ordered Teva not to launch prematurely a generic version of Novartis’ blockbuster drug Co-Diovan. The product which Teva intended to launch on 12 February 2011 – the expiry date of Novartis’ basic patent for valsartan (EP 443 983 B1) – contained, like Co-Diovan, valsartan and hydrochlorothiazide or ‘HCTZ’ as its active ingredients. However, this combination of valsartan and HCTZ is protected until 25 September 2012 by a Belgian SPC. 

Teva launched a nullity action against this SPC before the Antwerp Commercial Court and also contested its prima facie validity in the summary proceedings which Novartis subsequently brought against Teva. 

The main argument raised by Teva in support of its nullity allegations was that the product valsartan+HCTZ was not protected by the basic patent within the meaning of Article 3(a) of SPC Regulation 469/2009 because the combination of valsartan and HCTZ was not specifically disclosed in the claims of the basic patent. Novartis argued that a product is protected by a patent if it infringes that patent. In view of the absolute protection for valsartan under the basic patent, any medicinal product containing valsartan, whether alone or in combination with other active ingredients, would infringe and thus be “protected by” the basic patent. 

The Court of Appeal followed Novartis’ reasoning, referring to the application of the “infringement test” in a number of European countries. The fact that in other countries a different test was applied could not affect the prima facie validity of the SPC. Particularly in view of the various pending references to the ECJ from the English courts about the correctness of this different test, the Court of Appeal concluded that the final word on which test to apply should be left for the full trial before the Antwerp Commercial Court, which will take place in April 2011. The preliminary injunction was therefore granted until a decision in the case on the merits is issued or until 31 May 2011, whichever is earlier".

Philippe has kindly provided both the Flemish original and an English translation.

Memantine in Belgium

From Steven Catoor (Hoyng Monegier, Brussels) comes news of the decision of the judgment of the Brussels Commercial Court of 11 January 2011 on the Belgian SPC for memantine (Synthon v Merz). The judgment is in Dutch but Steven hopes to provide us with an unofficial English translation shortly.  Says Steven:

"The Court essentially (and quite logically) decided to await the outcome of the pending referral to the CJEU by the Mr Justice Floyd in the corresponding UK action (previously reported on the SPC Blog here and here). As to the basic patent invalidity claim raised by Synthon at the very last minute, the Court refers this issue to the general docket and leaves it up to the parties to arrange for a timetable to exchange submissions on the subject.

Nevertheless, there are a few interesting passages in the judgment.

In particular, the Commercial Court refers to the decision of the Brussels Court of Appeal in Almirall (see the SPC Blog here), a decision which was invoked by Synthon to argue that the duration of the memantine SPC should be 0 years under Article 13 of the SPC Regulation. Not only does the Court identify a series of factual circumstances which distinguish the current case from Almirall, but it also questions whether the reasoning of the Court of Appeal is in line with the Hässle and Pharmacia Italia judgments of the ECJ.

In addition, the Court opines that the ECJ’s Novartis judgment is of very little relevance in the current case given that this case concerned the interpretation of the EEA Agreement rather than the SPC Regulation".

I hope this is useful to you.

Belgian SPC Case

Last November, the Brussels Court of First Instance handed down a decision on the scope of protection conferred by SPCs. The case relates to a vinorelbine tartrate SPC and whether or not the scope of protection conferred by an SPC extends to the use of an active ingredient as such before it is transformed into a medicinal product.

In the case, the defendant,

O is a company that manufactures vinorelbine ditartrate in Belgium in its raw form for export purposes. The substance produced was sold to a company in the United States, which used it to manufacture and market a medicinal product whose therapeutic indication was identical to that for the drug produced by the exclusive licensee of the vinorelbine ditartrate patent, F.

The patent owner, C, and the exclusive licensee, F, pleaded

on the basis of the legislative history to Regulation 1768/92, that the terms “for any use of the product as a medicinal product ” are solely aimed at excluding from the scope of protection of the SPC such uses as do not fall within the pharmaceutical field. These terms therefore have to be construed in their broad sense as covering any use covered by the marketing authorization where what is ultimately concerned is the manufacture of a medicinal product.

The court followed this argument: the protection conferred by article 4 covers not only any use in a medicinal product (finished product), but also any use of the product covered by the patent (active ingredient) where that is destined for use as a medicinal product. The court briefly stated the reasons for its decision as being that the patented product is essential to manufacture of the medicinal product.

O also argued that the words “use of the product as a medicinal product” necessarily mean that the patented product (active ingredient) must be used as a medicinal product in the territory of Belgium for there to be an infringement, because the scope of the Belgian SPC is limited to that territory. According to that interpretation, there is no infringement in Belgium when all one does is manufacture the active ingredient and export it to the United States where it is transformed into a medicinal product.

C and F argued to the contrary that it is sufficient for there to be infringement that O should have manufactured the active ingredient in Belgium, even if for export purposes. In support of this interpretation, they made reference a contrario to EC Regulation 816/2006 which states that manufacture of an active ingredient protected by an SPC in state A with the sole aim of exporting it to state B with public health problems must be accorded a compulsory license. According to them, this regulation confirms that the patent-holder’s consent is necessary for any manufacture of the active ingredient, even if it is manufactured only for export purposes.

After stating very succinct reasoning on this point as well, the court followed the latter interpretation. It pointed out that the manufacture and offering for sale of a product protected by intellectual property rights are regarded as illicit acts and concluded that, for there to be infringement, it is sufficient for a protected product to be manufactured and sold in Belgium and be used in the manufacture of the medicinal product.

Thanks to Fernand de Visscher and Benjamin Docquir at Simont Braun for providing this information. Note: the decision is not yet published.

R&D incentives for patents and SPCs in Belgium

Writing on the IP Finance weblog this morning, Tom Swinnen (Thompson Hine LLP, Brussels) explains that, for the 2008 tax year, a new tax incentive has been introduced in Belgium which leads to a maximum effective tax rate of 6.8% on patent income. This is the Patent Income Deduction (PID) scheme which, he maintains, results in the lowest effective European tax rate on income derived from the licensing of patents or the use of patented products. The PID is available only in respect of patents and supplementary protection certificates, but not any other intellectual property rights. You can read Tom's piece in full here.

Forthcoming event with SPC content

Belgian patent attorney firm De Clercq Brants & Partners is organizing a one-day seminar on 14 November 2008 on "Patent Warming, Patent Warning? Patenting Life Sciences and Today’s Challenges in Patent Law and Practice”. Speakers in what is a very stimulating programme include Christophe Ronse (Altius), who is discussing the enforcement of pharmaceutical patents in Belgium and giving an update of SPC case law.

Full details of the seminar programme and registration form are available here. Bookings should be made before 31 October 2008, if possible.