It Ain’t Over ’til It’s Over

Case No. O2017_019 ¦ Decision of 21 December 2017 ¦ “Pemetrexed: Abweisung der Feststellungsklage auf Nichtverletzung (Rückweisung O2015_004)”

Note that Hepp Wenger Ryffel is involved in this matter on behalf of the plaintiff.
Lenny Kravitz; (c) Gage Skidmore, CC BY-SA 3.0
“It Ain’t Over ’til It’s Over” (Lenny Kravitz; © Gage Skidmore, CC BY-SA 3.0 license)

Pemetrexed revisited, once again:

As reported earlier on this Blog here, the Supreme Court had remitted the case to the FPC with the order to dismiss the suit with respect to the requested declaratory judgment of non-infringement for the diacid, and to also assess the two other salts that had initially been at stake in first instance proceedings.

Well, the first part is a no-brainer. The FPC is bound to the legal assessment of the Supreme Court, and it thus dismissed the suit with respect to the diacid.

As to the two other salts, i.e. pemetrexed dipotassium and pemetrexed ditromethamine, the FPC briefly assessed infringement under the doctrine of equivalents.

The first question to be answered in the assessment of infringement under the DoE is whether the replaced feature and the replacing feature have the same objective function. The decision holds that it is only the cation that is different, and that the dianion is the same in any event. Further, it is held that both the dipotassium and the ditromethamine salt will be dissociated under physiological conditions, and everything suggests that the mode of action is determined by the dianion.

Pemetrexeddikalium unterscheidet sich von Pemetrexeddinatrium bzw. Pemetrexeddisäure lediglich durch das Kation. Das Dianion ist in allen Fällen identisch. Pemetrexeddikalium liegt bei physiologischem pH dissoziiert in Kation und Dianion vor. Es spricht alles dafür, dass die Wirkungsweise durch das Pemetrexed-Dianion gegeben ist.

Aus diesen Gründen ist eine Gleichwirkung für Pemetrexeddikalium gegeben ist.

One may like or dislike the outcome as it is. Be this as it may. What is troubling me is that this reasoning is only focused on the mode of action of the dianion. Note that the dianion neither is the replaced feature nor the replacing feature. Does this reasoning actually address the first question of the FPC’s questionnaire for the assessment under the DoE at all?

Does the replacing feature objectively fulfil the same function? (‘Gleichwirkung’)

Is there a need to rephrase the first question? Time will show, I guess.

The FPC answered the second and third question in the affirmative, too. It did so by mere reference to the considerations of the Supreme Court.

In sum, all three pemetrexed forms (diacid, dipotassium and ditromethamine) are held to infringe the patent in suit.

Reported by Martin WILMING


Case No. O2017_019 ¦ Decision of 21 December 2017 ¦ “Pemetrexed: Abweisung der Feststellungsklage auf Nichtverletzung (Rückweisung O2015_004)”

Actavis Switzerland AG


(1) Eli Lilly and Company
(2) Eli Lilly (Suisse) SA

Composition of the Board of the FPC:

  • Dr. Dieter BRÄNDLE
  • Dr. Roland DUX


  • Dr. Roland DUX

Court Clerk:


Representative(s) of Plaintiff:

Representative(s) of Defendant:


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