Bayer at the CJEU on neonicotinoids. (Belatedly) of bees, ponies, sophistry and precaution.

The CJEU held (first Chamber, which includes the  CJEU President Koen Lenaerts) in C‑499/18 P Bayer Crop Science v European Commission a few months back. Here at GAVCLaw the judgment was firmly on our minds – but my analysis not yet put to paper.

The case centres around the legality of the conditions imposed by the EU for the approval of the active substances clothianidin, thiamethoxam and imidacloprid (these are neonicotinoids), and prohibiting the use and sale of seeds treated with plant protection products containing those active substances. The act challenged by Bayer is Commission Implementing Regulation 485/2013 and the justification for the measures are the documented losses of honeybee colonies as a result of the use of the substances.

The application follows a tried and tested path of applicants in the chemical and related sectors. Firstly and preferably, find some holes in the (often extensive) documentary trail of preparatory and advisory paperwork relied upon by the Institutions in their measure, and claim these devastate the legality of the eventual measure. A typical example would be ‘the studies relied upon reported testing of the substances on small ponies while the eventual regulation cites concerns for both small and medium-sized ponies’. Secondly, try and tempt the CJEU into finding fault with the application of core principles of EU law (such as subsidiarity, proportionality, ultra vires, attributed powers etc) and /or EU sectoral policy (such as in particular the precautionary principle), or confuse the Court with at best esoteric but usually sophistic discussions on eg ‘new and scientific knowledge’.

The General Court had found against Bayer. Much of the appeal before the CJEU discusses the first type of arguments and, like the General Court, dismisses them.

On the suggested infringement of the precautionary principle, the Court first of all rejects that precaution cannot be relied upon until an ‘exhaustive’ scientific assessment is made: [81]: ‘an exhaustive risk assessment cannot be required in a situation where the precautionary principle is applied, which equates to a situation in which there is scientific uncertainty.’ The point is NOT that precaution does not engage with science. It does. That is also where its weakness may lie: it desperately speaks the language of data, science and numbers yet as the saying goes, “Data is like a spy – if you torture it long enough, it will tell you anything you want to know.” The point is rather (see eg [78]) that for one to have to wait for every single new potential sub-study into a sub-issue, would hand industry the golden ticket for delay tactics; [82] that studies are underway which may call into question the available scientific and technical data, is not an obstacle to application of the precautionary principle.

Bayer put essentially the same argument to the CJEU with slightly differing angles (eg suggesting that for already approved active substances, precaution must be applied to a higher threshold than for new to be approved substances) and the Court rejected them at each turn.

Update 18 February 2022 Compare nb also recently the General Court in T‑518/19 Sipcam on economic cost-benefit and the precautionary principle.

A good judgment.

Geert.

EU environmental law (with Leonie Reins), Edward Elgar, 2018, p.28 ff.

 

 

 

 

 

Derivatives’ forum shopping aka Gerichtshof Einkaufen. Suing Bayer of Germany in New York, applying German law.

Many thanks indeed Kevin La Croix for flagging the suit brought in New York by a group of Bayer AG shareholders, against Bayer (with seat at Leverkusen, Germany), concerning the not altogether successful purchase of Monsanto by Bayer. Kevin has excellent analysis and I am happy to refer.

Claimants of course pre-empt arguments of lack of subject-matter jurisdiction and, subsidiarily, forum non conveniens – please refer to Kevin’s overview for the arguments to and fro. Most interesting. It brought back to me echoes of the Australian case of Tiger v Morris, not because the subject-matter is similar (it is not) but because in this increasingly globalised world (despite Covid19), courts everywhere are increasingly asked to consider the reach of their courts in cases with competing local and foreign interests. Comity considerations underlying the historic roots of conflict of laws are being brought back to the fore, no doubt also partially as a result of the impact of third party financing, contingency fees etc.

One to keep an eye on. One wonders whether Bayer might be launching a related case in Germany, then triggering A33/34 considerations.

Geert.

 

 

Compulsory licensing addressed in joint WTO, WHO, WIPO report on access to medical technologies

As reported earlier, India’s  compulsory license against Bayer, for the sale of its drug Sorafenib Tosylate (marketed as Nexavar), brought the possibilities for compulsory license under the spotlight. It also highlighted the complex web of intellectual property, and international trade law rules applicable to the case. Bayer’s application for a stay of that license, with the Intellectual Property Appellate Board was dismissed (link courtesy of SpicyIP), however the Appeal on substance is, I understand, still pending, and other possibilities for review with the courts in ordinary exist, too.

WHO, WTO and WIPO have now issued a rare joint report, in which the intersections between public health, intellectual property and trade are clarified. It does not contain a roadmap for the Indian courts to settle the case at issue, however there are quite a lot of sections in the report which one suspects might be invoked by either side in the various appeals.

Geert.

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