Lilly’s EP 1 313 508 on combination of pemetrexed and vitamin B12 held valid

Case No. O2018_003 | Decision of 15 October 2019 | “Patentnichtigkeit; Pemetrexed”

The patent in suit is Lilly‘s EP 1 313 508 B1; see the EPO Register and Swissreg for further details. In a nutshell, EP’508 relates to combination of pemetrexed disodium and vitamin B12. See this Blog here for a discussion about earlier infringement proceedings concerning the same patent.

Now, nullity is at stake.

An Opposition Division of the EPO had maintained the patent as granted with decision of 27 December 2010; an appeal had initially been lodged but withdrawn later. Related decisions in civil proceedings elsewhere had also addressed the validity of EP’508, e.g. in

Thus, it was an uphill fight for the plaintiff. And even though the FPC took the parallel decision of the German FPC into account, it explicitly disagreed. It is held on p 19 (penultimate and lastparagraph), that the German FPC erred with the finding that

[…] bei einer Pemetrexedgabe durch die Blockierung der drei Schlüsselenzyme Thymidylatsynthase (= TS), Dihydrofolatreduktase (= DHFR) und Glycinamidribonukleotidformyltransferase (= GARFT) im «DNA- Zyklus» nicht nur dieser Zyklus, sondern auch der «Methylierungszyklus» blockiert wird.

Consequently, the FPC did not put much weight (if any) on the parallel decision in Germany.

On the contrary, the decision holds that the claimed subject-matter was novel over Worzalla et al. since mere reference to a diet ‘Purina Chow #5001’ did not implicitly, yet clearly and unambiguously, disclose the presence of vitamin B12 (or folic acid).

Further, the decision rejects plaintiff’s argument re obviousness over Niyikiza et al. (abstract 609P bridging pages 126/127), Niyikiza et al. (abstract 2139 on the top right, referred to as act. 7_10 in the decision), the IBIS Guide to Drug-Herb and Drug Nutrient Interactions, Jackman and Calvert (which had been considered as closest prior art in EPO opposition proceedings).

The decision has been appealed to the Supreme Court.

A discussion of this decision is also available on the EPLAW Blog, provided by defendant’s counsel.

UPDATE 18 June 2020:

The Supreme Court has dismissed Sandoz’s appeal with decision of 1 May 2020 (published 17 June 2020); the full judgment is available here.

The operative part of the judgment has been published earlier by Lilly’s counsel on EPLaw Blog; available here.

Reported by Martin WILMING


Case No. O2018_003 | Decision of 15 October 2019 | “Patentnichtigkeit; Pemetrexed”

Sandoz Pharmaceuticals AG


Eli Lilly & Company

Panel of Judges:

    • Dr. Daniel ALDER
      • Dr. Roland DUX
      • Marco ZARDI

Court Clerk:

    •  Susanne ANDERHALDEN

Representative(s) of Plaintiff:

    • Dr. Markus WANG (Bär & Karrer)
    • Christoph FRAEFEL (SBMP), assisting in patent matters

Representative(s) of Defendant:


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Non-official English translation (first published on the EPLAW Blog):

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