AT – Eli Lilly PI / Appeal

Posted: April 27th, 2018

Austrian Court of Appeals confirms PI based on equivalent infringement of Eli Lilly’s Alimta®-Patent

In a decision of April 12th 2018, the Vienna Court of Appeals rejected an appeal against a preliminary injunction previously granted by the Vienna Commercial Court. The Court of Appeals confirmed that the offer or sale of a generic Pemetrexed product , which lists “Pemetrexed as Pemeterexeddiacid” as active ingredient, infringes the Austrian part of Eli Lilly’s patent EP 1 31 508 B1 (the Patent).

Claim 1 of the 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 (or a pharmaceutical derivative thereof) for inhibiting tumor growth. In finding infringement by equivalence, the Court of Appeals applied the three-prong Bicalutamid-test, which is the standard for equivalent infringement under Austrian case law and directly corresponds to the German Schneidmesser-test. The outcome of the decision corresponds to recent Supreme Court decisions in the UK and Switzerland, equally finding for infringement of pemetrexed salt or acid variants under their respective national tests in line with Art. 69 EPC.

The Austrian Court of Appeals confirmed the first instance decision on all substantive points. The preliminary injunction was granted conditional upon a security deposit by the plaintiff. Moreover, this case may still be subject to further developments, as the decision stems from preliminary proceedings and will need to be confirmed in subsequent main proceedings. In addition, the decision may still be overturned by way of an extraordinary appeal to the Austrian Supreme Court, although the option for an ordinary appeal was denied, as the Court of Appeals found no questions unanswered by existing case law. The threshold for extraordinary appeals to the Supreme Court is high, as it must be shown that the decision depends on a legal question of material importance beyond the particular case at hand, for example because the Court of Appeals deviates from the case law of the Supreme Court or if such case law of is absent or inconsistent. Issues of equivalent patent infringement are rarely picked up by the Supreme Court, as they regularly hinge upon technical/chemical questions specific to a particular case.

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

Headnote: Dominik Göbel and Manuel Wegrostek, Gassauer-Fleissner Rechtsanwälte

One Response

  1. Attentive observer says:

    As stated, the present AT decision about a PI is in line with other decisions in UK and Switzerland, but in Italy the decision went the other way. I am sure the matter is not yet settled in other jurisdictions.

    In AT the decision is just about a PI, not in substance. And things can still change, hence the necessity for the plaintiff to file a deposit of 850 000 €.

    When reading the present decision, I recalled what I read recently about a SPC which is disputed between Teva and Gilead, reference (Case C-121/17), and AG Wathelet position in this case.

    According to AG Wathelet, “a product is protected by a patent … if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and precisely identifiable in the wording of the claims of the basic patent”. I can only support this point of view. The present decision also goes back to the priority.

    When looking at the EP file in the register, it is clear that at the priority date, Lilly had never dreamed about anything than pemetrexed disodium. What was said in the introductory part of the description was pure speculation, and the examiner should have insisted that this speculative part should have been deleted.

    In any case the introductory part of the description talks about plenty of other things, but certainly not about the use of any other anion than disodium. It would have been easy to overcome the objection under Art 123(2) EPC, which lead to the limitation to pemetrexed disodium, by presenting experimental data showing that other anions could also be used. Then the claim as filed in reply to the first communication, pemetrexed in general, would have been allowable. it was, in my opinion not plausible that other salts could be used.

    In this respect I am challenging Lord Neuberger’s decision, as well as the present one.

    In view of the clear position of AG Wathelet, Lord Neuberger would not have been able to come up with his new equivalent theory, and he should have refrained to blame the examiner to limit the claim to disodium, as in view of the Guidelines and the case law of the BA, the examiner had no choice.

    The discussion is certainly not yet finished. What is nevertheless difficult to understand, is to apply the protocol on Art 69 when it talks about equivalents, whilst equivalents are not defined in it. During the Diplomatic conference of 2000, no agreement was reached on the definition of equivalents, but there was a proposal on the table.

    It is difficult to accept that shoddy drafting is rewarded later, by extending the scope of protection to any anion, when the proprietor did not even bothered to defend a broader claim during examination.

Leave a Reply