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Compulsory licensing – India move will test room for manoeuvre under WTO and TRIPS

India’s ‘Controller of patents’ has granted Natco a ‘compulsory license’ (‘CL’) for Bayer’s Sorafenib Tosylate (marketed as Nexavar). The drug extends the lives of terminal liver and kidney cancer patients. Put differently: the controller has forced Bayer to grant a license to Natco, to produce the drug, specifying inter alia a (low) sales price and royalties to be paid to Bayer.  Natco is an Indian pharmaceutical company (no surprise there), with an increasing portfolio in pharmaceutical R&D. In other words reportedly not a typical ‘generics’ company.

The ruling is of course subject to appeal. It is also the subject of intense debate under the WTO, in particular the TRIPS Agreement. TRIPS (Articles 30-31) leaves room for a CL system and prima facie leaves a lot of room for manoeuvre to WTO Members to grants such licenses. However underneath Article 30-31’s surface lies quite a bit more than might be assumed. Moreover, even if one takes Members’ discretion in applying these Articles at face value, the articles must not be applied stand-alone. In other words they do not give carte blanche for introducing requirements leading to CL which might otherwise be WTO inconsistent.

Watch this space: this case is a nugget for, yet again, disciplining regulatory autonomy (see here and here) under the WTO.

Geert.

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‘Exorbitant’ head of jurisdiction of Article 14 Code Civil (France) is not unconstitutional. Probably.

On 29 February last, the French Cour de Cassation decided not to grant leave for the constitutionality (or not) of Article 14 of the French Code Civil to be reviewed by the French Constitutional Court. Article 14 is an ‘exorbitant’ rule of jurisdiction. These are jurisdictional grounds in national law which rest on very weak of even spurious grounds, and which by virtue of Articles 3 and 4 of the Brussels I Regulation may not be invoked against those domiciled in one of the EU Member States. However they do regain full force as against those not domiciled in any of the EU Member States.

Article 14 Code Civil grants jurisdiction in civil cases to French courts, on the simple ground that plaintiff be a French national. A similarish provision in French criminal law was recently and famously invoked (but failed) in the prof Joseph Weiler litigation (French version here and unofficial English translation here).

The alleged unconstitutionality lies in the perceived ‘unfairness’ of such trials vis-a-vis the (non French, indeed by virtue of the Brussels I Regulation the non EU) defendants. The Cour de Cassation saw no merits in the arguments, arguably mostly on the ground of the diminishing practical impact of the provision. The Cour’s decision means that for the time being at least , the issue will not be sub judice in the French Constitutional  Court, however that does not mean of course that it might not end up at the European Court of Human Rights before long.

Geert.

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Patent infringement and the Brussels I Regulation – Cruz Villalon AG revisits some old chestnuts in Solvay

Solvay, Case C-616/10, offers a great opportunity for the European Court of Justice to revisit a number of old chestnuts in the application of the Brussels I Regulation (the Jurisdiction Regulation or ‘JR’): the exclusive ground of jurisdiction with respect to intellectual property rights, of Article 22(4); multipartite litigation in Article 6 JR; and finally provisional measures, referred to in Article 31. Cruz Villalon AG’s Opinion was issued on 29 March.

Solvay SA, a company established in Belgium and holding a European patent, valid in more than one Member State [don’t ask – European patent law is less harmonised than one might hope and even a ‘European’ patent does not necessarily and automatically cover all Member States], brought an action in the Rechtbank ’s-Gravenhage in the Netherlands for infringement of several national parts of the patent, in particular against three companies originating from two different Member States, Honeywell Fluorine Products Europe BV, established in the Netherlands, and Honeywell Belgium NV and Honeywell Europe NV, established in Belgium, for marketing a product manufactured by Honeywell International Inc. that was identical to the product under the above patent.  In the course of the proceedings, Solvay lodged an interim claim against the defendants in the main proceedings, seeking provisional relief in the form of a cross-border prohibition against infringement for the duration of the main proceedings.

Firstly, with respect to the multipartite jurisduction element: Article 6(1) allows the applicant to sue several defendants before the court where any one of them is domiciled, provided the claims are’ so closely connected that it is expedient to hear and determine them together to avoid the risk of irreconcilable judgments resulting from separate proceedings’. Per Roche Nederland, the Court had controversially held that parallel actions for infringement in different Member States, which, in accordance with Article 64(3) of the Munich Convention, must be examined in the light of the national law in force, are not in the context of the same legal situation and hence any divergences between decisions cannot be treated as contradictory – leaving no room for application of Article 6(1) to the benefit of holders of European patents vis-a-vis actions for infringement in different Member States. Cruz Villalon AG proposes to distinguish, not to overturn, Roche Nederland on the ground that in the case at issue, the objectionable behaviour concerned more than one undertaking, domiciled in more than one Member State, however accused of the same behaviour in the same Member State. If Article 6(1) were not to be applicable, the courts concerned would hence hold on the basis of the same lex loci protectionis (that of the Member State in which the alleged conduct is said to have taken place) and hence the risk of irreconcilable judgments great.

