IT – Eli Lilly / Alimta® – decision overturned

Posted: November 1st, 2018

Court of Milan overturns first instance decision on appeal (“reclamo”) and orders a preliminary injunction based on equivalent infringement of Eli Lilly’s Alimta® patent

In a decision of 15th October 2018 in urgent proceedings, the Court of Milan’s appeal panel (comprised of President and Judge rapporteur, Mr Claudio Marangoni and Judges Anna Bellesi and Alima Zana) overturned the first instance decision (reported here on EPLAW on 3 October 2017) in its entirety and refused to grant Fresenius Kabi’s a declaration of non-infringement. The Court found that Kabi’s generic pemetrexed product infringed Lilly’s patent by equivalence and ordered a preliminary injunction preventing its manufacture or supply in Italy.

Claim 1 of Lilly’s patent, covering Eli Lilly’s product Alimta®, is worded as a Swiss-type claim and refers to the use of pemetrexed disodium in a combination therapy together with vitamin B12 for inhibiting tumor growth. Kabi’s product is pemetrexed diacid in combination with tromethamine.

The Court dealt first with the relevance of prosecution file history when construing patent claims. They held that the role of the file history is secondary to the wording of the claims which the description and drawings can be used to interpret.

Lilly had amended as a result of an objection by the EPO examiner, under Art 123(2) EPC on added matter, from “pemetrexed” to “pemetrexed disodium”. The Italian Court held that the examination of the file history, if relevant at all, is substantially limited to the aspects of novelty and/or inventive step. An amendment introduced due to added matter cannot materially affect the application of the doctrine of equivalents since such objection only concerns formal issues regarding the literal wording of the amended claims, as compared to the patent application as filed.

On the facts, the Court held that the amendments made by Lilly did not restrict the interpretation of the patent’s scope of protection in such a manner as to exclude compounds that are equivalent to pemetrexed disodium.

The Court then agreed with the independent panel of experts that the skilled person would treat the disodium as a non-essential part of the invention since the invention was aimed at solving the clinical issue of toxicity by administering vitamin B12 with the pemetrexed anion. The skilled person would understand that the active moiety is the pemetrexed anion and the counterion has no therapeutic or toxic effect.

The Court agreed that it would therefore have been obvious to the skilled person to replace pemetrexed disodium with pemetrexed diacid (with tromethamine as in Kabi’s product) and that Fresenius Kabi’s products infringed Lilly’s patent by equivalence.

The decision brings Italy back into line with the UK, Germany, the Netherlands, Switzerland, Austria, Sweden, Denmark and Finland where the courts have all, to date, found that pemetrexed salt or acid variants infringe Lilly’s patent under their respective national tests in line with Art. 69 EPC.

The decision (in Italian) can be read here.
An informal translation of the decision in English can be read here.

Headnote: Daniel Brook and Emma Fulton (Hogan Lovells International LLP), Giovanni Ghirardi, Riccardo Fruscalzo and Giovanni Trabucco (Hogan Lovells Studio Legale Milano), who assisted Lilly during the PI proceedings in Italy together with Dr. Cristina Freyria Fava (Buzzi, Notaro & Antonielli d’Oulx) as Lilly’s technical expert.

One Response

  1. Attentive Observer says:

    It would have been a surprise if the Court of Milan’s appeal panel would not have followed the other courts throughout Europe.

    It still remains a matter of fact that the objection under Art 123(2) was fully justified (contrary to what was said by the UK Supreme Court). The examiner had no choice but to raise the objection as the only examples related exclusively to pemetrexed disodium.

    It is interesting to note that the Court of Milan’s appeal panel considers an objection under Art 123(2) as mere “formal issues regarding the literal wording of the amended claims”. All those applicants/proprietors having seen their application refused or their patent revoked under Art 123(2) would certainly like to see the BA of the EPO adopt such an attitude. But this will probably never happen.

    At filing/priority date it was by no way made plausible that any antifolate, and even any other pemetrexed ion would work. The mere listing of a lot of antifolates which could potentially be associated with Vitamin B 12 cannot equated with the technical teaching that their toxicity would be lowered when associated with said Vitamin B 12. The only example given was pemetrexed disodium.

    When reading the original description, I would like to understand from which elements it is possible to draw the conclusion that the “skilled person would understand that the active moiety is the pemetrexed anion and the counterion has no therapeutic or toxic effect”. If this would have been the case, then indeed the applicant would have been entitled to a broad protection. The applicant was only interested in a quick grant, and did not even try to explain what now seems obvious to all specialists.

    The original description contained lots of speculation, but no facts which would have made possible not to limit the claim to pemetrexed disodium, but to obtain a claim relating to pemetrexed in general, or even to any antifolate.

    When required to adapt the specification, the applicant has only deleted the passages on p 4, l 1-9 and p6, l 11-16. In the amended description, on page 2 the applicant insisted upon the difference between “that to which the patent relates” and “the subject-matter provided by the claims”.

    There was nothing in the description supporting the view that the reduction of toxicity was valid for any antifolate when combined with Vitamin B 12. As said, the only ever disclosed example of antifolate was pemetrexed disodium.

    Whilst the examiner did not give in and maintained its objection under Art 123(2), he gave in when it came to adapt the description.

    It this this trick that allowed the proprietor to reinvent his patent once he realised later that the claims were too limited.

    I have no share in any of the companies involved in the litigation, but in my humble opinion, all the decisions in favour of Ely Lilly are fundamentally flawed. They allow the proprietor to claim something he never invented, or at least never brought to light in his original application.

    This is the more so when looking at the fact that the Protocol on Interpretation as amended by EPC 2000 has an Art 2 relating to equivalents, but without defining what equivalents could be, as EPO’s proposal on this point was dismissed.

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