NL – Eli Lilly v. Fresenius – Case on the merits

Posted: June 21st, 2019

Eli Lilly and Company v. Fresenius Kabi Nederland B.V., District Court The Hague, 19 June 2019, Case no. ECLI:NL:RBDHA:2019:6107

Contrary to the Court of Appeal in summary proceedings, and contrary to various foreign decisions in parallel proceedings, the District Court of the Hague rules in the case on the merits that the scope of protection of Eli Lilly’s patent EP 1 313 508 (hereafter: EP 508), entitled ‘Combination containing an antifolate and methylmalonic acid lowering agent’ is limited to the use of pemetrexed disodium and that the pemetrexed tromethamine used by Fresenius falls outside the scope of protection, as the claims are consciously limited to pemetrexed disodium.

The Court reasons as follows. As the literal wording of the relevant part of the claim, read in light of the description, are not in line with the inventive concept of the patent, the man skilled in the art will wonder how he should interpret the limitation.

Upon consulting the prosecution file, the nature of the limitation and the way it occurred according to the prosecution history, the man skilled in the art or a third party will not consider the literal wording of the patent as a (clearly) unintentional limitation.

The prosecution file shows that Lilly after a Communication from the Examiner -without any discussion whatsoever- limited the claim to pemetrexed disodium. According to the Court, a third party may assume that this limitation was consciously made since Lilly -being a pharmaceutical superpower- is a knowledgeable applicant and was under no time pressure.

Therefore, Pemetrexed Fresenius, the pemetrexed tromethamine, does not fall within the scope of the claims of EP 508.

A copy of the decision (in Dutch) can be read here.

2 Responses

  1. MaxDrei says:

    From your report it seems to me that decisive for this court was the positive absence from the EPO prosecution history of any attorney argument from the Applicant, in support of a claim wider than “….. sodium”.

    Why was there no such argument though? Perhaps because, in some other jurisdictions, thus to argue, on the public record, and to lose, would kill off any “infringement by equivalent” argument. And was that the right decision? Time will tell. But (as we now know from the Supreme Court decision) it was for the UK.

    In which case, what do we learn from this case? Perhaps that Applicants are well advised to devote enough resources to getting their patent applications drafted competently ie with enough “intermediate generalisations” in the application as filed, because any attempt to slip them in during prosecution will likely land you in an appalling predicament. CATCH 22 with a vengeance.

  2. Attentive Observer says:

    One can only applaud the decision of the District court as it is the logical conclusion when one looks at the way Eli Lilly conducted the proceedings.

    Eli Lilly wanted to obtain a quick patent limited to pemetrexed disodium and it obtained it.

    Eli Lilly did not try whatsoever to show that the limitation was not a real one. The only usable examples in the original description was pemetrexed disodium, and the examiner in charge was correct when stating that a claim for pemetrexed in general was offending Art 123(2). Lord Neuberger was not correct when he blamed the examiner for requesting the limitation. The examiner had no other choice. A decision like that of Lord Neuberger has certainly not made a FTO analysis easier…..

    It was open to Eli Lilly to at least bring new examples of other salts than disodium. He might not have escaped the objection under Art 123(2), but it would not have been necessary to come to an infringement by equivalent based on Art 2 of the Protocol in which equivalents are not even defined! The patent would then have been granted with a STIN mention on the front page, cf. Guidelines H-V, 2.3.

    Eli Lilly could also have filed a main and auxiliary requests, the MR for pemetrexed and the AR for pemetrexed disodium. Grant could have proceed with the AR or an appeal could have been filed for the MR.

    Another possibility which was open to Eli Lilly was to file a divisional application for a broader claim. This is not uncommon, and corresponds to a strategic use of divisional applications, especially shortly before an OP:

    Eli Lylly did nothing but insisted on the sentence ““The Applicant seeks to draw a distinction between subject matter which is relevant to the invention which is indicated as being that to which “the present invention generally relates” and “the subject matter provided by the invention” which is the subject matter claimed”.””

    The examiner should have insisted that § [005] – [009] had to be aligned to § [010] and [011] which specifically deal with pemetrexed disodium.

    The events following grant can be considered as an incentive to slap dash drafting and prosecuting an application on the side of Eli Lilly.

    The District Court was thus correct to keep in mind the security of third parties. The comment that Eli Lilly is a large company with great experience in prosecution is very pertinent. It is too easy to leave things in the vague, and later wake up when competitors bring their products.

    Up to now only the German Federal Patent Court revoked the German part of the 568’ patent for lack of inventive step. It is interesting to note that according to this decision, the use of folic acid seems to have a much greater influence than that of B12 on the toxicity of folates, but that once he added folic acid, the addition of vitamin B12 appeared straightforward.

    One can think that Eli Lilly wanted to have a quick patent of the combination pemetrexed disodium + vitamin B12, as it only had experimental data on this and not for any other salt. The addition of folic acid was in claims 2 and 3.

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