The AG then turns to the application of Article 22(4), dealt with previously in particular in GAT. Here (as helpfully summarised by the AG) , the referring court asks, in essence, whether the fact that a defence of invalidity of a patent has been raised in interim proceedings for a cross-border prohibition against infringement, in parallel to main proceedings for infringement, is sufficient, and, if so, under what formal or procedural conditions, for Article 22(4) to become applicable. Applicability of Article 22(4)’s exclusive ground for jurisdiction is highly relevant: firstly, the court dealing with the case has to decline jurisdiction for the main proceedings on the basis of Article 25 (when an exclusive ground of jurisdiction is at stake, all other courts have to declare themselves without jurisdiction) and, secondly, as a consequence, it is then required to consider its competence to adjudicate on the interim proceedings on the basis of Article 31’s jurisdictional ground for provisional measures. After careful consideration in which the AG gives a brief ‘tour d’horizon’ of the various procedural realities that might exists, he advises that Article 22(4) is not applicable when the validity of a patent is raised only in interim proceedings, ! in so far as the decision likely to be adopted at the end of those proceedings does not have any final effect. Whether the latter is the case depends on the applicable law (see my comment above, re incomplete harmonisation of EU patent law).

I wonder whether the Court would be put off by the AG’s sidestep into what he calls ‘procedural reality’ (not a criterion which the Court generally is happy to entertain in the application of the JR) and whether, similarly, the criterion ‘final effect in accordance with the applicable law’ would offer enough legal certainty (which the CoJ definitely craves in the application of the JR).

One final consideration in the AG’s opinion is the application of Article 31’s jurisdictional ground for provisional measures (this question will only feature in the eventual judgment, should the Court reject the AG’s view on Article 22(4)). Article 31’s scope is limited. Amongst others, the measures within its scope must be of a ‘provisional’ nature, that is to say, per Reichert, be intended to preserve a factual or legal situation so as to safeguard rights the recognition of which is sought elsewhere from the court having jurisdiction as to the substance of the matter: that is a ratione temporis limitation.  In Van Uden, the court added a limitation ratione loci: there has to be a ‘real connecting link’ between the subject-matter of the provisional measures sought and the territorial jurisdiction of the Member State of the court seized. The AG suggests that applied to intellectual property rights (but with wider ramification), this condition does not imply that the measure must not have any ‘extraterritorial’ effect: rather, that for Article 31  to apply, there has to be a  minimum territorial localisation of the provisional measure sought. The existence of such real connecting link should be considered chiefly in the light of the enforcement procedures of the Member State of the court seized.

Not all of the considerations of the AG are likely to be entertained by the Court. Neither do they cover all aspects of the troublesome application of Article 22(4) [not much of which has made it into the review of the JR].

Geert.

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The Jurisdiction Regulation, trademarks and the internet – The Court of Justice in Wintersteiger

I have already reported recently on the application of the Brussels I Regulation and the internet [see here for my confused state on the Judgment in ‘G’]. In Wintersteiger (Judgment of 19 April 2012) the applicant is the proprietor of an Austrian trade mark. The defendant was a competitor established in Germany, who had registered Wintersteiger’s name as an AdWord on Google’s German search service. Whence users of google.de entering ‘Wintersteiger’ (looking for that make’s ski and snowboarding service tools) receive a link to Wintersteiger’s website as first search result, but also as the first AdLink on the right hand side of the screen, an advert for and link to the competitor’s website – which Wintersteiger considered an abuse of its trademark.

The case once again raised the question how one applies Article 5(3)’s ‘place where the harmful event occurred’ (since Mines de Potasse split in ‘place where the event giving rise to the damage’ and ‘place where the damage’ occurred as being two alternative connecting factors)  in an internet context.

The judgment of the Court of Justice confirms that the connecting factor ‘centre of interests’ in Kylie Minogue and eDate Advertising only holds for infringement of personality rights in an internet context. Trademark violation is distinguished, on the grounds that rebus sic stantibus intellectual property rights are protected on a territorial basis. The Court confines the ‘place where the damage occurred’ as the Member State in which the trade mark is registered. For the ‘place where the event giving rise to the damage’, the Court upheld ‘place of establishment of the advertiser’ as the jurisdictional basis (the Advocate General’s ‘means necessary for producing, a priori, an actual infringement of a trade mark in another Member State’ is a  more generic criterion however the Court did not uphold this as such).

