EPLAW PATENT BLOG

NL – Fresenius Kabi v. Eli Lilly and Company (pemetrexed) – Opinion Advocate General

Posted: April 21st, 2020

Fresenius Kabi Nederland BV v. Eli Lilly and Company, opinion Advocate General in the Supreme Court, The Netherlands, 30 March 2020, Case no. ECLI:NL:PHR:2020:269, provided by Chantal Morel and Mattie de Koning, Simmons & Simmons

On 30 March 2020, the Advocate General in the Supreme Court provided his opinion in the preliminary relief proceedings between Eli Lilly and Company (“Lilly”) and Fresenius Kabi Nederland (“Fresenius”) based on EP 1 313 508 B1 (“EP 508”). The Advocate General advises the Supreme Court to reject Fresenius’ appeal and to uphold the PI decision by the Preliminary Relief Judge of the District Court of The Hague of 24 October 2017, as confirmed by the Court of Appeal of The Hague on 8 May 2018 (decisions in Dutch here and here, reported here and here).

EP 508 primarily claims the use of pemetrexed disodium in combination therapy with vitamin B12 and optionally folic acid. Lilly markets the medicine Alimta which is protected by EP 508. Fresenius offers a generic drug with pemetrexed diacid, instead of pemetrexed disodium as claimed. Does this generic drug fall within the scope of protection of the Dutch part of EP 508?

Validity and infringement of EP 508 are at stake in proceedings throughout Europe. These proceedings have been extensively covered, also on this blog. In The Netherlands Lilly obtained preliminary injunctions not only against Fresenius, but also against Teva and Sandoz. The District Court of The Hague rejected Sandoz’ invalidity arguments in a first instance decision of 16 January 2019 (decision in Dutch here, reported here).

Contrary to the decision in the preliminary relief proceedings, the District Court of The Hague ruled on 19 June 2019 in the infringement case on the merits that Fresenius’ pemetrexed diacid does not fall within the scope of protection of EP 508 (decision in Dutch here, reported here). Appeal of this non-infringement decision on the merits is still pending.

The Advocate General’s opinion addresses the question whether the Court of Appeal’s 2018 confirmation of the District Court’s 2017 preliminary injunction against Fresenius was legally correct.

The Court of Appeal held that (when taking into account all aspects relevant for determining EP 508’s scope of protection and notwithstanding the narrow wording of the claims) the underlying inventive concept – the combined administration of pemetrexed with vitamin B12 resulting in a lower toxicity – justifies that other forms of pemetrexed which after dissolution release the pemetrexed anion and which are technically equivalent fall within the scope of protection as well. It rejected Fresenius’ argument that in the eyes of the skilled person a deliberate choice was made for the disodium salt. Lilly’s restriction was in response to the EPO Examiner’s 123(2) objection. According to the Court there was no technical reason for Lilly to limit the claims to the disodium form and the specification teaches no relevance whatsoever as to the form in which the pemetrexed anion is administered.

The Court of Appeal further held that a general rule that no protection can be sought for variants that were foreseeable on the relevant priority date should be dismissed, as this would mean that Article 2 of the Protocol would basically become mute. Such a general rule also does not follow from the case law of the Supreme Court.

The key issues are whether the Court of Appeal applied the correct legal standards in determining the scope of protection (including equivalents) of EP 508 and in assessing whether Lilly’s restriction of the claims during the EPO prosecution prevents a finding of equivalence.

The opinion first summarizes the Supreme Court case law on scope of protection, referring to its decisions in Bayer v Sandoz (ECLI:NL:HR:2016:196), MSD v Teva (ECLI:NL:HR:2017:2807) and Resolution v AstraZeneca (ECLI:NL:HR:2018:854). Article 69 EPC and its Protocol are leading in this respect. One of the elements (viewpoints) to take into account is “the inventive idea underlying the words of the claims”, in order to prevent an unnecessarily broad or too limited interpretation of the claim. It is relevant what the patent adds to the prior art. Under certain circumstances the public part of the prosecution history may also play a role.

The Advocate General goes on to emphasize that both claim interpretation and assessment of equivalence are factual determinations – this is standing Dutch case law. As a consequence, there is very little room for intervention by the Supreme Court if the lower court applied the correct legal standards and if it provided proper reasons for its decision. In preliminary relief proceedings the duty to state reasons is furthermore less strict.

Although Fresenius presented most of its grounds of appeal as complaints about the legal standards applied by the Court of Appeal, the Advocate General concludes that they in essence concern factual determinations. He concludes that the correct legal criteria were applied, so there is no violation of the law. That a factual assessment could also have resulted in a different outcome is not decisive. This is only relevant to the extent that the decision lacks proper reasoning, but that is not the case here either. The decision that Lilly’s restriction of the claims during the EPO prosecution does not prevent a finding of equivalence in this specific matter has also been properly motivated. Finally, as an obiter the Advocate General rejects a general “disclosed but not claimed is disclaimed” rule in Dutch patent law.

The decision of the Supreme Court will follow in due course. The opinion of the Advocate General (in Dutch) can be found here.


One Response

  1. Attentive Observer says:

    The famous pemetrexed disodium patent is a disgrace and a premium to slap dash drafting of applications.

    How is nowadays a FTO statement possible?

    The worse point is the reference to Art 2 of the protocol on interpretation of Art 69, but equivalents are nowhere defined.

    It is fully consciously that the applicant at the time limited its claims to pemetrexed disodium and it is only later that he woke up.

    A general file wrapper estoppel like in the US is not to be welcomed, but the attitude of the applicant during prosecution should be taken into account.

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