FR – Eli Lilly v. Fresenius Kabi / Comment Pierre Véron

Posted: September 26th, 2020

Eli Lilly and Company and Lilly France v. Fresenius Kabi France and Fresenius Kabi Groupe France, Judiciary Court of Paris, France, 11 September 2020, Docket № 17/10421, by Pierre Véron, Honorary President, EPLAW

Joining a majority of European Courts, the Paris court has held that Eli Lilly’s patent, claiming the combined administration of pemetrexed disodium with vitamin B12, is infringed by the marketing of pemetrexed diacid, and it has awarded the largest ever patent infringement damages award in Europe (28,000,000 €).

On 11 September 2020, the tribunal judiciaire de Paris (which, from January 2020, is the new name given to the Paris first instance court, which has jurisdiction for the whole of France for patent cases) issued a major decision in the pemetrexed saga that has been litigated in more than 10 European countries.

The entire comment (in English) can be read here.

The judgment (in French) can be read here.
The judgment (in English) can be read here.

One Response

  1. Attentive Observer says:

    One can agree or not with the decision of the Paris Court. I do not. That the Paris court did not go along infringement by equivalent goes even further than the route taken by for instance the UK Supreme Court.

    Disregarding the behaviour of the applicant during prosecution is not correct. Up to today it is only the District Court of The Hague who was consequent enough and took the behaviour of the applicant during examination to refuse a broad interpretation of the claim as has been done in other jurisdictions like here or in the UK.

    The original disclosure went on about the combination of any antifolate with vitamin B12. As the only example properly documented in the application, was pemetrexed disodium, the examiner invited the applicant to limit its claims to pemetrexed disodium.

    In reply the applicant claimed pemetrexed in general. The ED raised, in my opinion quite rightly, an objection under Art 123(2) as the only example was that of pemetrexed disodium. Lord Neuberger was in my opinion wrong when he criticised the ED for raising the objection under Art 123(2). The examiner had no choice.

    All along, the applicant was only interested in a quick grant and accepted the limitation. At no time the applicant tried to defend a broader claim, for instance by showing the possibility of using other anions or by filing a divisional in which a broader claim was pursued.

    The examiner required that the description was to be limited to the example disclosed, but the applicant refused and the examiner gave up. This could be considered as a fault, but in view of the attitude of the applicant I have some understanding.

    If the description had been more thoroughly adapted to the amended set of claims during prosecution, and if all generic mentions of any antifolate with vitamin B12 had been deleted when adapting the description to the granted claims, it would have been much more difficult for Eli Lilly to claim equivalents it never thought of, or even direct infringement.

    It was indeed the barely adapted description which turned out to be the loophole by which Eli Lilly attempted to broaden the scope, although this broadening was never envisaged and supported during the original examination. I suspect Eli Lilly did at the time only have data for pemetrexed disodium. If the examiner had insisted upon a proper limitation of pemetrexed disodium in the description, we would not be in the situation we are now.

    All positive decisions for Eli Lilly are an encouragement for slap dash drafting of claims and description. It is enough to put some speculative considerations at the beginning of the description and then to simply disclose one specific embodiment. With some luck, the speculations may turn to be correct. How can a freedom to operate study be carried out when such drafting practices are encouraged?

    If the UKSC wanted to overcome the blunder it made years ago with the Epilady/Improver decision, it should have chosen a different case.

    In my opinion, other courts followed the decision of the UKSC by fear of being left behind. Only the District Court of The Hague had the guts to say no. I hope the decision will be confirmed in appeal.

    I get the feeling that file history is duly taken into account when it confirms the interpretation that the court wants to adopt, but it is disregarded when it does not fit the court’s reasoning. But this is not correct. Although there is no file-wrapper- estoppel in the meaning of the US, the behaviour of an applicant during examination should be taken into account, especially in cases like the present one.

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