Precedent value of the judgment may be limited due to the specific facts of the case and the questions put to the Court (for non-EU readers: the Court of Justice practises judicial economy, hence questions not specifically asked are not entertained). In particular, the conclusion may only hold absolutely where there is only one trade mark held, in only one Member State (for EU readers and non-EU readers alike: EU trademark protection is a lot less harmonised than one may have assumed). The referring court moreover did not flag the many issues surrounding provisionary measures and intellectual property rights (see Article 31 of the Regulation and the Opinion of the same AG in Solvay, on which I report here).

Geert.

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Exam questions, anyone? Plain packaging regulations and domestic regulatory autonomy in WTO law

Update 10 June 2020 a lot has happened of course since this post – for the latest on the WTO front see the AB report confirming the legality of the measures under World Trade Organisation (TBT) rules.

Postscript January 2016 Reportedly the Permanent Court of Arbitration under UNCITRAL rules, has declined jurisdiction. The award is to be made public here once it has been cleared of confidential data.

Postscript June 2015: I have many other posts on the issue however I thought I”d here that in June 2015, Ukraine suspended its complaint against Australia. Simon Lester collates why. And end of May 2015, Norway Norway TBT plain packaing notification its plain packaging plans to the WTO TBT Committee, with extensive pre-emption of legal arguments against it.

Postscript 22 10 2013:  on the BIT front, see the interesting defence by the European Commission of BITs in October 2013 here. Reference is made ia to the ongoing Philip Morris and Vatenfall (Nuclear energy) issues.

Faculty everywhere have been handed a treasure trove of exam questions, courtesy of ‘plain packaging’ (students please look away now).  A variety of States are in the process of introducing ‘plain packaging’ requirements on tobacco products. Although they of course vary in detail, they generally require tobacco manufacturers to strip packaging of all tailored corporate content, resorting instead to prescribed generic packaging. The ‘plain’ packaging required is generally limited to brand name in standardised fashion (font size and lettering, colour…), joined by a number of health warnings (including, sometimes, images), excise duties requirements and ingredients listings.

Plain packaging ticks all the boxes of a classic ‘domestic regulatory autonomy’ dispute. It pitches the freedom of a sovereign State to pursue ‘regulatory’ interests (environment, public health, consumer protection, stability of the economy etc.) against the free trade commitments which the same State has voluntarily committed to. These trade commitments take the form of multilateral (such as the WTO, the EU’s Internal Market, or NAFTA) or bilateral (such as bilateral free trade agreements and customs unions) agreements. They most often do not, but sometimes do include procedural rights for private parties (as opposed to simply the States which have concluded the agreement) to launch legal proceedings should free trade (arguably) have been infringed. Such standing for private parties is the case in many BITs, i.e. Bilateral Investment Treaties, as well as for instance (subject to a number of whistles and bells), NAFTA.

Free trade agreements are not generally oblivious to the continuing desire of participating States to regulate the interests referred to above. Consequently they include room for ‘domestic regulatory autonomy’ to continue after the conclusion of the agreement, subject of course to checks and balances.

This fragile balance between free trade and regulatory autonomy is exactly what the current debate on plain packaging is all about. The issue is being fought on many fronts: At the World Trade Organisation, Ukraine have filed a complaint in March 2012 against Australia’s plain packaging laws on the basis of the TRIPS (intellectual property) and TBT (technical barriers to trade; product regulations) Agreements. Ukraine’s complaint is supported by a number of WTO Members with tobacco manufacturing interests.

Australia’s position is eagerly anticipated by other jurisdictions thinking of doing something similar.See e.g. here and here.

At a constitutional level, issues include free (commercial) speech (see here for the related issue of graphic warnings), expropriation (of the trademark), non-discrimination (why no plain packaging on alcohol, for instance).

At a level of BITs, the issue has rejuvinated the ‘regulatory takings’ debate (do new regulatory requriements of host States amount to a ‘regulatory taking’ (as compared to a straightforward expropriation) that may be incompatible with investment protection requirements. The Uruguay-Switserland (see here and enter search term ‘ICSID Case No. ARB/10/7’) and Australia-Hong Kong BITs are among those affected. One imagines that the necessity of the measure will be hotly contested, as the actual health impact of the measure is not entirely certain. See the (controversial) ruling of the European Free Trade Association’s Court on the related issue of display bans here and the excellent analysis of prof Alemanno.

One will have gathered: all of this is excellent material for those of us teaching Trade and regulatory law. Geert.

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G v Cornelius de Visser. The Court of Justice on tort, internet and the Jurisdiction Regulation

Applying private international law in the information society is a touch tricky. Traditional PIL having relied on territorial links, applying it in an internet context may sometimes be testing. Article 5(3) of the European ‘Jurisdiction Regulation’ is a special jurisdictional rule which allows plaintiff to sue elsewhere than in the domicile of the defendant, for actions based on tort. In eDate advertising (aka Kylie Minogue), the European Court of Justice fine-tuned the Shevill criteria for application of Article 5(3) JR in an internet context, adding the ‘centre of (the victim’s) interests’  as a potential forum in the case of infringement of one’s personality rights. [see here]

In G v Cornelius de Visser, Case C-292/10, the Court was asked to provide input in the event of the defendant’s domicile being unknown (but with the defendant presumed to be an EU citisen), and the precise location of the server on which the website is stored, also unknown, although most probably in EU territory.

