Posted: June 26th, 2020
On 1 May 2020, the Swiss Federal Supreme Court fully rejected Sandoz’ appeal against the decision of the Swiss Federal Patent Court (FPC) in Eli Lilly vs. Sandoz Pharmaceuticals (dated October 15, 2019) holding that the Swiss part of Eli Lilly’s patent EP 1 313 508 B1 regarding the use of the anti-cancer drug pemetrexed in combination with a vitamin B12 is valid.
This Swiss decision is the first final court decision on validity concerning Eli Lilly’s patent EP 1 313 508 B1 in a number of actions still ongoing in Europe.
The issues decided on focused on the disclosure of chapter 8 (Shih) of an anthology (Antifolate Drugs in Cancer Therapy, ed. Ann. L. Jackman, 1999) (and in particular the passage on p. 191 compared to the immediately following figure 4), and the combination of the disclosures of chapter 8 and chapter 12 (Mendelsohn).
With regard to an administration of pemetrexed in combination with folic acid based on the disclosure of chapter 8 the Court found that the FPC did not misinterpret Shih. Instead the Court acknowledged that the FPC rightly identified contradicting recommendations with regard to the efficacy of a pemetrexed-folic acid combination in chapter 8 and upon consideration of two further documents found further evidence for a negative effect of a folic acid administration.
In particular, the Court rejected the appellant’s argument that the skilled person would not have found a contradiction between the passage on p. 191 and figure 4 on p.192. The Court further disagreed with appellant’s argument that both the layman and the skilled person would conclude from figure 4 that the administration of extremely small doses of pemetrexed without folic acid should lead to fatalities. In addition, the Court found that the folic acid has clearly an effect on both efficacy and mortality and thus cannot simply be ignored as suggested by appellant.
The Court agreed with the FPC’s conclusion that based on Shih, and in particular figure 4, the skilled person had no motivation to administer folic acid as he would have been forced to massively increase the pemetrexed dosage in order to obtain a 100% inhibition – i.e. the same 100% inhibition that could have been achieved with a much lower dosage but without folic acid.
With regard to an administration of pemetrexed in combination with vitamin B12 (with or without folic acid) based on both chapters 8 and 12, the Court confirmed that being part of the same anthology is not sufficient to suggest a combination of the two disclosures. Neither is the fact that there are some structural similarities between pemetrexed and the antifolates discussed in chapter 12 as it is difficult to predict a pharmaceutical effect based on chemical structures. Thus, the Court rejected appellant’s argument as not sufficiently convincing to disprove the FPC’s reasoning that the skilled person had no motivation to combine the two chapters.
Reported by: Christian Hilti, Demian Stauber and Andrea Carreira, RENTSCH PARTNER