The Landgericht Regensburg asked no fewer than 11 questions of some complexity, with a degree of interdependence between them. The Court answered that Article 5(3) may certainly apply in such case, giving preference to legal certainty. However it expects due diligence on behalf of the national courts in making sure that a prima facie case of a link to the EU was established.

The ECJ failed subsequently to entertain the questions on the location of the harmful event given the uncertainty signalled above, for the relevant questions had been dropped by the referring court following the judgment in eDate Advertising. In my view, an answer to some of the now dropped questions on location of the harmful event (the locus delicti commissi) were certainly not nugatory, even after eDate Advertising. There is no Opinion of the Advocate General to assist.

Judgment in ‘G’

Geert.

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Boomerang torpedo or futile resistance?  West Tankers Inc v Allianz SPA & Anor [2012] EWCA Civ 27. English courts continue digging West Tankers

Aficionados of arbitration law will be aware of the long-running West Tankers saga. It pitches the English courts’ urge to uphold commercial arbitration, against the European Court of Justice’s zeal in upholding a pure (and in the case of the arbitration exception, far-fetched) lis alibi pendens rule. The battlefield at issue is the Brussels I Regulation on jurisdiction in civil and commercial matters. The Court of Justice ruled in February 2009 [Case C-185/07] that the English courts were out of their league in issuing an anti-suit injunction, prohibiting Allianz and Generali from pursuing the case in the Italian courts (on the basis of Article 5(3)’s special jurisdictional rule for tort) and obliging them to take the case to arbitration in London. Thus two cases continued: one, an arbitration proceeding, in London, with West Tankers and Erg (the initial counterparty) participating, but not Allianz and Generali (the insurers, subrograted into Erg’s rights). The other, for the Italian courts in ordinary, the current fate of which is less clear.

It would seem that West Tankers is now attempting to turn the Italian torpedo (launching proceedings in an Italian court to delay them) into a boomerang, by having the English courts enforce the arbitral award rendered in the meantime: West Tankers Inc v Allianz SPA & Anor [2012] EWCA Civ 27.

While this intention is not as such formulated, one assumes that this manoeuvre in part at least is meant to ensure that any judgment eventually rendered in Italy, will not be enforceable in England (or indeed elsewhere in the EU) as the High Court’s enforcement might qualify as a ‘prior’ judgment between the same parties, per Article 34 of the Regulation. One gets the feeling that West Tankers will once again end up in Luxembourg… I have an article on all the above forthcoming and will put it on SSRN once finalised.

Geert.

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Lies, Damn Lies and Statistics. On the Boundaries of European Private International Law and the European Ius Commune

A bit of a heavy-handed title however I am often reminded of this maxim, credited (perhaps incorrectly) to Benjamin Disraeli KG. Over at SSRN I refer to it in discussing the statistical merits of the proposed Common European Sales Law. Over and above the (lack of) justification for the proposal, its relationship with European Private International Law is very unclear. The European Commission marches on with its harmonisation of European conflicts law however I for one would argue that with the proposed CESL it may have hit the proverbial wall.

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2002866

Geert.

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Corporate Social Resonsibility used as stick and carrot – Court Amsterdam

End 2011, the Gerechtshof Amsterdam issued a further ruling in the long-running Trafigura case (exports of wastes, Ivory coast). I am restricted from commenting on the waste law merits of the case however it is interesting to note that the court employed CSR both as carrot and stick in determining punishment. As a stick: companies with a level of sophistication as Trafigura ought to organise themselves to be aware of the legal implications of their production process. As a carrot: the foundation created by the company supports global CSR projects, which merits a certain amount of leniency. As far as I am aware, this was the first time that CSR was used in such specific manner in court.

Geert.

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The EU’s external trade policy: Doha as well as FTAs

I have uploaded a short piece on the focus of the EU’s external trade policy given the continuing stalemate in the Doha Round over at the WTO.

However one spins the news coming out of the Geneva headquarters of the World Trade Organisation (‘WTO’), it would seem fair to say that the current ‘Doha’ or ‘Development’ or indeed ‘Millennium’ Round of multilateral trade negotiations is in dire straits. Overall agreement was narrowly missed in the summers of 2006 and again of 2008 (Doh!). Following this on-going failure, Free Trade Agreements (‘FTAs’) and Regional Trade Agreements (‘RTAs’) are very much en vogue, in the EU as elsewhere (Aha!).

Geert.

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